on doing your heart a fovor · a 'complaint department' for medical devices ... india and...

On Doing Your Heart A Fovor

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V O L . 2 1 N O . 2 M A R C H 1 9 8 7

Incon t i nence Comes Ou t o f t he C lose tAn estimated 12 million Americans suffer from an inability tocontrol their bladders, most of them too embarrassed to seekhelp. That's changing now, as sufferers learn that incontinencecan be treated and, often, even cured.

A 'Complaint Department' for Medical DevicesMonitoring the performance of thousands of medical devicesused by hospitals, clinics and doctors' offices is no easy task forFDA, but a computerized "complaint department" is helping.

Help for Slow-Growing ChildrenFor children who are lagging on the growth chart, injectionsof growth hormone may help them reach normal height. A newsynthetic version is making this hormone more widely available,but parents shouldn't think it's Junior's ticket to basketballs t a rdom.

Dining Out with a Healthy AppetiteA survey by the restaurant industry finds that Americans aretaking their appetite for healthful fare with them when they dineaway from home. And restaurants are catering to that desire.

Protecting Tots from Drug PoisoningsChild-resistant packaging for prescription drugs is no guaranteethat young children will be protected from their own curiosity,according to a government study.'The Piir May Not Mix Well with Other DrugsWomen on oral contraceptives may find that other drugs they'retaking can make The Pill less effective. Likewise, The Pill canincrease or decrease the potency of other drugs. Discussingthese potential interactions with a doctor is the best bet.

Planning a Diet for a Healthy HeartTo reduce the risk of heart attack and heart disease, expertsadvise a diet with less cholesterol and fat—especially saturatedfat. Here are some tips for a menu that will make your healthyheart smile.

Updates

T h e N o t e b o o k

Investigators' Reports

S u m m a r i e s o f C o u r t A c t i o n s

Otis R. Bowen, M.D.

Secretary, U.S. Department ofH e a l t h a n d H u m a n S e r v i c e s

Frank E. Young, M.D.Commissioner of Food and Drugs

John A. Norr is , J .D. , M.B.A.Deputy Commissioner of Foodand Drugs

Jack W. Mar t i nA s s o c i a t e C o m m i s s i o n e r f o r

P u b l i c A f f a i r s

W i l l i a m M . R a d o s / E d i t o r

Jesse R. Nichols/Art Director

Cover Design: Zeb Rogerson

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Inside Front Cover Photo

An implantable artificial urinary sphincter—developed by F. Brantley Scott, M.D.,of Houston—is used for sphincterweakness if other incontinence treatments have failed, A surgeon implantsthe fluid-filled cuff (upper right)a r o u n d t h e b l a d d e r ' ' n e c k ' ' a n d t h e

pump (bottom) in the male's scrotumor the female's labium majus—theouter fold of skin of the genitalorgans. Fluid pressure in the cuff prevents urination. When the patientsqueezes the pump several times, thefluid moves to the balloon (upperleft), and the loosened cuff allows urination, Automatical ly, the bal loongently forces the fluid back to thecuff. More about incontinence beginson page 4,(Photo courtesy of American MedicalSystems, Inc,, Minnetonka, Minn,)

FDA Consumer / March 1987 / 1

New Drug Against Leprosy

FDA has approved a drug to treat a form of leprosythat has grown increasingly resistant to other treatm e n t s .

The drug, clofazimine, has been available for over10 years in other countries and since 1966 as an investigational drug in this country for the approximately6,000 U.S. patients with lepromatous leprosy. But because of the relatively small number of U.S. patients—compared to 12 million cases of leprosy in other partsof the world—and successful treatment with otherdrugs, there had been little incentive to winclofazimine's approval in the United States.

However, lepromatous leprosy's resistance to otherdrugs continues to increase. To encourage a manufacturer to distribute clofazimine in this country, FDAdesignated it an "orphan" drug, thus providing incentives to develop, study and manufacture an otherwiseunprofitable therapy.

Clofazimine inhibits the growth of the bacteria thatcause leprosy, also called Hansen's disease, and isusually given with one or more other anti-leprosydrugs. In addition to clearing unsightly lesions, the drugmakes the disease less contagious so that patients cancirculate freely and function in society.

With prolonged use, clofazimine commonly causesa red to brownish-black discoloration of the skin. Thisdiscoloration will disappear if treatment is discontinued,but only after several months or years. A few patientsdevelop severe gastrointestinal problems while takingc l o f a z i m i n e .

Lepromatous leprosy is characterized by skin lesionsthat enlarge and spread, and by nerve involvementthat may cause loss of sensation and paralysis. Thedisease also can cause severe deformities and candamage the eyes, kidneys, testes and membranes ofthe mouth, nose and throat.

In the United States, leprosy occurs in the coastalareas of California, Florida, Hawaii, Puerto Rico,Texas and Louis iana.

Clofazimine will be marketed in capsule form underthe trade name Lamprene by Ciba-Geigy of Summit,N . J .

Reuse of Kidney Dialysis Equipment

FDA has denied a petition by six U.S. senators thatasked the agency to regulate the reuse of disposablekidney dialysis devices. The petition stemmed from the

senators' concern that the growing practice of reuseto save money might be hazardous.

The Senate Special Committee on Aging held hearings in March 1986 on reuse of the disposable equipment used to cleanse kidney patients' blood. Thepetition, filed in May 1986 by committee chairmanSen. John Heinz, R-Pa., and five other committeemembers, requested FDA to apply its Good Manufacturing Practices (GMP) authority to medical facilitiesthat reprocess dialysis components for reuse. It alsocalled for studies to determine if reuse was a safe pract ice.

In the denial, FDA Commissioner Frank E. Young,M.D., Ph.D., ruled that applying GMP regulationsto the nation's 1,400 dialysis clinics would constituteregulating medical practice, an area over which FDAdoes not have authority. Young noted that GMPs aredesigned to ensure quality control in manufacturing andare not intended to apply to how devices are used inmedica l fac i l i t ies .

Young said that other federal agencies are takingsteps to ensure safe reuse practices. For example, thePublic Health Service has developed guidelines forproper reuse and reprocessing. These guidelines essentially endorse others issued in October 1986 by theAssociation for the Advancement of Medical Instrumentation (AAMI), a private sector, standard-settingorganization. The association's guidelines were developed with input from FDA, the federal Centers forDisease Control, experts in hemodialysis, kidney patient groups, and dialysis equipment manufacturers.

Young added that the best way to ensure safe reuseis for the Health Care Financing Administration toadopt the PHS guidelines as part of its conditions forreimbursement under the Medicare End-Stage RenalDisease Program.

Reuse of dialysis equipment does not appear to beless safe than single use, although ways are neededto ensure that reprocessing and reuse are performedproperly. FDA is urging manufacturers of hemo-dialyzers and blood tubing to revise their product labeling to include specific instructions for reuse.

Low-Dose Rabies Vaccine

FDA has licensed a new low-dose rabies vaccineto protect people who are at high risk of exposure tothe deadly disease.

Like the standard rabies vaccine, which has beenin use since 1980, the new vaccine is made from rabies

2 / March 1987 / FDA Consumer

viruses grown in cultured human cells. But becauseit is one-tenth the currently used one-milliliter dose,the vaccine will be much less expensive.

The lower cost may encourage wider use by peoplevisiting or camping in areas where there are many rabidanimals. Also, it may be used to protect people traveling abroad to areas where rabies is endemic, such asparts of Africa, India and Latin America.

Both the new form, which is only for pre-exposureuse, and the standard vaccine—which is effectivebefore or after exposure—are injected in three dosesover three to four weeks for pre-exposure protection.Booster shots are given about every two years. Forpost-exposure treatment, five injections of the standardvaccine in the upper arm should begin within five daysof exposure.

U.S. studies demonstrated adequate immunity in100 percent of those receiving the new low-dose vacc i n e .

The new vaccine is manufactured by Institute Mer-ieux of Lyon, France, and it will be distributed in thiscountry by Merieux Institute Inc. of Miami, Fla.

Rabies in wild animals, including raccoons, skunksand bats, has been an increasing problem in parts ofthe United States in the past few years, notably in raccoons in the eastern United States.

Thousands of people receive rabies vaccinationseach year, although usually it is after, not before, beingbitten or otherwise exposed to rabies.

At present, there is no known method for controllingwildlife rabies. The best means available for protectinghumans against exposure to the disease is to immunizepets, which might otherwise expose people. Thoseat high risk—veterinarians, wildlife conservation personnel staff of quarantine kennels, and laboratory andfield personnel working with rabies—should receivepre-exposure immunization. For more about rabies, see"Raccoon-Borne Rabies Spreads" in the September1983 FDA Consumer.

Rx for Recurring Breast Cancer

A newly approved use for an anti-breast cancer drugcan significantly delay recurrence of the disease, according to three studies conducted by physicians in theUnited States, Canada and Europe.

FDA has approved tamoxifen citrate (brand nameNolvadex) to be used alone to delay recurrences ofbreast cancer in certain groups of women after surgery

(total mastectomy and axillary, or armpit, dissection).It is the only treatment approved for post-menopausalwomen whose breast cancer has spread to the lymphnodes under the arm. Tamoxifen was originally approved in 1978 as a palliative (relieving symptomswithout curing) in patients suffering from advancedb r e a s t c a n c e r .

A nonsteroidal anti-estrogen, tamoxifen competeswith the female hormone estrogen—which promotes thegrowth of estrogen-dependent breast cancer cells-for the estrogen-binding site in the breast cancer cell.When tamoxifen instead of estrogen binds to the cancercell, DNA synthesis is blocked, and the cell can nolonger reproduce or grow.

Because patients have few side effects while takingtamoxifen, there is an increasing trend toward usingthe drug for long-term adjuvant (immediately followingsurgery) treatment, according to the manufacturer,Stuart Pharmaceuticals, Wilmington, Del.

For more information on breast cancer, its detection,and treatment, see "Progress Against Breast Cancer"in the May 1986 FDA Consumer.

C o r r e c t i o n : T B P h o t o s

In the article "TB: Curable, Preventable, but Stilla Killer" in the December 1986-January 1987 FDAConsumer, credit should have been given to the American Lung Association for the photographs of the Tru-deau cottage at Saranac Lake, N.Y., and the youngsterbeing given a tuberculin test, both on page 9.

Correction: Ordering NutritionP u b l i c a t i o n s

The article "A How-To Guide to a Balanced Diet"in the October 1986 FDA Consumer contained incorrectinformation on ordering certain nutrition publicationsfrom the government. It should have stated that copiesof the publication "Dietary Guidelines for Americans"are available free by writing to: Food and Drug Administration, HFE-88, 5600 Fishers Lane, Rockville,Md. 20857. A series of supplements to the "DietaryGuidelines" is available for $4.50 for the set of sevenby writing to: Superintendent of Documents, Government Printing Office, Washington, D.C. 20402. Request stock number 001-000-04467-2. Orders also canbe phoned in and charged to a VISA or MasterCardby calling (202) 783-3238.


Incontinence Conies Out of the Closetby Dixie Farley

T Jnless 9-year-old Linda is wakened for a trip to the bathroom several times a\J night, she wets the bed. She's afraid to go on sleep-overs" with friends, andtime after time she comes home with her sweater tied around her hips to hide thefact that she's wet her clothes.

Greg, a successful young businessman, quit his job right after being promoted.The new position involved travel and, on the road, he was required to share hotelrooms. But he couldn't face his co-workers' finding out about his incontinence. Gregsettled for a lower-paying job elsewhere.

Marion, age 72, dreads returning to her dentist. She wet the dental chair duringher last visit because her appointment took longer than she had anticipated.

* *

For Linda, Greg, Marion, and otherswho suffer from urinary incontinence,or the involuntary passing of urine,here's good news: Incontinence can betreated and often cured, even in theelderly.

The National Institute on Aging estimates that over 12 mil l ion Americansare incontinent. In nursing homes, morethan 50 percent of patients over 65 areso affected; in fact, incontinence is thesecond most common reason for institu

tionalizing older people. (Dementia,or mental deterioration, is the first.) Outside nursing homes, incontinenceafflicts about 17 percent of elderly menand 37 percent of elderly women. It'sparticularly troubling for older womenbecause they generally live longer thanm e n .

Incontinence is costly, in dollars andin psychological trauma. U.S. SurgeonGeneral C. Everett Koop has estimatedthat, in nursing homes alone, the annualcost of caring for incontinent peopleis nearly $8 billion. And though inconti

nence isn't life-threatening, the stigmaattached to clothes-wetting, bed-wetting,and the resultant odor can inflict profound consequences: humiliation,depression and social withdrawal. Evenin the lives of people with only mildleakage, incontinence can be a rulingf o r c e .

Sad to say, only one in 12 peoplewith incontinence seeks medical help—a fact perhaps due to embarrassment,isolation, or the mistaken notion that incontinence is normal with aging.

' ' Incontinence is no more a normal

part of aging than is chest pain or diabetes," said Dr. Neil Resnick, of theHarvard Medical School, at a nationalconference sponsored in 1986 by theFood and Drug Administration and thePublic Health Service CoordinatingCommit tee on Women's Heal th Issues.

Normally, the urinary system removeswaste products from the body in a well-coordinated fashion. Through nervepathways, the brain synchronizes theindividual housecleaning tasks that na

ture has assigned to different body parts:The two kidneys move wastes from theblood into the urine, tubes called ureters(one per kidney) channel the urine tothe sac-l ike muscle called the bladderfor storage, and then, as needed, twosphincter muscles open and close thebladder out let to control ur ine flow tothe outside via a tube known as theu r e t h r a .

But sometimes the system doesn'twork the way it's supposed to. As Harvard's Resnick put it: "Either thebladder contracts when it should not,leading to the patient's being wet, or itfails to contract when it should, so thaturine builds up and spills over Eitherthe outlet is open when it ought to beclosed or it is closed when it ought to beopen." Resnick added that such factorsgenerally associated with aging, such asillness, medicines, and the weakeningof the urinary system, can increase a person's r isk of incont inence.

Incontinence occurs when one of those

working parts is adversely affected—by an obstruction in the urethral tube,for instance, or by an abnormality inthe sphincter muscle, bladder muscle,or both. It may result from a conditionas common as chronic constipation,particularly if stool is impacted, or fromthe lack of nearby toilets, as may bethe case for some patients in institutions.It may develop after a hysterectomyor prostate, rectal, or lower intestinalsurgery. Obesity and childbirth alsocan contr ibute to incont inence. Othercauses include drug side effects, multiplesclerosis, cancer, spinal cord injury,diabetes mellitus, stroke, Parkinson's

F D A C o n s u m e r / M a r c h 1 9 8 7 / 5

Many retail stores now carry productsfor managing the problems of incontinence: Leakproof underpants, pantyliners, and odor-masking tablets, forinstance. Medical supply stores sell anumber of other aids intended for usewith a doctor^s advice. At left centeris a urine collection system for use atb e d s i d e . A l s o s h o w n a r e c o l l e c t i o ndevices for use away from home.

6 / M a r c h 1 9 8 7 / F D A C o n s u m e r

The good news about incontinence is that it can betreated and often cured.

or Alzheimer's disease, and birth defects—80 percent to 90 percent of children bom with spina bifida areincont inent .

When acute (relatively severe, butof short duration) incontinence occurs,it's generally the result of another acutemedical problem. For instance, a heartattack or some type of infection maycause a mental state called delirium, inwhich consciousness can become soclouded that the patient has difficultycontrolling the bladder. Persistent incontinence, on the other hand, is not associated with an acute medical problem; itoften worsens over time and can occurin different ways:• Stress incontinence. Minor physicalstress such as coughing, sneezing, laughing or lifting results in small amountsof urine leakage. This is common inolder women, but is usually not seenin men unless there has been sphincterdamage during surgery.• Overflow incontinence. The persondoesn't feel the urge to void or isn'table to urinate normal amounts ("normal" generally being 8 to 20 ounces), sothe bladder overfills and spills smallamounts of urine.• Urge incontinence. The person feelsa strong desire to urinate, but can't getto a toilet before the bladder empties.• Primary enuresis (EN-you-REE-sis). This is the term most commonlyused for bed-wetting in children beyondthe age (5 years) when they should becapable of bladder control and in adultswho never gained nighttime control.• Reflex incontinence. The bladderfills and empties without the person'shaving any mental control over it at all.

The key weapon in the psychologicaland physical battle to stay dry is: Tellyour physician about the incontinence,so that a correct diagnosis can be madeand treatment options can be discussed.Ask whether you should consult a specialist in treating incontinence (for children, for example, a urologist whospecializes in pediatric problems; foradults, a geriatrician, gynecologist orurologist). Early diagnosis and treatmentare important for many reasons, butthey can be life-saving when the incontinence is the first sign of a serious medical condition, such as a tumor. If helpisn't forthcoming, see another doctor.

To begin the medical investigation,the physician usually takes a patient'shistory and performs an examination.Urine and blood specimens are collected,and tests are performed—how manyand what type depend on the patient'ssymptoms and history.

Patients may be asked to undergoprocedures called "urodynamic" teststo help the physician pinpoint whetherthe problem lies in the urinary systemand, if so, where. They're done on anoutpatient basis. One such test measuresthe speed of urine flow from the bladderas the person urinates into a special toiletconnected to a machine. An obstruct ionwould cause the flow to be slower thannormal. Other procedures test the sphincter and bladder muscles, as follows:One end of a catheter (a small plastictube) is passed up the urethra to the bladder, and an electrode carried by thecatheter is attached to the sphincter.Then, electrical impulses coming fromthe sphincter muscles and pressurechanges within the bladder are recorded.

The physician evaluates the readingsto see whether the muscles are functioning normally.

Other types of tests may be orderedas well.

Physicians treat incontinence by treating its underlying cause. Treatmentsi n c l u d e :• Battery-operated alarm. Used forbed-wetting, the alarm is triggered bythe wetting. Initially, for children, itmay be necessary for someone in thehousehold to respond to the alarm andwaken the patient. Once patients becomeconscious of the alarm, they shouldwaken on their own when it rings. Eventually, the patients are supposed to become so used to waking when wettingoccurs that they start waking beforehand.• Scheduled voiding regimens. Forurge incontinence, patients may be askedto wait longer before urinating,gradually increasing the "waitingperiod," or to urinate only at assignedintervals. Mentally impaired patientsmay be prompted to stay dry by simplybeing asked if they need to urinate and,if so, helped to the toilet. What worksfor one incontinence problem may notwork for another, so it's best to get medical advice before beginning a regimen.And, generally, women shouldn't put offurinating, as that can promote bladderi n f e c t i o n s .• ^'KegeV^ exercises. In 1948 ArnoldKegel, M.D., who was practicing inLos Angeles at that time, introduced exercises to strengthen the pelvic floormuscles in women with stress incontinence and, so, to preserve or regainbladder control. It's possible to feelwhere these muscles are, at one end of


Some patients with urinary incontinence—due to cancer, for instance—may be candidates for a surgical procedure in which a portion ofthe smal l in test ine is used to make as u b s t i t u t e b l a d d e r. T h e r e s u l t a n t''Kock pouch, ''pictured here, isnamed for the procedure's developer.Nils Kock, M.D., of Sweden. Thesurgeon first removes the bladder anddetaches a segment of the small intestine to make the pouch and twovalves, one for each end of thepouch. Collars of synthetic materialare used to hold the valves in place.One end of the pouch is connected tothe ureters; the valve there allowsurine to flow freely from the kidneysinto the pouch, but prevents backward flow. The other end opens tothe outside through the abdomen;that valve prevents leakage and allowsthe patient to insert a catheter fordrainage, as needed. No external collecting device is required.

C o l l a r s

A b d o m e n

I n fl o w v a l v e

K o c k p o u c h

O u t fl o w v a l v e

(Based on a drawing by Patricia Kynes, R,N., in theNovember-December 1986 Journal of Enterostomal Therapy.)

Urinary System

M a l e F e m a l e

■kidneys

u r e t e r s

b l a d d e r

u r e t h r a

8 / M a r c h 1 9 8 7 / F D A C o n s u m e r

Incont inence is not a normal part of aging.

the pelvic floor, by interrupting the flowseveral times during urination and, atthe other end, by drawing in the musclearound the anus as if to stop a bowelmovement. The patient is supposed torepeat the exercises—interrupting eachurination and tightening the pelvic floormuscles from back to front—many timesthroughout the day.

Harvard's Resnick advises that al lwomen who aren't pregnant practiceKegel exercises to strengthen the pelvicfloor muscles, which, in turn, may helpward off incontinence later in life. But,he says, people usually need professionalinstruction to do them correctly.• Drugs. Estrogen therapy is prescribedfor women with estrogen deficiency.The condition can cause the tissue liningof the urethra to become inflamed, andthe irritated tissue can cause or worsen

urge incontinence. The antispasmodicdrug flavoxate is prescribed to treat incontinence associated with such conditions as cystitis (inflammation of thebladder). Flavoxate decreases musclespasms in the bladder. However, thelarge dosages that are often required canbe hazardous to other tissue, and thepatient may have to contend with undesirable side effects, such as dry mouth,constipation, and blurred vision.• Reevaluation of drug therapy. Incontinence may be due to drugs the personis taking for some other condition: Sedatives or tranquilizers may dull the sensesso much that the urge to urinate isn'tfelt; anticholinergics prescribed forbowel spasm can decrease the bladder'sability to contract; diuretics, often givento lower blood pressure, increase urine

production; and cold medicines may increase the bladder outlet's resistanceso that the bladder doesn't completelyempty. Upon reevaluation, the physicianmay find that a different drug will workwithout causing incontinence.• Surgical procedures. Even frail,elderly patients can easily tolerate anumber of newer corrective procedures,says Resnick. Deep abdominal surgeryis usually not required; rather, the surgeon works through the vagina or a tinyabdominal incision and uses an endo

scope (a narrow tube-like instrument inserted via the urethra or the incision)to see inside the bladder. This way, thesurgeon can relieve an obstruction, tieup pelvic floor tissues to return a saggingurethra or bladder to a normal position,or repair a constantly opening bladderoutlet so that it closes properly. The hospital stay is usually only a day or two;a younger person may be in and out ofthe hospital the same day. Other surgicaloptions may be to implant an artificialsphincter or to reconstruct the bladder.(See illustration.)

Sometimes the underlying cause ofthe incontinence can't be cured, butthe situation is still far from hopeless.There are many measures to help a person stay dry: more frequent trips to thetoilet, a portable commode for invalids,and self-catheterization (after properinstructions) to empty the bladder severaltimes a day. There are urine collectiondevices and disposable pads and pantsavailable from medical supply stores,certain drugstores, and home health-carecatalogs. One product may work betterthan another, so a person may want to

try several. Also, oral deodorant tabletscan be taken as an aid to reduce urinaryodor. The active ingredient, chlo-rophyllin copper complex, helps to maskthe odor.

Incontinence will probably never leadthe list of tea-time topics of conversation. But health professionals, publichealth officials, women's groups, themedia, makers of incontinence-relatedproducts, and others personally acquainted with the difficult problem areerasing the incontinence stigma. ActressJune Allyson, appearing in ads thatpromote disposable absorbent pants,unashamedly acknowledges that hermother became incontinent after a strokeand that they're dealing with it. By beingso frank, Allyson also promotes theidea that it's all right to talk about incontinence. Two support groups for incontinent patients were incorporated in 1983:HIP, or Help for Incontinent People, andThe Simon Foundation, whose founder-d i rec tor i s herse l f incont inent . The

groups offer information about suchtopics as recovery after prostate surgery,cleaning urine stains from clothing, incontinence-treatment products, and treatment options. To receive an informationpacket (there may be a charge), sendthe request and a stamped, self-ad-dressed, business-size envelope to:• HIP, P.O. Box 544, Union, S.C.29379 (phone 803-585-8789), or• The Simon Foundation, P.O. Box835, Wilmette, 111. 60091 (phone1-800-23SIMON). ■

Dixie Farley is a member of FDA's public affairs staff.


A 'Complaint Department' for Medical Devicesby Richard C. Thompson

4 4^ aby Dies in Crib" read the head-jD line on an advertisement in a

Phoenix, Ariz., newspaper. It was meantto attract attention, and it did. And thatattention brought on an investigation bythe Food and Drug Administration.

The ad was for infant apnea monitors,which are used in hospital nurseriesand sometimes at home for babies whose

breathing may suddenly stop. The ad—run by a Phoenix firm—implied that anybaby might stop breathing and that thefirm's monitor—a crib pad with crudesensors, costing $1,200—would preventthat from happening.

An FDA investigator assigned to thecase found that the "firm" was a figuresalon operator who wanted to samplethe market. If enough people responded,he would add these medical devices—which by law he was not permitted tosell—to his line of cosmetic and weight-reducing products. FDA and the Arizonastate's attorney were the first to answerthe ad, at which point the salon operatorlost interest.

The tip-off on the ad came from aPhoenix hospital whose staff recognizedthe illegality of the offer. They werefamiliar with FDA's system for reportingmedical device problems and knew thattheir complaint would get a response.

The salon operator was stopped beforehe could do any harm. But other complaints in the files of FDA's Device Experience Network (DEN) show incidentsthat range from the merely inconvenientto the severely hazardous. Each hada potential for harm.

For example:• An observant Seatt le nurse noticed

leaks at closures on a tubing set usedin blood transfusions, which could leadto infection and possible clotting. Shereported this to DEN, and FDA contacted the firm, which immediately redesigned the units to solve the problemand replaced those in use.

• An Alabama clinic reported thata plastic tent used over the beds of children with respiratory problems carriedcharges of static electricity. This couldbe hazardous if flammable aerosols were

being used. Again, FDA contacted thefirm, which began working on the problem. First, it tried running a conductorcable from tent to bed, then realizeda child could move the cable, and insteadmade a ground strap part of the tenti t se l f .

• An Indiana hospital discoveredthat an alarm on an air/oxygen mixersometimes failed to sound if the oxygenline accidentally closed. Patients dependent on that extra oxygen would be inserious trouble, as had happened withone patient with a heart condition. Theproblem was found to be a design defect,which the manufacturer corrected, replacing all such units that were in usethroughout the country.

Until 11 years ago, incidents suchas these would probably not have beenreported to FDA and, even if they hadbeen, there would have been little FDAcould do. Lacking legal authority, theagency had few enforceable ways ofmonitoring the medical device industryor its products. In fact, with some exceptions, manufacturers were not even required to inform FDA when their devicescaused injury or death or were foundto be potentially hazardous.

Much of that changed in 1976, whenCongress passed the Medical DeviceAmendments to FDA 's bas ic law—theFederal Food, Drug, and Cosmetic Act.These amendments gave the agencythe authority it needed to ensure thesafety and effectiveness of thousandsof devices.

That authority was strengthened evenmore when FDA issued final regulationsin 1984 requiring manufacturers andimporters of medical devices to notifyFDA by telephone of hazards with their

products. They must alert the agencywithin five days of any death or seriousinjury related to their devices, and theymust confirm that report in writingwithin 15 days.

Problems and mal funct ions in whichdeath or injury did not occur, but whichmight happen again with more seriousconsequences must be reported to FDAin writing within 15 days after the firmlearns of them. Also, firms must nowaccept reports they receive from healthcare professionals such as nurses, physicians, pharmacists, laboratory staff andothers as "reasonable evidence" thata problem may exist with their devicesand that the problem must be reportedt o F D A .

In 1973, FDA set up a reporting system to provide the agency with information from health professionals aboutmedical device problems. But that system was only voluntary; the device firmswere under no obligation to alert FDAto hazards with their products.

Today's system—operated by theCenter for Devices and RadiologicalHealth—is FDA's way of keeping aneye on the device industry and its products . I t ident ifies ind iv idua l medica ldevices that are or could be hazardousor simply ineffective. It also is a mechanism for identifying recurring problems,design deficiencies, and device-uset rends .

One particular goal of DEN is to accumulate a data base—a dependablebody of knowledge—so that FDA candirect its resources and assign prioritiesto the parts of the industry and the kindsof devices that are most in need of regu l a t i o n .

DEN collects data on all problemsassociated with medical devices, medicallaboratory products, and radiologicalhealth products. This means some100,000 different items, ranging fromheart-lung machines and intricate body


This hright-eyecl hcihy recovering from ahdominai surgery is siirroiiiuled hy hightech mediccd devices, including electronic sensors and displays that monitor andinterpret every body function and activity. But there are also the not-so-high-techdevices: a respirator hose, drainage tubes and bottles, an intravenous hookup, andeven the bandages and adhesive tape.


Failed or faulty medical devices from FDA files

Although the control handle at lowerright would turn and seem to function,the valves inside this anesthesia machine were locked in the open position,allowing the wrong gasses in the wrongcombinations to reach the patient. Atleast two died. Al l machines in usewere seized by FDA, and the manufacturer faces criminal charges.

This X-ray of a failed hip replacementshows a complete fracture of the femoral stem, probably caused by metal fatigue after normal, sometimes strenuous, use. The pat ien t immobi l i zedand in pain and had to undergoanother operation. FDA is raising theperformance standard for such devicesto make them less likely to fail.

scanners to ordinary bandages andc r u t c h e s .

The kinds and scope of problemsbeing reported through DEN is intentionally all-inclusive. FDA decided in1973, when first developing the network,that health-care professionals who actually work with medical devices should beencouraged to report in their own wordsany problem they encountered or any observations they had about the device,including its function, its shape and design, the labeling, and instructions foruse. The system therefore results in agreat variety of reports, ranging fromfairly simple maintenance and usageproblems to incidents that could resultin death or injury.

A Texas surgeon, for example, toldDEN that handles on overhead operatingroom lights fell off during surgery, injuring members of the operating team andcontaminating the surgical field. FDAdiscussed the problem with the manufacturer, and the firm issued an urgentwarning, sending representatives withnew parts to correct the problem to hospitals and clinics using its equipment.

A Michigan nursing director complained to DEN that respirator tubingsometimes disconnected if patientsm o v e d a b o u t . F D A i n f o r m e d t h e m a n

ufacturer, and the firm recalled andredesigned the faulty assemblies.

A Pennsylvania hospital reported thatseveral new oxygen masks were closedoff at a hose entry point. The firm foundits own quality control to blame; themasks were replaced, and the firm thendistributed the defective ones to hospitalsas teaching aids in recognizing suchproblems.

DEN receives reports from manysources, but the principal conduit is theProblem Reporting Program (PRP) operated for FDA by the U.S. PharmacopeialConvention in Rockville, Md., just upthe street from EDA headquarters. USPis a nonprofit organization charteredin 1820 to set standards for drugs and

1 2 / M a r c h 1 9 8 7 / F D A C o n s u m e r

is recognized by the health professionsfor its overall competence in medicala r e a s .

There are 34 national health-care associations whose members—nurses, physicians, pharmacists and so forth—takepart in PRP. They include the AmericanMedical Association, the American Hospital Association, the American Collegeof Surgeons, the National League ofNursing, the American PharmaceuticalAssociation, and similar groups.

A member encountering a problemor making an observation about a medical device sends a report to the USP,which immediately forwards it to theFDA devices office and the device manufacturer. Those who feel the problemthey've discovered is urgent can callanytime, day or night, on a toll-free lineto USP. The importance of the USPconduit to FDA device survei l lance is

apparent. There are over 30,000 reportsin the PRP portion of the DEN file.

Device problem reports also comefrom the Veterans Admin is t ra t ion andthe Department of Defense and othergovernment agencies.

When a problem is reported, the information is entered in the DEN computersystem. This includes the device manufacturer, the name of the individualmaking the report, the device model andserial number, and a description of theproblem.

Each report is evaluated to determineif a hazard or violation of FDA regulations is involved. This means looking forreports of similar problems with thatmodel or lot number of the product. Thefirm's history of reported problems isalso reviewed for such things as qualitycontrol, sterility, and other manufacturing standards. Other sources of information, such as medical journals, canbe searched as well. The problem and allco l lected in format ion wi l l be rev iewed

by FDA's technical and scientific staff todetermine how serious it really is. Theappropriate FDA field office will be

asked to investigate the complaint.This generally involves a visit to the

device manufacturer and to the facilitythat submitted the report, to see firsthandwhat the problem is.

At the manufacturer, the FDA investigator discusses the problem with company officials and collects additionalinformation requested in the follow-upassignment. The investigator sends areport of the entire investigation backto the FDA devices office. In the report,the investigator may recommend obtaining a court injunction, seizing or recalling the product, prosecuting the firm,or similar act ion.

Medical device experts at FDA headquarters will determine if the manufacturer has corrected the problem or iffurther action is needed to protect thepublic. But regardless of how the problem is resolved or what regulatory actionis taken, the medical device staff willwant to determine exactly what causedthe problem in the first place. That finding too will be entered in the DEN file.

In fact, all information obtained inthe course of the review and investigation is entered as a cross-referencedrecord in the DEN data base. There arenow nearly 50,000 such problem reportsin the DEN files, most from voluntaryreporting by health professionals.

With the DEN files holding so muchdata, it's possible to analyze informationin a variety of ways, such as the kindsof products most likely to be recalled;the kind of problem most frequently reported with certain firms or certain products; or the number of problems a certainfirm has had with its product line.

The DEN system not only allowsFDA to identify patterns of problemswith firms and products, but also permitsthe agency to recognize and act quicklyon the fact that a just-reported problem issimilar to others reported earlier. Thisis DEN's more immediate public healthb e n e fi t .

Not all medical device problems are

due to manufacturing defects. For example, if FDA investigates a report andfinds that the problem is due to misuseof the product, it may mean that—whileno changes are required in the deviceitself—better labeling and instructionsmay be needed.

For example, eight nurses fromvarious hospitals reported over a periodof time that arterial catheters sometimesbroke or disconnected, with possiblyserious consequences to the patients.When the firm realized that the directions for use were badly written, allthe kits were recalled and the instructionsredone .

A New York hospital reported thatinstructions for administering intravenous fluid said to align a mark onthe bag with an arrow on a closure tape.But the tape had no arrow. The firmrecalled and destroyed the faulty tapes.

DEN provides FDA scientists withinformation useful in developing safetyand performance standards or reviewingrequests to market new products. It alsois a source of information used by FDAto issue warnings and advice on devicesafety, effectiveness and proper useto health-care professionals, hospitals,clinics, other users, and the deviceindustry itself.

Many times doctors and other healthprofessionals who have a problem with amedical device will figure a way to solvethe problem themselves, which takescare of their difficulty. But the defector malfunction may not be noticed bysomeone else using the device until it hasinjured a patient or the operator. SoFDA urges doctors, nurses and otherswho encounter a device problem to report it to FDA and the manufacturerso that patients and health professionalscan be spared the sometimes tragicconsequences. ■

Richard C. Thompson is a member ofFDA's public affairs staff.

F D A C o n s u m e r / M a r c h 1 9 8 7 / 1 3

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Help for Slow-Growing Childrenby Marta Vogel

6 C T guess it was my motherly instinct that told me somethingX was wrong," Chicago homemaker Mary Andrews says

of her son Deno's growth problem. "Up until Vh he grewnormally. But after that my sisters and in-laws would give mehand-me-downs [from their same-age children] and they wouldstil l fit him. I noticed that all the other kids were much taller."

When Deno was 4V2 and still not growing as fast as his playmates, his mother decided to see if the problem might be dueto some medical condi t ion.

The diagnosis on Deno was not encouraging. Doctors toldAndrews that her child had a deficiency of human growth hormone (hGH)—his pituitary gland did not release enough ofthe protein that made him grow. They predicted that he wouldnever reach more than 4 feet high.

"I was totally depressed," says Andrews of that diagnosis10 years ago. "I had never heard of anything like this." Atthe time, the treatment for Deno and thousands of othergrowth-deficient children in this country was thrice-weeklyinjections of human growth hormone (somatropin) taken fromthe pituitary (a small gland at the base of the brain) of cadavers. The yearly treatment for one child required hormonefrom 25 to 50 pituitary glands. Because of severely limitedand expensive supplies, children with hGH deficiency receivedthe hormone only until they had reached certain heights—5 feet 6 inches for boys and 5 feet 4 inches for girls.

Then, in April of 1985, three cases of an extremely rare,invariably fatal infection, Creutzfeldt-Jakob disease, werediagnosed in patients who had been using the hormone forfive to 12 years. Experts theorized that some batches of thecadaver-derived hormone had contained the virus that causesthe disease. (The virus is known to be harbored in the braintissues of diseased patients.) Since there was no way to guarantee that the virus would be totally removed during the purification process of growth hormone from pituitaries, distribution ofthe hormone was suspended.

But in October 1985, after three and a half years of clinicaltesting at 13 U.S. medical centers, the Food and Drug Administration approved a genetically engineered form of humangrowth hormone providing virtually limitless supplies to the10,000 to 15,000 American children in need of the growths t imu lan t .

"There is nothing but enthusiasm," says Denise Orenstein,executive director of the Human Growth Foundation, a Beth-esda, Md.-based nonprofit organization made up mainly of parents of children deficient in growth hormone. "This is thefirst time there has been an unlimited supply."

The biosynthetic hormone was developed by the San Francisco company Genentech. Marketed under the trade nameProtropin, it was only the second genetically engineered pharmaceutical, after insulin, to be approved in the United States.

(Genetic engineering, also known as recombinant DNAtechnology, is the process of introducing into a microorganismor other cell, DNA that contains genes for producing a specificprotein. The DNA is inserted into the "host" cell in such a

way that the cell treats it as its own, following the instructionscoded in the gene to make the desired protein, in this casehuman growth hormone.)

Just what causes hGH deficiency remains a mystery. Occasionally a tumor destroys the pituitary gland, or there is anabnormality of the chromosome that contains the gene forgrowth hormone. Environmental and nutritional influencesplay some kind of role; during protein deficiency and exercise,growth hormone production increases. Recent research indicates that the problem, in many cases, lies in a part of the braincalled the hypothalamus, which releases a substance knownas growth hormone-releasing factor. This substance stimulatesthe release of growth hormone from the pituitary gland.

How well the hypothalamus carries out its task may be affected by stress, brought on by a variety of conditions—nutritional deficiencies and psychological or physical disturbances,for example. This would explain why abused and poorly fedchildren sometimes stop growing, even though their pituitariesare producing—but not releasing—sufficient hGH.

Growth hormone deficiency should not be confused withdwarfism. (Achondroplasia, the most common type of dwarfism, is a hereditary disorder of bone formation. Theachondroplastic dwarf has a relatively large head, deformedvertebrae, and short extremities, in contrast to the well-proportioned but short body of the growth hormone deficient person.)

Diagnosis of growth hormone deficiency may be difficult.Because the hormone is produced in "spurts" by the pituitarygland, a normal blood test is unlikely to measure it accurately.The job of the diagnostician is to force the pituitary to releasea substantial amount at one time. Since growth hormone increases when the blood sugar level is low, blood is sometimesdrawn from children with a suspected deficiency after theyhave gone to sleep, after exercising, or after an injection ofcertain drugs. About 90 percent to 95 percent of the childrenwho show low levels of growth hormone after such stimulationwill benefit from hGH therapy.

According to Dr. Gilbert August, vice chairman of endocrinology and metabolism at Children's Hospital in Washington, D.C., the best candidates for hGH therapy are childrenwho show a "slowdown in the growth rate." Unlike normalchildren who grow about 2 inches a year between ages 3 and12, hGH-deficient children grow only an inch or an inch and aquarter a year.

"It's hard for the pediatrician to diagnose it because upto 2 [years of age], children are in constantly with all the shotsand their height is checked," notes Andrews, who is now active in the Chicago chapter of the Human Growth Foundation."But after that age, they [pediatricians] don't see the kidsas much. It's kind of up to the parent to spot it early enough."

Early enough means that children with hGH deficiencyshould be diagnosed before puberty, and the sooner, the better.HGH can be administered, says August, "as long as the

(Continued on page 17)


Does Your Child Need HumanGrowth Hormone?

The pituitary giand, at the base of the brain, reieases thehormone that controls growth. If not enough hormoneis released, growth is stunted.

In a society where tallness is valued—statistics show that executives and bank

presidents are taller than average, andtall women marry into a higher socialclass and tend to have higher payingjobs—it may be tempting for parentsto grasp at growth hormone as a social-climbing booster for their children.

Even though the American Academyof Pediatrics recently reviewed evidencethat supports a link between height andintelligence in children, it discouragedthe use of growth hormone to promotetaller and supposedly more intelligentchildren. The researchers suggest that intelligence scores "could be the consequence of years of height-basedexpectations of adults ... any effectof such growth-promoting therapies uponintellectual development or academicachievement must be considered un

likely."Nor is growth hormone recommended

for normal or slightly short childrenwhose parents may be overly ambitiousabout their offspring's athletic potential.The long-term physical and psychological effects of such use are unknown.

What is known is that the side effectsof taking hGH after puberty are significant and irreversible. Among them: muscle weakness, diabetes, and acromegaly—an abnormal enlargement ofthe hands, feet and face, resulting ina protmding forehead, a "lantern jaw,"broadened nose, and gapped teeth.

Nonetheless, parents should be onthe lookout for a child with true GrowthHormone Deficiency (GHD), whichis safely treatable if diagnosed early.Here's what to watch for:• Monitor your child's height andgrowth rate. Average expected growthis 6 to 8 inches during a child's firstyear, about 4 inches the second, 3 thethird, 2.8 in the fourth, then 2 to 2.5inches per year from ages 5 to 10. Morerapid growth begins at puberty, andusually ends at 16 to 18.• Most children with GHD appear normal at birth. GHD is usually not suspected until grade school or junior high

school, when the shortness becomesapparent.• If a child between 3 and 12 yearsgrows less than 2 inches per year, discuss it with your pediatrician. The doctormay suggest waiting to see if the child'sgrowth pattern changes.• A GHD child will be significantlyshorter than brothers or sisters at thesame age, with a chubby face and "babyfat ' ' around the waist. Such chi ldrenwill not outgrow shoes and clothing as

rapidly as other children of the samea g e .• Except for Alabama, state medicalprograms make hGH available to children who need it, and Medicaid doespay for the $8,000 to $14,000 a yearcosts. "Any child who needs it shouldbe able to get it," notes Dr. GilbertAugust of Children's Hospital in Washington, D.C. For more information,contact the Human Growth Foundation,4720 Montgomery Lane, Bethesda, Md.20814, (301) 656-7540. ■


(Continued from page 15)growth centers of the bone are still open, usually until aboutmid-puberty [about age 15]." However, he adds that "there isa limit to the amount of catch-up growth you can expect."

Patients receive injections three times a week until theyare at a bone age of 14 to 16. Children with growth hormonedeficiency often have a bone age that lags behind their chronological age. This allows for continued growth for a longertime. Deno, for example, now 15V2 and 5 feet 3 inches tall,will continue to receive the injections until the bone growthcenters (epiphyses) close, probably in another year and a half.By then, he is expected to reach 5 feet 6 inches.

There has been concern that administering the hormonemight produce the ill effects seen in people who naturally havetoo much of it—acromegaly (an abnormal enlargement of thehands, feet and face) and diabetes. But so far the only sideeffect of Protropin has been the production of antibodies to thebiosynthetic hormone in about 40 percent of the children whoparticipated in the clinical trials. At least one patient stoppedgrowing due to the antibodies, but resumed growth when givennatural hGH before its distribution was halted. Yet, for themost part, the antibodies do not appear to have an inhibitoryeffect on the hormone.

The antibody-producing side effect is "similar to insulin,"says August. "A certain percentage—over 50 percent—willdevelop antibodies with the old [animal-derived] insulin. Butwith the new [genetically engineered] human insulin, the number is very low."

An extra amino acid in the biosynthetic version of hGHmay be responsible for the antibody formation. So researchersare trying to produce an exact copy of the natural hormoneby removing the extra amino acid.

The record for first-year growth with the hormone is 7inches, but realistic expectations are 3 to 5 inches the firstyear, somewhat less the second year, and after that, a normalgrowth rate.

Physicians warn that often parents and children, enthusedby promises of height in a society that values it so highly,may expect far too much. In a study of 11 children who received hGH, Diane Rotnem, assistant professor of social workat The Yale Child Center in New Haven, Conn., found thatwhen children didn't grow as much as they had hoped, they became angry, pessimistic, guilty, and generally negative.

Deno has averaged 2 to 4 inches per year, but his motheradmits to impatience "if it looked like he wasn't growing" according to the wall marks at home that chart his progress.

Brian Stabler, associate professor of psychology at the University of North Carolina School of Medicine, reported in astudy of children getting hGH that 45 percent of the patientsand their parents overestimated the child's height in relation topeers, and nearly 80 percent had unrealistic expectations ofthe beneficial effects of hGH on the child.

"We are dealing with something that affects the body im

age," Stabler notes. "And there will be some families whowill hope and expect that changing the height will change everything else. Some are bound to be disappointed becauseits actual effect is very limited. All parents want their childrento be as handsome as possible. These things are perfectly understandable in the context of the society. The unreasonableness comes when they think that hGH will affect intelligence,physical attractiveness, athletics and social skills." Stablerurges counseling for the child and the parents. "If we workwith them, we should expect that they will have less psychological trauma," he says.

Psychologists stress the importance of a counseling programalong with the hormone injections to explain treatment limitations and realistic expectations.

"We meet regularly with the family," Stabler says. "Parents begin to think about terminal height and they need to thinkabout rate of growth. They tend to think in inches, and endocrinologists think in centimeters. We clarify their hopes andexpectations."

[Endocrinologists are specialists in the hormone-producingglands, such as the pituitary.]

Stabler is investigating how temperament might be a partof hGH deficiency. Past research has suggested that childrenwith hGH deficiency are more passive, shy and retiring.

Other research is examining whether biosynthetic growthhormone therapy is safe and effective treatment for Turner'ssyndrome, a chromosomal irregularity that may affect up to8,000 girls in the United States. Not only are these girls short,but they also may have other physical abnormalities, includingheart defects. Genentech plans to study the effects of hGHon 150 children with Turner's syndrome at six or seven medical centers, looking at both the physical and psychosocialeffects of the disease and its treatment.

With increased understanding of growth hormone, and withmore companies poised to spring into production, broaderapplications are in sight, particularly in the area of what iscalled "cosmetic endocrinology." Some researchers believethat the true function of growth hormone is not to stimulategrowth, but to conserve muscle tissue while reducing fat duringperiods of stress. Growth hormone apparently stimulates therelease of fat from cells and, during fasting, prevents the bodyfrom burning up muscle for fuel. So, hGH is being scrutinizedas a possible aid in weight reduction. In addition, since theproduction of hGH decreases with age, some researchers believe that it may eventually be used to retard wrinkling andthe fat distribution associated with aging. FDA has not approved hGH for either use because studies to prove its safetyand efficacy have not been completed. ■

Marta Vogel is a free-lance writer specializing in health reporting. She lives in Takoma Park, Md.

FDA Consumer h March 1987 I 17

Dining Out with a Healthy Appetite

When Americans dine out—asthey're doing more than ever before—they aren't leaving their taste fora healthy diet at home. So more andmore restaurants are changing theirmenus to satisfy a calorie-counting andnut r i t i on -consc ious c l ien te le .

Those were the findings of surveysof consumers and restaurant managersconducted last year for the NationalRestaurant Association (NRA).

In one survey, the 100,000-memberWashington, D.C.-based trade groupasked The Gallup Organization to pollconsumers about how they've changedtheir eating habits due to concerns abouthealth and nutri t ion. Three out of fiveconsumers said they had changed theireating habits at home, and two out offive said they had done so when they eatout. These overall results were closeto those of a similar survey in 1983. Butin asking about specific preferences,the 1986 poll found more restaurant patrons who said they're eating more vegetables, less fat, less meat, and fewerfried foods than three years before. Consumers also continue to use less sugarand salt, more fish, and more salads.

What Americans eat when they'redining out is of no small importance tot h e i r o v e r a l l h e a l t h a n d n u t r i t i o n a l w e l l -

being. The NRA estimates that morethan 45 billion meals are eaten in restaurants and school and work cafeterias

annually, and that, on the average, eachperson eats out about 192 times a year.

So restaurateurs are wise to cater tothe i r heal th-consc ious d iners . And the

survey of restaurant managers found

that they are doing just that. Accordingto Restaurants USA (a trade periodicalof the NRA, formerly called NRA News),'The majority of operators haveheal thfu l subst i tutes avai lable and . . .are willing to alter preparation methodswhen requested."

The survey—of 504 restaurateurs,done for the NRA by Gallup last year—confirmed the increased heal th-consciousness of those dining out. Half themanagers reported increased demandfor salads, fish and seafood. Two of fivenoted more requests for fresh vegetables,poultry, fresh fruit, and baked or broiledfoods. About one out of three mentioned

greater demand for lean meat and foodsprepared without sauces, butter or salt.Yet one-fourth of the managers reportedan increased demand for desserts. "Withthe exception of desserts,'' reportedRestaurants USA, "these foods reflectconsumer interest in a lower fat, lowercholesterol, higher fiber wellness diet."

In catering to their customers' healthful preferences, the survey found virtually all restaurants offering at least dietbeverages (95 percent) or sugar substitutes (92 percent). Most also offer decaffeinated coffee, margarine, whole-grain bread, rolls or crackers, and freshf r u i t f o r d e s s e r t . A b o u t o n e - t h i r d o f f e r

reduced-calorie salad dressings, low-fator skim milk, salt substitutes, and branc e r e a l s .

Almost three out of four restaurantswill alter the way they prepare foodat a diner's request, the survey found.At least nine out of 10 will serve a sauceor salad dressing on the side or cook

without sa l t . Most a lso wi l l cook wi th

margarine or vegetable oil to help dinerstrying to limit saturated fats (found inbutter, lard and shortening) because ofconcerns about cholesterol and heartdisease. Four out of five restaurants wil lbroil or bake a food instead of fryingit, and three out of five will remove theskin (high in fat) before cookingc h i c k e n .

A growing number of restaurants areactively promoting nutritious or low-calorie fare. Some highlight nutritiousitems on the menu, have special sectionsof the menu, or even have a separatemenu for heal th-consc ious d iners . Atother restaurants, the waiters and waitresses tell their customers about es

pecially healthful fare.However, very few restaurants have

gone so far as to put nutrition information on the menu. Only 4 percentof those surveyed even list calories,and only 2 percent tell the fat, sodiumor cholesterol content of their selections.Yet of those who don't put nutritioninformation on the menu, 17 percentsay it is available on request.

"Consumer in terest in nut r i t ion hasbeen steady over the past few years,"noted Restaurants USA. "Both federallyfunded public nutrition education programs and stronger scientific consensuson diet and disease are expected to notonly sustain but also to fuel the public'sin teres t in hea l th and nut r i t ion . " ■

When it comes to nutrition, what kindof a restaurant-goer are you? Turn thepage to find out.

FDA Consumer / March 1987 I 19

Diners' Clubs: The Four Varieties of Restaurant-Goers

When it comes to an appetite forhealthy and nutritious foods, restaurantdiners fall into four categories, accordingto a National Restaurant Associat ion

survey. At one extreme is the mostlyyoung and male "meat-and-potatoes"crowd; at the other is the mostly olderand female health-conscious group. Inbetween are those who don't care asmuch about good nutrition as about losing weight, and then there are thosewho can't decide what they want to eat.

Last year the restaurant trade groupconducted an in-depth attitude and behavior survey to probe how consumers'health and nutri t ion concerns affect what

they order when dining out. In analyzingthe results, NRA found, according toits publication. Restaurants USA (formerly NRA News), "that although mostAmericans are aware of health and nutrition issues, they are not all alike." Fourdistinct groups were identified:• Trad i t i ona l Consumers—the mea t -

and-potato eaters who "tend to eat whatthey like when they like."• Weight Conscious Consumers—whose"key words ... are diet, reduced calories

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and subs t i t u te . "• Hea l t h Consc ious Consumers—whoseinterest "stems from their desire to com

ply with the government's dietaryguidelines."• U n c o m m i t t e d C o n s u m e r s — w h o s emenu choices are "var ied and showno particular pattern."

The Traditional Consumers, whomake up 37 percent of the adult population, tend to be men between the agesof 18 and 34 who live in rural areas,have a high school education, and earnless than $40,000 a year. They frequentfast food places, do not diet, and exercise moderately. They do not restricttheir use of salt, sugar, fat or cholesterol,and don't eat foods high in fiber, starchor calcium. When eating out, they likesteak or roast beef, regular (not diet) softdrinks, fried chicken, fried fish and otherseafood, and "rich, gooey chocolatedesserts," according to Restaurant USA."To these people, taste is definitelythe most important thing."

Weight Conscious Consumers, whoaccount for 28 percent of the population.


tend to be 45- to 54-year-old womenwho live in urban areas and have a fam

ily income of more than $40,000 a year.They diet, they limit their use of salt,sugar, fat and cholesterol, and they eat /more foods high in fiber and calcium, f |

They patronize moderately priced ̂or 'Tine dining" restaurants, where theyopt for reduced-calorie salad dressing,sugar substitutes, diet soft drinks, rawvegetable appetizers, low-calorie entrees,and low-fat, low-calorie, fruit-baseddesserts. They would "eat out moreoften if it was not so fattening," saidNRA's magazine.

Health Conscious Consumers, about19 percent of the population, are generally women at least 55 years old, college-educated, and married with nochildren. They exercise often, limit theirsalt, sugar, fat and cholesterol, and prefer foods high in fiber, calcium andstarch. They seldom eat at fast-foodoutlets, preferring midscale and upscalerestaurants, where they tend to ordervegetables seasoned only with herbs orlemon juice, broiled or baked fish,whole-wheat bread and rolls, skinlesspoultry, and fresh fruit. RestaurantsUSA noted that this group is "morelikely to avoid some of the foods thecalorie watcher seeks out, such as dietsoft drinks, reduced-calorie salad dressing and sugar substitutes, because theseitems are processed foods."

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"This group believes that good dietand nutrition play a role in the prevention of serious illness," the trade groupreported. They are "less concerned withtaste and with watching calories" andare " less incl ined to foresake their commitment to health and nutr i t ion evenwhen dining out for a special occasion."

Finally, there are the UncommittedConsumers: They make up about 12percent of the population; they tend tobe men 35 to 64 years old who live inthe suburbs and make more than $40,000a year. These "busy, on-the-go consumers" don't diet; they frequent fastfood and midscale restaurants; they are"average" in their attempts to limitsalt, sugar, fat and cholesterol. Theydon't eat foods high in fiber, calciumor starch. What they like when diningout is whole-wheat bread and rolls, skinless poultry, diet sodas, and broiledor baked fish and other seafood.

"They are different from TraditionalConsumers in that they are less likelyto consume many of the traditionalfoods, such as mashed potatoes, enrichedwhite bread, and steak and roast beef,"NRA reported. Yet "they are not likelyto make a point of eating nutritiousfoods. They do not necessarily feel thatbeing in peak physical shape is important Perhaps they are still tryingto make up their minds about the waythey feel about health and nutrition." ■

For more results of the restaurant surveys, see the next page.


Changes in What Consumers Are Ordering at Restaurants^August 1983 M a r c h 1 9 8 6

P e r c e n t R a n k P e r c e n t R a n k

More vegetables 1 8 4 2 6 1

Less salt, no salt 2 5 1 2 3 2

Less sugar, no sugar 2 0 3 2 2 3

M o r e fi s h 2 0 2 2 1 4

Less fats 1 6 6 2 0 5

M o r e s a l a d s 1 8 5 18 6

L e s s m e a t 1 2 7 1 7 7

Fewer f r i ed foods 1 0 8 1 5 8

*Percent of those who have changed habits when eating away from home.Source: NRAIGallup surveys, August 1983 and March 1986.

Half the managers reportedincreased demand for saladsand seafood.

Foods and Beverages Consumers Are Likely To Try at a Restaurant

I t e m P e r c e n t W h oAre Very LikelyTo Try

I t e m P e r c e n t W h oAre Very LikelyTo T r y

F r e s h f r u i t 7 8 F r i e d c h i c k e n 3 2

L e a n m e a t s 6 4 Reduced-calorie salad dressing 3 0

Bro i l ed /baked fish o r sea food 6 3 D i e t s o f t d r i n k 3 0

Whole-wheat breads, rolls, crackers 5 9 C a f f e i n e - f r e e s o f t d r i n k 3 0

Steak or roast beef 5 8 Whole-grain pancakes/waffles 2 8

Poultry without skin 4 6 C a f f e i n e - f r e e c o f f e e 2 8

Raw vegetable appetizer 4 5 P r e m i u m i c e c r e a m 2 7

Whole-grain muffins 4 0 Low-fat, low-calorie fruit desserts 2 5

Vegetables seasoned only witb herbs or 3 6 Sugar substitutes 2 5

lemon juiceBagel/bread with low-fat cream cheese 2 4

F o o d c o o k e d w i t h o u t s a l t 3 5Rich, gooey or chocolate dessert 2 2

Regular soft drink 3 5F r u i t i c e / s o r b e t 2 2

F r i e d fi s h / s e a f o o d 3 4C a l o r i e - c o n t r o l l e d e n t r e e 2 0

Low-fat cottage cheese 3 3 Low-cholesterol egg substitute 9

C e r e a l w i t h l o w - f a t o r s k i m m i l k 3 3

Source: National Restaurant Association, August 1986.

22 I March 1987 / FDA Consumer

Type of Changes Operators Will Make*T y p e s o f C h a n g e s T y p e o f R e s t a u r a n t

A l l

R e s t a u r a n t s

(percent)

F a s tF o o d

(percent)

FamilyStyle(percent)

F i n e

Dining(percent)

A l l

O t h e r s

(percent)

Serve sauce on the side 9 6 9 0 9 5 1 0 0 9 7

Serve salad dressing on the side 9 3 7 8 9 3 1 0 0 9 5

C o o k w i t h o u t s a l t 9 0 8 8 8 7 9 7 9 2

Prepare foods in vegetable oil or margarine 8 3 7 1 8 4 9 0 8 1

Broil or bake food rather than fry it 8 0 4 8 8 5 9 6 7 8

Skin chicken before preparing 6 1 3 6 6 4 8 7 4 7

* Based on the 73 percent of respondents who said they would alter food preparation methods.Source: Galtup/NRA Operator Survey, June 1986.

Percent of Operators Offering Substitutes on Request

Almost three out of four restaurants will alter the waythey prepare food at adiner's request.

Make A va i lab leon Request

Type ofR e s t a u r a n t

All Operators(percent)

F a s t F o o d

(percent)N o n - F a s t F o o d

(percent)

Diet beverages 9 5 9 2 9 6

Sugar substitutes 9 2 8 5 9 4

C a f f e i n e - f r e e c o f f e e 8 4 6 1 9 0

Margarine 6 6 4 0 7 2

Whole-grain bread/rolls/crackers 6 2 3 8 6 8

F resh f r u i t f o r desse r t 5 9 3 2 6 6

Reduced-calorie salad dressing 3 7 3 2 3 9

L o w - f a t / s k i m m i l k 3 3 2 1 3 6

Sa l t subs t i t u t es 3 3 2 4 3 5

B r a n c e r e a l s 3 1 1 7 3 5

Source: GalluplNRA Operator Survey, June 1986.


by Bill Rados

Parents should not rely on child-resistant packaging alone to protect theiryoungsters from accidentally swallowingprescription drugs. According to a government survey, in some cases the safetypackages do not work as they should,or the caps have been left off or areloose. In other cases, the pharmacistmay have filled the prescription in anon-child-resistant package without thebuyer's knowledge.

These are some of the findings ofa 1986 study of 2,015 cases in whichchildren under 5 accidentally swallowedoral prescription drugs. The study wasdone by the American Association ofPoison Control Centers (AAPCC) for theU.S. Consumer Product Safety Commission (CPSC). Parents or other adultswho were in the house at the time wereinterviewed to learn how and wherethe accidents happened.

Childhood poisonings from prescription drugs have dropped markedly sincea federal regulation requiring child-resistant packaging was passed in 1974.Still, more than 60,000 cases of childrenunder 5 accidentally swallowing prescription drugs were reported to the 56AAPCC poison control centers in 1985,the last/year for which figures areavail̂ le.^Po see if the child-resistant packagesinvolved in the accidents were workingproperly, those interviewed were askedto send the drug containers to CPSC fortesting. Of the 306 child-resistantpackages received, 65 percent were notworking properly. The study reportstated that although the small numberof child-resistant packages received byCPSC could not be considered a representative sample of all prescriptiondrug packages, the high failure rate is"of concern." The report noted that"the problem suggests the continuingneed for survei l lance and enforcementof special packaging standards."

" B e c a u s e t h e d a t a s h o w t h a t s o m e

child-resistant packaging in the home

may not be functioning properly, parentscannot rely upon packaging alone toprevent access by young children," thereport warned.

Also alarming is the finding that 17percent of the drugs involved were inno container at all, but were found looseby the child.

Almost one- th i rd of a l l medic inesthat were in a prescription container atthe time of the accident were not inchild-resistant packaging. Yet, manyof the people surveyed said they hadnot asked for non-chi ld-resistant containers when the prescription was filled.Additionally, over half the containersthat weren't child-resistant had been dis

pensed to parents of children under 5,and 18 percent had been dispensed forthe child. These facts indicate that pharmacists may have dispensed non-child-resistant containers without a requestfrom the purchaser or a physician, inviolat ion of the Poison Prevention Pack

aging Act, according to CPSC.Ninety-one percent of the children

involved in the accidents were between1 and 3. Forty-three percent were age2. These findings indicate that "the normal developmental characteristics ofchildren are important risk factors,"CPSC stated.

The survey also asked about the typesof drugs involved, who they belongedto, and where the medicine was storedwhen the accident happened.

Ant ib io t ics were the most common

drug, representing 23 percent of all drugsin the study. These were often liquidantibiotics that had been prescribed forthe child or a brother or sister. Birthcontrol pills and other hormones were

the second most common drugs, representing 15 percent of the cases. Thenext three categories were painkillers(10 percent), heart drugs (9 percent), andsedatives (6 percent). These three areimportant because "they present substantial risk due to their potent toxicity,"according to CPSC.

It was the chi ld's mother to whomthe drugs most often belonged (27 percent), followed by the child (22 percent).Thirty-one percent of the drugs belongedto someone not in the child's immediate

family. This includes grandparents (17percent) and other older adults who oftenare taking highly toxic drugs and arenot always aware that they should takeextra precautions to keep their medicineout of the reach of young children.

The ki tchen was the most common

storage place for medicines (48 percentof the cases), followed by the bedroom(24 percent) and the living room (10percent). Interestingly, the bathroomwas fourth on the list (8 percent)."These findings indicate that medicationis stored where it is convenient to take,which makes it readily accessible to children as well," CPSC stated.

"The results of the survey show thatall consumers, regardless of whetherthey have young children of their ownor not, should take care to obtain theirprescriptions in child-resistant packagingand to always resecure the caps tightly,"CPSC concluded. "Additionally, caremust be taken to keep the medicinestored out of sight and out of reach, especially medicine being taken on a regul a r b a s i s . " ■

Bill Rados is the editor o/FDA Consumer.

Grandparents:Your Medicines Can Tempt Tbddlers

Grandparents should be careful aboutwhere they leave their prescriptiondrugs. According to a government survey, grandparents' medications, oftennot kept in child-resistant containers, accounted for almost one out of six casesin which small children swallowed prescription drugs.

The study of 2,015 reported poisonings involving oral prescription drugsamong children under 5 was done lastyear (see main story). The findings included information about where the poisonings took place and to whom themedication belonged.

Most of the poisonings involving a

grandparent's medicine happened whenthe child was visiting the grandparent,but in some cases, the grandparent livedwith or was visiting the child. Poisoningsinvolving a grandparent's medicine arepotentially more dangerous than others;they often involve some of the moretoxic medications, such as heart drugs,and thus "present the potential for realtragedy," according to the study report.

"The data suggest that consumerswithout young children need to be madeaware of ingestion hazards that existwhen a child is visiting another household or others are visiting the child'shousehold," the report stated. ■


'The M' May Not Mix Well with Other Drugsby Judith Willis

A young newlywed had been takingbirth control pills several monthsin the early 1970s when she developeda bladder infection. She consulted herdoctor, who prescribed an antibiotic. Theinfection cleared up quickly. But ninemonths later she gave birth to her firstch i l d .

Today, with proper communicationbetween physician and patient, theinadvertent pregnancy in this mythicalexample would be far less likely to occur. Many interactions between oralcontraceptives (OC's) containing bothestrogen and progestogen and otherdrugs are now well-known and includedin both the physician and patient labelingof the pill.

Such interactions can not only diminish the contraceptive's effectiveness,but also increase or decrease the potencyof the other drug. Both those who takeoral contraceptives and those who don'tmay find it interesting to look at whatis known about the how and why of suchOC-drug interactions.

Some drugs decrease contraceptiveeffectiveness apparently because they increase the metabolism of the contraceptives. This means that the liver breaksdown the hormones in the contraceptivefaster, and they are eliminated fromthe body more quickly. Thus, the levelsof estrogen and progestogen are reduced,sometimes so much that they no longersuppress ovulation. Breakthrough bleeding is often a symptom of this reducedeffectiveness. This type of interaction isof even more concern with the very-low-dose contraceptives, since the levelof hormones they contain is alreadyl o w .

Many interactions betweenoral contraceptives containing both estrogen and progestogen and other drugsare included in both thephysician and patient labeling of The Pill.

The first drug with which that typeof OC interaction was reported wasrifampicin, used to treat tuberculosis.In the early 1970s, medical journalsreported breakthrough bleeding and contraceptive failure in OC users takingrifampicin. Alerted to this effect withone drug, physicians over the next fewyears noted the possibility of this typeof decreased effectiveness with manydifferent drugs. They include:• antibiotics such as isoniazid, am-picillin, neomycin, penicillin V, tetracycline, chloramphenicol, sulfonamides,nitrofurantoin, and griseofulvin,• barbiturates,• anticonvulsants such as phenytoinand primidone, and• the anti-inflammatory phenylbutazone.

Also, some analgesics, tranquilizersand anti-migraine preparations may havethis type of interaction. OC users takingsuch drugs are advised to use an additional form of contraception until theydiscontinue therapy with the seconddrug.

When it comes to the other side ofthe coin—OC's affecting the potencyof other drugs—knowledge about suchinteractions is more limited. But again.

the how and why seem to be tied to theway the drug is metabolized; that is,changed into a form that can be eliminated from the body.

Some drugs are metabolized in theliver primarily by oxidation, and thusare excreted through the kidneys ratherthan the bowels. These drugs appearto be metabolized more slowly in OCusers, according to research by a groupof scientists headed by Darrell Aber-nathy, M.D., Ph.D., and reported in theApril 1, \9S2, New England Journalof Medicine. The researchers reportedthat long-term use of low-dose estrogen-containing OC's may cause diazepam(Valium), a benzodiazepine anti-anxietydrug, to stay in the body longer. Thismeans that OC users may require lowerdosages of diazepam and other drugsthat are metabolized in the same way.However, since not all people metabolizedrugs in the same way, the patientshould be monitored by her physicianto see if the dose should be adjusted.Other drugs that may stay in the bodylonger because of OC's include: otherbenzodiazepines such as chlordiazepox-ide (Librium); hydrocortisone; anti-pyrine; phenothiazines; and sometricyclic antidepressants.

In contrast, some drugs that are excreted mainly through the bowels (andat times partly through the kidneys) maybe eliminated more quickly in OC users.Even though the metabolism of somebenzodiazepines may be slowed byOC's, there are other benzodiazepines(such as lorazepam, oxazepam and tam-azepam) whose metabolism may be enhanced, so they may be excreted morequickly in women taking birth control


pills. However, information on exactlyhow such drugs interact with OC's isscarce. In an article in the September1982 issue of Obstetrics & Gynecology,Abemathy reported that, in women usinglow-dose OC's containing estrogen formore than three months, acetaminophen(Tylenol) was eliminated more quicklythan in non-OC users. The authorstheorized that this increase in the speedat which the drug is eliminated fromthe body might offer some protectionagainst liver toxicity in cases ofacetaminophen overdose.

But OC users taking only the recommended dosages of acetaminophen mightneed a higher dosage than non-OCusers. Again, because response to medication is so individual and because different combinations and dosages ofestrogen and progestogen may have differing effects, OC users should consulttheir physicians about any deviation fromrecommended dosages.

OC users taking other drugs may needto have the dosage monitored and possibly adjusted for a variety of reasons.Some epileptics may need a change inthe dosage of an anticonvulsant drugthey are taking, depending on the typeof OC they're using. But other womentaking the same combination may notneed the dosage changed. The exact reason for this "iffiness" is not known,but it may be because OC-relatedchanges in fluid retention could influencethe frequency of seizures. Because ofthese difficulties, many doctors recommend that women taking anticonvulsantsrely on another contraceptive than birthcontrol pills.

A s i m i l a r r e c o m m e n d a t i o n i s o f t e n

made for diabetics, because OC's maycause blood sugar levels to rise. If a

In most young, healthywomen, the effects of takingother drugs while on birthcontrol pills are no cause foralarm and should not keepwomen who can benefitfrom the contraceptivefrom taking it.

diabetic does take birth control pills,she should be closely monitored to seeif there needs to be a change in her diabetes medicat ion.

Hypertension can be a problem inwomen on birth control pills, andelevated blood pressure has been knownto occur in women not hypertensivebefore taking OC's. To complicate matters further, some of the medicationsused to control high blood pressure donot work the same way in those on ThePill as in non-OC users. In particular,the blood pressure drug guanethidineoften does not adequately control hypertension in OC users. OC users takingblood pressure drugs need to be morecarefully monitored.

In addition to interactions with drugs,OC's may also interact with certain vitamins. Labeling for birth control pillsnotes that OC users may have disturbances in the metabolism of tryptophan, an amino acid. Although sucha d i s t u r b a n c e i s n o t c o n s i d e r e d c a u s e

for undue concern, it may result in a deficiency of pyridoxine (vitamin Bg).Whether that is a cause for concern isnot known. Also, in rare cases, megaloblastic anemia, a certain type of anemia due to insufficient pyridoxine, has

been reported in OC users. In addition,levels of folic acid—one of the B vi

tamins—may be lower in women on TheP i l l .

Preliminary studies have shown thatvitamin C may increase the bioavailability of estrogens. This meansthat women using birth control pillswho take large doses of vitamin C maybe risking increased side effects fromthe pill's estrogen. For this reason, someexperts suggest that OC users take nomore than 1,000 milligrams of vitaminC daily.

Some laboratory test results can bealtered by OC use. The pathologist orother lab personnel should be informedwhen a woman undergoing lab testsis taking birth control pills so that thiscan be taken into consideration when

evaluating the tests. Tests that are alteredby OC use include those measuring:liver function, coagulation (clotting),thyroid function, blood triglyceridesand phospholipid (fats) concentrations,serum folate, glucose tolerance, andplasma levels of some trace minerals.

In most young, healthy women, theeffects of taking other drugs while usingoral contraceptives are no cause foralarm and should not keep women whocan benefit from the contraceptive effectiveness of OC's from taking them. Theeffects of OC-drug interactions may varygreatly from woman to woman. Yetwomen should be aware of the possibility of such interactions and tell theirdoctor if they are taking birth controlpills so that other therapy can be properly coordinated. ■

Judith Willis is editor of the FDA DrugBulletin, a publication for health profess i o n a l s .

28 / March 1987 t FDA Consumer

Planning a Diet for a Healthy Heartby Chris W. Lecos

Most health experts agree that Americans can help protect themselves fromheart disease and heart attack by eating less fat—particularly saturated fat—and less cholesterol .

Last November, FDA proposed a regulation to specify how information on fatand cholesterol content should be presented on food labels and packages.Meanwhile, health organizations from the government and the private sector areembarking on public education campaigns to help the public understand how dietary fat and cholesterol increase the risk of heart disease and how to eat to reducethat r isk .

As part of that campaign, FDA Consumer is publishing a series of articles onthe cholesterol-heart disease link. The first part appeared last month and discussedFDA's proposed cholesterol labeling regulation. This is Part 2, offering tips onplanning a diet for a healthy heart,

Coronary heart disease accounts for this condition, although it is not themore U.S. deaths annually—in ex- only risk factor: Individuals are alsocess of 550,000—than any other disease, at greater risk if they have high bloodincluding all forms of cancer. (The term pressure or diabetes, smoke cigarettes,coronary is derived from the Latin word or are overweight,corona, meaning crown, and refers to Atherosclerosis results from a buildupthe two arteries that originate in the aorta of solid material called plaque in andand supply blood directly to the heart, on the walls of blood vessels. Thesurrounding it much like a crown.) buildup of plaque, which contains cho-

Coronary heart disease is the most lesterol and other substances, can restrictcommon cause of disability in this coun- blood flow. Why plaque deposits aretry. It is costly in other terms, too— formed, what role cholesterol levels playimposing a financial burden in excess in plaque formation, and to what extentof $60 billion a year in direct and indi- the consumption of fat—especially satu-r e c t c o s t s . r a t e d f a t — a n d c h o l e s t e r o l i n f l u e n c e s

The National Institutes of Health esti- blood cholesterol levels are questionsmates that there are more than 5.4 mil- that continue to plague scientists andlion Americans "with symptomatic medical authorities,coronary heart disease and a large num- Despite the uncertainties, FDA, inber of others with undiagnosed coronary the regulation it proposed last Nov. 25disease, many of them young and highly for cholesterol labeling of foods, notedp r o d u c t i v e . " t h a t m o s t e x p e r t s b e l i e v e t h e r e i s " a

One major contributor to coronary correlation between the severity of theheart disease is atherosclerosis, or plaque deposits and the levels of cho-"hardening of the arteries." A high lesterol in the blood."blood cholesterol level contributes to The number of health experts who

FDA Consumer / Match 1987 / 29

accept the cholesterol-heart disease connection has been growing steadily. In1979, the U.S. Surgeon General issueda report that said Americans would behealthier if they consumed less saturatedfat and cholesterol. In 1980, and againin 1985, the Department of Health andHuman Services and the Departmentof Agriculture jointly published their"Dietary Guidelines for Americans,"which called for similar dietary changes.

At a December 1984 conference held

by the National Institutes of Health,a panel of experts reported that "elevated blood cholesterol level is a majorcause of coronary artery disease" andproper dietary changes could reduceblood cholesterol levels. The panel citeddata from more than a dozen clinicalstudies to support its conclusion.

One of the more important of thesewas a 7-to-lO year clinical study reported

Cutting Back on Fat and Cholesterol

To t a l F a t *

S a t u r a t e d F a t

Polyunsaturated Fat

C h o l e s t e r o l

Maximum Percent of Total Calories

Reduce to no more than 30%

Reduce to no more than 10%

Increase, up to 10%

N o m o r e t h a n 2 5 0 - 3 0 0

milligrams a day

The National Heart, Lung, and Blood Institute has recommended that all Americans over 2 years old moderate their intake of fat, especially saturated fat, andcholesterol. The chart above is based on a 1984 Consensus Development Conference Statement issued by the institute.

^Total fat includes not only saturated and polyunsaturated fat, but also mono-unsaturated fat, which would make up the remaining 10 percent of total fat.

How Much Fa t Shou ld You Eat?

Total DailyC a l o r i e s

M a x i m u m A m o u n t

of Fat (in Grams)

Americans are being urged to reduce their consumption of fat from the current average of 40 percent of total calories to no more than 30 percent. Aboveis a rough guide to help show the amount of fat that will provide 30 percentof total daily calories. For example, if you eat an average of 2,500 calories aday, 83 grams represents 30 percent of your total calories.

If you're not sure of your typical calorie intake, here's a rough guide: 2,000calories is the average suggested for women 23 to 50, and 2,700 calories is theaverage for men. Whether these levels are right for you depends on your age,body size, and level of activity.

in January 1984 by the National Heart,Lung, and Blood Institute (NHLBI).A total of 3,806 men who were considered at high risk of developing coronaryheart disease were in the study. Theprincipal aim was to determine how wellblood cholesterol levels could be treated

by drug therapy, but findings aboutdietary changes also made the studynoteworthy.

The participants in this study wereput on a diet that contained about 400milligrams of cholesterol a day and ^yasdesigned to lower cholesterol levelsby 3 percent to 5 percent. The diet included a high ratio of polyunsaturatedfats to saturated fats. After three months,the dietary changes resulted in a 3.5percent reduction in total cholesterolin the blood and a 4 percent drop inlow-density lipoprotein (LDL) cholesterol. (High levels of LDL cholesterolhave been associated with an increasedrisk of heart disease.)

The study also showed that an 8 percent reduct ion in blood cholesterol couldreduce the risk of coronary heart diseaseby 19 percent. And the risk was reducedby 50 percent for those participants whohad reduced their total blood cholesterol

by 25 percent. In effect, NHLBI said,the study showed that "for every 1 percent drop in plasma cholesterol, therewas a 2 percent reduction in coronaryheart d isease r isk."

Because of such findings, the NIHpanel recommended that Americanschange their diets to reduce the levelof blood cholesterol. The panel urgedeveryone except children under 2 toreduce fat intake from the current levelof about 40 percent of total calories tono more than 30 percent. Particularly,Americans should reduce their intakeof saturated fat from the current 16 percent to 18 percent of total calories toless than 10 percent. Consumption ofpolyunsaturated fats should be increasedfrom the current 5 percent to 8 percent,but to no more than 10 percent of totalcalories. And, finally, these experts said,cholesterol intake should amount to nomore than 250 to 300 milligrams a day.

Simi lar recommendat ions have beenmade by the American Heart Association, the American Medical Association,the federally created Inter-Society Commission for Heart Disease Resources, theWorld Health Organization, and otherpublic and private health authorities. ■

Chris W. Lecos is a member of FDA'spublic affairs staff.

Recipe for a Healthy-Heart Diet

The problem that confronts manypeople is how to translate recommendations for a reduced-cholesterol, reduced-fat diet into a shopping list and menufor themselves and their families.

In general, this means eating morefruits, vegetables, cereal grains andstarches, which have less fat (particularlysaturated fat) and no cholesterol, andchoosing vegetable oils such as saf-flower, sunflower, corn and soybeanoils, which have higher levels of polyunsaturated fatty acids and low levels ofsaturated fatty acids.

Here are some tips to help consumerspick and prepare foods lower in saturatedfat and cholesterol:• Switch from butter or a hydrogenatedmargarine high in saturated fatty acidsto one higher in polyunsaturates. Soft tubmargarines made from com, saffloweror sunflower oils are the best choices.• Use skim or low-fat (1 percent) milk.• Buy lean grades of meat and trim visible fat. Prepare mixed dishes thatcombine meat with other foods (vegetable stews or pasta, for example). Eatorgan meat, such as liver, brain andkidney, only occasionally.• Broil, bake or roast meat, fish andpoultry instead of pan-frying or deep-fat frying. Basting with wine, broth,lemon or tomato juice will prevent drying and give good flavor.• Eat more fish, poultry (without skin),and dried peas and beans.• Subst i tu te low-fat sandwich meatsior higher fat cold cuts, and use low-Fat hot dogs instead of regular varieties.Serve sliced turkey breast, low-fat ham,

and tuna or chicken salad instead of

bologna and other processed sandwichm e a t s .

• Use salad dressings made from oilsother than coconut or palm (olive oil, forinstance). Use yogurt as a substitutefor sour cream.• Substitute sherbet, ice milk, or nonfatfrozen yogurt or tofu desserts for icec r e a m .

• When baking, cut back on cholesterol-laden egg yolks by using only the whitesor by discarding every other yolk andsubstituting a teaspoon of polyunsaturated oil for each discarded yolk.• Reduce the amount of fat in recipesby a third to a half. If you use commercial cake mixes, for example, buy thoseto which you add the fat or oil. Usea polyunsaturated oil and reduce theamount by a third, while increasing thewater. For example, if the recipe callsfor three tablespoons of oil, use onlytwo, but add an extra tablespoon ofw a t e r .

• Cut down on baked goods made withlard, coconut oil, palm oil, or shortening, and those deep fried in fat, such asdoughnuts.• Instead of two-crust pies, serve single-crust (open-face) pies.• Use low-fat dried milk instead of non-

dairy creamers for coffee. Thesecreamers are generally high in coconutoi l , which contains saturated fats.• Use herbs or herb-f lavored croutonsinstead of bacon bits or cheese to flavorsalads or soups.• Instead of whipped cream or commercial toppings (which are high in fat.

especially saturated fats), make yourown with nonfat dried milk, or use ayogurt, tofu or fruit topping.• Substitute low-fat cheese such as part-skim mozzarella and ricotta in placeof regular varieties. Some products arepromoted as substitutes for cheese; readthe label to see if they contain saturatedfat .• Use low-fat cottage cheese blendedwith yogurt instead of cream cheese.Adding cornstarch will help prevent curdling when using this combination incooking.• Avoid already breaded chicken, fishand meat as well as packaged breadingmixes. Instead, make breading withplain bread crumbs. Coat food withcrumbs after dipping in skim milk mixedwith an egg white.• Instead of buttered popcorn, spraypopcorn lightly with a non-stick vegetable coating and then sprinkle with chilipowder, onion powder, or cinnamon.• Use a non-stick pan and vegetable-oil pan-coating instead of butter, margarine or oil when sauteing or fryingf o o d s .• Read labels for terms that reveal the

presence of cholesterol or saturatedfats—for example, egg and egg-yolksolids; whole-milk solids; palm, palmkernel or coconut oils; imitation or milkchocolate; shortening; hydrogenatedor hardened oils; lard; butter; and suetand animal byproducts. Substitute otherproducts for foods that have these ingred i e n t s . ■

Dairy Products when selecting dairy products in a healthy-heart diet, try the low-fat options. Low-fat milk, forexample, contains the vitamins, minerals and protein found in whole milk, but with less fat and cholesterol and fewerca lo r ies .

C a l o r i e s To t a l f a t S a t u r a t e d f a t C h o l e s t e r o l( A p p r o x i m a t e ) G r a m s Milligrams

MILK. YOGURT AND CHEESE:

Milk, whole, 1 cup

Milk, 2 percent fat, with nonfat milk solids, 1 cup

Milk, 1 percent fat, with nonfat milk solids, 1 cup

Skim milk with nonfat milk solids, 1 cup

Yogurt, plain, low-fat, 8-ounce carton

Yogurt, fruit-flavored, low-fat, 8-ounce carton

Cottage cheese, creamed, 1/2 cup

Cottage cheese, 1 percent fat, 1/2 cup

Cottage cheese, dry, 1/2 cup

Natural Cheddar cheese, 1 ounce

Mozzarella cheese, part skim milk, 1 ounce

Pasteurized process low-fat cheese product, 1 ounce

Pasteurized process filled cheese food (low cholesterol), 1 ounce

C R E A M A N D C O F F E E C R E A M E R S :

Sour cream, 1 tablespoon

Cream, table or light, 1 tablespoon

Cream, half-and-half, 1 tablespoon

Coffee creamer with coconut or palm oil, frozen liquid,1 tablespoon

Coffee creamer with coconut or palm oil, dry powder,1 teaspoon

D E S S E R T S :

Vanilla ice cream, 1/2 cup

Vanilla ice milk, 1/2 cup

Frozen yogurt, 1/2 cup

Orange sherbet, 1/2 cup

Source: Food 3, published by the American Dietetic Association based on material originally developed by the U.S, Department of Agriculture y 1982. One ounce = approximately 28 grams.

Meat, Poultry, Fish, Beans and EggsThe trimmable fat contributes much of the total fat and saturated fat to meat,while both the lean and the fat contain cholesterol. In comparison to meat, agreater percentage of the fat in fish is polyunsaturated.

To t a l f a t 'G r a m s

S a t u r a t e df a t

G r a m s

Polyuns a t u r a t e d

f a tG r a m s

C h o l e s t e r o lMilligrams

Beef rib roast. Choice grade,roasted, 2 ounces

Lean and fat 2 2 . 5 1 0 . 8 0 . 4 5 4

Lean only 7 . 6 3 . 7 . 2 5 2

Beef rump. Choice grade,roasted, 2 ounces

Lean and fat 1 5 . 6 7 . 5 . 3 5 4

Lean only 5 . 3 2 . 5 . 1 5 2

Beef rump. Good grade,roasted, 2 ounces

Lean and fat 1 3 . 3 6 . 4 . 3 5 4

Lean only 4 . 0 1 . 9 . 1 5 2

Ground beef patty, cooked,2 ounces

Regular 11 . 5 5 . 5 . 2 5 3

L e a n 6 . 4 3 . 1 . 1 5 3

E x t r a l e a n 3 . 5 1 . 7 . 1 5 2

Pork loin, lean, roasted,2 o u n c e s

Lean and fat 1 6 . 2 5 . 8 1 . 5 5 0

Lean only 8 . 0 2 . 9 . 7 5 0

Liver, beef, cooked with fatadded,2 ounces 6 . 0 1 . 7 . 6 2 4 8

Liver, chicken, simmered,2 ounces 2 . 5 . 6 0 4 2 3

Chicken, roasted, 2 ounces

Light meat with skin 6 . 2 1 . 7 1 . 3 4 8

Light meat without skin 2 . 6 . 7 . 6 4 8

Dark mea t w i th sk in 9 . 0 2 . 5 2 . 0 5 2

Dark mea t w i thou t sk in 5 . 6 1.5 1 . 3 5 3

Turkey, roasted, without skin2 o u n c e s

Light meat 1 . 8 . 6 . 5 3 9

D a r k m e a t 4 . 1 1 . 4 1 . 2 4 8

(Continued on next page)

Meat, Poultry, Fish, Beans and Eggs Polyun-(Continued from previous page) S a t u r a t e d s a t u r a t e d

To t a l f a t ' f a t f a t C h o l e s t e r o lG r a m s G r a m s G r a m s Milligrams

Halibut fdlets, broiled.2 ounces . 8 . 1 . 3 3 5

Cod fillets, broiled, 2o u n c e s . 5 . 1 . 2 3 5

Tuna, canned, oil pack.drained, 2 ounces 4 . 6 1 . 2 1 . 0 3 7

Shrimp, steamed, shelled.2 ounces . 9 . 1 . 4 1 1 7

Crab, cooked meat.2 ounces . 9 . 1 . 3 5 7

Oysters, shucked, cooked.2 ounces 1 . 5 . 4 . 4 3 6

Great northern or navybeans, cooked, 1/2 cup . 5 . 1 . 3 0

Canned beans with pork.1/2 cup . 6 . 1 . 3 0

Canned pork and beans intomato sauce, 1/2 cup 3 . 3 1 . 2 . 3 5

Egg, large, 1W h o l e 5 . 6 1 . 7 . 7 2 7 4

Y o l k 5 . 6 1 . 7 . 7 2 7 4

W h i t e T r a c e 0 0 0

^Totalfat includes mono-unsaturated fat as well as the amounts of saturated and polyunsaturatedfats shown in the two columns.

Source: Food 3, published by the American Dietetic Association from materialoriginally developed by the U.S. Department of Agriculture, 1982.

Fats and Oils

Animal fats tend to be higher in saturated fat than vegetable oils, which aregenerally higher in polyunsaturated fats. Vegetable shortenings and margarinesthat have been hardened by hydrogenation contain varying amounts of saturated fat, depending on the brand. Only animal fats contain cholesterol.Amounts given are for one tablespoon.

Polyuns a t u r a t e d s a t u r a t e d

T o t a l f a t ' f a t f a t C h o l e s t e r o lG r a m s G r a m s G r a m s M i l l i g r a m s

A N I M A L F A T S :

B e e f f a t 1 2 . 8 6 . 4 0 . 5 1 4

C h i c k e n f a t 1 2 . 8 3 . 8 2 . 7 1 1

y.. 4 ■

»■ ■'* '). 'r.' ■ • - t r■ n ■" >■■

- . , ^ ^ &', I#, m

4 ■ -

L a r d 1 2 . 8 5 . 0 1 . 4 1 2

B u t t e r 1 1 . 5 7 . 2 . 4 3 1

V E G E T A B L E O I L S :

C o r n 1 3 . 6 1 . 7 8 . 0 0

C o t t o n s e e d 1 3 . 6 3 . 5 7 . 1 0

P e a n u t 1 3 . 5 2 . 3 4 . 3 0

S a f fl o w e r 1 3 . 6 1 . 2 1 0 . 1 0

Soybean^ 1 3 . 6 2 . 0 7 . 9 0

Mixed (mostly soybean andsome cottonseed^ 1 3 . 6 2 . 4 6 . 5 0

S u n fl o w e r 1 3 . 6 1 . 4 8 . 9 0

O l i v e 1 3 . 5 1 . 8 1 . 1 0

C o c o n u t ^ 1 3 . 6 1 1 . 8 . 2 0

P a i m ^ 1 3 . 6 6 . 7 1 . 3 0

M A R G A R I N E :

Hard (stick) 1 1 . 4 2 . 1 3 . 6 0

Soft (tub) 11 . 4 1 . 8 4 . 8 0

Vegetable shortening,hydrogenated 1 2 . 8 3 . 9 1 . 8 0

S A L A D D R E S S I N G S :

Mayonnaise 11 . 0 1 . 6 5 . 7 8

Mayonnaise-type 4 . 9 . 7 2 . 6 4

I t a l i a n 7 . 1 1 . 0 4 . 1 0

Blue cheese 8 . 0 1 . 5 4 . 3 3

F r e n c h 6 . 4 1 . 5 3 . 4 0

T h o u s a n d I s l a n d 5 . 6 . 9 3 . 1 4

'Total fat includes mono-unsaturated fat as well as the amounts of saturated and polyunsaturatedfats shown in the two columns.^Soybean oils and soybean oil mixtures are the vegetable oils most commonly available to consumers.^Used in commercially prepared foods.

Source: Food 3, published by the American Dietetic Association from materialoriginally developed by the U.S. Department of Agriculture, 1982.

(Continued on next page)

Selected Snacks

Choose snacks with care. Be careful of trading off high fat and cholesterol forhigh sodium content. (Dietary sodium has been linked to high blood pressurein some people; high blood pressure, like high blood cholesterol levels, is a riskfactor for heart disease.)

To t a l f a t S a t u r a t e d f a t C h o l e s t e r o lG r a m s G r a m s Mil l igri

C R A C K E R A N D C H I P - T Y P E S :

Potato chips, 10 8 . 0 2 . 0 0

French fries, salted,10 long strips 1 0 . 3 2 . 6 0

Corn chips, 1/2 cup 6 . 1 1 . 3 0

Popcorn, plain, 1 cup . 3 T r a c e 0

Popcorn, salted andbuttered, 1 cup 2 . 0 . 9 4

Butter crackers, 4 2 . 3 . 8 0

Saltine crackers, 4 1 . 4 . 3 0

Whole-wheat crackers, 4 2 . 2 . 5 0

Pretzels, salted, 10 thins t i cks .1 T r a c e 0

N U T S A N D S E E D S :

Peanuts, roasted, salted,1/4 cup 1 7 . 9 3 . 9 0

Peanuts, dry-roasted,salted, 1/4 cup 1 7 . 6 3 . 1 0

Peanut butter, 2 tables p o o n s 1 5 . 3 2 . 8 0

Sunflower seeds, roasted,salted, 1/4 cup 1 6 . 8 3 . 2 0

D E S S E R T - T Y P E :

Chocolate chip cookies, 2 4 . 4 1 . 3 8

Frosted brownie, 1 6 . 6 2 . 2 1 2

Gingersnaps, 2 1 . 2 . 3 5

Sandwich-type cookies,chocolate or vanilla, 2 4 . 5 1 . 2 8

C h o c o l a t e - f r o s t e d

cupcake, 1 4 . 5 1 . 8 1 7

F r o s t e d c r e a m - fi l l e d

cupcake, 1 5 . 2 1 . 7 2 6

Doughnut, cake-type, 1 6 . 0 1 . 5 1 9

Doughnut, raised, 1 11 . 2 2 . 8 1 0

S o d i u mMilligrams

Source: Food 3, published by the American Dietetic Association from materialoriginally developed by the U,S. Department of Agriculture, 1982,

A Glossary ofCholesterol Thrms

Cholesterol: A fat-like substancefound in all foods of animalorigin (meat and dairy products),but not in food from plants.Some cholesterol is needed by thebody, but too much can build upin arteries, leading to heart disease, heart attack, or stroke.

Fat: A component of most foodsof plant or animal origin. Fat isan essential part of the diet. Notonly is it a major source of energy, but it also plays a key roleas a carrier of the fat-soluble vitamins, A, D, E and K, Dietaryfat also supplies the body with essential fatty acids, particularlylinoleic acid, necessary for propergrowth and healthy skin.

Fatty acids: The basic chemicalunits of fat. They can be eithersaturated, mono-unsaturated, orpolyunsaturated, depending onhow many hydrogen atoms theyhold. All dietary fats are a mixture of the three types of fattyacids, but vary in the amount ofeach that they contain.

Saturated fatty acids: Tend toraise blood cholesterol levels.

They are found in largestamounts in meat and dairy products, but also in some vegetableoils, including coconut and palmkerne l o i l s ,

Mono-unsaturated fatty acids:Found in varying amounts inboth plant and animal fat, Oliveoil, peanut oil, some margarines,and vegetable shortening tend tobe high in mono-unsaturated fattyacids.

Polyunsaturated fatty acids: Tendto lower b lood cholestero l leve ls .

They are found mainly in the fatof foods from plants, Safflower,sunflower, corn, soybean, andcottonseed oils contain largeamounts of polyunsaturated fattyac ids .


T h e N o t e b o o k

The Notebook: a potpourri of items of interest gatheredfrom FDA news releases, other news sources, and theFederal Register (designated PR, with date of publication). The Federal Register is available in many largepublic libraries.

■ Undissolved effervescent tablets create a burningsensation in the mouth and a foaming action that tendsto promote gagging. This should deter an accidentaloverdose by a child and is one of the reasons the Consumer Product Safety Commission has exempted Extra-Strength Alka-Seltzer effervescent tablets from child-resistant packaging requirements. Regular Alka-Seltzerand Alka-Seltzer Plus were exempted earlier (FR Dec.18).

■ Labels and ads for new animal drugs can say thatthe drugs are FDA-approved as long as drug sponsorsfollow a newly revised FDA guideline. The guideline(Compliance Policy Guide 7125.01) is available from theCenter for Veterinary Medicine, Information Office(HFV-11), 5600 Fishers Lane, Rockville, Md. 20857.

■ FDA has permanently listed D&C Red No. 8 andD&C Red No. 9 as color additives for use in drug andcosmetic lip products and in externally applied drugsand cosmetics (FR Dec. 5).

■ The Environmental Protection Agency has revokedits maximum residue levels in food and feed for four

already banned chemicals: aldrin, dieldrin, chlordaneand DDT. Instead FDA wi l l set act ion levels . Theseare temporary safety levels for pesticides on foods notnormally treated with the chemicals and are generallylower than the EPA levels (FR Dec. 24).

■ Label changes will be required on pesticide productscontaining cyanazine, EPA has proposed. Cyanazine,used to control grasses and weeds in com and othercrops, has been linked to birth defects in laboratory animals (FR Dec. 30).

■ A new mle from the U.S. Department of Agriculture's Food Safety and Inspection Service strengthenscontrols over the canning of meat and poultry products,updates the regulations to make them applicable to current canning technology, and makes the regulations moreconsistent with FDA requirements for most other cannedfoods (FR Dec. 19).

The Food Safety and Inspection Service also has confirmed a final mle to permit the use of gamma radiationfor control of Trichinella spiralis in fresh or previouslyfrozen pork (FR Dec. 5).

■ The Environmental Protection Agency has exemptedpheromone isomate-M, a biochemical pesticide usedon nectarines and peaches, from the requirement to establish a maximum permissible level for residues (FR Dec.11).

■ Two final rules on biologies: EDA has standardizedregulations governing licenses for ceil lines used toproduce viral vaccines and other biological products forhuman use (FR Dec. 10). FDA also clarified and updatedbiologic regulations on certain requirements for sterilitytesting of biological products (FR Dec. 15).

■ Although FDA has banned the use of sulfiting agentsas preservatives on fmits and vegetables to be servedor sold raw to consumers, EPA will continue to allowgrapes treated with sulfiting agents to be marketedas long as the grapes contain no detectable residues ofsul fur dioxide. This is an inter im measure unt i l EPAdecides whether to establish a permanent tolerance forsulfur dioxide in or on grapes (FR Dec. 31).

■ Ralston-Purina's advertising claims that its PuppyChow "can help reduce the severity of canine hip dysplasia" were based on inadequate clinical studies, ac-

. ■ . d i w . '

cording to the National Advertising Division (NAD) ofthe Council of Better Business Bureaus. However, NADsuspended its inquiry because print advertising was puton hold as a result of an unrelated query of the claims byFDA and a federal court suit by a competitor.

In another NAD case, the advertiser for Mrs. Winner'sShrimp & Crab Salad agreed to revise advertising onthe product, which is 45 percent surimi.

FDA Consumer / March 1987 t 37

Investigators'Reports

FromTMnted Feed toMothers' Milk

A Pesticide's DevastatingJourney Through the

Food Chainby Dixie Farley

Times became difficult last year formany people in and around Van Buren,Ark., when dairy herds on nearly 100farms were quarantined. Farmerswatched their livelihood literally godown the drain as they were forced todump milk by the thousands of gallons.Milk and milk products were recalledfrom eight states, and samples were analyzed. Even nursing mothers were advised to have their milk tested.

The problem was a pesticide calledheptachlor. It had contaminated cattlefeed produced in Van Buren and, fromthere, had traveled up the food chaint o t h e m i l k .

Heptachlor causes cancer in animals,may cause cancer in humans, and, in

(ftriA-CH

fact, is of sufficient health concern thatit's banned from all uses except killingtermites. In breast milk, heptachlor posesa special risk because the body absorbsit rapidly and can store it in fatty tissuefor a year or more. Breast milk, likecow's milk, is rich in fat, so it becomesa major route for elimination of heptachlor from the mother's body. A babyfed heptachlor-contaminated breast milk

could, in fact, have heptachlor levelsgreater than the mother.

FDA's New Orleans laboratory discovered heptachlor in seed and feedsamples collected during an inspectionof feed facilities in Van Buren duringJanuary and February 1986. Two VanBuren firms were involved: J.E.W.,Inc., bought seed and grain to make afuel-grade alcohol called gasohol andthen sold the mash byproduct to ValleyFeeds, Inc., which, in turn, sold it asan animal feed to farmers in Arkansas,Missouri and Oklahoma. Heptachlorwas in the seed J.E.W. bought, and itwas carried through to the finished feed.

FDA had identified a serous problem.But how widespread was it? To find


out, FDA investigators and scientistsfrom New Orleans, Dallas, Kansas City,Los Angeles, Minneapolis, Buffalo,Seattle, and Atlanta—with cooperationfrom state and local government agencies—collected and analyzed samplesfrom all milk and milk products produced within 150 miles of Van Buren,more than 1,400 samples in all.Eventually, the output of the quarantinedherds was recal led f rom out le ts inArkansas, Kansas, Louisiana,Mississippi, Missouri, Oklahoma, Tennessee and Texas.

On the recommendation of FDA,a U.S. attorney in Arkansas obtaineda consent decree under which J.E.W.and Valley Feeds agreed to stop sellingcontaminated mash and feed. The inves

tigations led to the involvement of theU.S. Department of Agriculture, the Environmental Protection Agency, theFBI, Congress, and even President Reagan. And in November 1986, Jack E.White, Brownie C. McBride, Jerry L.Einley, and Henry R. White of the VanBuren firms were indicted by a federalgrand jury. The 52 counts in the indictment included not only violations ofthe Federal Food, Drug, and CosmeticAct but also charges of fraud, racketeering, and other illegal acts. (Not all defendants were charged with all 52counts.)

FDA's involvement actually beganin 1984, when the agency's Nashville

dist r ic t o ffice not ified the New Or leansoffice that a Mississippi firm wassending J.E.W. a load of com contaminated with aflatoxin, a cancer-causingpoison produced by mold growing ongrain. Aflatoxin can't be entirely avoidedor eliminated from grain, but FDA cantake enforcement act ions i f the aflatoxinlevel is at or above 20 parts per billion.Grain contaminated wi th that muchaflatoxin can't be used for food or feed

and, even if it's used to make gasohol,any mash produced during the processinga l s o m u s t b e f r e e f r o m e x c e s s i v eaflatoxin before being used for feed.F D A ' s N a s h v i l l e o f fi c e h a d b e e n

monitoring the com in Mississippi. Nowit was New Orleans' tum.

So, FDA paid follow-up visits toJ.E.W. and Valley Feeds and collecteda number of samples for laboratory analysis. Excessive aflatoxin was foundin the com, in the gasohol mash, andi n t h e fi n i s h e d f e e d m a d e f r o m t h e m a s h .

The firms were notified of the findingsin February 1985.

Excessive aflatoxin was again foundin samples collected by FDA in visitslater that year. In November 1985, theagency wrote a second time to the firms,telling them of the contamination.

Then, during FDA's January-Febmary

1986 follow-up inspection, the investigator noticed that pink seeds weremixed with the grain used to make thegasohol. Seed grain is dyed an unnaturalcolor, such as pink, if it has been treatedwith a pesticide to signal that it shouldnot be used as feed.

Analysis of samples taken then revealed heptachlor as well as aflatoxin.One sample of finished feed, in fact,contained a heptachlor level that was athousand times greater than FDA'saction level. Samples of milk taken fromcows that ate feed produced by the firmsalso were found to contain substantialamounts of heptachlor and aflatoxin.

Action levels for pesticides like heptachlor are recommended by EPA andadopted and enforced by FDA. In animalfeed, the action level for heptachloris 0.03 parts per million; in milk fat,0.1 parts per million. Action levels forother chemical contaminants, such asmold toxins like aflatoxin, are determined and established by FDA. The action level for aflatoxin in most feed andfood is 20 parts per billion; in milk it'sonly 0.5 parts per billion.

After the heptachlor was identified,federal, state and local officials wentto work to protect the public from theconsequences.

Local health departments quarantinedsuspect dairy herds. The states embargoed milk from the quarantined cowsuntil tests showed it to be safe. FDA


and state officials monitored food-processing plants to see whether heptachlorshowed up in the dairy-based products.Products were held until analysis wascompleted.

Investigators from the U.S. Centersfor Disease Control in Atlanta collectedurine and blood samples from familieson farms with contaminated animals andthen tested the samples for pesticideand aflatoxin residues.

USDA tested random samples of meatas well as samples of meat suspectedof being contaminated. The suspectedcarcasses were held from sale until testswere completed. FDA alerted its fieldoffices to be on the lookout for anyonetrying to market meat and byproductsfrom carcasses of contaminated catt le.

In March, a task force representingFDA, USDA and EPA was set up tofind ways to solve the myriad problemsgrowing out of the contamination. Thet a s k f o r c e v i s i t e d f a r m e r s w i t h

quarantined herds and recommendedthat the farmers receive financial assistance. The Farmer 's Home Admin is t ration soon began providing loans to thestr icken farmers.

President Reagan asked Congress

to approve funds to compensate thefarmers for their losses. On July 2, thepresident signed legislation that set aside$8 million to repay the farmers for destroyed milk.

Because of the special heptachlorrisk for breast-feeding babies, Arkansasprovided free breast-milk testing throughthe University of Arkansas for MedicalSciences in Little Rock. Nearly athousand nursing mothers took advantageof the offer, with hundreds more

samples analyzed by private laboratories.Most of the samples were found to contain fairly low levels of heptachlor.There were no reports of acuteheptachlor poisoning.

Still, the mothers were understandablyworried about the risk of cancer for theirinfants. To help allay their fears, the director of the testing program developedan estimated cancer r isk assessment. "Achild that's bom and grows up in theUnited States," he said, "has a lifetimecancer risk of about one in 20. At the

typical levels we found in the breast-milksamples, the lifetime additional riskfor cancer for a child would be in the

range of one per 1,000 to one per10,000. That's a very small additionalr i s k . "

The university is leading a heptachlorstudy in collaboration with FDA's National Center for Toxicological Researchin Jefferson, Ark. "We would like totranslate our experience into somethingthat might help others who have to dealwith problems like this in the future,"said the study's spokesperson.

Dixie Farley is a member of FDA's public affairs staff.

Bug Spray-Drug Spray Mix-UpAn elementary school teacher's sharp

eye and keen sense of smell saved aBroward County, Fla., youngster frompossible injury and led to a recall ofa pesticide mislabeled as an aerosoldrug.

The youngster had suffered a playground-variety minor wound and wentto the teacher for first-aid. But whenthe teacher was about to spray the woundwith First-Aid Local Anesthetic Spray,she noticed the can had a fogger-typenozzle, such as is used on pesticide aerosols. As a precaution, she sprayed someof the contents on her palm and sniffedit. Sure enough, it smelled more likepesticide than medicine, so she stopped.

The teacher reported the problemto the Health and Safety Division ofthe Broward County School Board,which contacted the product's manufacturer, Rite-Off, Inc., of Bayshore, N.Y.,and the FDA office in Miami, whichsubsequently notified the New York dist r i c t o f fi c e .

An FDA investigator from the NewYork office visited Rite-Off s plant andfound that, indeed, the firm was produc

ing pesticide sprays as well as the anesthetic and that the cans had been mixed

up during packaging. He also foundthat numerous manufacturing practicesassociated with the dmg's productiondidn't comply with federal regulations:There were inadequate controls on theproduct's labeling and laboratory procedures and a lack of written proceduresa n d r e c o r d s .

The investigator collected severalsamples of the cans for testing at FDA'sNew York regional laboratory. The results showed the pesticide-type cans withthe drug labels did, in fact, contain thepesticide diazinon; and even the drug-type cans with the drug labels containeda trace amount of pesticide.

Could the pesticide hurt people ifit were sprayed on them? When any petroleum-based product (such as diazinon)is sprayed on the skin, especially onan open wound, there's a potential forirritation, inflammation, or even an allergic reaction.

When FDA not ified the firm of the

findings, Rite-Off told the agency ithad decided to "wr i te off " the first -aid spray from its product line. The firmrequested its one direct account. Mon

arch Surgical in Brooklyn, to return thestock on hand and to recall any cansalready distributed to sub-accounts, including schools. (Only 36 cases of thespray had been produced.)

Rite-Off officials personally pickedup Monarch's stock of 26 cases andthe 10 cases returned by sub-accounts.The recall was completed last July 28w h e n F D A v i s i t e d t h e m a n u f a c t u r e r a n d

witnessed the destruction of the entirestock. No serious il lnesses or deathswere reported.

Nobody Here But Us Tamales

One day last August, the NationalMaritime Fisheries Service (NMFS)at Terminal Island—a port location below Los Angeles—learned that a shipment of black-market clams smuggled inf r o m M e x i c o w a s t o l e a v e t h e L o s A n

geles airport going to a restaurant in Chicago. The NMFS agents had the nameof the shipper—the Stanford Company—and even the invoice numbers.

But when the agents arrived at theair freight office, there were no clamsto be seen. They did find the two cartonsthey had been told to look for, but the


labels on the outside said "tamales,"and the bills of lading said the same.

The agents checked the cartons moreclosely. They seemed awfully heavyto be tamales. Also, they sort of rattled.The agents opened them up and in eachthey found a burlap bag of clams in thes h e l l .

The clams were doing poorly andwere obviously the worse for wear, having been hauled across the Baja borderbelow San Diego and then slipped intoLos Angeles. They were long out ofthe water, covered with sand, and certainly not packed in ice. A fine treatthey would be for unsuspecting dinersup in the Windy City.

The NMFS agents seized the shipment, which totaled 120 pounds, andasked FDA's resident inspector at Terminal Island—with whom they had workedbefore—to have the FDA laboratoryin Los Angeles run some tests on thec l a m s .

The lab found no harmful bacteriaor toxins in the clams, but from their appearance, spoilage was not far away.Their handling and storage could nothave been worse, and they certainlydidn't come from a licensed supplier.

(Persons engaged in harvesting orpacking shellfish in the United Statesmust be inspected and licensed by the

states in which they operate to preventthe harvesting of shellfish from pollutedwaters. Those taken from such waterscan transmit intestinal disease such as

hepatitis A and can carry toxic chemicals. FDA and other federal agencies,such as NMFS, work closely with thestates to keep unsafe shellfish off themarket.)

The Los Angeles shipment of clamsdisguised as tamales was part of an informal but organized smuggling operationalong the California-Mexico border.In recent months, cars and trucks havebeen bringing across bags of bootlegclams, with some loads weighing up to900 pounds.

The clams are apparently gatheredby local fishermen in Mexican tidal waters of the Baja California area and thenpassed along to smugglers or broughtin by the fishermen themselves. Smugglers who are stopped at the border willsimply abandon their vehicles and theirloads, which are then confiscated by theU.S. Customs Serv ice.

Smugglers who get across the bordertake their c lams to "safe houses." There

they are repacked for air shipment outof Los Angeles to various restaurant destinations, usually on the East Coast.Persons making the shipments cannotbe traced, since they use inventednames, like the Stanford Co. mentionede a r l i e r .

Since these are violations of U.S.customs laws, they are under the jurisdiction of the U.S. Customs Service,which took over the contraband clamst u r n e d t a m a l e s .

Mourners Felled by PastaPoisoning

A f u n e r a l i s d i s t r e s s f u l u n d e r t h e b e s t

of condit ions. But for those who attended one such sad event in Middle-


town, N.J., last June, the distress wasintensified by the buffet following the funeral. About half of the 40 mournersbecame violently ill, suffering nausea,fever, headache and diarrhea—all signsof food poisoning, specifically salmonellosis, and, indeed, that's what it was.

F D A ' s N e w Yo r k d i s t r i c t o f fi c elearned of the outbreak on June 5 fromthe New Jersey State Health Department.State officials reported that the foodsmost likely to have caused the illnesseswere pasta products manufactured byRotanelli Foods, Inc., New Rochelle,N . Y .

Hard on the heels of the report ofthe outbreak came word of another. TheRockland County (New York) healthdepartment reported that 15 people became ill after attending a party . Againthe illness looked very much like salmonellosis, and the suspect foods hadbeen produced by Rotanelli Foods. Inboth cases, all the victims soon recovered.

FDA's investigation was conductedjointly with the U.S. Department ofAgriculture, the New York State Department of Agriculture and Markets, andthe New Jersey health department. Bothraw materials and finished products werecollected at Rotanelli Foods. Analysisby FDA's New York regional laboratoryfound that six of 22 samples of finishedproducts (including lasagna, manicotti,and stuffed shells) were contaminatedwith Salmonel la bacter ia .

In a meeting with FDA's New Yorkdistrict staff, officials from RotanelliFoods agreed to a nationwide recall oftheir products. The products, worth between $2 million and $3 million, wererecalled and destroyed under governmentsupervision.

The officials also agreed that the firmwould shut down and not resume man

ufacturing without the approval of FDAor the New York State Department ofAgriculture and Markets. Under theagreement, when the firm resumed man

ufacturing, it was audited by FDA andt h e s t a t e .

New York district investigators alsoc h e c k e d o u t s o m e o f R o t a n e l l i ' scustomers. One customer, Riviera Ravioli Inc., Bronx, N.Y., produced similarproducts—and also had a similar problem. Samples of cheese ravioli and blackpepper were contaminated with Salmonella bacteria. The firm destroyedthe contaminated black pepper and, atFDA's request, recalled and destroyedthe ravioli. Riviera also signed an agreement similar to Rotanelli's, stating thatit would shut down unti l the Salmonella

problem was solved. Both firms haveresumed operations and are being closelywatched by FDA and the New YorkState Department of Agriculture andM a r k e t s .

—This small sample of reports fromthe field was prepared by Carol Ballen-tine, Dixie Farley, Herman Janiger,and Richard Thompson.


Summaries of I Court Actions

Summaries of Court Actions are given pursuant to section 705of the Federal Food, Drug, and Cosmetic Act. Summaries of CourtActions report cases involving seizure proceedings, criminal proceedings, and injunction proceedings. Seizure proceedings are civilactions taken against goods alleged to be in violation, and criminaland injunction proceedings are against firms or individuals chargedto be responsible for violations. The cases generally involve foods,drugs, devices or cosmetics which were alleged to be adulteratedor misbranded or otherwise violative of the law when introducedinto and while in interstate commerce, or while held for sale aftershipment in interstate commerce.

Summaries of Court Actions are prepared by Food and DrugDivision, Office of the General Counsel, HHS.

Published by direction of the Secretary of Health and HumanServices.

S E I Z U R E A C T I O N S

Foods !Po isonous and De le te r ious Subs tances

PRODUCT: Peanuts, Tex Goober, at Little Rock, E. Dist.Ark.; Civil No. LR-C-86-66.CHARGED 2-3-86: When shipped by J.C. Traylor Farms, Inc.,Naples, Texas, the article contained the added poisonous or deleterious substance aflatoxin—402(a)(1).DISPOSITION: Consent—ordered destroyed. (F.D.C. No.64834; S. No. 86-314-362; S.J. No. 1)

Foods!Contamination, Spoilage, Insanitary HandlingPRODUCT: Artichoke linguine and other pasta products, atLa Mirada, C. Dist. Calif.; Civil No. 85-4484-JMI (Kx).CHARGED 7-9-85: When shipped by Shreveport MacaroniMfg. Co., Inc. (De Bole's Nutritional Foods, Inc.), Shreveport,La., the articles (labeled ''Artichoke Linguine [or other pasta]... Manufactured By De Boles Nutritional Foods, IncGarden City Park, NY") had been prepared, packed and heldunder insanitary conditions—402(a)(4).DISPOSITION: Default—ordered destroyed. (F.D.C. No.64658; S. No. 85-305-187 et al.; S.J. No. 2)

PRODUCT: Brazil nuts, 2 seizure actions, at Dallas, N. Dist.Texas; Civil Nos. 3-86-0306-R and 3-86-0305-R.

CHARGED 2-3-86: Whi le one unlabeled lot of nuts and one lotlabeled "Tripple HHH Brand" were held by Hines Nut Co.,Dallas, Texas (who had polished and rebagged these lots), andwhile one lot of unprocessed nuts was held for sale at a publicstorage facility, the articles contained moldy and rancid brazilnuts—402(a)(3).DISPOSITION: These articles were claimed by Hines Nut Co.,Dallas, Texas. The claimant moved for post-seizure sampling ofthe articles. The government did not oppose post-seizure sampling and entered into agreed orders for such sampling in bothseizure actions. Subsequently, pursuant to stipulation of the parties, the lot of unprocessed nuts was ordered released to theclaimant; and that action (Civil No. 3-86-0305-R) was orderedd ismissed .

In the remaining action, the unlabeled lot of nuts was similarly ordered released to the claimant, with the government releasing all claims as to such property; but the lot of nuts labeled"Tripple HHH Brand" was, by consent, condemned and wasauthorized to be released under bond to the claimant for salvaging. (F.D.C. Nos. 64835/6; S. Nos. 86-493-159 et al. and86-454-465; S.J. No. 3)

PRODUCT: Cashews in cans, at Norfolk, E. Dist. Va.; CivilN o . 8 6 - 3 2 3 - N .

CHARGED 5-15-86: When shipped from Mansfield, Mass., thearticle (labeled "Nutcracker Salted Fancy Whole Cashews ...International Nut Corp. Billerica, MA") contained insect filth—402(a)(3).DISPOSITION: Default—ordered destroyed. (F.D.C. No.64900; S. No. 86-440-922; S.J. No. 4)

PRODUCT: Flour, rice, thick soy sauce, and other foodstocks, at Philadelphia, E. Dist. Pa.; Civil No. 86-0155.CHARGED 1-10-86: While held by New Eastern Food Co.,Inc., Philadelphia, Pa., the articles were held under insanitaryconditions, and certain of the articles contained filth or were otherwise unfit for food—402(a)(3), 402(a)(4).D ISPOSIT ION: Consen t—au tho r i zed re l ease t o t he dea le r f o r

salvaging. (F.D.C. No. 64812; S. No. 86-474-056 et al.; S.J.No. 5)

PRODUCT: Flour, peanuts, cornstarch, cornmeal, breakfastcereal, cherry-flavored drink mix, candy, and other foodstocks, in permeable and impermeable containers, at Forrest


City, E. Dist. Ark.; Civil No. H-C-85-16.CHARGED 2-8-85: While held by Forrest City Grocery Co.,Forrest City, Ark., the articles had been held under insanitaryconditions, and some of the articles contained rodent filth—402(a)(3), 402(a)(4).D ISPOSIT ION: Consen t—autho r i zed re lease to the dea le r fo r

salvaging. (F.D.C. No. 64506; S. No. 85-313-809; S.J. No. 6)

PRODUCT: Flour, rice, cherry-flavored drink, and otherfood stocks, at Jacksonville, M. Dist. Fla.; Civil No. 86-77-C l V- J - 1 2 .CHARGED 2-3-86: While held by Chitty & Co., Jacksonville,Fla., the articles had been held under insanitary conditions; andsome of the ar t ic les conta ined rodent f i l th—402(a) (3) ,402(a)(4).DISPOSITION: The dealer filed a claim to the articles. The parties appeared before the court to discuss what was needed to bedone. Subsequently, a consent decree authorized release of thearticles to the dealer for salvaging. (F.D.C. No. 64838; S. No.86-356-625 et al.; S.J. No.7)

PRODUCT: Flour, starch, sugar, rice, and other food stocks,at Norfolk, E. Dist. Va.; Civil No. 86-54-N.CHARGED 1-31-86: While held by Norfolk Noodle Factory(Park F. Wong), Norfolk, Va., the articles had been held underinsanitary conditions, and one lot of flour contained rodentfilth-^02(a)(3), 402(a)(4).D ISPOSIT ION: Consen t—autho r i zed re lease to the dea le r fo r

salvaging. (F.D.C. No. 64831; S. No. 86-361-088 et al.;S.J.No. 8)

PRODUCT: Mushroom pieces and stems, canned. Sonny'sPride, at Kelton, E. Dist. Pa.; Civil No. 86-0323.CHARGED 1-17-86: When shipped by Ron Son MushroomsProducts, Inc., Glassboro, N.J., the article was unfit for fooddue to swollen and leaking containers—402(a)(3).DISPOSITION: Defaul t—ordered destroyed. (F.D.C. No.64787; S. No. 85-474-321; S.J. No. 9)

PRODUCT: Wheat berr ies, mung beans, and other food

stocks, at Austin, W. Dist. Texas; Civil No. A-86-CA-134.CHARGED 3-7-86: While held by Yellow Rose CooperativeWarehouse, Austin, Texas, the articles had been held under insanitary conditions—402(a)(4).D ISPOSIT ION: Consen t—au tho r i zed re lease to t he dea le r f o r

salvaging. (F.D.C. No. 64866; S. No. 86-492-343 et al.; S.J.No. 10)

Foods!Economic and Labeling Violations

PRODUCT: Chocolates, bottle-shaped and liquor-filled, atEnglewood, Dist. Colo.; Civil No. 86-F-723.CHARGED 4-15-86: When shipped by Chocolate Liquor Bottles, Inc., Manteno, 111., the articles were confectionery andcontained alcohol (approximately 1.7 percent to 3.9 percentfrom rum, scotch, amaretto, et al.) other than alcohol derivedsolely from use of flavoring extracts—402(d)(2).DISPOSITION: Default—ordered destroyed. (F.D.C. No.64841; S. No. 86-379-045 et al.; S.J. No. 11)

PRODUCT: "Orange" juice, concentrated, frozen, BodineGeneric, at Columbus, S. Dist. Ohio; Civil No. C-2-85-1012.CHARGED 6-21-85; When shipped by Bodine's Inc. FoodProducts, Chicago, 111., the article had had grapefruit solids (indicated by the presence of naringin) substituted for orangejuice—402(b)(2); the article had added grapefruit solids mixedor packed with the article so as to increase its bulk or weight andto reduce its quality—402(b)(4); and the article failed to conform to the definition and standard of identity for frozen concentrated orange juice —403(g)(1).DISPOSITION: Consent—authorized release to the shipper forbringing into compliance. (F.D.C. No. 64657; S. No.85-385-383; S.J. No. 12)

DrugslHuman UsePRODUCT: Cefaclor capsules, 2 seizure actions, at Eagan,Dist . Minn. , and Woonsocket , Dist . R. I . ; Civ i l Nos. CA85-0758 and 4-85-1572.CHARGED 11-18-85 and 12-6-85: When shipped by QualityKing Distributors, Inc., Deer Park, N.Y., the article was a


counterfeit of Ceclor brand of cefaclor capsules in that the articleand its labeling, without authorization, bore the trademark, tradename, and other identifying likeness of a drug manufacturerother than the person who in fact manufactured the article—201(g)(2); and the article contained for purposes of coloring thenonconforming color additive Patent Blue V—501(a)(4)(A).DISPOSITION; Default—ordered constructively destroyed bydelivery to FDA. (F.D.C. Nos. 64778/9; S. Nos. 85-296-090and 85-358-562; S.J. No. 13)

PRODUCT: Ephedrine sulfate tablets, S. Dist. Ga.; Civil No.C V 4 8 6 - 1 4 7 .CHARGED 4-16-86: When shipped by manufacturers inBohemia and Ronkonkoma, N.Y., Omaha, Neb., and Burn-ham, Pa., the article (labeled ''Stimulant Ephedrine Sulfate ...Distributed by Southside Specialty . . . Montgomery RoadsSavannah, Ga.'') was a new drug without an effective approvedNew Drug Application—505(a); while held by Southside Specialty, Savannah, Ga., who was repacking the OTC look-alikedrug, the article's labeling lacked adequate directions for useand was not exempt from such requirement, due to the article'snew drug status—502(f)(1); and the circumstances used for thepacking, processing and holding of the article failed to conformwith current good manufacturing practice—501(a)(2)(B).DISPOSITION: Default—ordered destroyed. (E.D.C. No.64862; S. No. 86-483-007 et al.; S.J. No. 14)

PRODUCT: Nu-Path tablets, at Watertown, Dist. S.D.; CivilNo. 86-1027.CHARGED 6-9-86: While held by Fashion Magic Distributors,Inc., Watertown, S.D., the labeling of the article (which was labeled "Homeopathic and Nutritional Formulation NU-PATH450 Tablets ... Vital Life Las Vegas, Nevada" and which wasaccompanied by a letter reading "March 2, 1986 ... Dear ...Nu-Path (formerly called By-Pass) .. . Don & Elaine" and aninsert reading "Information For Bypass Users") failed to bearadequate directions for the article's intended use for oral chelation treatment of occlusive vascular disease, and the article wasnot exempt due to its new drug status—502(0( 1); and the article's labeling was false and misleading due to representations

and suggestions that there was substantial scientific evidence toestablish that the article was safe and effective for oral chelationof occlusive vascular disease—502(a).DISPOSITION: Default—ordered destroyed. (F.D.C. No.64868; S. No. 86-472-068 et al.; S.J. No. 15)

PRODUCT: Pbenobarbital tablets, at Allentown, E. Dist Pa •C iv i l No . 86 -1021 .CHARGED 2-21-86: While held by Vale Chemical Co., Inc.,Allentown, Pa., the article fell below official compendium(U.S.P.) standards, because the article failed the dissolution requirements—501 (b).DISPOSITION: Default—ordered destroyed. (F.D.C.No.64824; S. No. 85-417-964; S.J. No. 16)

PRODUCT: Starch Blocker special legume protein concentrate tablets, at Deerfield Beach, S. Dist. Fla.; Civil No.8 2 - 6 6 3 8 - C i v - W M H .CHARGED 10-7-82: When shipped by Puritan's Pride VitaminWorld, Inc., Bohemia, N.Y., and by others, the articles (someof which were labeled "Starch Blocker Special Legume ProteinConcentrate ... Tablets ... inhibits the digestion ... starch ...Puritan's Pride [or "Nature's Bounty, Inc."] Bohemia, NewYork") were new drugs without effective approved New DrugApplications—505(a).DISPOSITION: The action was transferred to the S. Dist. ofN.Y. Ultimately, following a Court of Appeals opinion favorable to the government on the issues in the action, the articleswere ordered destroyed. (F.D.C. No. 63812; S.No. 82-239-765etal.;S.J. No. 17)

DrugslVeterinary

PRODUCT: Amino acid solutions for injection, at BlueSprings, W. Dist., Mo.; Civil No. 86-0083-CV-W-0.CHARGED 1-21-86: When shipped by Quality Plus ProductsCo., Inc., Fort Dodge, Iowa, the articles (labeled "Amino Lyte.. . amino acids ... B-Vitamins, electrolytes and dextrose ...Preservatives. Manufactured for Durvet, Inc. Blue Springs,Missouri" and "Amino Lyte 34x Concentrate ... amino acids


... B-Vitamins, electrolytes and dextrose in concentrated solut i on . . . P rese rva t i ves . . . Manu fac tu red f o r Du rve t , I nc . B lue

Springs, Missouri") were new drugs without effective approvedNew Drug Applications—501(a)(5).DISPOSITION: Consent—authorized release to Durvet, Inc.,Fort Dodge, Iowa, for relabeling. The decree also contained aprovision against the sale or distribution of such articles withany preservative and a provision providing for certain altereddistribution and labeling of the claimant's amino acid solutionsunder specified circumstances. (F.D.C. No. 64791; S. Nos.85-462-611/2; S.J. No. IS)

M e d i c a l D e v i c e s

PRODUCT: Bandages, Form-Cut Plastic Strips, at Buffalo,W. Dist. N.Y.; Civil No. 82-474-E.CHARGED 6-1-82: The articles (which had been manufacturedby Medex Products Corp., Buffalo, N.Y.) had been prepared,packed and held under insanitary conditions—501(a)(2)(A); andthe circumstances used for the articles' manufacture, packingand storage failed to conform with prescribed good manufacturing practices—501(h).D I S P O S I T I O N : C o n s e n t — a u t h o r i z e d r e l e a s e t o t h e m a n u f a cturer for salvaging. (F.D.C. No. 63723; S.No. 82-285-506; S.J.No. 19)

PRODUCT: Clamps for medical use, radiopaque, sterile, atFairport, W. Dist. N.Y.; Civil No. 85-0513T.CHARGED 4-17-85: The articles (which had been assembledand packaged by Duotek, Inc., Fairport, N.Y., and which werelabeled "Radiopaque External Clamp ... Sterile ... HealthmedCorporation . .. Fairport, N.Y.") had been manufactured,packed and stored under circumstances that failed to conform toprescribed good manufacturing practices—501(h).DISPOSITION: Consent—ordered destroyed. (F.D.C. No.64539; S. No. 85-479-583; S.J. No. 20)

PRODUCT: Surgical blades, at Fort Lee, Dist. N.J.; Civil No.8 5 - 2 9 2 7 .

CHARGED 6-14-85: The article, which was manufactured forand imported by Surgical Instrument Corp. of America, Inc.,

Fort Lee, N.J., and which was labeled "Sterile Carbon SteelSurgical Blades Sterilized by Gamma Radiation ... made inSheffield, England," was represented to be sterile, but itsquality fell below its represented quality, because its packagingcontained openings compromising the sterility of the contents—501(c); and the article's labeling claim of sterility was false andmisleading because of such package openings—502(a).DISPOSITION: The importer claimed the article and denied thecharges. The parties served written interrogatories on eachother. Subsequently, a consent decree authorized release to theimporter for salvaging (i.e., re-export to manufacturer of anysuspect blades and release to claimant of any remaining blades).(F.D.C. No. 64639; S. No. 85-311-993; S.J. No. 21)

PRODUCT: Transcutaneous e lect r ica l nerve st imulators,Pro-Med-100, at Leesburg, M. Dist. Fla.; Civil No. 85-95-C I V - O C - 1 6 .CHARGED 4-19-85: The labeling of the article (which had beenimported from Taiwan by Richard E. Brown & Assoc.,Leesburg, Fla., and which was accompanied by labeling readingas follows: (sleeve) "Health Message ... No need for shots ...No need for drugs Absolutely safe" and (manual) "InstructionManual A Guide to Your Correct Understanding and Use")failed to bear the required information for use under which licensed practitioners could use the device safely for the intendedpurpose—502(f)(1); the article's label lacked the name andplace of business of the manufacturer, packer or distributor; andits labeling lacked the prescription legend—502(0(1).DISPOSITION: Default—ordered destroyed. (F.D.C. No.64534; S. No. 85-333-763; S.J. No. 22)

PRODUCT: X-ray system, at Cape Coral, M. Dist. Calif.;C i v i l N o . 8 4 - I 6 2 - C i v - F T M - 1 5 .CHARGED on o r abou t 10 -22 -84 : The a r t i c l e l abe led "C-Arm... warning ... dangerous ... SIAS Bologna" (which had originally been imported for testing purposes, but had been subsequently sold to a hospital) had been manufactured and preparedin an unregistered establishment, and its manufacturer had notfiled the required pre-market notification—502(o); the methodsand controls used for the art icle's instal lat ion fai led to conform


with the regulation's requirements—501(h): and required labelinformation was not in such terms as to render it likely to be readand understood, because such information was in Italian ratherthan English—502(c).DISPOSITION: Default—ordered destroyed. (F.D.C. No.64356; S. No. 83-271-698; S.J. No. 23)

C R I M I N A L A C T I O N S

DEFENDANT: Frank A. Lucero, president of a medical diagnostic test-kit firm, Tempe, Dist. Ariz.; Criminal No.C R - 8 4 - 1 9 1 - W P C .CHARGED 6-6-84: That, in a matter within the jurisdiction ofFDA, the defendant knowingly submitted a Premarket ApprovalApplication containing materially false representations that certain medical tests had been performed concerning a gonorrheatest kit when, in fact, they had not—18 U.S.C. 1001.DISPOSITION: Guilty plea—five years' probation, and$10,000 fine. (Misc. No. 693; S.J. No. 24)

I N J U N C T I O N A C T I O N S

DEFENDANTS: Robert L. Crocker (t/a Farmville DiscountDrug), and Farmville Discount Drug, Inc., Farmville, E.D is t . N .C . ; C i v i l No . 84 -87 -C IV-8 .CHARGED 12-12-84 and amended 4-18-85, in a complaint forinjunction: That the individual defendant did business until July9, 1984, as Farmville Discount Drug, at Farmville, N.C., andsubsequently incorporated his business as Farmville DiscountDrug, Inc.; that the defendants, at Farmville, N.C., manufactured, processed, packed, labeled and distributed in interstatecommerce certain new drugs labeled "Sargenti RC2B Root Canal Cement" and "Prednisolone Root Canal Dressing"; that noapproved New Drug Applications were in effect for such drugs;that the defendants, drug producers, had failed to register andfailed to list each of their drugs with FDA; and that the defendants were well aware of the new drug status of their drugs—505(a), 510, 301(p).DISPOSITION: The individual defendant (who was the sole defendant named in the original complaint) denied the charges and

moved to dismiss the action, on the ground that the defendantwas incorrectly identified (as "Robert L. Crocker, an individualdoing business as Farmville Discount Drug") because he was nolonger doing business as Farmville Discount Drug since Farmville Discount Drug was incorporated on July 9, 1984. The individual defendant also asserted that the corporation was necessary as a defendant for adjudication of the action. The individualdefendant similarly objected to the government request for theproduction of documents. The U.S. magistrate recommendedthat the defendant 's mot ion to dismiss be denied and that the

government amend its complaint to add the corporation. Afterthe government filed the amended complaint for injunction, thedistrict court concluded that the magistrate's recommendationwas correct, adopted the recommendation as its own, and ordered the defendant's motion denied. Subsequently, a consentdecree of permanent injunction was filed which permanently enjoined the complained of violations, and enjoined operations involving the interstate shipment of any such drugs, or their production from interstate components, unless and until a numberof specified conditions were met. (Inj. No. 1061; S. No.82-285-433; S.J. No. 25)

DEFENDANTS: Northern Wholesale Veterinary Supply,Inc., and Mary Lynn Fliflet, president, Onalaska, W. Dist.Wis., Civil No. 84C 963 C.CHARGED 12-5-84 in a complaint for injunction: That the defendants, at Onalaska, Wis., operated a retail store and conducted an extensive mail-order business in various drugs, including veterinary prescription drugs; that the defendants hadbeen selling veterinary prescription drugs to lay persons withoutveterinarians' prescriptions; that FDA inspections revealed theover-the-counter distribution of veterinary prescription drugsand the lack of controls over the distribution of veterinary drugs;that FDA investigators made interstate mail-order purchases,without prescriptions, of a number of prescription veterinarydrugs from the defendants; that such mail-order purchases included chloramphenicol capsules, dexamethasone solution, andchorionic gonadotropin for injection; and that the defendantswere we l l aware tha t the i r ac t i v i t i es were in v io la t i on o f thelaw—502(D(1).

F D A C o n s u m e r / M a r c h 1 9 8 7 I 4 7

DISPOSITION: Consent decree of permanent injunction againstMary Lynn Fliflet enjoined the complained of violations as toher. The corporation litigated the action. Meanwhile, the ownership and management of the corporation changed, and the individual defendant was no longer an officer of the corporation.Subsequently, FDA inspection reflected corporation improvements and, pursuant to stipulation, the action against the corporation was dismissed. (Inj. No. 1072; S. No. 84-488-185 et al.;S.J. No. 26)

M I S C E L L A N E O U S A C T I O N S

SUBJECT: Hearing-aid conditions of sale, and discrepanciesbetween FDA and state requirements, Boston, Dist. Mass.;C i v i l No . 82 -1292 .CHARGED 2-24-82 by the Commonwealth of Massachusettsagainst Acting FDA Commissioner Mark Novitch in a suit forjudicial review: that Section 72 of the 1977 Massachusetts Actentitled ''Regulating the Sale of Hearing Aids" prescribed requirements that differed from the federal requirements, since theMassachusetts Act requires a hearing test evaluation in additionto a medical clearance evaluation (neither of which evaluationscould be waived except upon religious beliefs), and also requiresthat a contract for sale of a hearing aid device might not be entered into unless the evaluation requirements were met; thatMassachusetts filed an application for exemption from federalpreemption, but FDA granted an exemption from federal preemption only with respect to the provision concerning sale to achild under the age of 18; that Massachusetts' more stringent requirements were necessitated by compelling local conditions;and that the denial of Massachusetts' application for exemptionwas an action which was arbitrary, capricious, and an abuse ofd i s c r e t i o n .DISPOSITION: The parties filed motions for summary judgment. The District Court ruled in favor of the federal government. Massachusetts' position had been: 1) that the FDA regulations should have focused upon the burden on interstatecommerce posed by the state requirements and should not havetaken into account costs, availability, or other public health concerns; and 2) that FDA misapplied its own regulations due to in

adequate consideration of relevant factors concerning hearingevaluation and waiver requirements. The court found that theFDA regulations were reasonably related to the purposes of theenabling statute and that, although neither the "best interests ofpublic health" nor the "potential burden on interstate commerce" were factors expressly included in Section 521(b) of theMedical Device Amendments, yet both were appropriate considerations, as were the cost and the availability of medical devices. The court also found that FDA had extensively consideredthe wisdom of requiring an audiological evaluation before thepurchase of a hearing aid and had, upon such consideration,concluded that the public health would not be best served by requiring mandatory audiological evaluations.

The Commonwealth of Massachusetts appealed, but the Courtof Appeals found that FDA had applied its validly promulgatedstandards rationally and with reasoned explanation, and therefore affirmed the District Court's decision. The Court of Appeals noted that Massachusetts had made no comment on or objection to the questioned regulation—21 C.F.R. 808.25(g)(3)—before its final promulgation, and noted that Massachusetts hadhad actual notice. The Court of Appeals found that FDA's statutory authority to grant exemption from preemption was plainlydiscretionary and that FDA was well within its discretion, sincethe overriding purposes of the Medical Device Amendments was"to protect the public health" by ensuring "the safety and effectiveness of medical devices." The Court of Appeals agreed withFDA that additional regulatory requirements must be affirmatively justified as promoting public health if the regulated dev i c e s w e r e o t h e r w i s e s a f e a n d e f f e c t i v e .

Although FDA had ruled that mandatory audiological testingwas undesirable despite "conflicting and inconclusive" evidence of increased costs, and although FDA has relied on"strong state and local licensing provisions" when Massachusetts had not adopted such requirements for hearing aid dealers,the Court of Appeals found: that FDA had earlier considered andrejected such requirements in its own rulemaking; and thatFDA's reliance on its initial conclusions was not inappropriate,in the absence of new evidence indicating the desirability ofsuch requirements or their particular efficacy in Massachusetts.(Misc. No. 644; S.J. No. 27)

48 / March 1987 / FDA Consumer ☆ U . S . G O V E R N M E N T P R I N T I N G O F F I C E 1 9 8 7 - 1 8 1 - 3 4 1 / 6 0 0 0 2

SAVE A CHILDUse Child-Resistant Containers

MAKE ITulmOPEN"PUSH-AND-TURN" CONTAINERS

F i r s t . . .P u s h D o w nH A R D

T h e n . . .Tu rn Le f t

COUNTER OR TABLE TOP

When children are around:Close containers tightly • Store out of sight and out of reach

C o n s u m e r P r o d u c t S A F E T Y A L E RTFrom the U.S. Consumer Product Safety Commission, Washington, D.C. 20207