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Using herbs and other natural substances to fashionpotions to treat illness and disease is a practice that datesback thousands of years. Today, herbal products can bepurchased in thousands of retail outlets. The NaturalMarketing Institute reports that dietary supplementsincluding vitamins, minerals, and herbal remedies soldin retail stores rose 6% in 2003 to $19 billion. It esti-mates that 1500 herbal and botanical products are nowavailable in retail outlets.

Although many people take herbal and vitamin for-mulas for medical purposes, the federal government

does not consider them medicines. Even herbs contain-ing ephedra, which was used to treat asthma in the earlyand mid-20th century and has a long history of causinginjury and death, is still legal.

Government Oversight ScarceThe Dietary Supplement Health and Education Act

of 1994 (DSHEA) restricts the US Food and DrugAdministration’s (FDA) control over dietary supple-ments and expands the meaning of the term “dietarysupplements” beyond essential nutrients to include gin-

What Are They,and How AreThey Regulated?

Type “asthma cures” into your favorite search engine and you’ll

discover thousands of high-tech hucksters claiming their “all natural”

cures for asthma ranging from ginger water to exotic tree bark from

the Philippines. The proliferation of Web sites touting “miracle

cures” for asthma and allergies that work in as little as one week

dovetails with a growing interest in legitimate complementary and

alternative medicine (CAM). In its 2005 report titled, Complementary

and Alternative Medicine in the United States, the Federal Institutes

of Medicine reports more than one-third of adults state that they

have pursued some form of CAM treatment, such as herbal reme-

dies and acupuncture.

By Gregory Alford

Not Food, Not Medicine:UnderstandingDietary Supplements

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seng, kava, garlic, fish oils, herbals, botanicals, enzymes,and amino acids. As a result, “dietary supplements arenot regulated by the Food and Drug Administration thesame way prescription and over-the-counter medicationsare,” says Joan Pleuss, registered dietician andBionutrition Research Manager at the Medical Collegeof Wisconsin in Milwaukee. “They do not have to meetthe same standards for safety, effectiveness, and what theFDA calls ‘good manufacturing practices.’ ”

Instead, dietary supplements are considered morelike food in that their manufacturers and distributorsare largely responsible for ensuring the safety of theirproducts. Once a product enters the marketplace, theFDA does have the authority to take action against anydietary supplement product that presents a significantor unreasonable risk of illness or injury. However, in2004, the Supreme Court invalidated the FDA’s actionof removing ephedra from the market citing that it hadoverstepped its regulatory authority.

Supplement marketing is drawing considerable atten-tion from both the medical community and the federalgovernment. The DSHEA prohibits supplement labelsor marketing materials from claiming the product cantreat, prevent, diagnose, or cure specific diseases. TheFDA can take action against companies that violatemarketing rules, but the number of companies makingillegal claims on the Internet makes enforcement of thislaw problematic.

In 2003, the Journal of the American MedicalAssociation published a survey of health claims made onWeb sites touting dietary supplements. The surveyfound that “the public may be misled by vendors’ claimsthat herbal products can treat, prevent, diagnose, or curespecific diseases.” It found that 81% of supplementretail Web sites examined made at least one healthclaim. More than half of those sites contained illegalclaims. The study authors concluded that “more effec-tive regulation is required to put this class of therapeu-tics on the same evidence-based footing as other medici-nal products” (JAMA 2003;290:1505-9).

Triggering Allergic Reactions “I think there are useful substances in some herbs,”

says Marianne Frieri, MD, PhD, director of AllergyImmunology Training, and Clinical Immunopathologyat Nassau County Medical Center in East Meadow, NY.“But there is a lot of misleading information and conta-minated products on the market at the current time.What is needed are more controlled, double-blind peer-reviewed studies to provide more information about theeffects of herbs on health and disease processes.”

Some supplements, such as cayenne and St. JohnsWort, can interact with medications used to treat asth-ma, including the drug theophylline. Furthermore, sheadds that an important but often overlooked aspect of

What to Know Before Taking ASupplement

According to Clifford W. Bassett, MD,Attending, Department of Immunology andAllergy, Long Island College Hospital, NY, peo-ple with the following medical conditions maybe at higher risk for side effects associatedwith herbal supplements:

• High blood pressure

• Blood clotting problems

• Thyroid disease

• Enlarged prostate

• Glaucoma

• Parkinson’s disease

• Stroke

• Heart disease

• Epilepsy

Dr. Bassett provides the following tips to pro-vide assistance in the use of medicinal herbalremedies:

• Never give dietary supplements or herbalremedies to children without consulting apediatrician

• People about to undergo surgery mustinform their doctor regarding the use ofherbs

• Do not take supplements during pregnancyor while breast-feeding, as they could haveeffects on your baby

• Let your medical provider know which sup-plement you are using as some may have aninteraction with prescription and over-the-counter medications

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consuming herbal products is the potential for allergicreactions. For example, Dr. Frieri says that Echinacea,an herb often promoted as an asthma treatment, cantrigger anaphylaxis in people with a ragweed or sun-flower seed allergy. “An allergic person should be cau-tious about consuming any herbal supplement,” addsDr. Frieri. “Chamomile, a popular herb used in tea, cancause an allergic reaction in many people with ragweedallergies. And some herbal products contain moldspores that can trigger allergies and asthma.”

Sometimes, people get more than they paid for in adietary supplement. FDA testing of herbal supplementsregularly finds products that contain various steroids,heavy metals, and drugs that require a prescription inthe United States. When it finds these kinds of prod-ucts, the FDA blocks their importation, because theyare supplements with ingredients not listed on the prod-uct label.

“The number of herbal products is mind boggling,”says Dr. Frieri. “The FDA is overwhelmed. Physiciansare overwhelmed. The public is overwhelmed. Physiciansand the public need to be better educated about herbalsupplements because they are not going away.”

In the long run, Dr. Frieri says she is optimistic thatbeneficial properties will be found in herbs that can beextracted and purified, eventually benefiting asthmatics.Progress in research and education continues to bemade. The National Center for Complementary andAlternative Medicine, which is part of the NationalInstitutes of Health, as well as major universities andmedical centers, are sponsoring research on herbals andserve as reliable sources of information for physiciansand the public.

More Regulation on the Horizon?Pressure is mounting for stricter regulation of dietary

supplements. Senator Dick Durbin (D-IL) authored the

Dietary Supplement Safety Act in 2004. The bill wouldrequire that dietary supplement manufacturers reportserious adverse health events, such as heart attack,seizure, stroke, or death, to the FDA in a timely fash-ion. The bill would also require manufacturers of themost dangerous types of dietary supplements, stimu-lants, to submit proof that their product is safe prior tobringing it to market. However, the bill has never madeit out of committee.

What to Know Before Buying aDietary Supplement• Money back guarantees: Supplement

manufacturers know from experience that asubstantial percentage of people who buyineffective products will not ask for theirmoney back. Psychologists refer to this is“sunk cost” theory. As a result, products thatfail to live up to their promises can make agreat deal of money for their manufacturersand distributors.

• Ignore personal testimonies: Researchhas confirmed that even fake treatment madefrom an inactive substance, such as sugar,can have a “placebo effect.” A sham supple-ment or medication can improve people’shealth simply because they expect that it will.Even in controlled medical studies, it is nor-mal for about one-third of people to feel bet-ter in response to “treatment” with a placebo.

• Safety first: Some supplement ingredients,including nutrients and “natural” plant com-ponents, can be toxic.

• Ignore headlines: Asthma treatmentsshould be based on long-term research, nota single study. Be wary of claims that departfrom accepted scientific research.

• Spot false claims: Heed the saying, “Ifsomething sounds too good to be true, itprobably is.”

• Natural is not always better: Naturalingredients can be harmful in their own right.Natural substances can interact with medi-cine, be inappropriate for many health condi-tions and be harmful in high doses. Forexample, tea made from peppermint leavesis usually safe to drink, but peppermint oil(extracted from the leaves) is highly concen-trated and can be toxic.

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“Some products should be reviewed for safety beforebeing sold,” says Sen. Durbin, “and when evaluatingwhether sales of a problematic product should be sus-pended, the FDA should adopt the science-based stan-dard of ‘unreasonable risk’ rather than the standard oflegal certainty that is currently being used.”

Senator Orrin Hatch (R-UT), one of the authors ofthe 1994 DSHEA, blames lax enforcement of the Act bythe FDA for the perception that the industry is out ofcontrol. He says the Act was written to combat decadesof FDA animosity toward the supplement industry. Hesays the Act gave enforcement tools to the FDA that ithas underutilized.

“It has been obvious to even the most casualobservers that problems exist—problems that, in myview, could be handled by proper application of thelaw,” says Sen. Hatch. “For example, there are a host ofproducts in the marketplace making illegal claims. Iintend to continue our dialogue to make certain theyhave the tools they need to help maintain the publichealth, but to do so in a way that departs from FDA’spast history of animosity against healthful products.”

Dr. Frieri’s number one recommendation for peopletaking any type of supplement is that they tell theirphysician what they are consuming to help avoid interac-tions with medications. Even better would be to discussthe topic with a physician before taking any supplement.

Gregory Alford is a freelance writer and health columnistfor several newspapers in Illinois.

Reprint orders: Elsevier Inc., 11830 Westline Industrial Dr., St. Louis, MO 63146-3318; phone: 314-453-4350.doi:10.1016/j.asthmamag.2005.10.001

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Web Resources for More Information

The FDA Center for Food Safety and AppliedNutrition: www.cfsan.fda.gov/list.html

Mayo Clinic Complementary and AlternativeMedicine Center: www.mayoclinic.com

The National Center for Complementary andAlternative Medicine:http://nccam.nih.gov/health/supplements.htm

University of Utah Complementary andAlternative Medicine:http://uuhsc.utah.edu/healthinfo/adult/altmed/index.htm

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