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Pediatric Nutrition and Diet Issues of TM

Ann Weidenbenner, MS, RD, LDAnnette Haban-Bartz, MS, RD, LD

Bowel and Bladder Diet Issues■ Constipation

– high fiber – sorbitol– increased liquids– oils in diet

■ Diarrhea– replace lost fluids and electrolytes– adequate nutrition

■ Neurogenic bladder

Why use botanicals/herbs/supplements?

■ Looking for a cure■ “Just in case”■ Looking for a sense of control■ Natural versus synthetic■ Perceived lower cost of care

Supplements■ Vitamin

– Vitamin C • maintains skin integrity• helps heal wounds • important in immune function although no

available research to show that high supplements improves healing in healthy people

• Don’t overdose• maximum daily intakes

Supplements■ Transfer factor (from animals -- cows)

– people take it to improve immune system– little available information for effectiveness– concern about contamination with diseased

animal parts (Mad Cow Disease)– may improve stool frequency in AIDS

patients– No evidence that Transfer Factor is

effective for any indication.

Parents need to know■ Natural” doesn’t mean safe.■ Herbal-pharmaceutical and

herbal-herbal interactions occur.

■ Lack of standardization = variable results.

■ Contamination can occur, especially with heavy metals.

■ There is a lack of information about use with children.

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Parents need to know

■ Don’t use larger than recommended dosages.

■ Longer-term safety is not known.■ Avoid herbal treatments with known

adverse and toxic effects.■ Check with professionals before using

herbal treatments with children.■ Talk about your herbal therapies with

your doctor and other health professionals.

Gluten-free diet

■ Gluten-free diet has been used with some patients who claim that it helps with symptoms.

■ No research related to TM is available.■ This diet Is a very restrictive diet and

can be difficult to follow, but is not harmful as long as there are enough calories available for growth.

Drug/Nutrient Interactions

■ Medications can cause alterations in the absorption of nutrients.

■ Medications can cause concerns about eating, weight and other nutrition related issues.

Suggestions for relief of nutrition-related side effects of drugs

■ Taste and smell dysfunction– mask taste with food,

fruit juices or milk.– use gum, candy,

mints or lemon juice as mouth rinses

– encourage good oral hygiene

Suggestions for relief of nutrition-related side effects of drugs

■ Loss of appetite– provide calorically dense foods

or supplements– enhance flavors with

seasonings– provide variety– create pleasant eating

environment; limit distractions and pressures

– small frequent meals

Suggestions for relief of nutrition-related side effects of drugs

■ Epigastric distress– after taking drug, remain upright for

15-30 min.– identify individual foods that may

contribute to epigastric distress– offer small, frequent meals– avoid extremely hot or cold foods

or liquids

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Antibiotics

■ Erythromycin– take with water and on empty

stomach– food decreases absorption of

some forms of drug– possible:

• anorexia, n/v, diarrhea, oral yeast infection, epigastric distress

– caution with lactation

Antibiotics

■ Amoxicillan– recommend high fluid intake to increase

drug absorption– possible:

• GI distress, including diarrhea and n/v– caution with lactation

Antibiotics

■ Azithromycin– food can decrease

absorption by half– possible:

• n/v, abdominal pain, diarrhea– caution with lactation

GI Drugs■ Ranitidine (Zantac -- receptor

antagonist) – can induce Vit B12 depletion– increased risk of bleeding– limit caffeine– diet may be bland; take drug with meals– possible:

• n/v, abdominal pain, diarrhea, constipation– caution with lactation

CNS Drugs

■ Phenobarbital (anticonvulsant)– folate deficiency resulting in possible

megaloblastic anemia– Increases metabolism of Vit D and Vit K

• Vit D deficiency in long term use leading to Ca deficiency

• Vit K deficiency, especially in infant whose mother has taken drug

– increases Vit C and Vit B12 requirements

CNS Drugs■ Phenobarbital, continued

– Vit B6 may decrease drug effects

– possible:• n/v, constipation

– not for use with lactation– avoid alcohol and limit

caffeine

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CNS Drugs■ Phenytoin (Dilantin -- antiseizure)

– same vitamin concerns as Phenobarbital– high folic acid intake can interfere with

seizure control– possible gum hyperplasia, altered taste,

n/v, constipation,rickets or osteomalacia– Tube Feedings can decrease bioavialability

of the drug – caution with diabetes, can lead to

increased blood glucose

CNS Drugs

■ Gabapentin (Neurontin)– possible increase in weight and appetite– dry mouth or throat or stomach upset

Antidepressants■ Tricyclic antidepressants (Elavil,

Tofranil, etc..)– can cause taste changes and dry mouth– constipation or diarrhea and gas– possible reflux– increased appetite – weight gain– increased need for Riboflavin (B2)– limit caffeine intake – caution with lactation

Antidepressants

■ Serotonin re-uptake inhibitors (Prozac, Zoloft, Paxil)– Food increases drug’s absorption– anorexia with possible weight loss– nausea – diarrhea or constipation– dry mouth

Anti-anxiety

■ Benzodiazepines (Xanax, Klonopin, etc..)– gi distress (constipation, cramps or

diarrhea)– nausea/vomiting– weight loss or weight gain– increased salivation or dry mouth– caution for lactation

Laxatives (over the counter)■ EX-lax, Dulcolax

– increased intestinal movement can cause potassium deficiency.

– Long term use can decrease potassium and calcium stores.

– Nausea, belching, abdominal cramps and diarrhea

– Take on empty stomach with fluid.– Do not take within one hour of milk or

taking calcium or magnesium supplement

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Antispasmodic

■ Oxybutynin Cl (Ditropan)– Dry mouth– Nausea/vomiting– constipation– decreased GI motility

Steroids■ Prednisone

– possible: weight gain due to appetite or edema; stunting of growth in children with long term use; increased risk of drug-induced osteoporosis

– caution with diabetics– caution with lactation– some recommend multivitamin/mineral

supplement– diet may be low sodium and high protein

Questions?

Can Drinking Juice Help Ease Constipation?

Some juices are helpful in treating constipation. Pear, prune and apple juices all naturally contain the sugar alcohol, sorbitol that is poorly absorbed by the intestines. The sorbitol stays in the intestines for a longer time and pulls water back into the intestinal tract causing the contents to have more fluid and move easier through the bowel. These juices also contain fructose, a sugar found in many fruits, which can also be poorly absorbed. These two sugars together can increase the fluid in the bowel contents and make the bowel movement softer and more easily moved by your child.

Because sorbitol has in fact been used as a medication to alleviate constipation in extreme cases, using sorbitol containing juices and foods must be done with caution. Cramps or diarrhea can occur when too much sorbitol is taken. One 8 ounce glass of pear juice can contain as much as 7 grams of sorbitol. As little as 10 grams of sorbitol has been known to cause diarrhea in children. So, use discretion when giving juice to your child. Start out with a little and increase as needed. Clinical Nutrition Children’’s Hospital 6/2002

Ways to Increase Your Fiber Intake

The American Academy of Pediatrics suggests that children should eat daily at least 1 gram of fiber per pound of body weight but no more than 35 grams of fiber, yet the average American only eats 11 grams per day. Here are some suggestions to increase your fiber. You can find out how much fiber is in your food by looking at the Nutrition Facts Label on your food. Remember to look at the serving size also. ν Add kidney beans, garbanzos or other bean varieties into your salads. Each half-cup

serving is approximately 7-8 gram of fiber. ν Sprinkle wheat germ or bran onto your favorite cereal (hot or cold). ν Use whole-wheat flour when possible in your cooking

and baking and choose whole grain bread. Look on the label for breads with the highest amount of fiber per slice.

ν Eat at least five servings each day of fruits and

vegetables. Juices don’t have fiber. Fresh fruit has slightly higher fiber than canned. While all fruits have some fiber, there are some that are higher than others. Here are a few which have 3-4 grams of fiber: apple, pear, 1-cup blueberries, and 1 cup of strawberries, orange, and tangerine. Raspberries are high in fiber with 8 grams per one cup. Vegetables can be good sources of fiber also. Here are the ones that are have 3-4 grams of fiber: ½ cup squash, ½ cup peas, 1-cup carrots, ½ cup cauliflower, and 1 medium sweet potato.

ν Add chopped dried fruits to your cookies, muffins, pancakes or breads before baking.

Dried fruits have a higher amount of fiber than the fresh version. For example 1 cup of grapes has about 1 gram of fiber, but 1 cup of raisins has almost 7 grams. Packaged fruit leathers or snacks have no fiber.

ν Choose cereals with a minimum of five grams of fiber/serving. Some examples are:

Kellogg’s Brand -- Apple Cinnamon Squares, Blueberry Squares, Cracklin’ Oat Bran, Frosted Mini Wheats; Quaker -- Cinnamon Oat Squares, Crunchy Bran, Oat Bran. There are also many bran cereals that are not usually well liked by children. You can mix some of these higher fiber cereals into cereals that your children like.

ν Cook with brown rice rather than white rice. If it’s hard to make the switch, mix them

together. One cup of brown rice is 3 ½ grams of fiber. ν Choose fiber-rich snacks such as popcorn (1 gram of fiber per cup), raw vegetables

with reduced fat dip or whole grain crackers (7 Triscuit crackers have 4grams of fiber) with reduced-fat cheese.

Clinical Nutrition 5/2002 Revised 6/2002

Gluten- Free diet

• Gluten is a mixture of proteins found in wheat, rye, oats, triticale and barley and its derivatives.

• Gluten- free diet is not the same as wheat -free diet.

• Used for celiac disease or dermatitis herpetiformis (a

gluten- induced skin sensitivity) are the only two diseases where this diet is medically needed.

• Based on the “opioid excess theory” by Reichelt, et. al.

in 1990 that children with ASD have a leaky gut, which lead to the absorption of biologically active casein and gluten-derived peptides causing opiate behavior.

• May result in compromised nutritional status and

impaired growth of the child. • Recommended by some for persons with multiple

sclerosis using very limited dairy products, refined sugar and saturated fats. Possibility that patients with multiple sclerosis have neurologic complications of undiagnosed celiac disease.

Ann Weidenbenner, MS, RD, LD Bureau for Children with Medical Handicaps Ohio Department of Health 6/2002

Vitamins that are often used as Supplements Vitamin B6 (pyridoxine)

• Helps the body make make proteins, which are used to make cells. It also helps convert tryptophan (an amino acid) into niacin and serotonin (a brain chemical). It also helps produce insulin, hemoglobin, and antibodies to fight infection.

• Has been used for treatment of autism due to its role in the production of certain neurotransmitters; dopamine, GABA (gamma aminobutyric acid), serotonin, epinephrine, norepinephrine.

• Megadoses of B6 can cause a deficiency in magnesium so they are usually given together.

• Insufficient objective evidence to recommend vitamin B6 with magnesium as a treatment modality for children with Autism Spectrum Disorder.

• Acute doses of B6 can cause ataxia, loss of fine motor control, changes in gait and peripheral neuropathy.

• Tolerable upper limit for vitamin B6 is 30 – 80 mg/day for ages 1 – 18 year olds. Vitamin C

• Helps the body absorb iron from plant sources. • Helps produce collagen, a connective tissue that holds muscles, bones, and other

tissues together. • Helps form and repair red blood cells, and keeps capillary walls firm (protects against

bruising) • Good for healthy gums, to heal cuts and wounds and to help protect from infection by

keeping the immune system healthy. • RDA : Males/Females 1-3 yrs 40 mg 4-10 yrs 45 mg 11-14 yrs 50 mg 15+ yrs 60 mg • Easily destroyed by light, air, and heat. • Since it isn’t stored in the body, vitamin-C rich food needs to be consumed daily. Thiamin (vitamin B1)

• Helps all body cells produce energy from carbohydrates. • Excess amounts of thiamin are excreted in the urine. Extra amounts do not provide

extra energy. • Found in whole-grain and enriched grain products, pork, liver, and other organ

meats. • RDA: Children 4-8 yrs 0.6 mg 9 – 13 yrs 0.9 mg Males 14 – 70+ yrs. 1.2 mg Females 14 -18 1.0 mg 19-70+ yrs 1.1 mg

Ann Weidenbenner, MS, RD, LD Bureau for Children with Medical Handicaps Ohio Department of Health 6/2002

The Office of Health Promotion

Health-Related Web Site Evaluation Form Emory University School of Public Health

http://www.sph.emory.edu/WELLNESS/instrument.html

I. Web site information

Title of site: Subject of site: Web site address: Whom do you think is the intended audience? What do you think the objective is for this site?

Circle the number which you feel best represents the site: 1 = disagree, 2 = agree, 0 = not applicable (N/A). Add up the total points scored for each page at the bottom of each page. II. Content

Disagree Agree N/A 1. The purpose of the site is clearly stated or may be

clearly inferred.

1 2 0

2. The information covered does not appear to be an “infomercial” (i.e., an advertisement disguised as health education).

1 2 0

3. There is no bias evident.

1 2 0 4. If the site is opinionated, the author discusses all sides of

the issue, giving each due respect.

1 2 0

5. All aspects of the subject are covered adequately.

1 2 0 6. External Links are provided to fully cover the subject (if

not needed, circle 0). 1 2 0

III. Accuracy Disagree Agree N/A 7. The information is accurate (if not sure, circle 0).

1 2 0 8. Sources are clearly documented.

1 2 0 9. The web site states that it subscribes to HON code

principles. 1 2 0

Page Score _______

IV. Author Disagree Agree N/A 10. The site is sponsored by or is associated with an

institution or organization.

1 2 0

11. For sites created by an individual, author’s/editor’s credentials (educational background, professional affiliations, certifications, past writings, experience) are clearly stated

1 2 0

12. Contact information (email, address, and/or phone number) for the author/editor or webmaster is included.

1 2 0

V. Currency

Disagree Agree N/A 13. The date of publication is clearly posted.

1 2 0 14. The revision date is recent enough to account for

changes in the field.

1 2 0

VI. Audience

Disagree Agree N/A 15. The type of audience the author is addressing is evident

(academic, youth, minority, general, etc.).

1 2 0

16. The level of detail is appropriate for the audience.

1 2 0 17. The reading level is appropriate for the audience.

1 2 0 18. Technical level is appropriate for the audience.

1 2 0 VII. Navigation

Disagree Agree N/A 19. Internal links add to the usefulness of the site.

1 2 0 20. Information can be retrieved in a timely manner.

1 2 0 21. A search mechanism is necessary to make this site

useful.

1 2 0

22. A search mechanism is provided.

1 2 0 23. The site is organized in a logical manner, facilitating the

location of information.

1 2 0

24. Any software necessary to use the page has links to download software from the Internet. 1 2 0

Page Score _________

VIII. External Links Disagree Agree N/A 25. Links are relevant and appropriate for this site.

1 2 0 26. Links are operable.

1 2 0 27. Links are current enough to account for changes in the

field.

1 2 0

28. Links are appropriate for the audience (e.g. sites for the general public do not include links to highly technical sites).

1 2 0

29. Links connect to reliable information from reliable sources.

1 2 0

30. Links are provided to organizations that should be represented. 1 2 0

IX. Structure

Disagree Agree N/A 31. Educational graphics and art add to the usefulness of the

site.

1 2 0

32. Decorative graphics do not significantly slow downloading.

1 2 0

33. Text-only option is available for text-only Web browsers.

1 2 0

34. Usefulness of site does not suffer when using text-only option.

1 2 0

35. Options are available for disabled persons (large print, audio).

1 2 0

36. If audio and video are components of the site, and can not be accessed, the information on the site is still complete.

1 2 0

Page Score _________ Total Score _________ Total number of possible points _______ Percentage of total points _______

To calculate the web site’s score, the total points scored must be added up as well as total points possible. Total points possible is defined as the number of questions answered as either agree or disagree multiplied by two. The total score must then be divided by the total number of points possible to determine the overall rating of the web site.

Total score/Total number of possible points = percentage of total points

For example, if 30 out of 36 questions were answered with either disagree or agree, then the total number of points possible is 60 (30 multiplied by 2). If the total points scored was 54, then divide 54 by 60 (the total points possible). The overall rating of the web site is 90%, which falls into the excellent range. Total score: 54 Total number of possible points: 30 x 2 = 60 Percentage of total points: 54/60 = 90% Rating of web site: Excellent

Score Rating At least 90% of total possible points.

Excellent: This web site is an excellent source of health information. Consumers will be able to easily access and understand the information contained in this site. Do not hesitate to recommend this site to your clientele.

At least 75% of total possible points.

Adequate: While this web site provides relevant information and can be navigated without much trouble, it might not be the best site available. If another source cannot be located, this site will provide good information to your clientele. Care should be taken to discuss with your clientele what information was found on this web site and what information is still needed.

Less than 75% of total possible points.

Poor: This site should not be recommended to your clientele. Validity and reliability of the information can not be confirmed. All information on the site might not be accessible. Look for another web site to prevent false or partial information form being read.

U. S. Food and Drug Administration

Center for Food Safety and Applied Nutrition January 3, 2001

Overview of Dietary Supplements

What is a dietary supplement? Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.

What is a "new dietary ingredient" in a dietary supplement? The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances:

• a vitamin, • a mineral, • an herb or other botanical, • an amino acid, • a dietary substance for use by man to supplement the diet by increasing the total

dietary intake (e.g., enzymes or tissues from organs or glands), or • a concentrate, metabolite, constituent or extract.

A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement before October 15, 1994.

What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them? In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements. Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products. Also, manufacturers do not need to register themselves nor their dietary supplement products with FDA before producing or selling them. Currently, there are no FDA regulations that are specific to dietary supplements that establish a minimum standard of practice for manufacturing dietary supplements. However, FDA intends to issue regulations on good manufacturing practices that will focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements. At present, the manufacturer is responsible for establishing its own manufacturing practice guidelines to ensure that the dietary supplements it produces are safe and contain the ingredients listed on the label.

When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the U.S.? The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply. There is no authoritative list of dietary ingredients that were marketed before October 15, 1994. Therefore, manufacturers and distributors are responsible for determining if a dietary ingredient is "new", and if it is not, for documenting that the dietary supplements its sells, containing the dietary ingredient, were marketed before October 15, 1994. For more detailed information on new dietary ingredients, go to: http://www.cfsan.fda.gov/~dms/ds-ingrd.html.

What information must the manufacturer disclose on the label of a dietary supplement? FDA regulations require that certain information appear on dietary supplement labels. Information that must be on a dietary supplement label includes: a descriptive name of the product stating that it is a "supplement;" the name and place of business of the

manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product. In addition, each dietary supplement (except for some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a "Supplement Facts" panel. This label must identify each dietary ingredient contained in the product.

Must all ingredients be declared on the label of a dietary supplement? Yes, ingredients not listed on the "Supplement Facts" panel must be listed in the "other ingredient" statement beneath the panel. The types of ingredients listed there could include the source of dietary ingredients, if not identified in the "Supplement Facts" panel (e.g., rose hips as the source of vitamin C), other food ingredients (e.g., water and sugar), and technical additives or processing aids (e.g., gelatin, starch, colors, stabilizers, preservatives, and flavors). For more details, see: http://www.cfsan.fda.gov/~lrd/fr97923a.html.

Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving? Other than the manufacturer's responsibility to ensure safety, there are no rules that limit a serving size or the amount of a nutrient in any form of dietary supplements. This decision is made by the manufacturer and does not require FDA review or approval.

Where can I get information about a specific dietary supplement? Manufacturers and distributors do not need FDA approval to sell their dietary supplements. This means that FDA does not keep a list of manufacturers, distributors or the dietary supplement products they sell. If you want more detailed information than the label tells you about a specific product, you may contact the manufacturer of that brand directly. The name and address of the manufacturer or distributor can be found on the label of the dietary supplement.

Who has the responsibility for ensuring that a dietary supplement is safe? By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. Also unlike drug products, manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to FDA any reports they receive of injuries or illnesses that may be related to the use of their products. Under DSHEA, once the product is marketed, FDA has the responsibility for showing that a dietary supplement is "unsafe," before it can take action to restrict the product's use or removal from the marketplace.

Do manufacturers or distributors of dietary supplements have to tell FDA or consumers what evidence they have about their product's safety or what evidence they have to back up the claims they are making for them? No, except for rules described above that govern "new dietary ingredients," there is no provision under any law or regulation that FDA enforces that requires a firm to disclose to FDA or consumers the information they have about the safety or purported benefits of their dietary supplement products. Likewise, there is no prohibition against them making this information available either to FDA or to their customers. It is up to each firm to set its own policy on disclosure of such information. For more information on claims that can be made for dietary supplements, see (http://www.cfsan.fda.gov/~dms/hclaims.html).

How can consumers inform themselves about safety and other issues related to dietary supplements? It is important to be well informed about products before purchasing them. Because it is often difficult to know what information is reliable and what is questionable, consumers may first want to contact the manufacturer about the product they intend to purchase (see previous question "Where can I get information about a specific dietary supplement?"). In addition, to help consumers in their search to be better informed, FDA is providing the following sites: Tips For The Savvy Supplement User: Making Informed Decisions And Evaluating Information -- http://www.cfsan.fda.gov/~dms/ds-savvy.html (includes information on how to evaluate research findings and health information on-line) and Claims That Can Be Made for Conventional Foods and Dietary Supplements -- http://www.cfsan.fda.gov/~dms/hclaims.html, (provides information on what types of claims can be made for dietary supplements).

What is FDA's oversight responsibility for dietary supplements? Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. FDA's efforts to monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occaisional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency.

Does FDA routinely analyze the content of dietary supplements? In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law. The remaining funds are used for routine monitoring of products pulled from store shelves or collected during inspections of manufacturing firms. The agency does not analyze dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that the "Supplement Facts" label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the

label. FDA does not have resources to analyze dietary supplements sent to the agency by consumers who want to know their content. Instead, consumers may contact the manufacturer or a commercial laboratory for an analysis of the content.

Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition? No, a product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved--and thus illegal--drug. To maintain the product's status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994. *Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product.

Who validates claims and what kinds of claims can be made on dietary supplement labels? FDA receives many consumer inquiries about the validity of claims for dietary supplements, including product labels, advertisements, media, and printed materials. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, and, in the case of advertising, with the Federal Trade Commission. By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims. Some of these claims describe: the link between a food substance and disease or a health-related condition; the intended benefits of using the product; or the amount of a nutrient or dietary substance in a product. Different requirements generally apply to each type of claim, and are described in more detail at the following site: (http://www.cfsan.fda.gov/~dms/hclaims.html).

Why do some supplements have wording (a disclaimer) that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"? This statement or "disclaimer" is required by law (DSHEA) when a manufacturer makes a structure/function claim on a dietary supplement label. In general, these claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA. For this reason, the law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.

How are advertisements for dietary supplements regulated? The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but FTC's work is directed by different laws. For more information on FTC, go to: http://www.ftc.gov/bcp/menu-health.htm. Advertising and promotional

material received in the mail are also regulated under different laws and are subject to regulation by the U.S. Postal Inspection Service.

How do I, my health care provider, or any informed individual report a problem or illness caused by a dietary supplement to FDA? If you think you have suffered a serious harmful effect or illness from a product FDA regulates, including dietary supplements, the first thing you should do is contact or see your healthcare provider immediately. Then, you and your health care provider are encouraged to report this problem to FDA. Your health care provider can call FDA's MedWatch hotline at 1-800-FDA-1088, submit a report by fax to 1-800-FDA-0178 or on-line at: http://www.fda.gov/medwatch/report/hcp.htm. The MedWatch program provides a way for health care providers to report problems believed to be caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements. You, or anyone, may report a serious adverse event or illness directly to FDA if you believe it is related to the use of any of the above-mentioned products, by calling FDA at 1-800-FDA-1088, by fax at 1-800-FDA-0178 or reporting on-line at: http://www.fda.gov/medwatch/report/consumer/consumer.htm. FDA would like to know when you think a product caused you a serious problem, even if you are not sure that the product was the cause, or even if you do not visit a doctor or clinic. In addition to communicating with FDA on-line or by phone, you may use the postage-paid MedWatch form available from the FDA Web site. NOTE: The identity of the reporter and/or patient is kept confidential. For a general, not serious, complaint or concern about food products, including dietary supplements, you may contact the consumer complaint coordinator at the local FDA District Office nearest you. See the following Web address for the telephone number: http://www.fda.gov/opacom/backgrounders/complain.html.

For more recent information on Dietary Supplements See http://www.cfsan.fda.gov/~dms/supplmnt.html

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