Guide to Dietary Supplements : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 4)

In contrast, dietary supplement manufacturers that wish to market a new ingredient (that is, an ingredient not marketed in the United States before 1994) have two options. The first involves submitting to FDA, at least 75 days before the product is expected to go on the market, information that supports their conclusion that a new ingredient can reasonably be expected to be safe. Safe means that the new ingredient does not present a significant or unreasonable risk of illness or injury under conditions of use recommended in the product's labeling.

The information the manufacturer submits becomes publicly available 90 days after FDA receives it.

Another option for manufacturers is to petition FDA, asking the agency to establish the conditions under which the new dietary ingredient would reasonably be expected to be safe. To date, FDA's Center for Food Safety and Applied Nutrition has received no such petitions.

Under DSHEA, once a dietary supplement 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. This was the case when, in June 1997, FDA proposed, among other things, to limit the amount of ephedrine alkaloids in dietary supplements (marketed as ephedra, Ma huang, Chinese ephedra, and epitonin, for example) and provide warnings to consumers about hazards associated with use of dietary supplements containing the ingredients. The hazards ranged from nervousness, dizziness, and changes in blood pressure and heart rate to chest pain, heart attack, hepatitis, stroke, seizures, psychosis, and death. The proposal stemmed from FDA's review of adverse event reports it had received, scientific literature, and public comments. FDA has received many comments on the 1997 proposal and was reviewing them at press time.

Also in 1997, FDA identified contamination of the herbal ingredient plantain with the harmful herb Digitalis lanata after receiving a report of a complete heart block in a young woman. FDA traced all use of the contaminated ingredient and asked manufacturers and retailers to withdraw these products from the market. (For information about other potentially dangerous dietary supplements, see "Supplements Associated with Illnesses and Injuries.")

DSHEA also gives FDA authority to establish good manufacturing practices, or GMPs, for dietary supplements. In a February 1997 advance notice of proposed rulemaking, the agency said it would establish dietary supplement GMPs if, after public comment, it determined that GMPs for conventional food are not adequate to cover dietary supplements, as well. GMPs, the agency said, would ensure that dietary supplements are made under conditions that would result in safe and properly labeled products. At press time, FDA was reviewing comments on the 1997 notice.

Some supplement makers may already voluntarily follow GMPs devised, for example, by trade groups.

Besides FDA, individual states can take steps to restrict or stop the sale of potentially harmful dietary supplements within their jurisdictions. For example, Florida has banned some ephedra-containing products, and other states have said they are considering similar action.

Also, the industry strives to regulate itself, the Council for Responsible Nutrition's Cordaro says. He cites the GMPs that his trade group and others developed for their member companies. FDA is reviewing these GMPs as it considers whether to pursue mandatory industry-wide GMPs. Another example of self-regulation, Cordaro says, is the voluntary use of a warning about ephedra products that his organization drafted. He says that about 90 percent of U.S. manufacturers of products containing ephedra alkaloids now use this warning label.

Understanding Claims

Claims that tout a supplement's healthful benefits have always been a controversial feature of dietary supplements. Manufacturers often rely on them to sell their products. But consumers often wonder whether they can trust them.

Under DSHEA and previous food labeling laws, supplement manufacturers are allowed to use, when appropriate, three types of claims: nutrient-content claims, disease claims, and nutrition support claims, which include "structure-function claims."

Nutrient-content claims describe the level of a nutrient in a food or dietary supplement. For example, a supplement containing at least 200 milligrams of calcium per serving could carry the claim "high in calcium." A supplement with at least 12 mg per serving of vitamin C could state on its label, "Excellent source of vitamin C."

Disease claims show a link between a food or substance and a disease or health-related condition. FDA authorizes these claims based on a review of the scientific evidence. Or, after the agency is notified, the claims may be based on an authoritative statement from certain scientific bodies, such as the National Academy of Sciences, that shows or describes a well-established diet-to-health link. As of this writing, certain dietary supplements may be eligible to carry disease claims, such as claims that show a link between:

• the vitamin folic acid and a decreased risk of neural tube defect-affected pregnancy, if the supplement contains sufficient amounts of folic acid
• calcium and a lower risk of osteoporosis, if the supplement contains sufficient amounts of calcium
• psyllium seed husk (as part of a diet low in cholesterol and saturated fat) and coronary heart disease, if the supplement contains sufficient amounts of psyllium seed husk.

Nutrition support claims can describe a link between a nutrient and the deficiency disease that can result if the nutrient is lacking in the diet. For example, the label of a vitamin C supplement could state that vitamin C prevents scurvy. When these types of claims are used, the label must mention the prevalence of the nutrient-deficiency disease in the United States.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.