Dietary Supplements : Part 4

by Food and Drug Administration (FDA)

(Page 4 of 4)

Also included in the notice were findings by the Federation of American Societies for Experimental Biology, with which FDA had contracted to provide information on whether the use of amino acids in dietary supplements presents any particular safety concerns. The group found data to be inadequate to determine safe upper levels of use and advised that consumers not take amino acids except under responsible medical supervision.

FDA is evaluating these reports and other submitted data.

Precautions

For consumers who choose to take dietary supplements, FDA's Love suggests these precautions:

Be wary of unfounded medical claims for dietary supplements, and be sure to tell health-care providers about all supplements you take, including concentrations and amounts.

Children, adolescents, older or chronically ill people, and women who are pregnant or are breast-feeding should not use high-potency supplements or those used for medicinal purposes unless they have responsible medical supervision.

Keep supplements out of the reach of children.

FDA's Proposals

As required by the Dietary Supplement Act of 1992, FDA last June proposed dietary supplement labeling rules based on the Nutrition Labeling and Education Act of 1990.

In announcing the proposals, FDA Commissioner David A. Kessler, M.D., said, "FDA's goal is simple: We want people to have access to products that are safe, and we want to assure consumers that claims made about the health and nutritional benefits are truthful."

Among these proposals are the following:

Special rules for nutrition labeling would apply to dietary supplements of vitamins or minerals. (Nutrition labeling for products consisting of herbs or other nutritional substances would be like that for conventional foods.)

Vitamin and mineral nutrition labeling would be in a "Nutrition Facts" panel (see p. xx) that is as similar as possible to the conventional foods panel. (See "Nutrition Facts" to Help Consumers Eat Smart" in the May 1993 FDA Consumer.)

If a supplement bears a nutrient content claim, an adjacent referral statement would direct consumers to the nutrition panel.

If a claim uses either the term "free" or "low," the wording would have to make it clear the claim is true for all products of that type for example, instead of brand X, a fat-free vitamin C supplement, the claim would read brand X vitamin C, a fat-free supplement.

Supplements, including those for infants and children under 2, could be labeled with the term "sugar free" and its synonyms, such as "sugarless," "no sugar," and "trivial source of sugar."

The term "more" could be used in a claim if a product has 10 percent more of the Daily Value of a nutrient than the food to which it's being compared.

For health claims, supplements would be subject to the same scientific standard and procedures that are required for conventional foods.

Supplements would be exempt from the conventional foods requirement that, to bear health claims, products must contain 10 percent or more of the Daily Value of the nutrients vitamin A, vitamin C, iron, calcium, protein, or fiber.

How Supplements Are Regulated

Under the Federal Food, Drug, and Cosmetic (FD&C) Act, FDA regulates dietary supplements as foods, as long as no drug claims are made for them. The FD&C Act includes provisions to ensure that foods are safe and their labels are truthful and not misleading.

The Proxmire Amendment of 1976, introduced by then Sen. William Proxmire, D-Wis., restricts FDA's authority to limit supplement potency and the composition of most multi-nutrient products, except for safety reasons. It prohibits the agency from deeming a vitamin or mineral a drug solely because of potency.

When products are marketed for therapeutic use, FDA regulates them through its Center for Drug Evaluation and Research. The FD&C Act defines "drugs" as products intended to diagnose, cure, mitigate, treat, or prevent disease, or non-food products intended to affect the structure or a function of the body.

Between November 1990 and June 1993, FDA took actions against 188 products perceived as dietary supplements on grounds that they made unsubstantiated claims about serious medical conditions.

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.