FDA Questions Safety of Dietary Supplements
Farley, Dixie, Consumers' Research Magazine
When it comes to dietary supplements, consumers have the right to expect safety and to have information about products they choose so they know what they're getting, according to the Food and Drug Administration (FDA).
"Without the proper safety data," however, says Michael Taylor, FDA deputy commissioner for policy, "the agency has no way to ensure that many consumers taking supplements won't be at risk."
FDA is responsible under the federal Food, Drug and Cosmetic (FD&C) Act for ensuring that manufacturers of foods, including dietary supplements, provide safe ingredients for their products as well as accurate, complete labeling that is truthful and not misleading.
Defining a Dietary Supplement. The Nutrition Labeling and Education Act of 1990 (NLEA), which amended the FD&C Act, refers to dietary supplements as "vitamins, minerals, herbs, or other similar nutritional substances."
As commonly consumed, dietary supplements in the marketplace--in the form of capsules, tablets, liquids, or powders--include: vitamins, essential minerals, protein, amino acids, botanicals such as ginseng and yohimbe, extracts from animal glands, garlic extract, fish oils, fibers such as acacia and guar gum, compounds not generally recognized as foods or nutrients such as bioflavonoids, enzymes, germanium, nucleic acids, paraaminobenzoic acid, and rutin, and mixtures of these ingredients.
The Council for Responsible Nutrition, a trade organization for supplement manufacturers, reports that in 1991 some 40% of American adults took vitamin supplements, and retail sales for over-the-counter nutritional products totaled several billion dollars.
Most vitamin and mineral supplements usually pose no safety concerns for the general population. Scientists generally know more about these nutrients than about ingredients used in other types of dietary supplements. And most vitamin and mineral products are accurately labeled for content and are offered at moderate potencies.
"Our main concerns," Taylor says, "are with the array of other products that have unsubstantiated safety--such as amino acids and herbs and other botanicals. We know very little about some of these products' ingredients."
Diet and Disease. Recent attention to a possible effect of diet in reducing the risk of certain diseases has raised new safety issues about how the FDA should regulate dietary supplements. Growing scientific support for such benefits and increased consumer interest in improving health through diet provided much of the impetus for provisions of the NLEA to allow health claims for foods.
But because manufacturers believed the FDA would limit claims on their supplements under the NLEA, they conducted a rigorous consumer campaign to get Congress to limit FDA's authority.
"They wanted us to adopt a more relaxed standard for claims on supplements than Congress had adopted for conventional foods," Taylor says.
When the Dietary Supplement Act of 1992 became law on October 29, 1992, a year's moratorium was imposed on implementation of the NLEA with respect to supplements. But it called for the FDA to propose NLEA-based labeling rules for supplements by June 15, 1993 and to issue final rules in December, which the agency did (see "The FDA's Label Requirements," page 19).
In October 1993, the FDA published a proposed rule on allowing a health claim on foods, including supplements, which are good sources of folic acid. The claim would discuss the link between folic acid intake by women of childbearing age and a reduced risk of neural-tube birth defects in newborns. The agency also proposed amending its food additive rule for folic acid and its standard of identity to require the addition of folic acid to "enriched" grain products.
The FDA is working with manufacturers and scientists on other potential health claims such as those associating antioxidant vitamins (like vitamin C) with a reduced risk of cancer and other diseases. …