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. …
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Publication information: Article title: FDA Questions Safety of Dietary Supplements. Contributors: Farley, Dixie - Author. Magazine title: Consumers' Research Magazine. Volume: 77. Issue: 2 Publication date: February 1994. Page number: 15+. © 1999 Consumers' Research, Inc. COPYRIGHT 1994 Gale Group.
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