The Food and Drug Administration, or FDA, regulates the safety of food and drug products in the United States. Food supplements, also known as dietary supplements, are subject to some FDA regulation, but this regulation is less stringent than drug regulation. The FDA placess certain requirements on supplement manufacturers regarding labeling and claims about the products. However, FDA does not require supplement manufacturers to standardize products or to prove their safety prior to marketing.
Definition
The 1994 Dietary Supplement Health and Education Act defines a dietary supplement according to certain criteria. In order to be classified as a dietary supplement, a product must contain at least one dietary ingredient such as minerals, vitamins, herbs, botanicals or amino acids. The intention of the product must be to supplement the diet, and the supplement must be taken orally in the form of a liquid, tablet, pill or capsule. The product must be labeled as a dietary supplement. Tobacco is excluded from categorization as a dietary supplement.
FDA Regulation
The National Institutes of Health Office of Dietary Supplements reports that the FDA regulates dietary supplements as foods. However, the FDA's regulation of dietary supplements is different from its regulation of drugs and foodstuffs. The FDA regulates the claims that manufacturers may make on dietary supplement labels. However, the FDA does not review the ingredients of dietary supplements that were already on the market before October 1994. Supplements sold before adoption of the 1994 law are presumed to be safe and are not assessed individually by the FDA.
Labeling
The FDA requires manufacturers to include certain information on the label of a dietary supplement. The name of the product must be stated, including either the word "supplement" or a statement identifying the product as a supplement. The weight or quantity of the contents must be listed, together with directions for use and the manufacturer or distributor's name and business address. A supplement facts panel must list the serving size, amount per serving size, dietary ingredients, and the percentages of daily values where daily recommended values exist. Botanical ingredients must be listed according to the plant's scientific or common name. Other ingredients such as sweeteners, flavorings, colors and fillers must also be listed.
Safety
As at January 2011, manufacturers of dietary supplements are not required to prove to the FDA that their products are either safe or effective. However, the FDA does stipulate that manufacturers may not knowingly market products that are unsafe or ineffective. Once a dietary supplement is on the market, the FDA can only have the product removed or restricted by proving that the product is unsafe. In this way, the FDA's regulation of dietary supplements is essentially the opposite of its regulation of drugs. Drug safety must be proved before marketing; supplement safety must be disproved once marketing has already occurred.
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