In the United States, food supplements are a subcategory of products under the broad umbrella of "foods," but specific legislation governs their production and marketing. Because food supplements are not drugs or medicines, there is no requirement for pre-market approval. Federal authorities inspect production facilities, monitor labeling and conduct some spot analyses of food supplements on the market, but they rely heavily on consumers and manufacturers to report on any adverse effects of such products.
Definition
The 1994 Dietary Supplement Health and Education Act, or DSHEA, provides the official U.S. definition for a food supplement. This legislation describes a food supplement as a product that you consume orally and which contains one or more "dietary ingredients" to supplement food intake. "Dietary ingredients" include substances such as herbs, extracts, vitamins, minerals, enzymes, amino acids and organ tissue. The DSHEA does not specify or limit the format of food supplements, but it requires that products in food bar format bear nutritional labels like a conventional food product.
Regulations
The U.S. government does not regulate food supplements as medicines. Prior to 1994, food supplements fell under the Food Drug and Cosmetic Act, or FDCA, and legally were "foods." The DSHEA, however, established a new framework specifically for the production and labeling of dietary supplements. The U.S. Food and Drug Administration's Center for Food Safety and Nutrition oversees enforcement of this legislation. The U.S. Pharmacopeia and National Formulary provide specifications for these products, but compliance with these guidelines is voluntary. U.S. law requires manufacturers of food supplements to adhere to Current Good Manufacturing Practices, or cGMPs, but there were no final cGMP regulations for these products as of 2011. In the interim, the FDA's 2003 draft guidelines for dietary ingredients and the USP's "Manufacturing Practices for Nutritional Supplements" serve as the operating standards.
Manufacturer Responsibilities
By law, manufacturers of food supplements must ensure that a food supplement is safe before they release the product onto the market. They also must have evidence to support any claims they make about the health benefits of such a product. They may not make claims that a product prevents, treats or cures a medical condition because such a claim would recategorize the supplement as a drug, which would require pre-release FDA approval. There is no requirement for companies to obtain approval or register a food supplement before marketing it, but they must register the facilities where they manufacture such products with the FDA. Manufacturers may choose whether or not to report an "adverse event" when a food supplement causes a health problem, but this reporting becomes mandatory if the impact is life-threatening, requires hospitalization or medical intervention or if it causes incapacitation or disability.
FDA's Role
In most cases, the FDA's responsibilities begin when a food supplement enters the marketplace. The FDA monitors reports of adverse impacts, which may come from consumers as well as manufacturers. The FDA can remove a food supplement from the market only after it obtains evidence that the product is unsafe. For food supplements that contain new dietary ingredients --- those created after 1994 --- the FDA must conduct a safety and labeling review before market release. The FDA also monitors claims on food supplement product labels and conducts laboratory analysis of these products on a random basis.
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