Regulation of Dietary Supplements

In 1994 the U.S. Congress passed the Dietary Supplement Health and Education Act (DSHEA), which President Bill Clinton signed into law the same year. One provision of DSHEA clarified the definition for dietary supplements outlined above. DSHEA also mandated the establishment of the Office of Dietary Supplements (ODS) within the National Institutes of Health. The ODS coordinates research on dietary supplements and acts as a clearinghouse for regulatory issues. It also maintains an excellent resource for consumers, the International Bibliographic Information on Dietary Supplements (IBIDS), which is a database that contains citations published in scientific journals on the topic of dietary supplements. The public can access IBIDS on the ODS website.

DSHEA established a new regulatory framework for supplement safety and for the labeling of dietary supplements by the U.S. Food and Drug Administration (FDA). Dietary supplements are regulated under food law, but with certain provisions that apply only to dietary supplements. For example, dietary supplements escape the stringent approval process that food additives and drugs must go through before being marketed to the public, unless the manufacturer of a dietary supplement makes a claim for therapeutic efficacy.

DSHEA also gave manufacturers the freedom to provide information about product benefits on labels through three types of claims. Health claims describe a relationship between a food substance and a disease or health-related condition. For example, the health claim "diets high in calcium may reduce the risk of osteoporosis" has been authorized by the FDA and may appear on the labels of dietary supplements. Structure function claims may state a benefit related to a nutrient-deficiency disease (such as scurvy, which is caused by a deficiency of vitamin C), as long as the statement tells how widespread the disease is. These claims may also describe the role of a nutrient intended to affect a structure or function—for example, "antioxidants maintain cell integrity," or "calcium builds strong bones." Nutrient content claims describe the level of a nutrient or dietary substance in a product, using FDA-regulated terms such as "good source," "high," or "free." For example, if a label claims a dietary supplement is fat-free, the supplement must contain less than 0.5 grams of fat per serving.

However, information on supplement labels cannot be false or misleading. For example, statements that a product will treat, cure, or diagnose a disease are reserved for drugs. That is why the label of the popular herbal extract echinacea may boast that the herb "supports good immune function" but will not claim to "cure your cold."

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