Dietary supplements, sometimes called food or nutritional supplements, are popular products people use to improve nutrition and health. Because they are not categorized as "drugs," these products are not subject to approval by the U.S. Food and Drug Administration before reaching the market. Understanding what constitutes a dietary supplement can help you identify these products and better understand safety risks.
Supplements
Congress defined the term "dietary supplement" as part of the Dietary Supplement Health and Education Act, or DSHEA, of 1994, according to the FDA. The law states that a dietary supplement is any product that a person ingests orally and that contains a dietary ingredient that the manufacturer intends to supplement the consumer's diet. These supplements are, for regulatory purposes, not considered drugs. Instead, they are a special category under the general category of "foods."
Dietary Ingredients
The DSHEA also defines what constitutes a "dietary ingredient." A dietary ingredient is any combination of vitamins, minerals, herbs or botanicals, amino acids, dietary substances used to increase dietary intake or concentrate, metabolite, constituent or extract, according to the FDA. Further a "new dietary ingredient" is any such substance that was not sold as a dietary supplement in the United States before Oct. 15, 1994.
Significance
Products that qualify as a dietary supplements are not subject to the more rigorous drug approval process imposed by federal law. The FDA reports that dietary supplement manufacturers are responsible for determining whether a supplement is safe and suited for human use. The FDA does not require the manufacturer to submit the product for approval or testing. However, the manufacturers do have to register with the FDA before they can sell the product under the terms of the Bioterrorism Act.
Notification
If a manufacturer intends to market or sell a product that contains a new dietary ingredient, under the terms of the DSHEA, the manufacturer must notify the FDA of this and demonstrate that the product is reasonably expected to be safe. However, there is no single declarative or exhaustive list of ingredients used prior to the passage of the DSHEA, and manufacturers are responsible for determining if the dietary supplement they have developed qualifies as a new dietary ingredient.
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