Dietary Supplements

   

 


Requirements for Dietary Supplements

The U.S. Food and Drug Administration (FDA) outlines a number of labeling requirements for the marketing of dietary supplements in the Dietary Supplement Health and Education Act of 1994 (DSHEA). The DSHEA offers an extensive list of specific regulations and exemptions in addition to setting a standard for defining products as dietary supplements.

According the DSHEA, a product qualifies as a dietary supplement if it contains one or more vitamin, mineral, herb/botanical, amino acid, or any substance used to increase dietary intake of that substance. A product is also a dietary supplement if it contains any of these ingredients in the form of a concentrate, constituent, extract, or metabolite.

Dietary supplement labeling differs from standard food labeling. Whereas food labels are required to have a “Nutrition Facts” panel, dietary supplements must have a “Supplement Facts” panel containing information specifically pertaining to supplement ingredients. If dietary supplements contain other ingredients, they must be listed in an additional information panel. Dietary supplement labels cannot bear ingredients listed in zero amounts or in quantities that cannot be measured.

Similar to food labeling, however, dietary supplement labels must also include the standard statement of identity and net quantity of contents on the primary display panel with ingredient listing and manufacturer’s name and address on the informational panel.

Please consult the following sources for further information on dietary supplement labeling, including marketing a new dietary ingredient and the acceptable format of a Supplement Facts panel: