DSHEA/ 21 CFR Part 111 Define the Term “Dietary Supplement”

The definition of the Term “Dietary Supplement” as set by DSHEA and 21CFR Part 11 is important to adhere to in manufacturing and advertising.

Recently the FDA came down hard on a company selling enhanced spring water. The FDA took issue with the company representing their water products as conventional foods. The problem the FDA identified is that the water products contain vitamins and minerals and are therefore considered dietary supplements.

The Dietary Supplement Health and Education Act (DSHEA) and corresponding regulations in 21 CFR part 111 define dietary supplements as orally delivered products that contain one or more dietary ingredients. According to the Office of Dietary Supplements at the FDA, ingredients are usually defined as including plant extracts, enzymes, vitamins, minerals, amino acids, and hormonal products that are available without prescription and are consumed in addition to the regular diet. Dietary supplements must include a statement of identity as a “dietary supplement” on their label in addition to the statement that their claims have not been evaluated by the FDA.

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