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Natural Foods Merchandiser

DSHEA: What it does

The Dietary Supplement Health and Education Act of 1994, which amended the Federal Food, Drug and Cosmetic Act, defined the term “dietary supplement” and created a new regulatory framework for the safety and labeling of dietary supplements. In addition to DSHEA, several federal rules for supplements have been published since 1994, including:

  • Dietary supplement manufacturers are responsible for ensuring that their supplements are safe before they’re marketed.

  • The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.

  • Manufacturers do not need to register products with the FDA or get FDA approval before producing and selling dietary supplements. The exception: a new dietary ingredient.

  • Manufacturers must follow Current Good Manufacturing Practices to ensure identity, purity, quality, strength and composition of dietary supplements.

  • Labels must include a descriptive name of the product stating it is a “supplement;” the name and place of business of the manufacturer, packer or distributor; a complete list of ingredients; and the net contents of the product. A “Supplements Facts” panel must identify each dietary ingredient contained in the product.

  • Manufacturers may make three types of claims for dietary supplements: health claims, structure/function claims and nutrient content claims. Different requirements apply to each type of claim.

  • Manufacturers and distributors must submit serious adverse events reports to the FDA.

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