Are supplements FDA approved?

The FDA (Food and Drug Administration) does not conduct pre-market authorization of dietary supplements. And no dietary supplements in the United States are “FDA approved.”

The Food and Drug Administration regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA). Under DSHEA, dietary supplements are in a special category listed under the general umbrella of “foods.”

The FDA requires that dietary supplement manufacturers follow Good Manufacturing Practices (GMPs) for dietary supplements (21 CFR, part 111). USANA meets and exceeds these standards.

Otherwise, the FDA is primarily responsible for taking action against any unsafe dietary supplement product after it has entered the market. The FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the oversight of dietary supplements after they reach the market. Their mandate is to monitor the marketplace for products that may be considered unsafe or make false or misleading claims.

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