Are supplements FDA approved?
USANA voluntarily follows the Good Manufacturing Practices (GMP) required of pharmaceuticals.
The FDA 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 does not have direct jurisdiction over dietary supplements and no dietary supplements in the U.S. are “FDA approved.” The Food and Drug Administration requires that dietary supplement manufacturers follow GMPs for dietary supplements (21 CFR, part 111). USANA, however, voluntarily follows the more stringent GMP for pharmaceuticals (21 CFR, part 211) as the basis for its quality assurance program, which regulates virtually every aspect of manufacturing, including facility design and maintenance, raw material specification and control, supplier validation, product design and testing, and more.
The FDA is responsible for taking action against any unsafe dietary supplement product (usually done only 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 products that make false or misleading claims.