cGMP Requirements for Dietary Supplements
Current Good Manufacturing Practices (cGMP) Requirements for Dietary Supplements FDA's regulation of dietary supplements is more of a combination between the agency's regulation of conventional foods and drugs products. One thing that is clear is that under the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress placed the responsibility of ensuring the safety of any dietary supplement or ingredient on the product's manufacturer and/or distributor. The manufacturer or distributor is expected to ensure the safety of its products before marketing them in the United States and must also make certain they properly label their products with truthful and non-misleading information.
Although the dietary supplement manufacturer or distributor must ensure the safety of its products, in order for FDA to bring an action against a dietary supplement already on the market, FDA bears the “burden of proof” (must demonstrate) that it is unsafe. FDA also conducts certain post-marketing surveillance of dietary supplements on the market, by receiving CFSAN Adverse Event Reports in their reporting System (called CAERS). Through facility, import inspections, and website reviews FDA makes certain that dietary supplements are properly labeled and do not make implied or explicit drug (disease claims). FDA works with the Federal Trade Commission (FTC), which regulates dietary supplement advertising. These two agencies work in concert to regulate labeling (including Internet marketing sites) and advertising claims associated with dietary supplements and other products. The DSHEA amended the Food Drug & Cosmetic Act to provide FDA with express statutory authority to prescribe current good manufacturing practice (CGMP) regulations for dietary supplements.
On March 13, 2003, FDA published a proposed rule that included provisions regarding manufacturing, packaging, labeling, testing, quality control, releasing for distribution, and holding of dietary ingredients and dietary supplements. Very recently these regulations were finalized into a final rule, making them mandatory. However, there is an enforcement grace period that is based upon the size of the company (small, medium, and large) responsible for making the products. There have recently been an increase in the number of threatened enforcement actions against dietary supplement contract manufacturers for conforming with FDA's GMP requirements. In the past, FDA reserved these kinds of threats for drug manufacturers. With the advent of the final DS GMP rule, the agency is flexing its regulatory muscles and reaching more and more into the dietary supplement manufacturing industry -- even before the rule is subject to enforcement.
FDAImports.com consultants and affiliated attorneys provide clients with the information and experience necessary to ensure compliance with labeling and CGMP requirements and FTC’s advertising regulations and guidelines.
To learn more about FDA's labeling requirements, new dietary ingredient regulations, and structure of function claims permissible under DSHEA, please review our Dietary Supplement Ingredients & Labeling pages.
