Dietary Supplements | Good Manufacturing Practices
Except for dietary supplements containing new dietary ingredients, dietary supplement manufacturers and distributors are not required to obtain FDA approval for dietary supplements before marketing them in the U.S. However, before marketing a dietary supplement, you are responsible for ensuring that: 1) the products you manufacture or distribute are safe; 2) that any claims made about the products are not false or misleading; and 3) that the products comply with the Federal Food Drug, and Cosmetic Act (FDCA) and FDA regulations in all respects.
The Dietary Supplement Health and Education Act (DSHEA) amended the FDCA to provide FDA with express statutory authority to prescribe current good manufacturing practice (GMP) regulations for dietary supplement manufacturers and distributors. Pursuant to DSHEA, FDA has established dietary supplement GMP regulations which now apply to practically every dietary supplement manufacturer and distributor to one degree or another. The FDA dietary supplement GMPs are a kind of combination between the agency's regulation of conventional foods and drug 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 dietary supplement 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 the products are properly labeled with truthful and non-misleading information.
One of the key FDA regulatory requirements relating to dietary supplement safety and truthfulness in labeling and marketing involves manufacturing and distributing dietary supplements in accordance with FDA’s dietary supplement GMP regulations.
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