Supplement companies often put a seal or stamp on their website or product labels with words such as “Certified GMP,” “FDA Approved Facility,” or “CGMP Inspected Facility,” but these should not be mistaken as indications of safety or federal approval. There is no “official” seal or stamp, and misuse of the Food and Drug Administration (FDA) logo is illegal. FDA does not approve or certify facilities or dietary supplement products. Instead, companies are expected to comply, by law, with CGMP (Current Good Manufacturing Practices) regulations. These regulations require that they produce and test their finished products in a way that eliminates the possibility of accidental contamination or tainting and ensure that the ingredients on the label match what’s in the product.

The Food and Drug Administration (FDA) law requires that dietary supplement companies prepare their products according to CGMPs as described in 21 CFR 111. These requirements help ensure that a dietary supplement product is manufactured, prepared, and stored properly and meet certain quality standards. Manufacturers, distributors, and importers of dietary supplements are responsible for complying with CGMPs, which include instructions for manufacturers to keep extensive records and test ingredients prior to manufacturing and products prior to distributing.

There is no approval process for dietary supplements. It is the responsibility of the manufacturer or distributor to ensure that the dietary supplement product they introduce into the market is safe. 

You might be interested in reading “Why doesn't FDA stop unsafe supplements from reaching the market?”  And for in-depth information about CGMPs, see Current Good Manufacturing Practice (CGMP) Regulations.

Updated 25 June 2018

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