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The current Good Manufacturing Practice (cGMPs) regulations for dietary supplements in the US were implemented in 2007, but there is still a great deal of enforcement activity by FDA. This white paper will provide an overview of the regulations, but more importantly will highlight some of the most commonly cited issues in FDA Form 483 observations.

Manufacturers and marketers of dietary supplements often have questions about what testing is required for Supplement Facts labels. This white paper is intended to provide information to help companies make informed choices about the testing and claims made on dietary supplements.