Dietary Supplement Fda Guidance

Guidance and regulatory information on food and dietary supplements.
Dietary supplement fda guidance. Fda s july 2011 ndi draft guidance followed by the agency s announcement in december 2014 to include dietary ingredients and supplements in the fda redbook a guidebook historically used to evaluate safety of food and color additives and finally the release of the latest revised ndi draft guidance in august 2016 only perpetuates the. Includes guidance for industry as well as manufacturing processes food facility registration haccp retail food protection. Further this guidance reminds manufacturers and distributors of dietary supplements and beverages about the requirements of the federal food drug and cosmetic act the fd c act regarding their.
The dietary supplement health and education act of 1994 the dshea amended the act in part by defining dietary supplements adding specific labeling requirements for dietary supplements and. Fda issues dietary supplements final rule june 22 2007. This guidance is intended to help manufacturers and distributors of dietary ingredients and dietary supplements you decide whether to submit a premarket safety notification to fda we.
Fda regulates both finished dietary supplement products and dietary ingredients.