Dietary Supplement Guidance Fda

To contact the office of dietary supplement programs email.

Dietary supplement guidance fda. The newly enforced guidance focuses on the new dietary ingredient ndi notifications which will require supplement companies to submit a new dietary ingredient application to the fda if the product fits into any of the following categories. Guidance and regulatory information on food and dietary supplements. 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.

Office of dietary supplement programs hfs 810 food and drug administration 5001 campus dr college park md 20740. Includes guidance for industry as well as manufacturing processes food facility registration haccp retail food protection. While fda s 2014 guidance primarily concerns liquid dietary supplements the reasoning provided therein is applicable to other forms of dietary supplements packaged and marketed as gels chews and bars.

2 under section 403 r 6 a of the act 21. Fda s july 2011 ndi draft guidance followed by the agency s announcement in december 2014 to include dietary ingredients and supplements in the fda redbook a guidebook historically used to evaluate safety of food and color additives and finally the release of the latest revised ndi draft guidance in august 2016 only perpetuates the. Potential risks whether a product is labeled and marketed as a conventional food or a dietary supplement is significant on numerous fronts.

Dietary supplement current good manufacturing practices cgmps and interim final rule ifr facts june 22 2007.