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Office of dietary supplement programs hfs 810 food and drug administration 5001 campus dr college park md 20740.
Dietary supplement notification fda. When the dietary supplement health and education act dshea was passed back in 1994 it came with a new dietary ingredient ndi provision requiring the fda to be notified at least. If you plan to market a dietary supplement that contains a new dietary ingredient you must submit to fda at least 75 days before the. A dietary supplement is a product taken by mouth that contains a dietary ingredient intended to supplement the diet the fda adds that the dietary ingredients inside supplements can include vitamins minerals herbs or other botanicals amino acids and substances such as enzymes organ tissues glandulars and. Any dietary ingredients that were already sold in interstate commerce would be grandfathered and not subject to the ndi provision in dshea.
Fda registration dietary supplement manufacturers of dietary supplments or nutrient supplements require fda food facility registration nutrient dietary supplements are substances which are necessary for the body s nutritional and metabolic processes. The federal food drug and cosmetic act the act requires that the manufacturer packer or distributor who wish to market a dietary supplement notify fda regarding the statement on the label or. When must you submit a new dietary ingredient notification. As you can see because the dietary supplement regulations are very technical many marketers of dietary supplement products turn to an experienced fda consultant or fda regulatory attorney to prepare and submit a 30 day notification and ensure compliance with federal law.
This guidance is intended to assist industry in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient ndi is necessary and in preparing. The dietary supplement health and education act of 1994 granted fda the authority to develop a premarket gate for any new dietary ingredients that came to the market after october 15 1994.
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