How are products that combine a drug and a dietary supplement regulated?
A product that combines a drug and a dietary supplement (without including a device or biological product) is not a combination product as defined in 21 CFR 3.2(e). Information about the regulation of dietary supplements is provided at http://www.cfsan.fda.gov/~dms/supplmnt.html . You should refer any specific questions about combination drug-dietary supplement products to the responsible reviewing Division in CDER’s Office of New Drugs http://www.fda.gov/cder/cderorg/OND.PDF . If you are unsure which CDER Division would be responsible for the review of your product, or if you have a general inquiry, please contact the Regulatory Affairs Team in CDER’s Office of New Drugs at (301) 796-0700.
A product that combines a drug and a dietary supplement (without including a device or biological product) is not a combination product as defined in 21 CFR 3.2(e). Information about the regulation of dietary supplements is provided on the Dietary Supplements section of the FDA website. You should refer any specific questions about combination drug-dietary supplement products to the responsible reviewing Division in CDER’s Office of New Drugs. The contact information can be located on the CDER Reference Guide. If you are unsure which CDER Division would be responsible for the review of your product, or if you have a general inquiry, please contact the Regulatory Affairs Team in CDER’s Office of New Drugs at (301) 796-0700.
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