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Background – With the increasing popularity of products containing cannabis and cannabis-derived
compounds (including cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC)), FDA is aware that
some companies are marketing conventional food products and products labeled as dietary supplements that contain cannabis or cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). Here is what you need to know about FDA’s regulation of these types of products.
THC or CBD products cannot be sold as dietary supplements under the FD&C Act
Under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)], THC and CBD products are
excluded from the dietary supplement definition. Under that provision, if a substance (such as THC or
CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement.
There is an exception to section 201(ff)(3)(B) if the substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were
authorized, as applicable. However, the agency is not aware of any evidence that CBD or THC were
marketed in conventional foods or dietary supplements prior to being subject to substantial clinical
investigations. Therefore, both CBD and THC are excluded from the dietary supplement definition and
cannot be sold or marketed as such.
THC or CBD cannot be added to food for humans or animals under the FD&C Act
Under section 301(ll) of the FD&C Act [21 U.S.C. § 331(ll)], it is prohibited to introduce or deliver for
introduction into interstate commerce any food (including any animal food or feed) to which has been
added a substance which is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or a drug for which substantial clinical investigations have been
instituted and for which the existence of such investigations has been made public. There are exceptions, including when the drug was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted or, in the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling. However, based on available evidence, FDA has concluded that none of these is the case for THC or CBD. FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added.
Ingredients derived from cannabis that do not contain CBD or THC might be able to be used in
foods and dietary supplements if all other FD&C requirements are met.
Ingredients that are derived from parts of the cannabis plant that contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant, might be able to be marketed as dietary supplements and/or conventional foods. These products must still comply with all applicable laws and regulations governing dietary supplements and conventional foods, including requirements related to safety (e.g., new dietary ingredients, food additive),
Continue at: https://www.fda.gov/media/131878/download
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