14. Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?
FDA has approved Epidiolex, which contains a purified form of the drug substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 years of age and older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. That means FDA has concluded that this particular drug product is safe and effective for its intended use.
A. It depends, among other things, on the intended use of the product and how it is labeled and marketed. Even if a CBD product meets the definition of “hemp” under the 2018 Farm Bill (see Question #2), it still must comply with all other applicable laws, including the FD&C Act. The below questions and answers explain some of the ways that specific parts of the FD&C Act can affect the legality of CBD products.
Questions and Answers
A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. 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. FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.
23. What should I do if my child eats something containing cannabis?
26. Can approved human drugs containing CBD or synthetic THC be used extralabel in animals?
3. Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?
“Pure” CBD, also called “CBD isolate,” is called that because all other cannabinoids have been removed. So have terpenes and flavonoids, which give marijuana its strong aroma and earthy flavor.
Michigan State University provides funding as a founding partner of The Conversation US.
CBD is a compound found in cannabis. There are hundreds of such compounds, which are termed “cannabinoids,” because they interact with receptors involved in a variety of functions like appetite, anxiety, depression and pain sensation. THC is also a cannabinoid.
Hemp, marijuana and cannabanoidals
Clinical research indicates that CBD is effective at treating epilepsy. Anecdotal evidence suggests it can help with pain and even anxiety – though scientifically the jury is still out on that.
Though 15 states have now legalized recreational marijuana, it remains illegal federally in the United States. Technically, those in possession of marijuana in a legal weed state can still be punished under federal law, and traveling across state borders with cannabis is prohibited.
Our recent study found that Americans perceive hemp and CBD to be more like over-the-counter medication and THC to be more like a prescription drug. Still, the average person in the U.S. does not view hemp, CBD, THC or even marijuana in the same light as illicit substances like meth and cocaine – even though both are classified by the DEA as having a lower potential for abuse than marijuana.
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