FDA evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products

FDA has seen products containing cannabis or cannabis derivatives that are marketed as human drugs, dietary supplements, conventional foods, animal foods and drugs, and cosmetics. The public is looking to the FDA for clarity on what pathways are available to market such products lawfully under these authorities. Hemp is cannabis and cannabis derivatives with extremely low (no more than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). The 2018 Farm Bill removed hemp from the Controlled Substances Act, which means that it is no longer a controlled substance under federal law. The FDA had issued multiple warning letters to companies marketing cannabidiol (CBD) products with egregious and unfounded claims that are aimed at vulnerable populations. In May the FDA will hold a public hearing about the regulatory status of existing products and the lawful way products containing cannabis or cannabis-derived compounds can be marketed. For example, recently the FDA allowed Epidiolex – a purified form of CBD that the FDA approved in 2018 for use in the treatment of certain seizure disorders. The FDA identified certain safety risks, including the potential for liver injury. There are unresolved questions regarding the cumulative exposure to CBD if people access it across a broad range of consumer products, as well as questions regarding the intended functionality of CBD in such products. Additionally, there are open questions about whether some threshold level of CBD could be allowed in foods without undermining the drug approval process or diminishing commercial incentives for further clinical study of the relevant drug substance. FDA vows to take action against companies illegally selling these types of products. The FDA is announcing that it has issued warning letters, in collaboration with the Federal Trade Commission, to three companies (i) Advanced spine and plan LLC; (ii) Nutra Pure LLC; and (iii) PotNetwork Holdings Inc. in response to their making unsubstantiated claims The companies made unfounded, egregious claims about their products' ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient data. @ https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635048.htm?utm_campaign=040219_Statement_FDA%20announces%20new%20steps%20on%20cannabis-related%20products&utm_medium=email&utm_source=Eloqua" rel="nofollow noopener noreferrer" target="_blank">https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635048.htm?utm_campaign=040219_Statement_FDA%20announces%20new%20steps%20on%20cannabis-related%20products&utm_medium=email&utm_source=Eloqua
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products

FDA is announcing a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities.

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