It seems like everyone and their dog are using products containing CBD, but are they safe, effective, and in compliance with the Food, Drug, and Cosmetic (FD&C) Act? A hearing was held on May 31 to discuss just that. Many stakeholders shared their experiences and challenges and convinced the FDA to open a docket for public comments until July 16, 2019.1
While you may want to enter this market while it’s hot, no new decisions about how cannabis-derived products will be regulated have been made, therefore current regulations still apply. Currently, CBD and THC are both regulated as products intended to have a therapeutic or medical use (drugs) and as such are not to be marketed as a dietary supplement or food additive and require a regulatory submission to FDA.1
FDA still has many questions regarding CBD such as “how much CBD is safe to consume in a day? How will it interact with other drugs the person might be taking? What if she’s pregnant? What if children access CBD products like gummy edibles? What happens when someone chronically uses CBD for prolonged periods?”. It is because of questions like these paired with the concern about marketing claiming these products can prevent, mitigate, treat, or even cure diseases, FDA has and will likely continue to issue warning letters to companies selling unapproved CBD products.2
Each state does have its own laws regarding cannabis and cannabis-derived products, but federally FDA has not set forth a different pathway for the clearance or approval of such products other than the current regulations.1
The exception of this rule are products made from cannabis derivatives with very low THC content, less than 0.3% dry weight, or hemp as the Agriculture Improvement Act of 2018 removed it from the Controlled Substance Act’s definition of marijuana. Therefore, hulled hemp seed, hemp seed protein powder, and hemp seed oil were able to be generally recognized as safe by FDA in 2018.2
FDA is working to continue taking an appropriate, well-informed, and science-based approach to the regulation of cannabis and cannabis derivatives and is taking public comments.2 You can submit comments regarding the regulation of cannabis and its derivatives here: https://www.regulations.gov/docket?D=FDA-2019-N-1482.
Have questions about the current regulations or need help ensuring you are compliant with the FD&C Act? Contact us at 248-987-4497 or firstname.lastname@example.org.
1FDA FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers retrieved on July 3, 2019, at https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers#fdaroleresearch.
2FDA Remarks by Dr. Sharpless at the FDA Public Hearing on Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds retrieved on July 3, 2019, at https://www.fda.gov/news-events/speeches-fda-officials/remarks-dr-sharpless-fda-public-hearing-scientific-data-and-information-about-products-containing.