Will the FDA Act against cannabis or cannabis-related products that are in violation of the FD&C Act?
Officially from the FDA: “When a product is in violation of the FD&C Act, the FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. The FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.
Bottom Line: At this point it has taken no action beyond enforcement letters. And it doesn’t seem to have the resources to enforce its existing regulations so some compromise will probably have to be reached.
What is the FDA Doing now: Not Much
After hemp and its derivatives were federally legalized under the 2018 Farm Bill, the FDA was mandated under separate appropriations legislation passed late last year to provide an update on its regulatory approach to CBD within 60 days. That deadline passed early last year, but eventually the report and a supplementary notice were made public in the middle of last year.
The agency reviewed what’s known about CBD—acknowledging that data was limited “because cannabis-derived CBD was a Schedule I controlled substance” prior to hemp legalization. The roadblocks to research caused by marijuana’s ongoing restrictive Schedule I status is something legalization advocates have long pointed out.
Future of FDA Regulations: Now We Have Silence
On November 1, 2019 Dr. Stephen Hahn was nominated as the Commissioner of Food and Drugs at the Department of Health and Human Services. Dr. Hahn was confirmed as Commissioner on December 12, 2019.
At this point he has made no strong indications of any more significant future enforcement measures.
Future of State Enforcement on Behalf of FDA: Don’t Bet the Farm on it
The FDA admits; “While the states have their own enforcement programs, as the regulating agency FDA is much more capable of consistent enforcement across the board. State enforcement, for the most part, consists of a patchwork of regulations that are inconsistent across the country and enforcement is generally under-funded and minimally effective. The varying legality of hemp and marijuana products across the country also means that various states will enforce their laws differently. While states have a strong interest in protecting their citizens, it is challenging for them to establish standards for products that are distributed nationally. Thus, federal enforcement is likely to be the most effective in curbing the proliferation of unlawful CBD products.”