The passage of the Agricultural Act of 2018 (“2018 Farm Bill”) unequivocally removed hemp-derived CBD (“Hemp CBD”) from the Controlled Substances Act (“CSA”). But the 2018 Farm Bill also made clear that the Food and Drug Administration (“FDA”) would retain sole authority over consumer products that contain Hemp CBD. The FDA has approved CBD for use as a drug to treat epilepsy but has stated on its website and in warning letters to CBD manufacturers and distributors that Hemp CBD cannot be sold as a food or dietary supplement. Some states have taken a similar position, strictly limiting the ability to distribute Hemp CBD products in their boundaries. However, the FDA’s position is not codified in any law or regulation and the agency is facing pressure from the public and from federal lawmakers to come up with a system that provides greater access to Hemp CBD.
Our attorneys understand the challenges unique to Hemp CBD and can assist our clients in making business decisions in light of immense regulatory uncertainty. We help our clients with the following:
- Establishing verification and chain of custody procedures to provide evidence to support regulatory determination that CBD is derived from legal hemp rather than marijuana.
- Advising clients of risks associated with transporting hemp across state lines and developing solutions to navigate and mitigate those risks,
- Assisting clients in obtaining licenses and regulatory approvals required to process hemp in Hemp CBD or manufacture Hemp CBD products,
- Inform clients of how various states regulate and Hemp CBD, including advising clients where Hemp CBD sales are prohibited, and helping to develop regulatory compliance in client procedures.
- Reviewing and revising Hemp CBD labels or marketing plans in light of the FDA’s position on Hemp CBD and state-level requirements.,
- Updating clients on developments at the Federal and state level that impacts Hemp CBD and/or other secondary cannabinoids.
Hemp CBD is not the only cannabinoid naturally occurring in or derived from hemp. In the years following the 2018 Farm Bill, our attorneys have worked with clients who are focused on lesser known or newly discovered hemp-derived cannabinoids such as CBG, CBN, THCV, and Delta-8 THC, to name a few. These novel cannabinoids have their own unique sets of challenges in comparison to Hemp CBD and our attorneys can assist you in evaluating the risks and rewards unique to the developing cannabinoid markets.