By Stephanie Carr • June 30, 2019•Ms. JD, Writers in Residence
Many people assume that any and all hemp-derived CBD products are legal, and can be sold, pursuant to passage of the 2018 Farm Bill. But those people are wrong and could unknowingly place themselves in legal jeopardy. For practitioners looking to break into the cannabis law field, understanding the FDA's position on CBD products in food or cosmetic products is a good way to start.
The 2018 Farm Bill exempts hemp and hemp-derived products, including CBD, from the Controlled Substances Act (CSA). But the U.S. Food and Drug Administration (FDA) has made clear that it retains authority to regulate products containing cannabis or cannabis-derived compounds under the Food Drug and Cosmetics Act (FDCA), regardless of whether they're derived from hemp. In other words, the FDA may still consider food, supplements, or cosmetics as "impermissible" if they contain hemp-derived CBD.
The main rationale for the FDA's tight grip on CBD products is as follows. First, it's concerned about the potential for liver injury and cumulative exposure to CBD if accessed by individuals from a range of products. Second, the FDA is worried that widespread commercial availability of CBD products negatively impacts research that may otherwise be performed and show support for regulatory approval through the FDA drug review process. Third, the FDA doesn't want patients to forgo appropriate medical treatment in favor of using unapproved products to treat their conditions. The FDA is concerned about "egregious claims" by companies that sell and market CBD products, which could influence consumers to not use approved therapies to treat serious diseases.
The FDA's position on CBD is rapidly changing with several recent events. On April 2, 2019, the outgoing FDA Commissioner, Scott Gottlieb, issued a press release reinforcing the FDA's position and outlining what steps are in store over the next several months. One of the scheduled steps was a public hearing on May 31, 2019, to allow stakeholders to share experiences and challenges with CBD products.
Attorneys who advise companies that sell CBD products should understand recent events and be aware of what's coming next. They should also be aware of the following issues and advise their clients accordingly:
- Identify how the CBD product is defined under the FDCA.
- Review former Commissioner Gottlieb's testimony regarding the FDA's "enforcement discretion" for taking action against manufacturers of CBD products.
- Review recent state actions. Some states have banned CBD-infused food products while others have released policies allowing hemp-derived CBD in foods. Understand how state law can mitigate civil tort risk, even if the state law is preempted by federal law.
- Help clients understand how the current climate is one of measured risk versus legal certainty when it comes to selling CBD products that fall within the realm of FDA regulation. Discuss potential civil tort exposure and issues with insurance coverage related to those risks.