In the dawn of the new administration, the U.S. Food and Drug Administration (FDA) withdrew its “Cannabidiol Enforcement Policy,” a document that stakeholders had hoped would deliver long-overdue guidance on cannabidiol (CBD) regulations. The White House had completed its review of the document back in July, although no subsequent action followed, and the contents were never released to the public. The document was not specifically targeted—a Biden administration memo instructed the federal agencies to withdraw all pending rules—and so we cannot draw any conclusions at this point on whether the freeze represents a change in approach on CBD regulation from the prior administration.
FDA has been using its enforcement discretion since hemp-derived CBD was legalized under the Agriculture Improvement Act of 2018, or Farm Bill. Hemp, like marijuana, is a type of Cannibis Sativa plant, the difference being that hemp is defined by the Farm Bill as containing low concentrations (less than 0.3%) of tetrahydrocannabinol (THC). According to the federal Food, Drug & Cosmetic Act and FDA regulations, CBD products cannot be marketed as food additives, dietary supplements, or for therapeutic uses and treatment of diseases. But with little guidance surrounding these regulations, and consumer demand for CBD stronger than ever, CBD manufacturers and retailers have flooded the market with potentially illegal products. As we reported last year, the FDA has issued a steady stream of warning letters to companies marketing CBD products that have made unsubstantiated claims about the therapeutic potential of their products. The agency continued this practice in 2020, focusing primarily on products making egregious unfounded health claims. And while hemp-derived CBD is now legal, marijuana-derived CBD is still considered a controlled substance under the federal enforcement scheme.
In a July 2020 progress report to Congress, FDA confirmed that it was working towards a “risk-based enforcement policy” that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions. As part of this effort, FDA had opened a public docket for confidential submission of scientific data on CBD to the agency, as well as initiating its own research, “as the agency continues to move forward to explore viable pathways for CBD products outside the drug context.”
Looking ahead, we will be closely watching how the new leadership at the FDA prioritizes CBD policy reform and enforcement. While President Biden and Vice-President Harris were far from supporters of the cannabis industry in their respective careers, they have since touted reform—Harris was the chief sponsor of the MORE Act, a major step in decriminalizing marijuana at the federal level. “Under a Biden-Harris administration, we will decriminalize the use of marijuana and automatically expunge all marijuana use convictions and incarcerations for drug use alone,” promised Harris. With the new administration, coupled with a Democrat-controlled Congress, it is likely that the cannabis industry can expect more support and meaningful reform from the federal government.