FDA Continues Enforcement Actions on CBD Makers, Calls for Stakeholder Input

April 8, 2019

When Congress passed the 2018 Farm Bill that, among other things, took hemp off the list of DEA controlled substances, it maintained the role of the FDA in regulating products containing cannabis or cannabis-derived compounds.

CBD makers across the country felt that, as a result of the passage of the bill, all CBD products were now legal. But that’s not the case. In fact, the FDA has continued enforcement actions against some CBD makers.  “As we’ve stated before, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products,” FDA Commissioner Scott Gottlieb wrote in a statement released April 2 (1). “Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that’s marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it may be introduced into interstate commerce.

Additionally, it is unlawful to introduce food containing added CBD, or the psychoactive compound THC, into interstate commerce, or to market CBD or THC products as dietary supplements.

“There are also unresolved questions regarding the cumulative exposure to CBD if people access it across a broad range of consumer products, as well as questions regarding the intended functionality of CBD in such products. Additionally, there are open questions about whether some threshold level of CBD could be allowed in foods without undermining the drug approval process or diminishing commercial incentives for further clinical study of the relevant drug substance.”

Gottlieb went on to cite recent enforcement action warning letters to three CBD manufacturers – Advanced Spine and Pain, Nutra Pure, and Pot Network Holdings – that “used these online platforms to make unfounded, egregious claims about their products' ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious
diseases, without sufficient evidence and the legally required FDA approval.”

Gottlieb called for the formation of a high-level internal agency working group to “explore potential pathways for dietary supplements or conventional foods containing CBD to be lawfully marketed,” along with a public hearing to be conducted on May 31 to hear from CBD industry stakeholders about how the FDA can work with CBD makers going forward.