March 1, 2019

FDA Open to “Alternative Approaches” to Regulating CBD

Holland & Knight Healthcare Blog
Sara M. Klock | Michael J. Werner

FDA has announced plans to seek congressional and stakeholder input on "possible alternative approaches" to regulating cannabis and cannabis-derived products. The announcement came as Commissioner Scott Gottlieb spoke on the Agency's New Steps to Promote Food Safety at the National Association of State Department of Agriculture Winter Policy Conference on Feb. 26, 2019. As a first step, FDA will convene an internal working group and then hold its first public meeting in April 2019, to begin the process of a creating a regulatory framework.

FDA has the authority to regulate and enforce products containing cannabis and cannabis-derived compounds, even with the removal of hemp and cannabis derivatives with less than 3% Tetrahydrocannabinol (THC) from the definition of marijuana in the 2018 Farm Bill (as discussed here). Drugs containing cannabidiol (CBD) or THC are regulated under FDA's existing framework and FDA has approved drugs with these ingredients. However, food and dietary supplements containing CBD or THC cannot legally be marketed, because under existing FDA regulations, chemicals cannot be marketed as food or dietary supplements if they are active ingredients in already approved drugs. To permit such marketing, FDA would need to change its rules through a rulemaking process. FDA intends to seek "broad public input on this pathway, including information on the science and safety behind CBD," but the Agency is also going to explore "alternative approaches … to make sure that [the Agency] ha[s] an appropriately efficient and predicable regulatory framework for regulating CBD products."

According to Gottlieb, FDA is aware of the public interest surrounding cannabis and cannabis-derived products, but "CBD isn't risk free" and the Agency will continue to take enforcement action against "products not approved by the FDA mak[ing] unproven claims of therapeutic benefit."

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