On May 31, 2019, the U.S. Food and Drug Administration (“FDA”) held a much-anticipated public hearing regarding “Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds.” Since that time, FDA has reiterated its existing regulatory and enforcement approach to products containing cannabidiol (“CBD”) while also evaluating other science-based policy approaches for CBD products. The agency has emphasized that it is aiming to protect patients and the public health, foster innovation for safe and appropriate products, and promote consumer confidence.
FDA’s actions follow the enactment of the 2018 Farm Bill. As Ropes & Gray previously reported (see Alert and podcast), the 2018 Farm Bill removed hemp—defined as cannabis and cannabis derivatives with concentrations of THC no more than 0.3%—from the definition of marijuana in the Controlled Substances Act (“CSA”). This legislation meant that hemp, including CBD derived from hemp, was no longer unlawful under the CSA. However, the 2018 Farm Bill expressly preserved FDA’s authority to regulate such products.
This Alert summarizes the following recent developments related to FDA’s regulation of CBD products:
Public Comments: The closing of the comment period on July 16, 2019 for FDA’s public hearing docket, with nearly 4500 comments submitted;
Recent FDA Warning Letter: FDA’s issuance of a warning letter on July 22, 2019, to a firm marketing CBD products with unsubstantiated disease claims; and
FDA Testimony: Testimony of FDA’s Principal Deputy Commissioner, Amy Abernethy, before the Senate Committee on Agriculture, Nutrition, and Forestry on July 25, 2019.