Senate Leader Mitch McConnell (R-KY) inserted
regarding products containing cannabidiol (CBD) derived from hemp into proposed 2020 Senate Appropriations legislation. The report language doesn’t propose to change federal law on this issue, but it is a very strongly worded call for the U.S. Food and Drug Administration (FDA) to take the following significant actions with respect to products containing CBD derived from hemp as defined in section 297A of the Agricultural Marketing Act of 1946 (7 U.S.C. 1639o):
- “Within 90 days, FDA shall provide a report on the progress towards obtaining and analyzing data to help determine a policy of enforcement discretion, and the process in which CBD meeting the definition of hemp will be evaluated for use in products.”
- “Within 120 days, FDA shall issue a policy of enforcement discretion with regard to certain products containing CBD meeting the definition of hemp as defined by section 297A of the Agricultural Marketing Act of 1964 (7 U.S.C. 1639).”
- “Such enforcement discretion shall be in effect until FDA establishes a process for stakeholders to notify FDA for use of CBD in products that include safety studies for intended use per product, and makes a determination about such product.”
This approach differs from the legislative proposal recently drafted and submitted to McConnell’s office by a coalition of dietary supplement trade associations, but AHPA still supports the inclusion of this report language as a positive interim step. The 2018 Farm Bill was signed just over nine months ago, and the hemp-derived CBD industry continues to wait for FDA to take concrete actions towards defining a legal path for use of hemp-derived CBD as a lawful dietary ingredient.
Among other suggested actions, AHPA has advocated for FDA to formally issue guidance regarding the Agency’s exercise of enforcement discretion with respect to the provisions of the Food Drug & Cosmetic Act (FD&C Act) on which FDA bases its position that CBD-containing supplements and foods are unlawful, conditioned on a product’s compliance with all other FDA-enforced requirements applicable to dietary supplements and foods, respectively. AHPA presented this request both in oral comments delivered at the May 31, 2019 public hearing and in written comments submitted to the hearing docket.
While a regulatory or legislative solution is ultimately required, an interim policy of enforcement discretion would help align FDA’s actions with Congress’s intent to permit the sale of products containing hemp-derived CBD as expressed in the 2018 Farm Bill. It would also provide the industry with some measure of regulatory certainty until either completion of a potential FDA rulemaking on hemp-derived CBD products or Congress provides clarity on the issue through a change in the law.