The push and pull on CBD regulation continues.
Earlier this week, Minnesota Representative Colin Peterson introduced a H.R. 5587, which would regulate CBD as a dietary supplement. Specifically, the bill would amend the federal Food, Drug, and Cosmetic Act to add “other than hemp-derived cannabidiol” after the term “article” in Section 21 U.S.C. 321 (ff)(3)(B). If passed, the statute would effectively read as follows:
“The term dietary supplement … does … not include an article, other than hemp-derived cannabidiol, that is approved as a new drug…..”
The bill proposes adding similar language to the definition of “Prohibited Act.”
In addition, the bill would require USDA to conduct a study on the market and regulatory barriers for producers operating under the domestic hemp production program.
What About the Agriculture Appropriations Bill?
While there has been considerable pressure on FDA to clarify a non-drug pathway for CBD, H.R. 5587 appears to get ahead of FDA’s mandate per the 2020 Agriculture Appropriations bill, which was passed in December 2019.
The language in the Ag Appropriations Committee Report currently allocates $2 million to the FDA for “research, policy evaluation, market surveillance, and issuance of an enforcement discretion policy” with respect to hemp-derived CBD products. Specifically, the joint explanatory statement directs FDA to use data to develop and implement an enforcement discretion policy for products containing hemp-derived CBD. The bill also requires FDA to report on its progress. Key dates are as follows:
|Action Item||Due Date|
|FDA due to report to Congress on progress in crafting an enforcement discretion policy||February 20, 2020|
|FDA report to Congress on sampling study of adulterated or misbranded nature of currently-marketed CBD products||June 20, 2020|
As we discussed here, FDA has taken the position that CBD is not generally recognized as safe and may introduce risks relating to liver toxicity, male reproductive health, and potential drug interactions.
Meanwhile, Back At The FDA…..
Earlier this week, FDA Principal Deputy Commissioner Amy Abernethy told Politico that FDA is grappling with data collection as it determines what to do about CBD and may consider generating its own data to fill existing gaps.
FDA officials testified this week at the House Energy and Commerce Committee in a hearing titled “Cannabis Policy In The New Decade.” Stay tuned here for further developments.