Overview
The joint explanatory statement attached to the recently-enacted 2020 appropriations package[1] contains several cannabis-related provisions for federal regulators to implement in the coming months.
In the past, Congress has been hesitant to include any language governing the federal treatment of cannabis, with the exception of a long-standing appropriations rider that prohibits the Department of Justice from using appropriated funds to interfere in states that have legalized marijuana for medical use.
This year, however, Congress agreed on several significant provisions that:
- Encourage the National Institutes of Health to consider additional investment in studying the medicinal effects and toxicology of cannabidiol (CBD) and other cannabinoids;
- Direct the National Institute on Drug Abuse to report on the barriers to research that result from a drug's Schedule I classification;
- Fund hemp-related activities across the country (e.g., nearly $16.5 million to the Agriculture Marketing Service for the implementation of its hemp production program, $2 million for hemp research, etc.); and
- Recommend the Agency for Healthcare Research and Quality issue $1 million in grants toward research into the use of products like CBD and kratom to treat pain in place of opioids.
Perhaps most notably, the joint explanatory statement allocates $2 million to the Food and Drug Administration (FDA) for "research, policy evaluation, market surveillance, and issuance of an enforcement discretion policy" with respect to hemp-derived CBD products.[2] Specifically, the joint explanatory statement directs FDA to use data to develop and implement an enforcement discretion policy for products containing hemp-derived CBD. Unlike the explanatory text that accompanied the Senate's agriculture appropriations bill, the statement does not affirmatively provide that the "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." Nonetheless, a report on the agency’s progress in crafting this enforcement discretion policy is due by February 20, 2020.
Products under FDA's jurisdiction include, but are not limited to, cosmetics, dietary supplements, drugs, food, food-contact materials, medical devices, and tobacco products.[3] Yet, as discussed in our recent update, New Class Action Filings and FDA Warnings Highlight Increased Regulatory and Litigation Risk for CBD Products, the regulatory status of FDA-regulated products that contain CBD varies significantly and will depend on the classification of the product and the product's marketing claims.
The appropriations bill further directs FDA to conduct a sampling study to evaluate products containing CBD that are currently on the market and to determine the extent to which such products are adulterated (i.e., injurious to health) or misbranded (i.e., false or misleading labels).[4] A report on FDA's findings is due to Congress by June 20, 2020.
Though the enforcement discretion policy could offer some reassurance to entities interested in entering the hemp-derived CBD market, its creation—along with the other research, evaluation, and reporting obligations—will be layered on top of FDA's efforts (and associated restrictions) regarding the development of regulatory pathways for hemp-derived CBD products.
[1] See Consolidated Appropriations Act of 2020 (H.R. 1158).
[2] See Explanatory Statement on Fiscal 2020 Eight-Bill Spending Package (Agriculture), Title VI ("Related Agencies and Food and Drug Administration"), pages 28-29.
[3] See Section 201(f) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. ch. 9 § 301, et seq.
[4] Designated in the appropriations bill as "mislabeled."
