By: Jessica Wasserman, Esq.
This morning, Senate Majority Leader Mitch McConnell proposed report language that would require the FDA to, within 4 months, issue a formal enforcement policy on the sale of hemp CBD products. FDA’s current position is that CBD as an ingredient in food and supplements is illegal as an unapproved drug, while at the same time not enforcing this legal interpretation except in limited situations. This legislation, if passed, would make formal that FDA will not enforce against CBD supplements and foods until such time as it issues a regulation clarifying the regulatory pathway to gaining approval for CBD supplements and foods. If passed, this legislation would give some legal protection for CBD companies marketing food and supplements.
The U.S. Senate Appropriations Subcommittee on Agriculture will today consider the language introduced by McConnell.
As previously mentioned, the Committee provides $2,000,000 for research, policy evaluation, market surveillance, issuance of an enforcement discretion policy, and appropriate regulatory activities with respect to products under the jurisdiction of the Food and Drug Administration which contain cannabidiol (CBD) and meet the definition of hemp, as set forth in section 297A of the Agricultural Marketing Act of 1946 (7 U.S.C. 1639o).
Within 90 days, FDA shall provide the Committee with a report regarding the Agency’s progress toward 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.
FDA is encouraged to consider existing and ongoing medical research related to CBD that is being undertaken pursuant to an Investigation New Drug (IND) application in the development of a regulatory pathway for CBD in products under the jurisdiction of FDA and to ensure that any future regulatory activity does not discourage the development of new drugs.
Specifically,
Within 90 days, provide Congress a report outlining its efforts to develop an enforcement discretion policy on hemp CBD;
Within 120 days, issue its formal enforcement discretion policy on hemp CBD;
Keep the enforcement discretion policy in effect until the agency has implemented its final regulatory process; and
Ensure that going forward, CBD manufacturers would be able share safety data through existing FDA notification procedures (the NDI and GRAS processes) to be fully compliant with federal law and policy.
Until FDA issues a full regulation, the proposed legislation could be a step toward lifting the current regulatory uncertainty that has discouraged many companies from entering the industry while waiting for clarification. As well, some local governments have been unwilling to fully allow CBD while waiting on FDA. Financial institutions will be encouraged to work with CBD companies, and in the long run, it would set forward a fair and expeditious path for hemp CBD products to be formally recognized as safe and legal as a matter of federal law.
The bill will be marked up by the full Senate Appropriations Committee on Thursday, and could go to the full Senate soon.
For companies and others interested in fully legalizing CBD as a legal FDA regulated ingredient, now is the time to reach out to Members of Congress in support of this legislation.
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