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Market Confusion on CBD and Hemp; FDA Commissioner Resigns amid Congressional Pressure for Federal Guidance

The Commissioner of the Food and Drug Administration (FDA), Scott Gottlieb M.D., who has received high marks for his leadership of the agency since May 2017, announced his resignation on March 5, 2019, stating that he wants to spend more time with his family. Gottlieb’s resignation came only days following his testimony before the House Appropriations Committee regarding the FDA’s regulatory plans for CBD (cannabidiol). Congress also heard testimony from the Secretary of the U.S. Department of Agriculture on the status of industrial hemp cultivation pursuant to the 2018 Farm Bill. 

FDA Commissioner Testifies about CBD

In testimony before the House Appropriations Committee, FDA Commissioner Gottlieb detailed the start of new regulatory plans for CBD. Initially, the FDA will hold a public meeting in April to hear from industry stakeholders about effective regulations for hemp-derived CBD. Gottlieb also mentioned that the FDA is forming a work group with “some senior officials in the agency” to study regulatory options for CBD. 

Gottlieb noted that creating a regulatory framework for CBD “is not a straightforward issue” because CBD is a compound in an existing FDA-approved medication and under the Federal Food, Drug, and Cosmetic Act (FDCA) it cannot be added to products intended for human consumption. 

Hinting at a possible regulatory framework, Gottlieb said “CBD could potentially exist in a high concentration, pure formulation as a pharmaceutical product” while also existing at lower concentrations in products that could be sold as foods and dietary supplements.

Gottlieb acknowledged the possibility that promulgating CBD regulations could take longer than expected, testifying he will seek congressional guidance to “have a discussion about whether or not there are other frameworks that could help address this” if the FDA determines that the pathway to CBD regulations could be a multi-year process.

USDA Secretary Testifies about 2018 Farm Bill

Meanwhile, USDA Secretary Sonny Perdue testified before the full House Agriculture Committee on the status of the 2018 Farm Bill. “Proceeding very judiciously because of the uniqueness of the hemp crop,” Perdue stated that the USDA plans to issue its hemp regulations by fall 2019 and in time for the 2020 growing season. Accordingly, the USDA is hosting a webinar listening session on industrial hemp production on March 13, 2019.

Under the 2018 Farm Bill, the USDA is tasked with issuing regulations to implement a program for commercial production of industrial hemp across the United States. The USDA also must review and approve industrial hemp plans submitted by states or Indian tribes within 60 days of submission.

Secretary Perdue made clear that the USDA will not begin approving state plans until final USDA regulations are in place. Nevertheless, several states have already submitted plans for USDA approval, including Pennsylvania and Kentucky. Accordingly, these plans will have to wait for approval until USDA regulations are finalized.

Confusion to Persist

Although many were looking for clarity coming out of these recent hearings, Commissioner Gottlieb’s sudden resignation has created further uncertainty with regard to how the FDA will manage the regulatory pathway for CBD. The expectation that the FDA will liberalize its position on CBD also comes at a time when the agency is preparing to take a more aggressive stance on regulating the dietary supplement industry. Whoever takes the helm at FDA, it should be expected that the agency will maintain a fairly consistent position that CBD and other cannabinoids must follow the scientific process like any other chemical component, which will take many months at the minimum.

© 2019 Wilson Elser

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About this Author

Neil Willner, Wilson Elser Law Firm, White Plains, Health Care and Cannabis Law Attorney
Associate

Neil Willner focuses his legal practice on medical malpractice, dental malpractice, nursing home liability and general liability centered on complex litigation. His clients include physicians, prominent New York hospitals and nursing homes, and national dental corporations as well as summer camps. Neil served as a paralegal and a member of trial team in a medical malpractice defense firm while attending law school at night, giving him insights into all facets of the practice. Neil was also a law clerk at a New York firm working on product liability and medical...

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Ian A. Stewart, Wilson Elser, Data Privacy Lawyer, General Liability Attorney
Partner

Ian Stewart handles complex litigation in state and federal courts, where he frequently defends catastrophic multi-party litigation. Ian’s practice includes product liability, professional liability, construction defects and general liability matters, as well as data privacy and intellectual property litigation.

Ian is committed to client communication and cost-effective litigation management. He is a proponent of efficient claim resolution, including alternative dispute resolution (ADR). He has served as a pro bono mediator and previously served as national chair of the Claims and Litigation Management Alliance’s ADR Committee.  Ian has developed courses on negotiation strategy and ADR bargaining tactics.

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