Post date: 7/19/2019

The CBD market is exploding, with a new report from Brightfield Group predicting sales of CBD products will grow seven-fold, to $23.7 billion, by year-end 2023. And the Food and Drug Administration (FDA) is trying to play catch up. In a series of tweets posted on July 12, Dr. Amy Abernethy, the FDA’s Acting CIO, said the agency is “expediting” the rulemaking process around hemp-derived CBD products and plans to issue a progress report on its work by fall.

The FDA was assigned rulemaking authority for hemp-derived products, like CBD, under the 2018 Farm Bill, which removed hemp from the list of banned substances under the federal Controlled Substances Act. In May the FDA held a public hearing during which Acting Director Norman E. “Ned” Sharpless, MD, suggested it could take the agency 3 years, or more, for the agency to issue CBD regulations. “There are still lots of questions we will need to answer to answer to ensure the FDA is taking an appropriate, well-informed and science-based approach to the regulation of cannabis and cannabis derivatives, including CBD,” he said.

Hemp farmers, lawmakers and others have balked at the prospect of a multi-year rulemaking process. Senator Ron Wyden (D-OR) said it was “fully unacceptable” in a June 25 letter to Sharpless and Department of Health and Human Services (HHS) Secretary Alex Azar. (The FDA is an agency of HHS.) “The regulatory confusion and uncertainty surrounding CBD cannot continue for that length of time,” Wyden insisted. He urged the FDA to “immediately issue enforcement discretion guidance not later than August 1, 2019, and promptly issue an interim final rule, pending issuance of a permanent final rule” regarding CBD as a food additive and dietary supplement.

Wyden’s letter followed action in the U.S. House of Representatives prodding FDA action on CBD regulations. A funding bill approved by the full House includes a directive that the FDA “undertake a process to make lawful a safe level for conventional foods and dietary supplements containing cannabidiol (CBD) so long as the products are compliant with all other FDA rules and regulations.”

Senator Mitch McConnell (R-KY) met with Sharpless on June 27 to discuss the matter. McConnell, the top Republican in the Senate, is credited with authoring the 2018 Farm Bill provision removing hemp from the federal list of controlled substances. “Congress’ intent was clear with passage of the Farm Bill that these products should be legal, and our farmers, producers and manufacturers need clarity as well as a workable pathway forward regarding the agency’s enforcement and potential regulatory plans for certain CBD products,” Sen. McConnell said.

Abernethy’s tweets suggest the FDA is hurrying along the process. “The FDA is expediting its work to address the many questions about cannabidiol (CDB). This is an important national issue with public health impacts, & and important topic for American help farmers and many other stakeholders,” she wrote. “We plan to report on our progress around the end of summer/early fall.”

In a related development, Sen. Wyden in late June introduced legislation, the State Cannabis Commerce Act, to permanently protect all state cannabis programs from federal interference, and to allow for interstate cannabis commerce between states that have legal cannabis programs. An identical bill was introduced in the House by Representative Earl Blumenauer (D-OR). “The federal government is hopelessly out of touch with the American people on cannabis,” Rep. Bluemauer said in a statement. “It is past time we protect the states, like Oregon, that have gotten it right.”

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