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FDA Plans to Expedite Development of CBD Regulations


In a series of tweets issued on Friday, July 12, 2019, FDA Principal Deputy Commissioner Amy Abernathy, M.D., Ph.D., announced that the Agency plans to expedite the development of regulations specific to cannabidiol (CBD), with the intent of issuing a progress report by the end of summer or early Fall 2019.

Principal Deputy Commissioner Abernathy's announcement comes on the heels of increased bipartisan pressure from Congress on the FDA to act expeditiously in developing sound regulations governing the sale, distribution, and use of CBD, particularly with respect to CBD as a food additive and dietary ingredient. On June 25, 2019, Senator Ron Wyden issued a letter to the FDA urging the Agency to issue formal guidance announcing a CBD enforcement discretion policy no later than August 1, 2019. Senator Wyden further urged the FDA, pending publication of a permanent final rule, to issue an interim final rule ensuring that a regulatory pathway exists for the lawful use of CBD as a food additive and as a dietary ingredient. Across the aisle, on June 27, 2019, Senate Majority Leader Mitch McConnell met with Acting FDA Commissioner Ned Sharpless and similarly urged him to develop regulations so that hemp-derived CBD can be lawfully marketed in the United States. Following the meeting, Senator McConnell issued a public statement reaffirming that "Congress's intent was clear from the passage of the Farm Bill that these products [CBD foods and dietary ingredients] should be legal, and our farmers, producers and manufacturers need clarity as well as a workable pathway forward regarding the agency's enforcement."

Principal Deputy Commissioner Abernathy's July 12, 2019 tweets read the "FDA is expediting its work to address the many questions about cannabidiol (CBD). This is an important national issue with public health impact, & an important topic for American hemp farmers and many other stakeholders. We are enthusiastic about research into the therapeutic benefits of CBD products but also need to balance safety. To understand the breadth of issues and gather data on safety we have conducted a public hearing, reviewed the medical literature, and have an open public docket…. We plan to report on our progress around end of summer/early fall."

For assistance with understanding laws governing CBD in your state or jurisdiction, please contact the author of this alert, Kyle Diamantas, or any member of Baker Donelson's FDA Group.

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