With the legalization of certain hemp and CBD products in December, a new industry has emerged, ripe for regulation.

Last Wednesday, at a hearing held by the House Appropriations Committee, U.S. Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb revealed the FDA’s plan to conduct public hearings on cannabidiol (“CBD”) starting in April. Acknowledging the legalization of hemp and hemp-derived products in December of 2018, Gottlieb stated that he was forming a collective of senior officials to produce new FDA laws for the industry.1

Although he did warn that the April hearings would not be a “straightforward issue,”Gottlieb still went on to offer information on considerations that may determine the ensuing legislative framework. He also proposed theories on potential rules that may emerge from the upcoming discussions. According to CNBC, the FDA commissioner suggested that lower concentrations of cannabidiol could, in the future, be considered food products with a different review process than products with higher concentrations, which could be subject to tougher drug restrictions.3

“We believe it does have therapeutic value and has been demonstrated,” Gottlieb explained. “But I will tell you this is not a straightforward process. There’s not a good proxy for us doing this through regulation.”Should it take the FDA over two nears to formally enact updated rules, he suggested congressional intervention. Gottlieb went on to offer the option of bringing the issue to Congress, stating, “and if we get comments back and find this is sufficiently complicated for the agency, we will come back and have a conversation with Congress on with how we might be able to work together on this.”5

The proposed hearings are a direct federal response to the legal uncertainty created by the legalization of hemp with the Agricultural Improvement Act of 2018 – or “2018 Farm Bill” – which contrary to popular belief, did not actually legalize CBD products for human use. California took measures to ban the sale of food and beverages containing CBD last year, however, even after the passing of the 2018 Farm Bill, Maine, Ohio, and New York City have issued similar statements just this month. Despite the “legalization” of hemp and CBD, the Farm Bill states that it will not supersede or alter the Federal Food, Drug, and Cosmetic Act (“FD&C”). The FD&C requires any food additive products or products sold as a form of medical treatment to complete the FDA’s drug approval procedures to be legal.6

The expectations of a booming hemp industry via the passing of the 2018 Farm Bill have not fully materialized despite public interest, but market participants hope further regulation will provide more clarity and stability to the emerging market.7

 


  1. LaVito, Angelica. “FDA Plans First Public Hearings on Legalizing CBD Foods in April.” CNBC. February 27, 2019. Accessed March 01, 2019. https://www.cnbc.com/2019/02/27/fda-plans-first-public-hearings-on-legalizing-cbd-foods-in-april.html.
  2. Jaeger, Kyle. “FDA Head Reveals New Details About Agency’s CBD Regulation Plans.” Marijuana Moment. February 27, 2019. Accessed March 01, 2019. https://www.marijuanamoment.net/fda-head-reveals-new-details-about-agencys-cbd-regulation-plans/.
  3. LaVito, Angelica. “FDA Plans First Public Hearings on Legalizing CBD Foods in April.”
  4. Jaeger, Kyle. “FDA Head Reveals New Details About Agency’s CBD Regulation Plans.”
  5. LaVito, Angelica. “FDA Plans First Public Hearings on Legalizing CBD Foods in April.”
  6. Office of the Commissioner. “Public Health Focus – FDA and Marijuana: Questions and Answers.” U S Food and Drug Administration Home Page. Accessed February 07, 2019. https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.html.
  7. LaVito, Angelica. “The Cannabis Industry Is Begging the FDA for Some CBD Regulations as Gottlieb Heads to the Hill.” CNBC. February 27, 2019. Accessed March 01, 2019. https://www.cnbc.com/2019/02/27/the-cannabis-industry-is-begging-the-fda-for-some-cbd-regulations.html.

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