New bi-partisan federal legislation would authorize the U.S. Food and Drug Administration (FDA) to regulate hemp-derived cannabidiol (CBD) products as dietary supplements and allow companies to lawfully market the products as such. The bill would also require a study and report from the U.S. Department of Agriculture (USDA) on the regulatory and market barriers for farmers engaged in hemp production.
“The last two Farm Bills were landmark successes for hemp, but we are still very early in this process, and growers need regulatory certainty,” Rep. Collin Peterson (D-MN), chairman of the House Agriculture Committee and sponsor of the bill, said in a press release. “This bill will allow the FDA to regulate CBD that comes from hemp as a dietary supplement, providing a pathway forward for hemp-derived products.”
FDA Oversight Over CBD
While the 2018 Farm legalized hemp, along with CBD products derived from it, the growth of the industry has been hampered by the FDA’s position that companies marketing CBD products should be required to prove that they are safe and effective, much like is required for pharmaceuticals.
The 2018 Farm Bill did not alter the authority of the FDA to regulate hemp under applicable FDA laws, such as the Federal Food, Drug, and Cosmetic Act (FD&C Act). Currently, the FDA treats products containing CBD the same way it treats other FDA-regulated products, which means that any product intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug subject to the FDA approval process.
While the FDA has been taking a discretionary approach, it has sent warning letters to companies that it believes are making unsubstantiated health claims about their CBD products. Late last year, Curaleaf became one of the most well-known cannabis companies to draw the ire of the FDA. While the FDA is working to establish a regulatory path for CBD, it has stated that the process could take years.
Legislation to Amend FD&C Act
The federal bill, H.R. 5587, would break the regulatory statement by amending the FD&C Act with respect to the regulation of hemp-derived CBD and hemp-derived CBD containing substances. The change would allow hemp-derived CBD to be marketed in dietary supplements and as food and beverage additives.
H.R. 5587 is co-sponsored by Rep. Chellie Pingree (D-ME), James Comer (R-KY) and Thomas Massie (R-KY). The sponsors, along with other Congressional supporters of the hemp industry, including Senate Majority Leader Mitch McConnell (R-KY), argue that Congress intended to legalize the marketing and sale of hemp-based products under the 2018 Farm Bill.
H.R. 5587 also requires the USDA to determine if there are other regulatory roadblocks for the hemp industry. The USDA would specifically be required to research the costs of implementing a hemp testing program, the costs of destroying hemp with excess THC content, the “feasibility” of the testing timeline farmers must follow and “other known or potential challenges” related to participation in a domestic hemp market. The USDA would be required to issue a report on its findings within one year of the bill’s enactment.
Following its introduction, H.R. 5587 was referred to the Agriculture and Energy and Commerce Committees. We will continue to track the status of the CBD legislation and provide updates.
If you have questions, please contact us
If you have any questions or if you would like to discuss the matter further, please contact me, Dan McKillop, or the Scarinci Hollenbeck attorney with whom you work, at 201-806-3364.