At the end of September, the United States Food and Drug Administration (FDA) hired cannabis policy expert Norman Birenbaum as a Senior Public Health Advisor at FDA’s Center for Regulatory Programs.
Mr. Birenbaum comes to FDA with a deep background in regulation in several state cannabis departments. Most recently, in New York State he served as the Director of Cannabis Programs (2019-2022), and before that, was the Implementation Director for Policies and Programs in the Office of Cannabis Regulations in Rhode Island (2016-2019).
FDA has been criticized for inadequate enforcement of unlawful cannabis-containing products and for failing to develop a pathway for the addition of CBD to foods and/or dietary supplements. Bringing Mr. Birenbaum on may signal FDA is reinvigorating its Cannabis Working Group and a renewed agency commitment to oversight over cannabis, including cannabidiol (CBD). Bringing a cannabis policy expert with expertise outside of FDA’s traditional purview expertise might also indicate that the agency is considering future reform and regulations, and the possibility that it may have to assume new responsibilities if federal cannabis legislation is enacted.
Notably, this hire happened several days before the October 6, 2022, announcement from President Biden on “Marijuana Reform” (the Statement).
The Statement included three new White House actions on cannabis. The President announced Federal pardons for individuals convicted of Federal marijuana possession and encouraged State Governors to do the same for persons convicted of State marijuana possession offenses. In relevant part to FDA, the third part of the announcement stated:
- “Third, I am asking the Secretary of Health and Human Services (HHS) and the Attorney General to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law. [Emphasis added] Federal law currently classifies marijuana in Schedule I of the Controlled Substances Act [CSA], the classification meant for the most dangerous substances. This is the same schedule as for heroin and LSD, and even higher than the classification of fentanyl and methamphetamine – the drugs that are driving our overdose epidemic.”
Schedule I drugs, substances, or chemicals are illegal drugs with no currently accepted medical use and a high potential for abuse, such as heroin. In contrast, other legal controlled substances are categorized in lesser Schedules of control (Schedules II through V), including pain medications, anabolic steroids, attention deficit disorder drugs, and anti-epilepsy drugs. Removing marijuana entirely from the CSA (that is, “descheduling”) or “rescheduling” marijuana to a lower Schedule would require Congress to amend the CSA or rulemaking from the Drug Enforcement Administration (DEA). DEA has previously denied petitions to reschedule marijuana.
Importantly, for the food industry, even if marijuana was descheduled or rescheduled, the Food, Drug, and Cosmetic Act (FDC Act) still applies. Cannabis would therefore remain an unlawful ingredient in food and dietary supplements under the FDC Act even if it is descheduled or rescheduled.
While the FDA effort and the Administration’s statement are separate actions, the collective movement around cannabis regulations and reform shows an increased level of engagement and commitment to cannabis by the Administration at the highest levels.
OFW Law will continue to monitor Federal and relevant state cannabis updates. If you have any questions and/or need assistance, please contact us.
