The US Food and Drug Administration could be signaling a new direction in the regulation of cannabis with the recent hiring of Norman Birenbaum as senior public health advisor at the agency’s Center for Regulatory Programs. In the position, a first for the FDA, he will advise the agency on cannabis research and regulatory policy. The FDA appointed Birenbaum, who formerly led cannabis regulation efforts in two states, on September 26.
Birenbaum is an experienced cannabis regulator, serving for four years as the head of the hemp and medical marijuana programs in Rhode Island, where he created the state’s Office of Cannabis Regulation. At the end of 2019, he was appointed New York’s first Director of Cannabis Programs, leading efforts to develop policy and regulate the state’s hemp and medicinal cannabis programs for more than two years.
While still at the helm of New York’s cannabis oversight efforts, Birenbaum joined with cannabis regulators from 18 additional states to form the Cannabis Regulators Association (CANNRA), serving as the inaugural president of the group. As more states opted into the legalization of cannabis, the group was formed to facilitate collaboration between regulators and help stakeholders find objective data and evidence-based approaches to policymaking and implementation of regulation.
“The Cannabis Regulators Association will provide a much needed forum for regulators to engage with each other to identify and develop best practices, create model policies that safeguard public health and safety, and promote regulatory certainty for industry participants,” Birenbaum said in a statement from CANNRA when the group launched two years ago.
In his new position with the federal government, Birenbaum will be tasked with “advancing [the FDA’s] efforts related to research and regulation of cannabis,” according to an agency announcement cited by Stat.
Dr. Douglas Throckmorton, FDA deputy director for regulatory programs, said that Birenbaum’s wealth of experience in cannabis policy analysis and legislative outreach will help the agency form partnerships and collaborate with policymakers and stakeholders including the healthcare community, patients and patient advocacy groups, according to a report from Financial Assets.
Birenbaum’s Appointment Widely Praised by Cannabis Community
Birenbaum’s appointment as an FDA cannabis policy advisor has been well-received by hemp and cannabis policy reform advocates. Shawn Hauser, a partner at Vicente Sederberg LLP and co-chair of the law firm’s Hemp and Cannabinoids Department, wrote in an email to Cannabis Now that his hiring and subsequent efforts could lead to further action on both marijuana and hemp policy reform.
“Given Mr. Birenbaum’s significant experience and leadership in the regulated cannabis industry, especially overseeing NY’s robust medical marijuana and hemp programs and founding CANRA, I’m optimistic that this is a very positive step forward for responsible and sensible regulation of cannabis and hemp at the federal level, including for long overdue federal oversight over CBD and other hemp-derived cannabinoids.” Hauser wrote.
Jonathan Miller, general counsel for the US Hemp Roundtable, said that the move to hire Birenbaum could signal a new willingness by the FDA to regulate CBD. Despite the legalization of hemp agriculture by Congress with the passage of the 2018 Farm Bill, the agency has still not issued regulations to allow for the legal use of the cannabinoid.
“After four years of inaction, we are hopeful that the appointment of Norman Birenbaum by the FDA signals a positive step forward for the regulation of hemp-derived cannabinoids such as CBD,” Miller said in a statement from the hemp industry trade group. “We appreciated working with Birenbaum on the development on New York’s landmark regulatory regime for hemp, and we look forward to working closely with him on the development of a regulatory framework for CBD products to ensure consumer safety and product quality across the country.”
And Morgan Fox, the political director for the National Association for the Reform of Marijuana Laws (NORML), also applauded the move by the FDA.
“Given the agency’s relatively ineffective approach to this issue over the years, it is good to see them being more proactive and bringing on people with actual cannabis experience,” Fox told L.A. Weekly. “The FDA’s work related to cannabis is likely going to increase and become more complicated in the not-too-distant future, and it should be preparing for this now by continuing to bring on additional staff with a wide array of expertise in the space.”
Birenbaum’s hiring by the FDA continues its measured pace of action on cannabis regulation. In May, the agency announced that Principal Deputy Commissioner Janet Woodcock would chair the agency’s Cannabis Products Council, an intra-agency group tasked with working on cannabis product policy, enforcement and outreach issues, as well as helping the FDA implement a data collection plan for cannabis products.