US FDA Heightens Focus On Cannabis With Hiring Of Norman Birenbaum As Public Health Advisor
Executive Summary
Industry reps are glad that Birenbaum, who was the chief cannabis policy advisor to the governors of New York and Rhode Island, was given a prominent role at FDA that could spur regulatory action.
Norman Birenbaum’s appointment as a senior public health adviser in the US Food and Drug Administration’s Center for Drug Evaluation and Research is a positive development for the cannabis industry given his previous work helped legalize cannabis use in New York.
Birenbaum previously served as the chief cannabis policy advisor to the governors of New York and Rhode Island and led the agencies responsible for cannabis regulation and research in both states.
FDA’s Douglas Throckmorton, deputy center director for regulatory programs, sent a notice to CDER staff on 26 September that Birenbaum had joined the Office of the Center Director that day.
“Norman will be the center lead and advisor responsible for advancing our efforts related to research and regulation of cannabis as part of CDER’s work in controlled substances,” Throckmorton stated.
Birenbaum oversaw New York’s medical marijuana and industrial hemp programs. Throckmorton said this work culminated in the successful 2021 passage of the Marijuana Regulation and Taxation Act, which legalized cannabis for adult use in New York and created a consolidated Office of Cannabis Management to oversee all cannabis sectors within the state.
Prior to joining former governor Andrew Cuomo’s administration, Birenbaum established the Rhode Island Office of Cannabis Regulation, where he oversaw Rhode Island’s medical marijuana and industrial hemp programs and led former governor Gina Raimondo’s efforts to legalize cannabis for adult use.
Birenbaum was also the founding president of the Cannabis Regulators Association, whose members represent the primary cannabis regulatory agencies from 43 states and US territories. In addition, he served on the staffs of Sen. Elizabeth Warren, D-Mass., and former Massachusetts Governor Deval Patrick.
Industry Is Hopeful
Individuals representing the hemp and cannabis industries see Birenbaum’s hiring as a positive sign of what the agency may do in the space.
"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," U.S. Hemp Rountable General Counsel Jonathan Miller said in a statement.
“The cannabis industry is excited to see that Norman Birenbaum will serve as Senior Public Health Advisor to the FDA due to his deep background in cannabis regulation at the state level,” Rod Kight, an attorney who represents businesses in the cannabis industry, told the Pink Sheet.
“Although some industry associations contend that this hire by the FDA may hint towards regulatory action by the FDA on cannabis products, it is more likely that the FDA is preparing for Congressional action on cannabis in the near future,” Kight added.
He said the appointment of Birenbaum should be viewed through the lens of prior FDA actions on cannabis, such as the public hearing in 2019 and formation of a cannabis working group, “in which the agency appears to be preparing for future policy shifts initiated by Congress but is mostly refusing to regulate cannabis consumer products at this time.”
Rachel Gillette, a partner in Holland & Hart’s cannabis industry group, said the hiring may indicate that the FDA is evolving in its thinking on cannabis from focusing on its harms to evaluating its benefits.
Having someone with a background leading state efforts “might lead someone to think the federal government may change its thinking on prohibition of cannabis,” she said. “This could be a first step to put someone in place to assist with the effort to legalize cannabis.”
Cannabis Drug Products
The cannabis plant contains more then 80 biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
The FDA has approved one cannabis-derived product, GW Pharmaceuticals plc’s Epidiolex, which contains a purified form of CBD, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome and seizures associated with tuberous sclerosis. (Also see "Gottlieb: Epidiolex Approval Covers One Specific Cannabidiol Medication, Not Marijuana" - Pink Sheet, 25 Jun, 2018.)
It has also approved three cannabis-related drug products. They include Marinol and Syndros, whose active ingredient is dronabinal, a synthetic form of THC, for treatment of anorexia associated with weight loss in AIDS patients and chemotherapy-induced nausea and vomiting in those who have failed to respond adequately to conventional antiemetic treatments. Marinol was approved in 1985 and Syndros in 2016. The agency approved Valeant’s synthetic cannabinoid Cesamet (nabilone) for second-line treatment of nausea and vomiting associated with chemotherapy in 2006.
‘Swim Lane’ For Food, Supplements?
Gillette noted that the agency’s position has been that because CBD is a component of an approved drug (Epidiolex) it can’t be used in food and dietary supplements.
“The hope is that somehow FDA will create a swim lane for those in the hemp industry to sell food and dietary supplements with some level of CBD,” Gillette said.
As for the cannabis industry, which is focused on use of cannabis for medical and recreational purposes, she said its concern is that the FDA will intervene and prevent it from doing what has been permitted under state laws.
The passage of the 2018 Farm Bill removed hemp from the Controlled Substances Act so that cannabis plants and derivatives that contain no more than 0.3% THC on a dry weight basis are no longer controlled substances under federal law. However, the law explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the Food, Drug, and Cosmetic Act and Section 351 of the Public Health Service Act.
The agency has concluded that THC and CBD products are excluded from the dietary supplement definition and thus cannot be marketed as such. FDA says ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements.
Elusive Regulatory Pathway
The hemp industry has sought FDA guidance on its enforcement policy. (Also see "US Hemp Product Industry ‘Dying On Vine’ Without Lawful Use Legislation Or Enforcement Guidance" - HBW Insight, 7 Apr, 2022.)
In February, the National Products Association submitted a citizen petition to the FDA requesting that the commissioner either determine that CBD is not excluded from the definition of a dietary supplement or exercise enforcement discretion, or alternatively that the agency recommend that the Department of Health and Human Services promulgate a regulation establishing that CBD is lawful under the FDCA. (Also see "NPA Petitions US FDA To Act On CBD Regulation" - HBW Insight, 22 Feb, 2022.)
The U.S. Hemp Roundtable, a coalition of companies and organizations advocating for hemp and CBD products, has recommended requiring FDA to establish a separate regulatory pathway for the use of CBD and other hemp ingredients in supplements, foods and beverages.
Thus far, a regulatory pathway appears elusive. For example, at a June meeting of the agency’s Science Board, FDA officials noted safety concerns about cannabinoids in non-drug products, particularly with long-term use. (Also see "Safety Concerns Are US FDA's Answer To Question On Regulatory Pathway For Hemp’s Lawful Use" - HBW Insight, 14 Jun, 2022.)
The FDA could weigh in on cannabis legislation. Gillette said several bills have been introduced that have provisions for FDA regulation of cannabis products, including the Cannabis Administration and Opportunity Act, S. 4591.
That bill would decriminalize and deschedule cannabis. However, it has a proposed limit of 0.001% tetrahydrocannabinol per 100 g cannabis by dry weight for ingredients derived from cannabis to qualify as hemp. The U.S. Hemp Roundtable says this would impose a devastating setback to a thriving industry and further limit opportunities for already struggling hemp farmers. (Also see "Senate Cannabis Bill Could Torch US Hemp Market By Slashing THC Limit Below Farm Bill Level" - HBW Insight, 11 Aug, 2022.)
The Hemp Access and Consumer Safety Act, S. 1698, would allow hemp and hemp-derived ingredients to be included in food and dietary supplements. The measure was introduced in the Senate by Sen. Ron Wyden, D-OR, in September 2021 and has not advanced.
A similar bill, Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act, H.R. 841, was introduced in the House by Rep. Kurt Schrader, D-OR, in February 2021.