Photo courtesy of Philip Steffan.
Federal officials from the U.S. Food and Drug Administration (FDA) met this week for a wide-ranging educational webinar about cannabis, outlining matters such as the plant’s chemical makeup, differences between marijuana and hemp, clinical and therapeutic effects of cannabinoids as well as ongoing health and safety concerns around the drug’s use.
Hosted by FDA’s Division of Drug Information, which is part of the agency’s Center for Drug Evaluation and Research (CDER), the webinar was designed to provide information “targeting the needs of all health care professionals, including physicians, physician assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, and certified public health professionals.”
The event comes as the federal government considers the Biden administration’s proposed rescheduling of cannabis, which would move it from Schedule I to Schedule III of the federal Controlled Substances Act (CSA), effectively legalizing certain FDA-approved forms of medical marijuana.
Meanwhile, many U.S. doctors have for years expressed that they feel “completely in the dark” about marijuana’s medical benefits and risks despite state-level legalization and surging interest from both patients and adult consumers.
FDA’s cannabis-focused discussion on Tuesday, part of the agency’s ongoing Drug Topics series of educational webinars, focused predominantly on basic cannabis information, such as different species of the plant and their characteristics, the complex chemistry of the marijuana plant as well as how intoxicating hemp products have complicated state and federal enforcement efforts.
As an FDA description of the event says, the webinar “provided insights into the landscape of the cannabis marketplace and some general information on how products are manufactured and regulated. It discussed clinical and pharmacological considerations along with known drug-drug interactions that can impact patients.”
Another of the webinar’s learning objectives was to inform healthcare providers of FDA surveillance programs that monitor adverse events related to marijuana and cannabis-derived products. The programs allow reporting of cannabis-related health consequences from health professionals as well as from law enforcement and consumers.
Cassandra Taylor, a public health advisor at FDA, noted during Tuesday’s presentation that one key difference between hemp and marijuana markets is that hemp products can legally cross state lines, while marijuana must remain within the borders of a legal state. That, along with scant regulation in most jurisdictions, makes matters harder for officials to track and increases public health risks.
“These hemp-derived intoxicating products are interstate markets,” Taylor said. “That means they’re going across state lines, and again, [are] largely underregulated.”
“When your patients are being exposed to these products in this hemp and intoxicating marketplace,” the FDA official told the audience of largely healthcare professionals, “they’re being exposed to compounds that we know next to nothing about, and they have pretty much unknown safety profiles.”
Sales of intoxicating hemp products are happening nearly nationwide, Taylor added, and they don’t have seed-to-sale tracking requirements that state-legal marijuana markets do. “It really makes regulatory actions quite difficult,” she said.
Other speakers included Scott Janiczak, a research officer at the Office of Pharmacovigilance and Epidemiology and the Office of Surveillance and Epidemiology within FDA, as well as Steven Galati, a doctor and controlled substance staff member for the Office of the Center Director.
The event follows a similar webinar from March of last year that focused on basic cannabis information, how raw plant material is processed into products, what products are on the market and how manufacturing controls are “an integral part of protecting the public health.”
At the congressional level, Rep. Morgan Griffith (R-VA) has sponsored legislation to require FDA to regulate hemp and its derivatives like CBD after the agency declined to enact its own rules
Speakers at Tuesday’s event also described differences between state medical and adult-use marijuana programs, with medical marijuana systems requiring a recommendation—and often a diagnosis of one of the state’s qualifying conditions—in order to be eligible.
As concern about hemp-derived cannabinoids grows, congressional lawmakers have been exploring legislative options to impose a general ban on hemp-derived cannabinoids such as delta-8 THC.
Rep. Mary Miller’s (R-IL) amendment to the 2024 Farm Bill, for example, was approved by a House committee in May and would remove cannabinoids that are “synthesized or manufactured outside of the plant” from the federal definition of legal hemp. The change is backed by prohibitionists as well as some marijuana companies, who’ve described the restriction as a fix to a “loophole” that was created under the 2018 Farm Bill that federally legalized hemp and its derivatives.
Anti-drug groups, law enforcement and some health organizations have called on Congress to embrace the ban, arguing that “trying to regulate semi-synthetic cannabinoids will not work.”
In addition to Miller’s amendment in the 2025 Farm Bill, the House Appropriations Committee in July approved a separate spending bill that contains a similar provision to prohibit cannabinoid products such as delta-8 THC and CBD containing any “quantifiable” amount of THC.
Hemp-derived cannabinoids also came up in a recent federal appeals court decision in which judges ruled that cannabinoids derived from hemp, such as THC-O-acetate, indeed qualify as hemp and are legal under the 2018 Farm Bill. In making that ruling, the court rejected the Drug Enforcement Administration’s (DEA) more restrictive interpretation of the law.
How to address hemp-derived cannabinoids has caused some fractures within the cannabis community, and in some cases marijuana businesses have found themselves on the same side as prohibitionists in pushing a derivatives ban.
In California, meanwhile, Gov. Gavin Newsom (D) is also attempting to rein in the proliferation of products that contain intoxicating hemp-derived cannabinoids. While many support the aims of the proposal, some stakeholders contend it could ultimately limit access to federally legal CBD products.
A report from the Congressional Research Service recently said that FDA has the ability to authorize tobacco products containing hemp-derived cannabinoids, although the agency has yet to receive any applications for such a product. Marijuana, meanwhile, would still be banned as a tobacco additive even if it’s moved to Schedule III of the CSA.
A top FDA official separately said last month that the agency retains authority to remove cannabis-infused foods and drinks from the market, though that level of enforcement action is rare and is most commonly executed by local law enforcement.
While FDA’s enforcement actions on cannabis have been largely hands-off in the past, the agency did partner with Hawaii law enforcement in a “unique” surveillance operation in 2022 that led to the arrests of two people associated with a hemp business who were suspected of violating state drug laws.
Also in 2022, FDA sent information to the Minnesota Board of Pharmacy about a cannabis product line that it received consumer complaints about, leading to a lawsuit against the delta-8 THC company Northland Vapor, which was accused of violating the state’s unique THC edibles law that was enacted that year.
Less directly related to human health, an organization of livestock feed control officials earlier this year voted to allow commercial farmers to begin using hemp seed meal as food for egg-laying hens. Under the new policy, which was recommended by FDA, hemp meal can account for up to 20 percent of hens’ diet.
Separately, a recent study found that if FDA were to approve therapeutic psilocybin, as many as 6 in 10 people currently receiving treatment for depression in the U.S. could qualify for psychedelic-assisted therapy.
Ben Adlin via (https://www.marijuanamoment.net/fda-educates-healthcare-professionals-on-marijuana-hemp-and-the-emerging-cannabinoid-market/)
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