Why the FDA will have a hard time properly Regulating Cannabis
The Food and Drug Administration has done a generally exemplary job of executing its mandate throughout its 118-year modern history.
But the federal rescheduling of cannabis, which President Biden recently confirmed is moving forward, will pose unique challenges to FDA regulators.
The plan is to move cannabis from Schedule I, which includes drugs with “no currently accepted medical use,” such as LSD and ecstasy, to the less-dangerous Schedule III category, which includes drugs that have “a moderate to low potential for physical and psychological dependence.”
It is common to hear that the FDA will soon regulate cannabis as a consequence of rescheduling it. But that statement isn’t quite accurate, because states will regulate non-FDA-approved cannabis products. This speaks directly to the difficulties that the agency will have in both setting and executing its consumer protection mandate after the cannabis rescheduling process is complete.
What will be under the FDA’s regulatory purview once the move to Schedule III is complete isn’t cannabis per se, but rather cannabis-derived pharmaceutical products which, by and large, consumers aren’t asking for and don’t particularly like. When NuggMD, the company I work for, polled nearly 800 cannabis consumers late last year, 77% said they prefer traditional botanical cannabis products to pharmaceutical products that contain cannabis.
The politics of cannabis also makes regulating it extra challenging. Another poll we conducted among a random selection of 635 likely voters who use cannabis showed that the Biden-Harris ticket could reap a political benefit by touting rescheduling to voters. But although framing rescheduling as a win for cannabis voters would help Democrats in November, it would also cause consumers to conflate rescheduling cannabis with the legalization of all cannabis products. But cannabis flower, the part of the plant that is traditionally consumed by smoking, will still be illegal federally under the rescheduling proposal, even though its use has been legalized in many states. It won’t even be part of the conversation. Neither will the vape pens or pre-rolls sold in the country’s many medical cannabis dispensaries.
The point is that there’s a long way between rescheduling cannabis and legalizing it. Politics is making that space very muddy. Consumers and health regulators essentially speak different languages, which will make it difficult for the FDA to navigate.
FDA is not equipped to regulate cannabis
Many experts in the cannabis industry have an incomplete understanding of FDA guidelines for new drugs and requirements for interstate commerce of such products. Likewise, many FDA officials and health care regulators have an incomplete understanding of the cannabis industry and cannabis consumers, particularly why they prefer certain ingestion methods depending on their conditions or the effects they desire.
The FDA generally deals in absolutes: single-compound drugs with uniform effects and standardized doses that can be recommended to wide segments of the population with roughly similar results. But the dosage of cannabis varies widely depending on individual physiology, with some users getting uncomfortably high from 5 milligram edible doses and others feeling nothing at 50 milligrams or more. Effects of smoking cannabis depend on the amount and ratio of tetrahydrocannabinol (THC), terpene, and minor cannabinoids that a particular plant contains.
For a drug to be approved by the FDA, it must be proven in clinical trials to be safe, effective for its intended use, and manufactured with uniform quality and potency. Inhaled cannabis varies tremendously in these aspects, and this variance is largely dictated by Mother Nature.
For example, the cannabinoids in cannabis flower work in conjunction with one another to produce the effects that consumers want, from euphoria to pain relief, anxiety reduction, restfulness, and many others. THC is one such cannabinoid, but to get the desired effect, others such as cannabidiol or cannabigerol are also necessary. Schedule III would be an absolute boon for cannabis consumers if it were possible to scale production in a way where cannabinoid combinations meet the FDA’s uniform quality and potency requirements. But that isn’t possible. Tetra Bio-Pharma tried to create such a product recently, and it didn’t work out because its inhaled cannabis flower was never approved.
This is also why dronabinol, a pharmaceutical product made of pure THC without any other cannabinoids, isn’t part of the policy conversation, even though the FDA approved it in 1985 to treat AIDS/HIV-related anorexia and chemotherapy-induced nausea. The fact that consuming dronabinol can generate a range of unpleasant side effects meant that regulators evidently had no concern that it would penetrate the recreational market. It is a very good product for a handful of very narrow use cases, and a disaster for others.
Even if a botanical cannabis product were successfully created to meet the FDA’s requirements, an individual would have to smoke it or vape it to get the prescribed effect. Not only has the FDA never approved a drug for use through smoking, because of the inherent health risks, but it has not proven to be possible to measure a precise dose of the active ingredients after combustion. Tetra tried to get around this barrier by using standardized crushed flower pellets and a vaporizer that was proven not to leach chemicals into the vapor, with no success.
Consumers, including patients, prefer inhaled cannabis
Rescheduling cannabis will establish that the plant has proven medical legitimacy, which is great news for the industry and for millions of cannabis consumers, including those who use it for medical reasons. But FDA regulators need to understand which consumption methods medical cannabis patients prefer and why.
Inhaled cannabis is the most common method of consumption. It begins working in five minutes or less, and often yields near-immediate relief. It also wears off faster, which makes the dose easier to titrate to avoid overconsumption and unpleasant side effects. Edible cannabis, in contrast, takes between 30 and 90 minutes to take effect, sometimes longer, and the effects persist for three to six hours — sometimes longer — depending on the dose. That can lead to intolerable side effects that last for hours due to accidental overconsumption.
The only pharmaceutical cannabis products the FDA is equipped to approve are single-compound pharmaceutical-grade products like pills and suppositories — products consumers don’t want because they prefer botanical products. The FDA’s uniformity requirements simply don’t work for botanical cannabis, and if changing the approval criteria for cannabis products is the plan from here on out, then Congress must act, because the FDA can’t do that on its own.
