The role of HHS come Federal Adult-use Legalization
Say lawmakers finally legalize cannabis, then what?
One artery of cannabis policy making will be The Department of Health and Human Services (HHS), headed by Health Secretary Xavier Becerra, former Attorney General of California. As an agency of the Executive branch, HHS has the power to enact laws within the scope of its authority, conduct investigations, and enforce laws. Under its umbrella are many agencies, but those most concerned with cannabis are the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).
Legalization could come through both re-scheduling and de-scheduling cannabis from the list of Controlled Substances. Both means are possible but could have drastically different outcomes. De-scheduling would take place if The MORE Act (which passed the House in fall 2020) or Senate Majority Leader Schumer’s complementary Cannabis Administration and Opportunity Act were passed. Schumer’s bill differs from the MORE Act: in addition to de-scheduling cannabis, it adds a definition of non-medical cannabis to the Federal Food, Drug, and Cosmetics (FD&C) Act and creates a new sub-agency within the FDA called the Center for Cannabis Products, which would handle cannabis products which do not make claims that trigger FDA regulation.
These de-scheduling bills represent the current best chances of federal legalization, and de-scheduling would trigger HHS to promulgate certain regulations affecting all varieties of cannabis markets.
The Secretary of Health and Human Services has a couple of powers which could be used regarding cannabis. While the DOJ plays the key role in cannabis scheduling, the HHS’ medical and scientific reviews are “binding” on the DOJ's classification decisions, so HHS plays a key role in the executive process. Like if Biden were to re-schedule cannabis by executive order, for instance. Health Secretary Becerra has also stated publicly his belief that the government needs to shift its stance on cannabis, and as HHS Secretary he has the power to unilaterally submit a petition for rescheduling to the Attorney General, Merrick Garland. After DOJ reviews such a request, the FDA (under the HHS) would do an analysis and then Becerra would send this to the DOJ, as the AG is authorized to ultimately add or remove items from Schedules.
Once cannabis is de-scheduled, seamless transition into production, marketing, and distribution will not occur like some might think. Like we saw as soon as lawmakers legalized hemp in 2018, the industry began a slow march through a minefield of contradictory and grey-area regulations. The same could happen with cannabis.
According to Sean M. O’Connor and Erika Leitzan’s “The Surprising Reach of FDA Regulation of Cannabis Even after Rescheduling,” in the American University Law Review, complex and wide-ranging FDA regulations for medical cannabis would kick in as soon as cannabis were de-scheduled.
And for recreational cannabis as well. Eric N. Lindblom, a Senior Scholar at the O'Neill Institute for National & Global Health Law at Georgetown University Law Center, argues that even those cannabis products that FDA has not caught making medical claims likely “qualify as supplements, foods, cosmetics, or tobacco products that have largely failed to comply with related Federal Food, Drug, and Cosmetic (FD&C) Act provisions and FDA regulations.” As FDA’s definition of a “drug” includes “any product “intended to affect the structure or any function of the body,” state-legal recreational cannabis also likely falls under FDA jurisdiction in addition to medical cannabis. While the FDA so far has given state-legal cannabis markets a free pass, Lindblom notes that were FDA to “strictly” enforce its own provisions, the “vast majority of state-legalized cannabis products” would need to be removed from their state markets, a consequence only potentially avoided by businesses claiming they are only producing and selling in-state.
FDA handles good manufacturing practice, medical claims, dietary supplements, labeling requirements, and basically anything that could be related to substances we put in our bodies.
So when it comes to cannabis, FDA would continue regulating anything with THC and CBD in it as long as they make certain medical claims, despite its scheduling status. FDA considers a wide variety of claims to be “medical” in nature, so if they so much as begin to think a business has implied medical benefits, they will step in. And drug claims do not need to be explicit for FDA to take notice. The company will have to undergo a rigorous testing research and testing program, and “any other cannabis constituent would need to be chemically distinct from those already under clinical investigation or approved as new drugs -- such as dronabinol (synthetic D9-THC) and CBD.” (O’Connor and Leitzan) These powers are laid out it the Federal Food, Drug, and Cosmetic (FD&C) Act.
After de-scheduling, however, some cannabis-based products could be made, sold, and used only within the borders of one state, without any component that traveled in interstate commerce, and FDA would have no jurisdiction if that were the case. The FDA is required to step in and regulate food and drug products as soon as they cross state lines.
Since FDA regulations would preclude most varieties of anticipated commerce, including medical claims going through the drug approval processes and pathways for conventional foods (except for certain hemp seed ingredients), we could see the agency crack down hard. And cannabis of course cannot be sold as a dietary supplement without going through an equally arduous process and forget about getting cannabis into food products.
Regarding medical, O’Connor and Leitzan argue that FDA would likely designate cannabis-derived drug products prescription products, citing how prescription status is required for any drugs considered “not safe for use except under the supervision of” licensed prescribers due to its “toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use.” Being a prescription drug, a cannabis-based drug—whether edible, inhaled, ingested, or applied topically—would require FDA- approved labeling for prescribers. Due to the high investment barriers and lacking assurance that a cannabis-based product would be unique enough to cut through the market noise due to patent and regulatory exclusivity restrictions, many large companies might just forego cannabis all together, opening space for serious market consolidation in the medical sphere.
O’Connor and Leitzan also note regulatory complexities with inhalation as a mode of consumption, as products intended for inhalation through combustion face higher regulatory hurdles. As FDA officials have been skeptical that combustion of cannabis could deliver consistent dosage, cannabis-based drugs presented in dosage forms not intended for inhalation (especially combustion) “are less likely to raise complex regulatory issues and less likely to meet resistance from the agency. But each route of administration and dosage form will present issues for consideration,” they write.
According to O’Connor and Leitzan, three potential pathways to market exist for federal-legal medical cannabis after de-scheduling: intrastate products produced and sold within a single state’s borders; small-molecule-drug products following completion of a conventional research program FDA approval of NDA; testing and marketing after premarket submission to FDA some sort of “an herbal dietary supplement that does not include any ingredient or substance currently approved as a drug or even in clinical trials – which rules out any products containing THC or CBD.”
And regarding food, the first issue with cannabis in food is the “drug exclusion issue,” meaning a company must ensuring their food product contains only ingredients not already studied or approved in new drugs (which excludes at least dronabinol and CBD) and make no claims relating to the medical benefits of cannabis in the food (though perhaps making health claims tied to nutritive benefits, with FDA’s permission).
Regardless, O’Connor and Leitzan believe that “there would still be a non-trivial risk that the FDA would classify the product as a drug.” For instance, FDA just recently rejected Charlotte’s Web CBD’s request to make their CBD products dietary supplements, likely signaling they would like to wait for Congressional action, but also the drug exclusion rule means that Epiodolex is stopping these CBD products from obtaining an OK. Regardless, dietary supplements would take years to get on the shelves.
Having written all this, President Biden has yet to appoint an FDA Commissioner, a process which, as Politico points out, remains crucial as the FDA works on the policy front line against the ongoing COVID-19 pandemic. It is likely that the FDA’s commissioner will have a more immediate effect on the hemp product and CBD industry, and any federally legal cannabis industry (if it gets legalized).
Most importantly regarding Schumer’s bill, National Law Review correctly notes that though the Cannabis Administration and Opportunity Act aims to regulate cannabis like alcohol, cannabis’ complexity as a pharmacological substance raises the question: would the FDA’s eventual final rule making pre-empt state cannabis program rules? It is difficult to tell at this point.
The National Institutes of Health conducts research on a wide number of cannabinoids and the endocannabinoid system, falling under the umbrellas of cannabinoid research, cannabidiol research, and therapeutic cannabinoid research. According to “Challenges and Barriers in Conducting Cannabis Research,” research cannabis is only available through the National Institute on Drug Abuse (NIDA) Drug Supply Program, which only gets cannabis from the University of Mississippi, cannabis found to be closer to hemp in THC content than the cannabis that both medical and recreational users use in legal states. The DEA, which controls who can produce this research marijuana, has recently opened the door for more applicants, so this situation may change in the future.
As such, de-scheduling would obviously remove many barriers to research, which NIH would play a major role in directing.
SAMHSA is responsible for overseeing prevention programs for even legal drugs, so their watchful eye on marijuana will not go away just because it has been de-scheduled. It is likely, however, that the relative safety of cannabis when compared to opioids and other drugs will mean that more focus will be put on the latter.