The Centers for Disease Control and Prevention (CDC) recently identified vitamin E acetate, an additive used to dilute some THC-containing vaping products, as the likely culprit in 2,807 hospitalized cases or deaths. Because it suspects the unregulated cannabis market is responsible for these tainted products, the CDC is advising consumers to avoid THC vaping products acquired from informal sources such as friends, family, or street or online dealers.
To avert similar future harms related to cannabis product quality, policymakers have several options ranging from supporting prevention and education campaigns to promoting the safety of vaping products by increasing enforcement against the illicit market. Another option is national cannabis policy reform. Federal policymakers could reform the scheduling of cannabis or limit federal interference with licit state markets. In states with legalized commercial sale, officials could implement additional testing and quality assessment requirements and consider other supply chain architectures beyond existing models.
The below proposals are by no means exhaustive of the panoply of options available to address potential harms associated with vaping. Our goal is to explore how cannabis policy reform could leverage regulatory controls to address the product quality concerns responsible for the recent vaping-related outbreak.
Moving Beyond Bans
In response to the rise in vaping related illness, Massachusetts Governor Charlie Baker temporarily banned the sale of vaping products, including nicotine and cannabis. While the ban on nicotine and cannabis vape sales ended on December 11, 2019, most cannabis vaping products remain quarantined (PDF) by the Massachusetts Cannabis Control Commission, and Governor Baker signed legislation to restrict the sale of flavored vaping products. A handful of other governors have also prohibited the sale of flavored vape cartridges. On January 2, 2020, the Food and Drug Administration (FDA) extended these bans federally in its announcement that it will bar most flavored products with the exception of tobacco and menthol. The ban came into effect on February 6, 2020.
While it is too early to tell if these prohibitions will help reduce vaping-related illness, outright bans are an imperfect solution. First, they can be poorly targeted. For instance, if THC-containing products are involved in an outbreak, a crackdown on tobacco or flavored vaping products (including those that contain nicotine) will have little effect on liquids containing cannabis-derived compounds. Second, a ban targeting vaping products may spark an increase in purchases from informal and unregulated sources. Third, general product bans create access barriers for individuals who vape for therapeutic reasons or to quit smoking cigarettes or other combustible products that carry more established health risks. Finally, some bans may be struck down when challenged in a court of law, as was the case with Michigan's emergency ban (PDF) on flavored products.
The growing prevalence of vaping-related illnesses suggests a need for policy action.Share on Twitter
Even if bans aren't the clear solution, the growing prevalence of vaping-related illnesses suggests a need for policy action. Cannabis policy reform may offer additional tools that can target the likely culprit in vaping-related lung illness and create a regulated supply to promote product quality without inhibiting access to vaping products for smoking cessation. Here are some ideas policymakers may want to consider.
Federal policymakers could influence product quality by reforming the scheduling of cannabis under the Controlled Substances Act (CSA), the federal law that governs the supply and possession of controlled substances. Passed in 1970, the CSA organizes controlled substances into schedules based on their potential for abuse and accepted medical use. Currently, THC-containing cannabis products are Schedule I substances under the CSA, along with drugs such as heroin and ecstasy. Schedule I includes substances deemed as having a high abuse potential, no accepted medical use, and a lack of safety for medical treatment. Substances on Schedules II–V remain subject to varying degrees of control but have a recognized medical use. FDA-approved products containing Schedule II–V substances may be prescribed under certain conditions.
The designation of cannabis as a Schedule I substance remains controversial. Cannabis use has been associated with substantial adverse effects, particularly for adolescents. Despite these potential health consequences, advocates for amending the CSA argue that cannabis' placement in Schedule I is not scientifically justified; they contend that cannabis is not highly addictive or dangerous for adult populations and that cannabis has likely medicinal benefits.
Amending cannabis' schedule in the CSA to recognize its medicinal value would provide policymakers with additional regulatory controls available to promote product quality. One reform option is to remove cannabis from the CSA schedules altogether. If descheduled, cannabis would meet the threshold for FDA jurisdiction, as do other products such as nicotine and tobacco that are not scheduled under the CSA. Two additional options include creating a new schedule for less harmful substances with no accepted medical use and rescheduling THC-containing products to Schedule II or higher.
The federal government could create a new schedule that distinguishes substances with no approved medical use by abuse potential. The CSA does not differentiate drugs in Schedule I by their harmfulness; the law only distinguishes substances with an approved medical use by their adverse health consequences. Congress could break up Schedule I into two categories. Substances with known adverse health effects, such as heroin, would remain subject to the burdensome restrictions currently associated with Schedule I. Less harmful substances, such as cannabis, could be placed in a new schedule and subject to similar regulatory review as higher schedules, including the requirement that the substances receive FDA approval before prescription eligibility. This new schedule could also facilitate cannabis-related research by applying the research-related requirements associated with higher schedules.
Congress or the Drug Enforcement Administration (DEA) could also reschedule THC-containing products to II or higher. The 2018 DEA rule did just that for cannabis products with no more than 0.1 percent THC. The rule reschedules cannabis products that meet the THC threshold and undergo FDA regulatory review to Schedule V; similar products that are not FDA-approved remain in Schedule I. The FDA approved the first cannabis-derived product, Epidiolex, in 2018.
If THC-containing products were placed in a new schedule or rescheduled, the federal government could institute testing requirements and product restrictions, such as premarket approval (PMA). PMA is an FDA process to evaluate the safety and effectiveness of certain medical devices. Properly designed and implemented PMA systems create an external review system that transfers the authority that designates a product as being safe from the private sector to the public sector. Devices subject to PMA must receive approval of its PMA application before marketing the device. No tobacco vaping product has yet undergone premarket review. The FDA issued a rule with guidance for manufacturers submitting tobacco vaping products for PMA, which requires electronic nicotine delivery systems on the market as of August 8, 2016, to submit to the PMA process by May 12, 2020.
In addition to scheduling reform, federal policymakers could facilitate state regulation of cannabis supply by passing legislation that would inhibit the federal government from interfering with state legal markets. Several pending federal bills would do just that. This protection would address concern from state officials about placing employees at risk of violating federal law by handling cannabis products. While Attorney General William Barr stated that he would not use federal resources to “go after” cannabis companies complying with state law, and the 2014 Rohrabacher-Blumenauer Amendment prohibits the Department of Justice from spending federal funds to interfere with state-legal medical cannabis programs, removing the threat of federal prosecution for recreational products through statute provides policy stability across administrations. It is important to also note that the Rohrabacher-Blumenauer Amendment does not fully protect medical cannabis market participants; the amendment must be renewed each fiscal year to remain in effect, and President Donald Trump's statement at an extension signing left open the possibility for potential federal enforcement actions against the cannabis industry.
State Reforms Where Adult Cannabis Use Is Legal
Even if the federal government does not reform its approach toward cannabis, state policymakers could leverage other regulatory controls to promote vaping product quality. Given the complexity of the federal rescheduling process and the urgency of the vaping-related outbreak, states currently can consider limiting all legal vaping products to those that currently can be approved through the PMA process. San Francisco was the first major U.S. jurisdiction to pass a prohibition on the sale of tobacco vaping products (including those that contain nicotine) that have not undergone the PMA process. Other jurisdictions could follow San Francisco's lead by enacting a similar ban, or, in states with legal markets, extend the prohibition to cannabis that can be regulated by the FDA (that is, products with no more than 0.1 percent THC).
Even if the federal government does not reform its approach toward cannabis, state policymakers could leverage other regulatory controls to promote vaping product quality.Share on Twitter
As noted earlier, a downside of this proposal is that no tobacco vaping product has yet undergone the PMA process, meaning that this targeted ban is effectively a prohibition on all tobacco vaping products. The FDA is supposed to complete its review of an application for PMA within 180 days after the date of filing, with some exceptions and opportunities for extension, implying that a vaping device may not be approved until the end of 2020.
In the meantime, policymakers could choose to implement rigorous testing requirements and product restrictions at the state level. For example, states could develop a subnational mechanism similar to a PMA. Specifically, the state could ban vaping products unless they receive a determination from a state entity that the product meets pre-defined quality standards.
Policymakers in states with legalized markets could extend these subnational testing requirements to cannabis products. Currently, testing requirements applied to cannabis-derived products vary by state. Common requirements include assessing the THC/CBD ratio and presence of pesticides and other contaminants. The recent outbreak implies that vitamin E acetate should be added to testing protocols. While it may be challenging for states to develop requirements, policymakers could look to other states with comprehensive oversight, such as New York (PDF), for guidance.
Regulatory controls applied to cannabis markets by legalized jurisdictions would likely have spillover effects on other states. Two in three Americans live in one of the 33 states and D.C. that have a medical cannabis law; more than 25 percent live in one of the 11 states and D.C. with some form of recreational cannabis legalization. The scale of legalization demonstrates that a well-regulated licit market will likely decrease the diffusion of unregulated and illegal products across the country. However, as long as there remains some heterogeneity in the status of cannabis legalization across jurisdictions, policymakers should monitor the potential for interstate spillovers and regulate price accordingly to deter purchases from the informal market.
The design of legalized markets also warrants careful attention. Cannabis legalization is often framed as a binary choice between prohibition and a commercial market model that licenses for-profit entities to oversee product cultivation through retail sale. In reality, states have at their disposal a myriad of supply chain architectures. For example, unlike all other U.S. states with legalized adult recreational supply, Vermont legalized possession, use, and cultivation, but not commercial sale; the law restricts cultivation to two mature and four immature plants per person.
Canada provides an example of part–government-operated supply. The Canadian federal government devolved regulatory control of recreational cannabis distribution to provincial and territorial governments. Most provinces currently have government monopolies over wholesale recreational cannabis sale. A number of provinces also limit retail and online sale to public entities. These government-run models offer an alternative with greater public oversight over the evolving recreational supply chain compared to commercial designs.
Assigning regulatory control to a public health agency, rather than a revenue-raising department or a Liquor Control Board, may shift the emphasis toward reducing the size of the illegal market while minimizing unsafe use.Share on Twitter
Policymakers in states that have not yet legalized adult cannabis supply, including the four northeastern governors who are considering legalization partly as a response to the vaping crisis, should not only think carefully about the supply chain architecture but the type of agency responsible for designing and implementing the rules. For example, assigning regulatory control to a public health agency, rather than a revenue-raising department or a Liquor Control Board, may shift the emphasis toward reducing the size of the illegal market while minimizing unsafe use. While allocating additional resources for licensing, monitoring, and enforcement may prove challenging when those capacities are already available in other administrative departments, states may choose to model Massachusetts and create an independent agency exclusively responsible for cannabis regulation.
Regardless of medicinal or recreational legalization status, all states could benefit by making pursuing individuals diluting THC-containing vaping products an enforcement priority. State (and federal) officials could minimize the spread of these diluted products by actively investigating the illegal market, determining the sources of diluted products, and bringing enforcement actions.
Policymakers can wield a multitude of tools to address vaping-related illness. Cannabis policy reform is one option. As federal and state policymakers consider cannabis policy redesign, the regulatory burden imposed on the nascent legal industry is an important consideration. If the costs associated with new regulatory requirements are so great that the legal industry cannot compete with the illegal market, policymakers could risk encouraging the survival of the illicit industry—especially if states do not increase enforcement against the illegal market. Policymakers therefore may face challenges in balancing comprehensive regulatory design that promotes product safety with its potential to bolster the illegal and unregulated market.
Amanda Mauri is a Ph.D. student in the health services organization and policy & political science programs at the University of Michigan. Rebecca Haffajee is a lawyer and policy researcher at the nonprofit, nonpartisan RAND Corporation and an adjunct assistant professor at the University of Michigan School of Public Health.
This commentary was first published on March 26, 2020 on Health Affairs Blog. Copyright ©2020 Health Affairs by Project HOPE — The People-to-People Health Foundation, Inc.
Commentary gives RAND researchers a platform to convey insights based on their professional expertise and often on their peer-reviewed research and analysis.