Background
By the end of 2021, ninety-one percent of Americans reported favoring some form of marijuana legalization. To date, eighteen (18) states and Washington, DC, have legalized adult recreational use of marijuana, and thirty-seven (37) states and four (4) territories have medical use programs. More states will likely be expanding access to marijuana with ballot measures in November 2022.
Yet, despite its widespread legality under state law, marijuana is and remains illegal under the federal Controlled Substances Act (CSA). While dozens of cannabis-related bills have been introduced in the House and Senate, and discussions continue, a federal, comprehensive bi-partisan strategy for the legalization and regulation of marijuana has been slow to emerge.
The Marijuana Opportunity, Reinvestment and Expungement (MORE) Act is a long-proposed comprehensive piece for federal marijuana legalization. This bill, introduced by Jerry Nadler (D-NY) in 2019, passed the House in December 2020, but did not advance in the Senate and was reintroduced in the House on May 28, 2021. The MORE Act would decriminalize marijuana on the federal level and remove marijuana from the Controlled Substances Act, (CSA) and includes provisions to promote criminal justice, social and economic reform. On April 1, 2022, the House once again voted to pass the MORE Act. The MORE Act is now moving to the Senate though it is, once again, unlikely to progress.
In July 2021, Senate Majority Leader Chuck Schumer (D-NY) and Senators Cory Booker (D-NJ) and Ron Wyden (D-OR) released their vision for comprehensive marijuana legalization and reform, the Cannabis Administration and Opportunity (CAOA) Act. The CAOA, issued by the Sponsoring Offices as a Discussion Draft, proposed, among other things, decriminalizing cannabis at the federal level, removing marijuana from the CSA, setting minimum standards for all cannabis products currently marketed in state-legal programs, amending the Federal Food Drug and Cosmetic Act (FD&CA), and expressly assigning oversight of cannabis in food, dietary supplements, drugs and cosmetics to the United States Food and Drug Administration (FDA). The CAOA Sponsoring Offices solicited comments on the Discussion Draft and are expected to formally introduce the CAOA in April 2022 (potentially “4-20”).
The Mace Bill
The newest effort at comprehensive cannabis legalization and reform is the States Reform Act (SRA or Mace Bill), introduced in the House on November 15, 2021, by Representative Mace (R-SC). The Mace Bill, similar to the MORE Act and the CAOA, touts decriminalization of cannabis and provides retroactive expungement for most non-violent federal cannabis offenses.
In the April 1 House vote, Representative Mace voted against the MORE Act last week, citing its high proposed excise tax of 8% and that the bill gave too much authority over cannabis to the federal government. The Mace Bill proposes a low 3% excise tax, limits the social equity reforms of other legislative proposals, and maintains significant state authority over the use, distribution, sale, and manufacturing of cannabis. Under the Mace Bill, federal oversight is limited mostly to the Alcohol and Tobacco Tax and Trade Bureau (TTB) (to be renamed the Alcohol, Tobacco, and Cannabis Tax and Trade Bureau to include cannabis), rather than the FDA.
The Mace Bill has attracted attention as a potentially bipartisan vehicle for comprehensive cannabis reform and has earned support from important business interests such as Amazon. However, the Mace Bill, as it stands, also presents serious concerns in how it proposes to permit cannabis in drugs and in conventional foods, beverages and dietary supplements without FDA oversight. These concerns include the following:
- Regulating Cannabis “Like Alcohol” To Eliminate FDA Oversight
The Mace Bill designates TTB as the primary federal regulatory authority over cannabis, with a responsibility to regulate its promotion, sale, and distribution. The Alcohol, Tobacco, Firearms, and Explosives Bureau (ATF) would serve as the primary law enforcement agency. Many federal marijuana proposals, including the Mace Bill, seek to treat cannabis “like alcohol” and afford states considerable authority to regulate cannabis within their borders, much as exists for alcoholic beverages.
The Mace Bill, however, takes this concept further and specifically allots to FDA only the authority over cannabis that the agency currently has over alcohol, and no more. Currently, the FDA’s authority over alcoholic beverages is limited and TTB, not FDA, is responsible for most wine, beer, and distilled spirit labeling/health-related claims. The result of the Mace Bill appears to be little to no role for FDA in the regulation of cannabis, at all.
- Curtails FDA Authority To Protect Public Health
Removing FDA from any oversight over cannabis is concerning because FDA is the primary federal agency responsible for protecting public health. FDA is charged with ensuring: that foods, dietary supplements, and cosmetics are safe for use by humans and animals; and, that drugs have substantial evidence of their effectiveness (typically shown through randomized clinical trials) and can be safely used under their FDA-approved labeled conditions for use. The FDA has been working to develop more data about products containing cannabis and cannabis-derived compounds and FDA has frequently taken enforcement action against products containing (or purporting to contain)one cannabinoid, cannabidiol (CBD). As explained in more detail below, the agency’s position is that CBD is a prescription drug ingredient and that it is not a lawful or safe ingredient in foods or dietary supplements.[1]
The summary accompanying the Mace Bill’s release emphasizes that the limitation upon FDA authority is intentional and will “ensur[e] that cannabis products in interstate commerce will be treated like alcohol and that the regulatory issues harming the industrial hemp-derived CBD industry will not be repeated in the cannabis space.” The Mace Bill’s provision that it affords to FDA the same authority over cannabis that the agency has with respect to alcohol would, therefore, be a significant limitation upon the agency’s ability to regulate unsafe or unproven cannabis products.
- Declares that Cannabis Is A Safe And Effective Medical Treatment
Determinations that a product can treat disease are typically only made by FDA as part of a rigorous pre-approval process and the product’s safety and effectiveness must be demonstrated by substantial evidence in the form of robust, randomized clinical trial data. To date, FDA has approved cannabis-derived or cannabis-related compounds for only three medical conditions: some rare forms of epilepsy; chemotherapy-induced nausea; and anorexia associated with weight loss in AIDS patients.
The Mace Bill replaces FDA’s drug approval role and declares that cannabis is a safe and effective drug and approves cannabis for the treatment of arthritis, post-traumatic stress disorder, insomnia, temporary and chronic pain, and other serious medical conditions. Any other indication for therapeutic use consistent with a state medical cannabis program is also deemed to be approved.
At this time, however, no cannabis product has been approved by FDA for any of these conditions, and the data supporting cannabis as a treatment for these and most other diseases and condition is very thin.[2] Moreover, legislative declarations that cannabis is “approved” to treat serious medical conditions (even when scientific data do not support these conclusions), would likely undermine any incentive to develop the robust clinical data on the therapeutic benefits of cannabis – there is no reason to invest in research to determine what cannabis can and cannot treat if the equivalent of an FDA drug approval is available through a legislative declaration.
- Declares That Cannabis Is GRAS In Food And Not A New Dietary Ingredient
As stated above,[3] to assure the safety of food for consumption, ingredients in food must be Generally Recognized as Safe (GRAS) and, if not GRAS, subject to an FDA-approved food additive petition. The Mace Bill declares that cannabis-infused foods and beverages are GRAS but does not provide the science-based evidence that FDA would need to actually verify safety and quality.
Similarly, though marketers must notify FDA of new dietary ingredients in dietary supplements and obtain the agency’s approval for their use (this is known as a new dietary ingredient notification or NDIN, the Mace Bill declares that cannabis-infused dietary supplements are not “new” and therefore do not have to be submitted to the agency. Nonetheless, FDA has already rejected NDINs for products containing CBD (here and here)) because FDA has concluded that there were inadequate demonstrations of safety.
***
Though many cannabis proposals have been introduced in Congress, federal legislation on the legalization of marijuana still remains elusive. The Mace Bill makes a serious effort to tackle cannabis reform and address the unsustainable patchwork of state laws (and disregard for federal law); the Mace Bill might also represent the beginning of an effort to achieve bipartisan compromise. However, a close read of the law shows that it goes much further than merely treating marijuana “just like alcohol.” The Mace Bill makes scientific judgments typically afforded to the FDA, appears to significantly limit FDA’s ability to protect public health, and eliminates the agency’s authority to require that cannabis products demonstrate that they are actually effective therapy for the serious medical conditions they purport to treat.
OFW Law will continue to stay abreast of cannabis regulations and legislation. Please contact Tish Pahl (tpahl@ofwlaw.com) or Kyla Kaplan (kkaplan@ofwlaw.com) if you have further questions.
[1] FDA has explained that there is only limited data currently on the science, safety, and quality of cannabis products. In numerous warning letters, FDA has stated that CBD is not Generally Recognized As Safe (GRAS) and so may not be added to food unless as an FDA-approved food additive. In recent reviews of the clinical and pre-clinical data submitted in support of the safety of CBD in two full spectrum hemp extract products, the agency concluded that there was an inadequate demonstration of safety because, among other things, the submissions did not adequately address CBD’s potential liver and reproductive toxicity. See NDIN to Charlotte’s Web and NDIN to Irwin Naturals.
[2] In 2017, the Institute of Medicine National Academy of Sciences (NAS) examined over 10,000 studies on cannabis and found only three conditions for which the benefit(s) of cannabis use by humans is strong: pain, nausea related to chemotherapy, and spasticity in patients with multiple sclerosis. An analysis published in 2019 in The Lancet Psychiatry of 83 studies investigating cannabis concluded there is “scarce” or “very low quality” evidence supporting cannabinoids for numerous mental conditions, including post-traumatic stress disorder. In August 2021, the Journal of Psychiatric Research published findings of limited evidence for the effectiveness of cannabis to acutely treat a narrow range of psychiatric symptoms and no evidence supporting the mid- to long-range effectiveness of any currently available cannabis therapy.
[3] See Footnote 1.
