As a Washington, DC-based Food and Drug Administration (FDA) regulatory attorney, I have been interested in the developments that took place in 2021 regulating cannabis for health and safety. The Marijuana Opportunity Reinvestment and Expungement Act (MORE Act), first introduced in the House in 2019, did not address the regulation of cannabis products for health and safety, focusing instead on the important matters of decriminalization, social justice, and taxation. See https://bit.ly/3itEfqX. It has been exciting, therefore, to see two new bills in Congress in 2021 that tackled the complex problem of how to regulate cannabis products for health and safety.
The Cannabis Administration and Opportunity Act, put forward (not yet introduced) by three Senate Democrats, and the Mace Act, introduced in the House by Congresswoman Mace, received many comments and much media reaction, particularly on the new health and safety regulatory provisions. See https://bit.ly/3up0PXi and https://bit.ly/353Lwe0.
The first basic question for resolution in this area is which regulatory agency will have the lead in regulating cannabis products, with the candidates being either the FDA or the Treasury Alcohol and Tobacco Tax and Trade Bureau (TTB). See https://www.ttb.gov/. The Senate CAOA legislation gives the FDA the primary role in regulating cannabis products, and the Mace bill gives the primary role to TTB and the states. The Mace bill explicitly preserves state primacy for maintaining the existing state medical marijuana programs.
The FDA has jurisdiction over pharmaceuticals, medical devices (vapes and patches), food, dietary supplements, and cosmetics (topicals). The TTB has jurisdiction over alcohol products. A TTB regulatory approach is perceived as lighter because alcohol products are not subject to the strict regime of human health and safety validation generally required for FDA-regulated products.
The complexity of the regulatory issues for cannabis stems from the broad range of different cannabis products and the different laws and regulations applicable to a cannabis product depending on the product delivery form. There is agreement among stakeholders that pharmaceutical products such as Epidiolex (active ingredient is cannabis-derived CBD isolate) should go through the drug approval process at FDA. When it comes to edibles, including gummies, chocolates, tinctures, supplements, etc., it is not clear that TTB has the expertise to regulate these products, though the concern with FDA is that the agency would overburden the cannabis industry and stifle its development. The concern about FDA regulation stems in part from the inability of the FDA to provide a regulatory pathway for Cannabidiol (CBD) products, something the agency committed to three years ago. See https://bit.ly/3D4RbNr. Some stakeholders fear that FDA may be most comfortable with the full pharmaceutical drug approval process and not allocate resources to providing a pathway for other products.
Another overlay to the regulatory discussion is the role of product claims (statements on products such as “promotes a good night’s sleep” or “cures your hangover”). The FDA regulates products according to the use of the product and allows claims according to the category of the product and the substantiation of the claim. Different types of claims are allowed depending on whether the product is a pharmaceutical, a dietary supplement, or a food. Some stakeholders have asked whether FDA would allow products without claims to be legally on the market. For example, raw cannabis flower without claims should not be required to have FDA approval before being marketed. What claims will be legally allowed by the FDA is another complexity to be addressed.
In addition, the FDA regulates products according to dosage for drugs and serving size for foods and supplements. There has been considerable discussion about whether FDA might allow cannabis products to be legally marketed across several swim lanes—meaning pharmaceuticals, supplements, and foods could contain cannabis (perhaps at different levels). It is possible in theory, although extremely rare, for a single active “article” (molecule) to be approved as a pharmaceutical at a high dose and allowed in a food or supplement at a lower serving size. This has led to consideration of whether for cannabis a cannabinoid might be allowed in different products at differing safety limit levels.
There was hope once hemp-derived CBD was de-scheduled in the 2018 Farm Bill, that hemp-derived products could be a test case for how to regulate a cannabis product. See https://bit.ly/3ir4oqy. In 2021, however, the FDA closed the door on this possibility. At the end of 2021, the FDA refused to authorize two petitions filed by CBD companies, alleging that the products were not reviewable because CBD had already been approved as a pharmaceutical (Epidiolex) and that, in addition, the safety data was not adequate. See https://bit.ly/37JwNpy at (a)(1)(ff). This decision increased distrust of the FDA among stakeholders, who fear that as long as the FDA shuts the door on safety data, there will be no pathway or incentive for stakeholders to develop safety data for legal cannabinoid products. This will leave CBD in regulatory limbo and reduce confidence in the FDA as the appropriate regulator for cannabis products.
In 2021, there were also state-level regulatory developments that may impact the eventual federal regulation of cannabis products. At the state level, Oregon is issuing regulations that limit the level of THC allowed in CBD products, introducing the concept of “intoxication” as a factor in determining regulation. This concept could creep into federal regulations, creating another layer for regulatory consideration.
With the federal legislation unlikely to move forward in 2022, an election year, there is additional time to develop these regulatory approaches. Although admittedly complicated, the bottom line is that the cannabis plant is an established recreational product (like alcohol) and a promising pharmaceutical and wellness product. We will eventually figure out a way for all of these uses and sectors to thrive.