The 2018 Farm Bill redefined the meaning of hemp, opening the door to a variety of small and large companies that began producing, manufacturing and marketing cannabinoids for a variety of purposes with little to no oversight. As federal policy lags around hemp and cannabidiol (CBD) product manufacturing and marketing, the players operating within its framework have begun taking advantage of this lack of federal oversight to the detriment of consumers.
Two concerning issues are playing out across the U.S. today. First, diverging interpretations of federal law have led to a surge in unregulated delta-8 products of dubious quality and legality. Second, lobbyists for the cannabis industry are using observational studies and incomplete data to support arguments that cannabis-based products are safe. Both situations are leaving consumers vulnerable.
Loopholes in the Law
The Farm Bill defined hemp as cannabis containing less than 0.3% delta-9 Tetrahydrocannabinol (THC) by dry weight. This removed it from the definition of marijuana (still considered an illicit drug) and made it legal to cultivate and sell.
Despite the fact that it is still illegal under the Food Drug and Cosmetic Act (FDCA) to add hemp or hemp-derived substances to foods or dietary supplements, companies in the cannabis industry are claiming the Farm Bill has left room for them to produce another hemp-derived product—delta-8 THC.
Delta-8 is a chemical analog, or variation, of delta-9, the intoxicating cannabinoid found in marijuana. Companies began to mass produce delta-8 soon after the Farm Bill’s passage, with many marketing the substance as a safer way to get “high” because it has a somewhat less intoxicating effect than delta-9.
Some in the legal field have begun weighing in, warning that these companies selling delta-8 are playing with fire because it is still considered illegal under the Controlled Substances Act (CSA) if it is synthetically derived.1 Others counter that because delta-8 is a derivative of hemp, it remains lawful under the Farm Bill, and the CSA.2
Without laws governing how delta-8 is produced, manufacturers creating it are operating without clearly defined federally regulated standards and oversight. This puts consumers at risk of receiving intoxicating products that have not been adequately tested for contaminants, residual solvents, or any other unknown compounds.
To highlight the dangers of unregulated delta-8 products currently on the market, the U.S. Cannabis Council commissioned testing from eight states across the U.S. Test results showed products contained “vastly varying” amounts of delta-8 THC, as well as pesticides and heavy metals.3 Notably, all samples contained more delta-9 than was legally permitted.4
States are beginning to clamp down on delta-8, but each state interprets the federal law differently. This divergence is causing more confusion for consumers and businesses alike. Without clarity, consumers are left with a lack of information that leaves them vulnerable to products of questionable quality, safety and in some cases, legality.
Not All Data Is Created Equal
As policymakers continue to reassess cannabis legislation around delta-8 and all cannabis-based products including “medical” and “recreational” marijuana, lobbyists for the cannabis industry are presenting them with observational studies, rather than rigorous scientific evidence to support their interests. While observational data provides valuable signals about the effects of a given drug or behavior; it does not provide healthcare providers or patients with clarity around the safety and efficacy of a drug for a specific condition at a specific dose.
In a recently released joint statement, the FDA reiterated its ongoing work to better understand the safety profiles of cannabis-based products on the market.5 It acknowledged the enthusiasm expressed by many groups currently providing data to the agency around these products, but countered that existing efforts “are not adequate to fill the outstanding knowledge gaps” and that “observational studies that are too small or that do not include techniques to ensure data quality or methodological rigor are of limited use for public health decision making.”6
The statement is a reminder that even well-intentioned efforts to prove the quality of cannabis-based products need to be backed by scientific evidence. To protect the public, policy makers need to be able to decipher between good and bad data.
1This Drug Gets You High, and Is Legal (Maybe) Across the Country, The New York Times, available here: https://www.nytimes.com/2021/02/27/health/marijuana-hemp-delta-8-thc.html, Accessed on June 24, 2021
2Delta 8 THC: Legal or Not? Kight on Cannabis, Available here: https://cannabusiness.law/delta-8-thc-legal-or-not/, Accessed on August 12, 2021.
3The Unregulated Distribution and Sale of Consumer Products, U.S. Cannabis Council, pg. 2, Available at https://irp.cdn-website.com/6531d7ca/files/uploaded/USCC%20Delta-8%20Kit.pdf. Accessed August 24, 2021.
4The Unregulated Distribution and Sale of Consumer Products, U.S. Cannabis Council, pg. 5, Available at https://irp.cdn-website.com/6531d7ca/files/uploaded/USCC%20Delta-8%20Kit.pdf. Accessed August 24, 2021.
5Better Data for Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products, FDA joint statement, available at https://www.fda.gov/news-events/fda-voices/better-data-better-understanding-use-and-safety-profile-cannabidiol-cbd-products Accessed on June 24, 2021
6Better Data for Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products, FDA joint statement, available at https://www.fda.gov/news-events/fda-voices/better-data-better-understanding-use-and-safety-profile-cannabidiol-cbd-products Accessed on June 24, 2021