When Congress passed the Agriculture Improvement Act, otherwise known as the Farm Bill, in 2018, it created what former Principal Deputy Commissioner of the FDA, Amy Abernethy, MD, PhD., deemed a “policy sea change.”1 By removing hemp from the definition of marijuana, if it contained no more than 0.3% delta-9 tetrahydrocannabinol (delta-9 THC) by dry weight, it was no longer considered a controlled substance and could be legally cultivated.
At the time of passage, public discussion focused on potential opportunities to provide American farmers with another revenue stream.2 But once enacted, the law inadvertently enabled a flood of unregulated cannabis-based products of questionable safety and quality to enter the market without regulations or oversight to protect consumers. Three years later, confusion around the legality of cannabis-based products continues to put consumers at risk.
The Introduction of Delta-8
Delta-9 THC and CBD (cannabidiol) are the two most well-known cannabinoids found in cannabis, but only Delta-9 THC is considered an intoxicant. By setting a limit on the amount of delta-9 THC that could be found in hemp and cannabis-based products, the Farm Bill enabled companies to manufacture and sell products that were not, in theory, thought to be able to produce the intoxicating “high” associated with delta-9 THC. As long as their products stay below the 0.3% limit on delta-9 THC, they are exempt from being deemed controlled substances, and therefore descheduled under the Controlled Substances Act.
The Farm Bill’s limit is confined to delta-9 THC and no explicit restrictions are set on delta-8 THC, a compound with a similar chemical structure. This loophole is leading some to argue that the lack of specific language limiting other cannabinoids means they may be sold legally.3 Known in some circles as “marijuana light,”4 companies are touting delta-8 as a safer alternative to delta-9 because it produces a less robust intoxicating effect. (This opinion has not been proven clinically and animal studies contradict it.)5 Yet, sellers and consumers have responded. Delta-8 is currently the fastest growing segment of the hemp-derived products market in the U.S.6
In late 2020, the Drug Enforcement Agency (DEA) issued an interim final rule7 stating that all synthetically derived tetrahydrocannabinols remain Schedule 1 controlled substances, making them illegal under federal law. Delta-8 is a tetrahydrocannabinol that can either be extracted from the cannabis plant or produced synthetically in a lab. Some point to the interim rule, arguing that delta-8 is only considered a Schedule 1 substance if it is manufactured synthetically and not when it is extracted directly from the plant.8 However, it is commonly understood among industry players that delta-8 is typically synthetically derived. They argue there isn’t enough delta-8 naturally occurring in the cannabis plant to make its extraction economically practical.9
While ambiguity remains about the cannabinoid’s legality, products containing delta-8 continue to be manufactured and marketed to consumers across the country. Intoxicating products that have not been adequately tested for impurities can be easily accessed online and are cropping up in retail stores across the U.S.10 In an attempt to protect unwitting consumers, including minors, seventeen states have made it illegal to sell delta-8 containing products.* But plenty of states have not banned its sale and business continues to grow. Until clear regulations are in place, the onus is on consumers to be vigilant and informed about the potential risk of delta-8 and its presence in products they purchase.
The FDA’s Stance on Regulation:
The day the Farm Bill passed, out of concern for the public, the Food and Drug Administration (FDA) put out a statement11 reiterating its stance on hemp and cannabis-derived products. The agency made clear that these products are still illegal under federal law if they 1) claim any therapeutic benefit and have not been subject to FDA review or 2) are sold in foods or dietary supplements. The agency also restated its explicit authority over these products, encompassing all cannabis-based products.
None of these products are subject to the same regulatory testing controls required for prescription medications under the FDA. The agency plays a pivotal role in protecting public health by overseeing the safety and effectiveness of the prescription medications that come to market. It determines consistency of potency, contamination testing, manufacturing, labeling and assesses the risk and benefits of all drug products sold in the United States.
There is still no federal standard to ensure that the cannabis-based products being sold today are tested for quality, including contamination and potency, as well as safety and effectiveness. This puts the onus on consumers and their healthcare providers to evaluate the safety of products that have not been approved for medical use.
Regulators, policymakers, and healthcare providers all have a role to play when it comes to public health and safety. Until better efficacy data and uniform standards of quality and safety around cannabis-based products exist, education and advocacy are pivotal to helping consumers make informed decisions about these products.
*As of July 21, 2021 the following states have either banned or restricted delta-8: Alaska, Arkansas, Arizona, Colorado, Delaware, Idaho, Iowa, Kentucky, Michigan, Mississippi, Montana, New York, North Dakota, Rhode Island, Utah, Vermont, Washington.
1Hemp Production and the 2018 Farm Bill, Testimony of Amy Abernethy, MD, PhD., available at fda.gov/news-events/congressional-testimony/hemp-production-and-2018-farm-bill-07252019, Accessed June 24, 2021
2The Farm Bill, hemp legalization and the status of CBD, available at: https://www.brookings.edu/blog/fixgov/2018/12/14/the-farm-bill-hemp-and-cbd-explainer/, Accessed August 17, 2021
3The 2018 Farm Bill Does Not Support the DEA Interim Rule, available at https://harrisbricken.com/cannalawblog/the-2018-farm-bill-does-not-support-the-dea-interim-rule/, Accessed on August 17, 2021
4This Drug Gets You High, and Is Legal (Maybe) Across the Country, New York Times, available at https://www.nytimes.com/2021/02/27/health/marijuana-hemp-delta-8-thc.html, Accessed June 24, 2021
5Stereospecificity of the discriminative stimulus functions of the dimethylheptyl homologs of 11-hydroxy-delta 8-tetrahydrocannabinol in rats and pigeons, available here: https://pubmed.ncbi.nlm.nih.gov/2550611/, Accessed July 20, 2021
6This Drug Gets You High, and Is Legal (Maybe) Across the Country, New York Times, available at: https://www.nytimes.com/2021/02/27/health/marijuana-hemp-delta-8-thc.html, Accessed July 20, 2021
7Interim Final Rule, Drug Enforcement Administration, available at https://www.deadiversion.usdoj.gov/fed_regs/rules/2020/fr0821.htm, Accessed on June 24 2021
8Thorne, G., The 2018 Farm Bill Does Not Support the DEA Interim Rule, available at: https://harrisbricken.com/cannalawblog/the-2018-farm-bill-does-not-support-the-dea-interim-rule/, Accessed on August 17, 2021
9Thorne, G., The 2018 Farm Bill Does Not Support the DEA Interim Rule, available at: https://harrisbricken.com/cannalawblog/the-2018-farm-bill-does-not-support-the-dea-interim-rule/, Accessed on August 17, 2021
10Erickson, B., Delta-8-THC Craze Concerns Chemists, Chemical & Engineering News, available at https://cen.acs.org/biological-chemistry/natural-products/Delta-8-THC-craze-concerns-chemists/99/i31, Accessed on August 17, 2021
11FDA statement from FDA Commissioner Scott Gottlieb, M.D., on Signing of the Agriculture Improvement Act and the Agency’s Regulation of Products Containing Cannabis and Cannabis-derived Compounds, available at https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-signing-agriculture-improvement-act-and-agencys Accessed June 24, 2021.