On May 4, 2022, the U.S. Food and Drug Administration (FDA) for the first time issued warning letters related to products containing delta-8 tetrahydrocannabinol (delta-8 THC). FDA has previously sent warning letters to other companies illegally selling unapproved and misbranded cannabidiol (CBD) products that claimed to treat illness in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as we have discussed in prior posts (one example here). In a separate recent slew of CBD-related actions, FDA issued warning letters jointly with the Federal Trade Commission (FTC) to seven companies for selling CBD products with claims that they will treat or prevent COVID-19. (FDA has not approved any CBD-containing products other than one prescription human drug product to treat rare, severe forms of epilepsy.) However, the recent delta-8 THC letters are focused on FD&C Act violations and only signed by FDA officials, notwithstanding that FTC advertising issues likely exist for those products too, suggesting that the agency may have wanted to send a clear message about the risk to the public health and the FD&C Act problems with such products.
Delta-8 THC is a cannabinoid occurring naturally in the Cannabis sativa plant, of which marijuana and hemp are two varieties. Delta-8 THC products have proliferated since the passage of the Agriculture Improvement Act of 2018, but FDA has remained relatively hands-off when it comes to enforcement related to these products. The warning letters issued on May 4 indicate that advertising delta-8 THC products as capable of treating or preventing sickness or disease will elicit action from the agency.
Background on Delta-8 THC
From a botanical standpoint, “cannabis” plants comprise of both marijuana and hemp. Delta-9 THC – not delta-8 THC – is the cannabinoid molecule that has long been recognized as the marijuana plant’s main psychoactive ingredient. FDA stated in its May 4 news release regarding the new warning letters that delta-8 THC similarly has psychoactive and intoxicating effects and may be dangerous to consumers.
Marijuana containing more than 0.3% of delta-9 THC (on a dry weight basis) is federally unlawful under the Controlled Substances Act. But the Agriculture Improvement Act of 2018 (also called the 2018 Farm Bill) legalized the hemp plant and its derivatives containing less than 0.3% delta-9 THC. Delta-8 THC, which is derived and extracted from hemp via a chemical process, would appear to be a type of legal hemp derivative because the starting plants are considered lawful under the 2018 Farm Bill. In 2020, however, the U.S. Drug Enforcement Agency promulgated an interim final rule clarifying that any synthetically derived THC is a controlled substance that is unlawful under the Controlled Substances Act. Whether delta-8 THC is legal under federal law, therefore, turns on whether the process used to extract the cannabinoid is the type of synthesis prohibited by the interim final rule.
FDA’s Warning Letters
Amidst this uncertainty regarding the legality of delta-8 THC under the Controlled Substances Act, FDA issued warning letters to five manufacturers for selling delta-8 THC products in ways that the agency asserts are in violation of the FD&C Act. Specifically, the letters allege that these manufacturers: 1) marketed delta-8 THC products as unapproved drugs by advertising them as treatments for various medical conditions; 2) provided inadequate directions for use, rendering those products misbranded; and 3) unlawfully added delta-8 THC to food products, among other possible violations of the FD&C Act.
FDA appears to have been motivated to act and send a strong message to the burgeoning delta-8 THC market after receiving 104 reports of adverse events in consumers who used delta-8 THC products between December 1, 2020 and February 28, 2022. In addition, FDA states that national poison control centers received 2,362 exposure cases of delta-8 THC products between January 1, 2021 and February 28, 2022. These observations also prompted FDA to release a consumer update to educate the public on health risks related to delta-8 THC products – none of which has been evaluated or approved by the FDA for safe use in any context. FDA expressed particular concern over how the products are packaged and labeled in ways that may appeal to children.
FDA has requested written responses from the companies stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in the FDA taking legal action, including seizing products or seeking injunctions.