On May 4, 2022, the United States Food and Drug Administration (FDA) issued for the first time Warning Letters to companies selling products containing delta-8 tetrahydrocannabinol (delta-8 THC). While the FDA has sent warnings to companies utilizing hemp-derived cannabidiol (CBD) before, this is the first set of Warning Letters to those selling delta-8 THC products for both human and animal consumption. The agency analyzed both the product labeling and claims made on the companies’ websites in addressing allegations of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act), including marketing unapproved new drugs, misbranding, and adulteration when adding delta-8 THC to human and food products.
Delta-8 THC is one of more than one hundred cannabinoids found in the Cannabis sativa L. plant; however, delta-8 THC is not found naturally in significant amounts and concentrated amounts of delta-8 THC are typically synthesized from CBD. Delta-8 THC can have psychoactive and intoxicating effects and therefore, can be dangerous to consumers.
Marketing Unapproved New Drugs
Five companies received warning letters because their products were marketed as drugs (both for human and/or animal use). There is currently no FDA-approved drug containing delta-8 THC. Any delta-8 products that claim to diagnose, cure, mitigate, treat, or prevent disease are considered unapproved drugs in violation of the FD&C Act (section 201(g)(1)). Some examples of claims observed on product labels and in advertising that the FDA makes note of include “pain relief and inflammation,” “helps fight cancer,” “relieves nausea,” and “treats seizures.”
Under section 502(f)(1) of the FD&C Act, FDA warned companies that their products were misbranded because their labeling failed to include adequate directions for use. This means that the products are marketed to the public similar to the manner by which a drug is marketed (when they are, in fact, not an FDA-approved drug), and adequate directions are not provided (and cannot be provided) for the average person to use the drug safely for the purposes described.
Adulteration: Adding delta-8 THC to Food Products
Under section 301(ll) of the FD&C Act, any food, including animal feed, to which an approved drug has been added, or for which there have been “substantial clinical investigations” known to the public, is prohibited. FDA has concluded that section 301(ll) applies to CBD. FDA asserts in some of the Warning Letters where the products are marketed, in part, as conventional human or animal foods, that because there is an approved drug that has CBD as the approved drug substance, the section 301(ll) prohibition applies.
In other of the recent Warning Letters, the products are labeled as if the Delta-8 THC were a “food additive.” Under section 201(s) of the FD&C Act, the term “food additive” refers to any substance that intended use of which results in it becoming a component of any food. If a substance is not a food additive, it can also be added to food if it is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception. Delta-8 THC is not GRAS and is not an approved food additive. Further, FDA states that there is currently no basis for delta-8 THC to be considered GRAS or an approved food additive.
Although not all of the May 4, 2022, Warning Letters assert the same bases for characterizing the products as “adulterated” or “misbranded,” the agency included language that “This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products.”
On May 4, 2022, FDA released another consumer update to warn the public of the dangers of delta-8 THC. FDA has released consumer updates before to warn consumers of delta-8 THC. FDA has also noticed a continual increase in reports of adverse effects relating to delta-8 THC consumption. FDA concludes by saying that a company’s “failure to promptly address the violations may result in legal action, including product seizure and/or injunction.”
OFW Law will continue to monitor the developments with regulation of cannabis, including warning letters and agency actions targeting companies illegally selling products. Please contact us if you have any questions.