Earlier today, May 4, 2022, the FDA issued warning letters to five companies selling products that contain delta-8 tetrahydrocannabinol (Delta-8 THC). Several of the companies also manufactured products containing hemp-derived cannabidiol (CBD). Significantly, today’s actions represent the first time the FDA has issued warning letters for products containing Delta-8 THC. According to the agency, “Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers,” and the FDA has received reports of adverse events after individuals consumed products containing Delta-8 THC.
Delta-8 THC is one of many cannabinoids produced in the cannabis plant, and it can have psychoactive and intoxicating effects. Products containing Delta-8 are available in numerous forms, such as edibles, extracts, and tinctures. Today’s five warning letters allege the companies violated federal law in the marketing of unapproved Delta-8 THC products as treatments for various medical conditions or for therapeutic use. The letters further claimed violations regarding drug misbranding and the addition of Delta-8 THC in food, such as gummies, chocolate, caramels, and chewing gum.
In announcing the warning letters, FDA Principal Deputy Commissioner Janet Woodcock, M.D. stated that the agency “is very concerned about the growing popularity of [D]elta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety.” Dr. Woodcock proceeded to note the agency’s concern that “some of the food products are packaged and labeled in ways that may appeal to children.”
Today’s announcement detailed that the FDA was prepared to monitor the marketplace and take action “when companies illegally sell products that pose a risk to public health.” The agency’s warning letters indicate the agency may continue to take a risk-based strategy targeting products targeted at children, or those making unapproved claims meant to diagnose, cure, mitigate, treat, or prevent disease. The letters noted that there are no FDA-approved drugs containing Delta-8 THC, meaning that the agency may regard a Delta-8 THC product with drug-related claims as an unapproved new drug. Several of its letters today also alleged violations of federal law related to CBD.
The FDA’s warning letters represent the agency’s first set of warning letters regarding Delta-8 THC. Previously, the agency published a Consumer Update expressing its concerns about the safety of Delta-8 THC, particularly for children and pets. The FDA also noted an increasing number of exposure cases involving products containing Delta-8 THC received by poison control centers. Notably, these letters are similar to previous warning letters that the agency has sent to companies regarding CBD products in that the products at issue appear to have attracted the FDA’s attention because they make drug-like claims regarding CBD and Delta-8 THC. For example, the recipient of one of the letters marketed its products by claiming that Delta-8 THC helped relieve vomiting in children undergoing chemotherapy. This suggests that—similar to its approach to CBD—the FDA is taking a relatively ambivalent approach to Delta-8 THC products by targeting what it perceives as particularly egregious misconduct, while ignoring the vast majority of foods, beverages, and dietary supplements that contain Delta-8 THC, at least for now.
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