Warning Letters Sent to Companies Marketing Delta-8 THC Products as Treatments

Warning letters were sent to 5 companies illegally selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC), according to the Food and Drug Administration (FDA).

The term THC commonly refers to the delta-8 THC isomer, which is psychoactive and causes euphoria. However, THC contains several other isomers including delta-8 THC, which is approximately 50 to 75% as psychoactive as delta-9 THC. Cannabidiol (CBD) products containing delta-8 THC are becoming more prominent in both marijuana and hemp marketplaces. Some of these products may potentially be confused with hemp or CBD products, which are non-psychoactive.

The following companies have received warning letters for selling products containing delta-8 THC as unapproved treatments for various medical conditions or for other therapeutic uses: 

• ATLRx Inc.
• BioMD Plus LLC
• Delta 8 Hemp
• Kingdom Harvest LLC
• M Six Labs Inc.

The letters cite violations related to drug misbranding and the addition of delta-8 THC in foods, such as gummies, chocolate, caramels, chewing gum, and peanut brittle.

“The FDA is very concerned about the growing popularity of delta-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,” said FDA Principal Deputy Commissioner Janet Woodcock, MD. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children.”

Some adverse event reports received by the Agency have involved the need for hospitalization or emergency room treatment. National poison control centers have also been seeing an influx of exposure cases related to delta-8 THC products.

In September 2021, the Centers for Disease Control and Prevention (CDC) issued an advisory regarding the increased availability of cannabis products containing delta-8 THC and the potential for adverse events due to insufficient labeling of products.

There are no FDA-approved drugs containing delta-8 THC. Epidiolex (cannabidiol) oral solution, used to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, is currently the only FDA-approved CBD product.

Reference

FDA issues warning letters to companies illegally selling CBD and delta-8 THC products. News release. US Food and Drug Administration. Accessed May 4, 2022. https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-companies-illegally-selling-cbd-and-delta-8-thc-products