On Wednesday, the Food and Drug Administration (FDA) sent warning letters to five companies for selling products containing delta-8 THC, as the agency says the use of this ingredient violates the Federal Food, Drug & Cosmetics Act (FD&C Act) due to the “psychoactive and intoxicating effects” it has on users. The FDA has requested that the following companies cease marketing and selling these products.
The five companies selling delta-8 THC products are ATLRx Inc., BioMD Plus LLC, Delta 8 Hemp, Kingdom Harvest LLC and M Six Labs Inc.
The FDA warned that any product containing delta-8 THC that claims to “diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug” and that, due to a lack of testing with this substance, it is very dangerous to use. This particularly type of tetrahydrocannabinol is not naturally occurring, being derived from CBD products, which makes it more potent, and therefore potentially more dangerous. The aforementioned companies marketed these products as (unapproved) treatments for medical conditions and for therapeutic uses, despite not being authorized by the FDA to do so.
Further in the letter, the FDA has found there has been an “increasing number of exposure cases involving products containing delta-8 THC received by national poison control centers and alerts issued by state poison control centers describing safety concerns and adverse events with products containing delta-8 THC.” They reiterated that this product is not safe for humans or animals to consume in any way, shape or form and that they have only approved one CBD product for a rare form of epilepsy, meaning that essentially all forms are unapproved by the administration.
The FDA has given these companies fifteen days to state how they will address these violations. However, “failure to promptly address the violations may result in legal action, including product seizure and/or injunction.”
