On May 4th, 2022 the FDA (Food and Drug Administration) issued five letters to companies that they believe have violated the FD&C Act (Federal Food, Drug, and Cosmetic Act) in the selling of their Delta 8 THC products; this is the first time the FDA has issued warnings in reference to Delta 8 THC. In their studies, the FDA found some users experienced adverse side effects. Delta 8 THC is known to cause mild psychoactivity.
The companies that received these warnings letters are:
- ATLRX Inc.
- BioMD Plus LLC
- Delta 8 Hemp
- Kingdom Harvest LLC
- M Six Labs Inc
The reason as to why they received these letters is due to an FDA claim that they marketed their Delta 8 THC products as treatment for medical ailments, and the ability to provide therapeutic relief. The companies were also cited for brand misrepresentation for product use, in addition to carrying infused food items. Presently, the FDA has not approved drugs containing Delta 8 THC. As taken from their website: “There are no FDA-approved drugs containing delta-8 THC. Any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug. The FDA has not evaluated whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns.”
The FDA has issued similar warnings to other companies in reference to CBD – a naturally occurring compound that is also found in the cannabis plant. (Fun fact: while Delta 8 THC is also found within the cannabis plant, it only occurs in trace amounts!) Those companies were also marketing CBD as having both therapeutic and medicinal properties.
What is Delta 8 THC?
Delta 8 THC is one of the multitude of cannabinoids found within the cannabis plant! Its extraction process is a little different, however. Delta 8 THC is an analog of THC and is made using CBD isolate. That’s a lot of sciencey stuffs, but just know that in reference to the actual plant, it’s challenging to come by! Since Delta 8 THC is derived from industrialized hemp and falls within the 0.3% THC threshold, it’s legal to be sold and distributed to the public! At or below 0.3% THC (per dry weight) is the threshold set by federal regulation. The Farm Bill, passed in 2018, allows for the production and sale of hemp and hemp-derived products!
Should We Be Concerned?
While I myself am not a medical professional and can’t make any recommendations, I can present you with what we currently know:
The extraction process, having been performed correctly, results in a pure and refined product. There are concerns in reference to quality, given our industry is new and unregulated. Some suppliers will cut costs as they can, and it usually begins with price over quality. The best advice I could give a potential consumer is to do your research! Companies that produce the higher quality product you’re looking for will provide resources that it’s been properly tested by a third-party company.
Users of Delta 8 THC also report that it can cause mild psychoactivity in comparison to its famed cousin, Delta 9 THC. Some prefer the more mild effects as they tend to be more palatable for their systems! Each of us has an Endocannabinoid System that interacts with cannabinoids (both the ones we consume and those naturally produced by our bodies) and our bodies respond to things very differently! While research is still being studied as to how our bodies respond to Delta 8 THC specifically, it’s important to note if you do partake, that you do so minimally at first, until you’ve got a good idea of how your body’s going to respond to it!
- Commissioner, O. of the. (n.d.). FDA issues warning letters to companies illegally selling CBD and delta-8 THC products. U.S. Food and Drug Administration. Retrieved May 13, 2022, from https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-companies-illegally-selling-cbd-and-delta-8-thc-products