FDA Issues Warnings to Companies Selling Delta-8 THC Products
Five companies in four states get official letters, a first from the federal agency.
U.S. federal authorities have battled with states for two years as Delta-8 THC has soared in popularity across the country.
A synthetic CBD extract that affects the endocannabinoid system similar to popular marijuana compound Delta-9 THC, Delta-8 provides slightly milder versions of the typical weed buzz – which can include feelings of energy, euphoria, relaxation, sleepiness and even pain relief. For that reason, it’s known as ‘marijuana-lite’ or ‘diet weed.’
Unlike Delta-9, Delta-8 can be legally sold in CBD stores thanks to the 2018 Farm Bill, which gave Americans the legal right to grow and sell hemp as long as the products contain less than 0.3 percent Delta-9.
At least 13 states have stepped in to ban Delta-8 after concluding that it’s too similar to Delta-9 to be widely available to customers. And while federal authorities have mostly remained quiet on Delta-8, a series of warning letters issued Wednesday threaten to drastically shift the status-quo.
What the feds say
In emails sent to five different CBD vendors that sell Delta-8 products online and ship them across state lines, the FDA accused company CEOs of fabricating the benefits of their edibles, tinctures, pet products and other items.
“We are not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that any of these products are generally recognized as safe and effective,” the feds wrote in an email to Chase Slappey, CEO of ALTRx, Inc in Alpharetta, Georgia.
The official warning letter went on to call ALTRx’s CBD and Delta-8 THC “new drugs” that “may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect.”
Warning letters to four other vendors — BioMD Plus LLC in Marietta, Georgia; Delta 8 Hemp in Los Angeles; Kingdom Harvest LLC in Hendersonville, North Carolina and M Six Labs Inc. in Saukville, Wisconsin — included similar claims.
Hemp and cannabis companies respond
Kingdom Harvest CEO Shelle Rogers said in an email that the company’s products do in fact comply with federal and state guidelines and that Kingdom Harvest plans to formally respond to the FDA in the coming days.
“Our company has been an advocate for regulations within the fast growing Hemp Industry and it is our desire to continue to work within the parameters of both federal and state law,” Rogers wrote. “We have initial grave concern with the somewhat sweeping aspects of the letter and how the FDA’s position complies with existing law.”
Wednesday’s warning letters represented the first time the FDA has issued such notices for products containing Delta-8. According to the agency’s website, companies issued a warning are given a specified amount of time to respond and make changes satisfactory to the FDA. Representatives from the other four companies did not immediately respond to emails for comment.