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FDA Sends Warning Letters to Businesses Improperly Selling Delta-8 |

Recently, the FDA sent out letters highlighting new concerns regarding companies that sell delta-8 THC products claiming benefits. 

Some companies had pet products with CBD. However, this announcement highlighted the hemp-derived, delta-8 products that were marketed for human use. It is the first time that individual businesses have been warned about delta-8 THC.

Specifically, the FDA says the products are marketed in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act), and most of the concern surrounds medical claims on the labeling. Per the announcement, any delta-8 THC product claiming to “diagnose, cure, mitigate, treat, or prevent diseases” is considered an unapproved new drug. 

FDA continues to remind us that unapproved delta-8-THC products have not been evaluated for effectiveness in medical claims. This includes dosages and interactions as well as potential side effects. They can be found at almost every location, even gas stations.

“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, M.D. 

“It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.” 

Recent FDA consumer updates gave a warning about potential health risks of THC-derived delta-8 products. 

“Several months ago, they came out with questions regarding delta-8 and made it It is clear that it was their opinion that ‘buyer beware,’ and that there are many unsafe delta-8 products here in the marketplace that are injuring people,” U.S. Hemp Roundtable’s General Counsel Jonathan Miller told Chronic NewsYou can reach them by phone. “This is now step two in terms of sending out warning letters.” 

U.S. Hemp Roundtable represents a group of dozens leading hemp organizations and companies committed to safe practices. This organization is frequently contacted with questions about the controversial topic of delta-8 THC.

Businesses that sell delta-8 THC products should be worried This depends. “I would not be surprised to see actual enforcement actions in the not-so-distant future. We’re seeing a tide of action right now at the state level, and I think that’s going to continue,” Miller said, but added that he expects the delta-8 THC market to continue to thrive in places such as adult-use markets. 

“The general consensus—maybe not from everybody—is that D8 products that use good manufacturing practices in adult-use marketplaces have a future,” Miller added. “I don’t think anyone’s talking about a ban of delta-8 products in the sense that delta-9 is banned, but I think those folks who are selling poorly manufactured products at gas stations without any controls should be forewarned that public policy is moving strongly against them.”

It applies to any questionable psychoactive product that is sold in stores where they are not permitted to. “Stop making medical claims, use good manufacturing practices and sell them in adult-use marketplaces,” he said.

Concerning hemp products the FDA explained that Epidiolex was approved by all relevant authorities for medical claims. Even Charlotte’s Web full-spectrum CBD extract was denied FDA approval as a dietary extract. 

Individual warning letters were issued by the FDA to these companies:

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

Companies that use delta-8 THC products need to be aware of the FDA’s current pattern.