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

The FDA recently sent letters with a new emphasis towards companies selling delta-8 THC products with purported benefits. 

Some of the companies sold pet products containing CBD, the announcement highlighted hemp-derived delta-8 products, marketed for human consumption. This marks the first time individual companies have received such a letter warning 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. 

The FDA sends continual reminders that it has not evaluated whether unapproved delta-8 THC products are effective for medical claims, which involves dosages, interactions, or whether they have potentially dangerous side effects. These products can be found just about everywhere including gas stations and CBD shops.

“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.” 

The FDA recently published a consumer update giving a general warning to consumers about the potential health hazards of delta-8 THC products. 

“Several months ago, they came out with questions regarding delta-8 and made it 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 High Times on the phone. “This is now step two in terms of sending out warning letters.” 

The U.S. Hemp Roundtable is a coalition of dozens of leading hemp companies and organizations committed to safer practices. The organization receives questions swirling around the murky topic of delta-8 THC regularly.

Should businesses that deal with delta-8 THC products be concerned? That 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.”

This applies to questionable psychoactive products that are sold in stores that are generally not authorized to do so. “Stop making medical claims, use good manufacturing practices and sell them in adult-use marketplaces,” he said.

Regarding hemp products, the FDA went on to remind that Epidiolex alone has been fully approved at all levels for medical claims. Even Charlotte’s Web full-spectrum CBD extract was denied FDA approval as a dietary extract. 

The FDA issued individual warning letters to the following companies:

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

Businesses involved with delta-8 THC products should take note about the pattern the FDA is taking.