FDA Sends Warning Letters to Companies Illegal Selling Delta-8 |

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

Some of the companies were selling CBD-containing pet products, with the announcement highlighting hemp-derived Delta-8 products being marketed for human consumption. This is the first time individual companies have received such a written warning about Delta-8-THC.

Specifically, the FDA says the products are being marketed in a way that violates the Federal Food, Drug, and Cosmetic Act (FD&C Act), and most concerns are about medical claims on the labeling. According to the announcement, any delta-8 THC product that claims to “diagnose, cure, mitigate, treat, or prevent disease” is considered an unapproved new drug.

Delta-8 THC products can be hazardous to consumers. Delta-8 THC has psychoactive and intoxicating effects, and the FDA has received reports of side effects experienced by patients who have consumed these products.

— US FDA (@US_FDA) May 4, 2022

The FDA is a constant reminder that they have not evaluated whether unapproved delta-8-THC products are effective for medical claims, which involves dosages, drug interactions, or potentially dangerous side effects. These products can be found just about anywhere, including gas stations and CBD stores.

“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 associated with a variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” said Janet Woodcock, MD, the FDA’s chief deputy commissioner

“It is extremely worrying that some foods are packaged and labeled in a way that is appealing to children. We will continue to protect the health and safety of Americans by monitoring the marketplace and taking action when companies are illegally selling products that pose a risk to public health.”

The FDA recently issued a consumer update warning consumers generally about the potential health hazards of delta-8 THC products.

“A few months ago they asked questions about Delta-8 and made it clear that they believe ‘buyers beware’ and that there are many unsafe Delta-8 products on the market here that are hurting people,” USA Jonathan Miller , general counsel of the Hemp Roundtable, told the High Times over the phone. “This is now step two in terms of warnings.”

The US Hemp Roundtable is a coalition of dozens of leading hemp companies and organizations dedicated to promoting safer practices. The organization regularly receives questions about the murky topic of delta-8-THC.

Should companies dealing in delta-8 THC products be concerned? Depends on. “I wouldn’t be surprised to see actual enforcement action in the not too distant future. We’re seeing a spate of action at the state level right now, and I think that will continue,” Miller said, but added that he expects the delta-8 THC market to grow in places like adult-use markets will continue to thrive.

“The general consensus – perhaps not all – is that D8 products that use good manufacturing practices in adult markets have a future,” Miller added. “I don’t think anyone is talking about a ban on Delta 8 products in the sense that Delta 9 is banned, but I think those who are selling poorly made products at gas stations without any control should be forewarned, that this is public order to move strongly against them.”

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

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

The FDA has issued individual warning letters to the following companies:

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

Companies dealing with delta-8 THC products should refer to the FDA’s template.