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

The FDA recently sent out letters with a new focus on 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 is the first time that individual companies have received such a warning letter regarding delta-8 THC.

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

The FDA sends continuous reminders that it has not evaluated whether unapproved delta-8 THC products are effective for medical claims, which involve dosages, interactions, or have 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 lessen side effects related to a wide variety of diseases or medical conditions, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” a said FDA Senior Deputy Commissioner Janet Woodcock, MD.

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

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

“Several months ago they asked about the delta-8 and did disengage that they were of the view that ‘buyer beware’ and that there are many dangerous delta-8 products here on the market that are hurting people,” said Jonathan Miller, general counsel for the U.S. Roundtable on hemp. Highlights on the phone. “This is now the second step in terms of sending out warning letters.”

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

Should companies dealing with delta-8 THC products be concerned? It depends. “I wouldn’t be surprised to see real enforcement action in the not so distant future. We’re seeing a flurry of state-level action right now, and I think that’s going to continue,” Miller said, but added that he expects the delta-8 THC market to continue to rise. thrive in places such as adult-use markets. .

“The general consensus — perhaps not by everyone — is that D8 products that use good manufacturing practices in adult-use markets have a future,” Miller added. “I don’t think anyone is talking about banning delta-8 products in the sense that delta-9 is banned, but I think people who are selling poorly made products at gas stations without any checks should be warned that public policy is moving strongly against them.

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

Regarding hemp products, the FDA then recalled 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 has sent individual warning letters to the following companies:

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

Companies involved with delta-8 THC products should take note of the scheme adopted by the FDA.

About Patrick K. Moon

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