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FDA Issues its First Warning Letters on Delta-8 THC

By Leo Bear-McGuinness

Published: May 05, 2022   

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FDA Issues its First Warning Letters on Delta-8 THC

The US Food and Drug Administration (FDA) has issued warning letters to five companies for selling delta-8 THC products.

According to the administration, the products were illegally marketed as unapproved treatments for various medical conditions.

The letters are the first the FDA has ever issued regarding delta-8 THC. The popular form of THC has been a concern of the FDA’s since last September, when the administration published a notice warning about its dangers.

“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide,” FDA Principal Deputy Commissioner Janet Woodcock said in a statement following the issuing of the five letters.

“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,” she continued.

“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 five companies issued delta-8 warnings were:

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

The companies have 15 working days to explain in writing how they will “address these violations and prevent their recurrence”. Failure to comply could result in legal action, including product seizures.

Delta-8 THC has a slightly different molecular structure to its more famous relative, delta-9 THC (commonly known as THC), which helped it initially evade many of the rules and restrictions that govern the sale THC in the US. Yet delta-8 can still induce highs comparable to its more prohibited cousin.

Naturally, then, the US has experienced a boom of delta-8 THC popularity over the two years, much to the concern of industry analysts. Given the often clandestine way the compound is produced, many cannabis chemists and industry regulators have argued that delta-8 products pose a health risk to consumers, especially minors.

 

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