SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) issued its first warning letters to companies selling products made with delta-8 tetrahydrocannabinol (THC).
The companies the FDA warned on May 4 were: ATLRx Inc., Alpharetta, Ga.; BioMD Plus LLC, Marietta, Ga.; Delta 8 Hemp, Los Angeles; Kingdom Harvest, Hendersonville, N.C.; and M Six Labs Inc., Saukville, Wis. More information on each, along with warning letters for other CBD-related products, can be found on the FDA’s website.
The warning letters address the illegal marketing of unapproved delta-8 THC products by companies as unapproved treatments for various medical conditions or for other therapeutic uses. The letters also cite violations related to drug misbranding and the addition of delta-8 THC in foods such as gummies, chocolate, caramels, chewing gum and peanut brittle.
“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.
Some of the delta-8 THC food products are also packaged and labeled in ways that appeal to children, Woodcock said.
Delta-8 THC is one of more than 100 cannabinoids produced in the cannabis sativa plant, but is not found naturally in significant amounts, according to the FDA. Concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD) and have psychoactive and intoxicating effects. Products containing delta-8 THC can come in a variety of forms including candy, cookies, gummies, vape cartridges, smokeable hemp and more.
There are no FDA-approved drugs containing delta-8 THC, and the agency has not evaluated whether these drugs are effective for the uses manufactures claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products or whether they have dangerous side effects or other safety concerns, the agency said.
“The FDA has received adverse event reports involving products containing delta-8 THC from consumers, healthcare practitioners and law enforcement, some of which resulted in the need for hospitalization or emergency room treatment. The agency is also aware of an increasing number of exposure cases involving products containing delta-8 THC received by national poison control centers and alerts issued by state poison control centers describing safety concerns and adverse events with products containing delta-8 THC,” the FDA said.
The agency has also sent warning letters to other companies illegally selling unapproved CBD products that claimed to treat or prevent various disease. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy.
The FDA requested written responses from the companies within 15 working days stating how they will address the violations and prevent their recurrence. Failure to do so could result in legal action, the agency said.
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