FDA Warning Letters for Products Containing CBD and Delta-8 THC

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5/6 June 2024

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The U.S. Food and Drug Administration (FDA) issued several Warning Letters to companies for illegally selling cannabidiol (CBD) products and products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC). Violations include the marketing of unapproved new drugs, misbranding, and adding delta-8 THC to food products. It is the first time the FDA has issued Warning Letters for products containing delta-8 THC. According to the FDA, delta-8 THC "has psychoactive and intoxicating effects and may be dangerous to consumers" (see also: USP Cannabis Expert Panel statement on delta-8 THC published on USP´s "Cannabis for medical use" website). Moreover, the agency has received reports of adverse events experienced by patients who have consumed these products.

The FDA previously already sent Warning Letters to other companies illegally selling unapproved CBD products that claimed to diagnose, cure, mitigate, treat or prevent various diseases.

Warning Letters to companies for selling products labeled as containing delta-8 THC

The agency issued Warning Letters to five companies for selling products labeled as containing delta-8 THC. Currently, there are no FDA-approved drugs containing delta-8 THC. Thus, any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered to be an unapproved new drug.

Delta-8 THC is one of over 100 cannabinoids produced in Cannabis sativa L. but is not found naturally in significant amounts. According to the agency, "concentrated amounts of delta-8 THC are typically manufactured from hemp-derived CBD and have psychoactive and intoxicating effects". The FDA warning letters address the illegal marketing of unapproved delta-8 THC products as unapproved treatments for various medical conditions / therapeutic uses. The letters also cite violations related to the addition of delta-8 THC in foods, like chocolate, caramels, chewing gum, and peanut brittle.

The FDA and the USP recently published updates expressing serious concerns about the potential health effects of delta-8 THC products.