On May 4th, 2022, the FDA issued warning letters to five companies for selling CBD and other products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC). Some of the products, including capsules, tinctures, gummies, and topical creams, use CBD in the product name, but also list delta-8 THC on the label.

Both CDB and THC are compounds derived from hemp, but CBD is not believed to have psychoactive properties. THC is known to have psychoactive and intoxicating effects, and, the FDA has warned consumers, is associated with certain health risks and adverse effects such as confusion, dizziness, vomiting, and hallucinations.

(See ConsumerLab’s Review of CBD & Hemp Extract Supplements, Lotions, and Balms for more about the differences between CBD and THC, and our tests of CBD products).

According to the FDA’s news release about the warnings, “CBD and delta-8 THC are unapproved food additives for use in any human or animal food product, as the FDA is not aware of any basis to conclude that the substances are generally recognized as safe (GRAS) or otherwise exempt from food additive requirements.” The agency also noted that it has not approved delta-8 THC as an ingredient in any drugs. It has approved one CDB product, Epidiolex, to treat rare, severe forms of epilepsy, but this product requires a prescription.

They were promoted to prevent and/or treat conditions. To read the full warning letter issued to each company, use the links below.

• ATLRx Inc., (Delta 8 THC Caramels, Delta 8 Gummies, and other products)
• BioMD Plus LLC (CBD Capsules, CBD Pain Relief Cream, and other products)
• Delta 8 Hemp (Delta 8 THC Vape Cartridge, Delta 8 THC Disposable Vape Pen, Delta 8 Infused Sour Gummies and other products)
• Kingdom Harvest LLC (Delta 8 Chewing Gum, Delta 8 Peanut Brittle, and other products)
• M Six Labs Inc. (Magnolia Botanicals CBD Avocado Oil Tincture, Nobel Hemp CBD Snapping Rocks, Silver Lake Delta 8 Atomic Crystals, and other products)

The companies must respond to the FDA in writing within 15 working days of receipt of the warnings stating how they will address any violations.

For more information use the link below.

FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products

See related recalls and warnings:

FDA Warns Seller of Magnesium, CBD, Herbal Extracts & More

CBD Products Were Promoted to Treat Cancer and Alzheimer's Without Proof, Says FTC

Maker of Care by Design CBD Settles Charges of Unsupported Claims

CBD Seller Warned for Drug and COVID-19 Claims

FTC Takes Further Action Against Deceptive CBD Claims