On November 16, 2022, the FDA issued warning letters to five companies for selling products such as gummies, tea, cookies, lollipops, fruit snacks, hard candies, and pet treats containing cannabidiol (CBD) and/or delta-8 tetrahydrocannabinol (delta-8 THC) as conventional food products. The agency emphasized that CBD is not approved for use as a food additive, and expressed concern that many of the products are sold in forms that resemble conventional foods that may appeal to children, such as fruit snacks, lollipops and cookies.

CBD and THC are both derived from hemp, but CBD is not believed to have psychoactive properties. THC and delta-8 THC are known to have psychoactive and intoxicating effects, and, can cause adverse effects such as confusion, dizziness, vomiting, and hallucinations.

According to the FDA, “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.

(See ConsumerLab’s Review of CBD & Hemp Extract Supplements, Lotions, and Balms for more information and our tests of CBD products.)

Additionally, the agency warned companies for selling topical CBD products that were promoted with statements suggesting they could help prevent COVID-19, treat mood disorders, or provide sun protection. For example, CBD + ZINC OXIDE Sunscreen was promoted with the statement, “This cbd infused sunscreen is…rated to block UVA and UVB rays.”

To read the full warning letter issued to each company, use the links below.

• 11-11-11 Brands (Mood33 Hemp Infused Herbal Tea)
• Newhere Inc dba CBDFx (CBDFx Mixed Berry Gummies 1500mg, CBD Cookies with Protein 20mg, CBD Lemonade)
• CBD American Shaman, LLC (CBD Suckers, CBD Hard Candies, Soft & Tender Doggy Chews, Horsey Chews, Doggy Nugs, and Kitty Nugs)
• Naturally Infused LLC (CBD Lollipops, CBD Infused Sugar, CBD Gummies, CBD Infused coffees, D8 THC Infused coffees, and Delta-8 THC Gummies)
• Infusionz, LLC ( CBD gummies, CBD fruit snacks, CBD gum)

The companies must respond to the agency within 15 days of receipt of the letter outlining any steps to address any violations.

See related recalls and warnings:

Seller of CBD Warned for COVID-19 Claims

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

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

Seller of CBD Tinctures, Creams & Pet Products Promoted for Pain, Cancer & More Warned by FDA

FDA Warns Five Companies for Selling CBD Supplements, Gummies and Creams with Delta-8 THC