WASHINGTON — The US Food and Drug Administration sent warning letters dated May 4 to five companies that sell products containing cannabidiol (CBD) and delta-8 tetrahydrocannabinol (delta-8 THC). All the letters said the companies’ products were unapproved new drugs sold in violation of the Federal Food, Drug, and Cosmetic Act.
The products ranged from chocolate, honey and coffee in the food and beverage space to gummies, tinctures and capsules in the dietary supplement space to salves, lotions and hand sanitizers in the personal care space. Several pet products, including CBD pet oil tincture and CBD pet treats, were found in violation of the Federal Food, Drug, and Cosmetic Act as well.
Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers, according to the FDA. Delta-8 THC is one of over 100 cannabinoids produced in the Cannabis sativa L. plant although it is not found in significant amounts. Concentrated amounts of delta-8 THC typically are manufactured from hemp-derived CBD, according to the FDA.
The warning letters address the illegal marketing of unapproved delta-8 THC products by companies as unapproved treatments for various medical conditions or other therapeutic uses.
“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide,” said Janet Woodcock, MD, principal deputy commissioner for the FDA. “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.
“It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. 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 psychoactive compound in marijuana is delta-9 tetrahydrocannabinol, according to the Agriculture Improvement Act of 2018, also known as the farm bill, which legalized the commercial farming of hemp in the United States. Cannabis sativa L. plants with less than 0.3% THC are classified as hemp. Over 0.3% classifies the plants as marijuana. CBD is found in both hemp and marijuana, but the FDA does not allow it in food, beverages or dietary supplements because CBD is an active ingredient in Epidiolex, an FDA-approved drug.
The FDA in its warning letter to ATLRx, Alpharetta, Ga., said the products Delta 8 terpene gummies, Delta 8 chocolate, Delta 8 THC caramels, Delta 8 gummies, Delta 8 THC soft gel capsules, CBD sleep gummies, CBD gummies, CBD capsules, Delta 8 THC tincture, CBD oil tincture, CBD salve, CBD topical full-spectrum lotion and CBD lavender-scented hand sanitizer were being sold as unapproved new drugs as were CBD pet oil tincture and CBD pet treats.
BioMD Plus LLC, Marietta, Ga., received a warning letter for its CBD oil, CBD capsules, vegan CBD gummies, CBD pain relief cream, Delta 8 THC gummies and Delta 8 THC vape cartridge as well as pet CBD oil.
Delta 8 Hemp, Los Angeles, received a warning letter for its Delta 8 THC distillate oil, Delta 8 THC vape cartridge, Delta 8 THC disposable vape pen, Delta 8 THC tincture, Delta 8-infused gummies and Delta-8 infused sour gummies.
Kingdom Harvest, Hendersonville, NC, received a warning letter for its D8 sublingual oil, Delta 8 disposable vape cartridge, whole-spectrum hemp extract, CBD vape, blood sugar support, CBD gummies, Stella’s Baby Care diaper cream, pain-relieving CBD cream, pain-relieving cream, CBD and menthol pain freeze roll-on, immune boost water soluble mix, broad-spectrum THC-free organic honey, CBD fair trade coffee, CBD-infused organic tea, Delta 8 chewing gum, Delta 8 gummies and Delta 8 peanut brittle.M Six Labs, Inc., Saukville, Wis., received a warning letter for its Silver Lake Delta 8 uncut glass dab syringe, Silver Lake CBD MCT oil tincture, Magnolia Botanicals CBD avocado oil tincture, Chaz Ortiz CBD 500-mg essential balm, Magnolia Botanicals CBD 500-mg balm stick, Silver Lake CBD vegan chew, Nobel Hemp CBD Snapping Rocks, Nobel Hemp CBD chews, Nobel Hemp Delta 8 vegan gummy, Silver Lake Delta 8 atomic crystals, Silver Lake Delta 8 tincture, Silver Lake Delta 8-infused sugar, Silver Lake vegan chews Delta 8, Magnolia Botanicals CBD Canna Rocks Popping Candy, Magnolia Botanicals vegan hemp chews and Silver Lake CBD-infused sugar. The warning letter also applied to the company’s Magnolia Botanicals MB pet hemp oil, Nobel Hemp pet comfort tincture and Silver Lake pet comfort tincture.