WASHINGTON — The U.S. 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 of the letters stated that the companies’ products were unapproved new drugs sold in violation of the federal Food, Drug, and Cosmetic Act.
Products ranged from chocolate, honey, and coffee in the food and beverage space to gummies, tinctures, and capsules in the dietary supplements space to ointments, lotions, and hand sanitizers in the personal care space. Several pet products, including CBD pet oil tincture and CBD pet treats, have also been found to violate federal food, drug, and cosmetic law.
According to the FDA, delta-8 THC has psychoactive and intoxicating effects and may be dangerous for consumers. Delta-8 THC is one of over 100 cannabinoids produced in the Cannabis sativa L. plant although it is not found in significant quantities. According to the FDA, concentrated amounts of delta-8 THC are typically made from hemp-derived CBD.
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 sold online and in stores nationwide,” said Janet Woodcock, MD, senior deputy commissioner of the FDA. “These products often include claims that they treat or reduce side effects related to a wide variety of diseases or medical conditions, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety.
“It is extremely disturbing that some food products are packaged and labeled in a way that appeals to children. We will continue to protect the health and safety of Americans 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 cultivation of hemp in the United States. Cannabis sativa L. plants with less than 0.3% THC are classified as hemp. More than 0.3% classify the plants as marijuana. CBD is found in both hemp and marijuana, but the FDA does not allow it in foods, 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, Georgia, stated that the products Delta 8 Terpene Gummies, Delta 8 Chocolate, Delta 8 THC Toffees, Delta 8 Gummies, Delta 8 THC Softgels, CBD Sleep Gummies , CBD gummies, CBD capsules, Delta 8 THC tincture, CBD oil tincture, CBD ointment, CBD full-spectrum topical lotion, and CBD lavender-scented hand sanitizer were sold as new drugs unapproved, just like CBD oil tincture for pets and CBD treats for pets.
BioMD Plus LLC, Marietta, Georgia, has received a warning letter for its CBD Oil, CBD Capsules, Vegan CBD Gummies, CBD Pain Cream, Delta 8 THC Gummies and Delta 8 THC Vape Cartridge as well as its CBD oil for pets.
Delta 8 Hemp, Los Angeles, has received a warning letter for its Delta 8 THC Distilled Oil, Delta 8 THC Vape Cartridge, Delta 8 THC Disposable Vape Pen, Delta 8 THC Tincture, Delta 8 Infused Gummies and Delta-8 infused tangy gummies.
Kingdom Harvest, Hendersonville, NC, has received a warning letter for its D8 Sublingual Oil, Delta 8 Disposable Vape Cartridge, Full Spectrum Hemp Extract, CBD Vape, Blood Sugar Support, Gummies CBD, Stella’s Baby Care Diaper Cream, CBD Pain Relief Cream, Pain Relief Cream, CBD & Menthol Pain Relief Roll-On, Immune Boosting Water Soluble Blend, THC-Free Organic Broad Spectrum Honey , Fair Trade CBD Coffee, Organic CBD Infused Tea, Delta 8 Chewing Gum, Delta 8 Gums, and Delta 8 Peanut Crunch.
M Six Labs, Inc., Saukville, Wis., has received a warning letter for its Silver Lake Delta 8 Uncut Glass Syringe, Silver Lake CBD MCT Oil Tincture, Avocado Magnolia Oil Tincture Botanicals CBD, Chaz Ortiz CBD Essential Balm 500mg, Magnolia Botanicals CBD Balm Stick 500mg, Silver Lake CBD Vegan Chewing Gum, Snapping CBD Nobel Hemp Rocks, Nobel Hemp CBD Chewing Gum, Nobel Hemp Delta 8 Vegan Gum, Crystals Atomic Silver Lake Delta 8, Silver Lake Delta 8 Tincture, Silver Lake Delta 8 -Infused Sugar, Silver Lake Delta 8 Vegan Chews, Magnolia Botanicals CBD Canna Rocks Popping Candy, Magnolia Botanicals Hemp Vegan Chews, and CBD Infused Sugar Silver Lake. The warning letter also applied to Magnolia Botanicals MB Pet Hemp Oil, Nobel Hemp Pet Comfort Tincture and Silver Lake Pet Comfort Tincture.