Fifteen companies recently received warning letters from the U.S. Food and Drug Administration (FDA) for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). The warnings include marketing CBD products to treat diseases or for other therapeutic uses for animals and/or humans.
Of the 15 warning letters issued, 13 included products for animals, wrote Bill Bookout, president of the National Animal Supplement Council (NASC), in a letter to the industry.
"Someone asked me, ‘Is FDA now including structure/function claims in the actions?’ Yes, but you will note that in each case there are egregious claims in violation involving ‘diagnose, prevent, treat and/or cure’ (overt or implied) and when FDA takes action, they will cite all violations," Bookout said.
The companies marketing pet products that received letters are:
- KOI CBD of Norwalk, Calif., which sells KOI Naturals CBD Spray for Pets
- Mr. Pink Collections of Beverly Hills, Calif., which makes Mr. Pink Natural CBD Oil for Pets, (also referred to as Vegan Bacon Flavored Pet CBD Oil)
- Noli Oil of Southlake, Texas, which sells Dog Treats (Beef Flavored) and Pet CBD Oil
- Natural Native of Norman, Okla., which makes Native Pet CBD Oil (150mg, 300mg, & 600mg)
- Apex Hemp Oil of Redmond, Ore., which sells Apex CBD Livestock Pellets, Apex Organic K9 Oil and Apex CBD Dog Treats
- Sunflora, Inc. of Tampa, Fla.,/The CBD Store, LLC dba Your CBD Store of Bradenton, Fla., which makes SunMed Bacon Dog Treats, SunMed Pet Bark Bits Beef, SunMed Dog Lamb Bits and SunMed Pet Tincture
- Private I Salon of Charlotte, N.C., which sells Natural Flavor Pet Drops and CBD Pet Treats
- Organix Industries, Inc. dba Plant Organix of San Bernardino, Calif., which makes Hemp Pet Tinctures and Hemp Pet Treats
- Red Pill Medical Inc. of Phoenix, which makes Red Pill CBD Pet
- Sabai Ventures Ltd of Los Angeles, which sells Pets Tincture, and Chill Chews Soft Chews for Dogs
- Daddy Burt Hemp Co., of Lexington, Ky., which makes CBD Oil for Pets (250 mg Bacon Flavor)
- Whole Leaf Organics LLC of Sherman Oaks, Calif., which makes CBD-Ex, CBD-Max (100 mg), CBD-Rx, CBD Defend and CBD Enflame
- Infinite Product Co. LLLP dba Infinite CBD of Lakewood, Colo., which sells Pet Droppers and Launch Pad
Under the FD&C Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of animals or humans, is a drug. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy, officials noted.
Other violations as outlined in the FDA’s warning letters include marketing CBD products as dietary supplements and adding CBD to human and animal foods.
The FDA has requested responses from the companies stating how the companies will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction, officials said.
"I know there are many companies trying to act responsibly and pave a reasonable, fair and responsible pathway," Bookout said. "It is unfortunate that a few bad actors cause the industry to be painted with a broad brush. Each of our members knows NASC is trying to positively contribute to a responsible outcome."
In related news, FDA officials said that they cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food. A revised Consumer Update detailing safety concerns about CBD products can be found here.