The Food and Drug Administration (FDA) sent letters to four CBD companies warning them against selling unauthorized CBD products for use in food-producing animals. Companies being warned are Haniel Concepts (doing business as Free State Oils), Hope Botanicals, Plantacea LLC (doing business as Kahm CBD) and Kingdom Harvest.
The agency made clear that it is trying to keep animals and their food safe, considering that so far it has not authorized any human or animal products with CBD. The only cannabis-derived substance approved by the FDA is Epidiolex, a prescription drug that treats rare and severe forms of epilepsy in children, made by Jazz Pharma (NASDAQ:JAZZ). All other CBD products intended for use as a drug (to treat a disease or otherwise have a therapeutic use or affect functions of the body of humans or animals) are unauthorized and illegal.
Some of the four companies claimed their products help “farm animals with stress, anxiety, pain, inflammation, injuries.”
FDA Response
“Unapproved drugs like these CBD products have not been evaluated by the FDA to determine whether they are effective for their intended use, what the proper dosage might be, how the products could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns,” the agency said in a press release.
It further stressed concern about the safety of food products such as meat, eggs, and milk from the animals that have consumed CBD products.
The FDA provided these companies with 15 working days to respond and explain how they plan to correct the violations and prevent repeating them. Companies that don’t comply could be legally prosecuted.
FDA & CBD Companies: Complicated History
The censure comes on the heels of an initial FDA warning to five companies for selling products containing delta-8 THC in violation of the Federal Food, Drug, and Cosmetic Act. The letters were issued several weeks prior to an Appeals Court ruling that delta-8 THC is federally legal under the 2018 Farm Bill.
Earlier this year, the FDA also warns CBD companies to stop claiming their products can treat COVID-19. In November, the FDA also warned some 15 companies to stop selling illegal CBD products.
While there is a growing body of research that demonstrates the many health benefits of CBD, almost everyone agrees that more studies are needed. Until that happens and we have enough evidence in our hands, will CBD companies stop the hype or will the FDA continue to intervene? I guess we’ll see, although it’s hard to imagine warnings will be enough to curtail the misinformation.
Photo: Courtesy of Thomas Iversen on Unsplash
