WASHINGTON — The U.S. Food and Drug Administration (FDA) has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that allegedly violate the Federal Food, Drug and Cosmetic Act (FD&C Act), the agency said.
The agency said it intends to pursue companies that “illegally market CBD products with claims that they can treat medical conditions,” which includes opioid addiction, or that offer CBD products as an alternative to opioids.
“The opioid crisis continues to be a serious problem in the United States, and we will continue to crack down on companies that attempt to benefit from selling products with unfounded treatment claims,” said Amy Abernethy, principal deputy commissioner of the FDA. “CBD has not been shown to treat opioid addiction. Opioid addiction is a real problem in our country, and those who are addicted need to seek out proper treatment from a healthcare provider. There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD, and we will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law.”
The two warning letters were issued to:
- BIOTA Biosciences LLC, Seattle, for allegedly marketing and distributing injectable CBD products as well as an injectable curcumin product. These products are allegedly marketed for diseases and as an alternative to opioids. BIOTA Biosciences markets private-label CBD and wholesale CBD extracts, and their products include beverages, bulk CBD extracts and water-soluble CBD, as well as injectable curcumin, the FDA said.
- Homero Corp., Manchester, N.H., doing business as Natures CBD Oil Distribution of New Hampshire, for allegedly marketing and distributing CBD products as a treatment to opioid addiction as well as other diseases, the FDA said. The firm is a distributor of CBD products as well as a retailer for Green Roads CBD products.
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 humans or animals, is a drug, the agency said. The FDA said it has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy.