The U.S. Food and Drug Administration (FDA) has sent warning letters to two companies operating in the CBD space for violating the Federal Food, Drug and Cosmetic Act (FD&C Act), according to a news release from the agency.
The FDA said in the release that it sent a warning letter to BIOTA Biosciences, LLC “for marketing and distributing injectable CBD products as well as an injectable curcumin product.” The company claimed that its products could be used as an alternative to opioids and also marketed its products “for serious diseases,” according to the FDA.
The agency also issued a warning letter to Homero Corp, doing business as Natures CBD Oil Distribution, “for marketing and distributing CBD products as a treatment to opioid addiction as well as other diseases.”
“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 FDA Principal Deputy Commissioner Amy Abernethy in a prepared statement. “CBD has not been shown to treat opioid addiction.”
The FDA has approved only one CBD product, Epidiolex, and has not evaluated the efficacy, dosage, side effects nor safety concerns relating to any unapproved CBD products, according to the release.
The companies have 15 days to respond to the FDA with a statement of how they will address the violations.
“Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction,” the release stated.