Two companies selling unapproved cannabidiol (CBD) products including for the treatment of opioid addiction, have been handed warning letters from the FDA.
The US Food and Drug Administration (FDA) has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic (FD&C) Act.
This action is part of the FDA’s efforts to pursue companies that illegally market CBD products with claims that they can treat medical conditions including opioid addiction or as an alternative to opioids.
The two warning letters were issued to:
- BIOTA Biosciences, LLC for marketing and distributing injectable CBD products as well as an injectable curcumin product. These products are marketed for serious diseases and as an alternative to opioids.
- Homero Corp DBA Natures CBD Oil Distribution for marketing and distributing CBD products as a treatment to opioid addiction as well as other serious diseases. The firm is an own label distributor for CBD products as well as a retailer for Green Roads CBD products.
“The opioid crisis continues to be a serious problem in the US 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 Dr Amy Abernethy. “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 health care provider.”
Unlike drugs approved by the FDA, there has been no FDA evaluation of whether these unapproved products are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or whether they have dangerous side effects or other safety concerns. In addition, the manufacturing process of unapproved CBD drug products has not been subject to FDA review as part of the approval processes.
The FDA has requested responses from the companies within 15 working days stating how they will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.