The U.S. Food and Drug Administration 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 Act (FD&C Act). This action is a continuation 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 of Washington state 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. 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.
• Homero Corp DBA Natures CBD Oil Distribution of New Hampshire 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.
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.
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 human or animal drug approval processes. Consumers may also put off getting important medical care, such as proper diagnosis, treatment and supportive care due to unsubstantiated claims associated with CBD products. For that reason, it’s important that consumers talk to a health care professional about the best way to treat diseases or conditions with existing, approved treatment options.
In March, the FDA provided updates on its work related to CBD products with a focus on protecting public health and providing market clarity. The FDA continues to be concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD “can’t hurt.” The FDA remains focused on educating the public about the number of questions that remain regarding CBD’s safety. There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.
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.
