Companies in Washington state, New Hampshire threatened with seizure, injunction

The FDA issued warning letters to a pair of manufacturers for claiming that their unapproved cannabidiol (CBD) products can be used to treat opioid addiction or as an alternative to opioids, along with other medical conditions.

The first company, BIOTA Biosciences, LLC of Washington state, “markets private label CBD and wholesale CBD extracts,” the FDA explained, “and their products include beverages, bulk CBD extracts, and water soluble CBD, as well as injectable curcumin [a compound found in turmeric].” According to the agency, BIOTA marketed its “Cannabidiol (CBD) Complex,” “Cannabidiol+Curcumin,” and “Curcumin Complex” products for “serious diseases and as an alternative to opioids.”

The second company, Homero Corp DBA Natures CBD Oil Distribution of New Hampshire, which produces its own CBD products and serves as a retailer for CBD products from Green Roads, touted its CBD oils as a treatment for opioid addiction, as well as AIDS, Alzheimer’s disease, autism, cancer, diabetes, heart disease, kidney disease, liver disease, Parkinson’s disease, Prion/Mad Cow disease, traumatic brain injury, asthma, seizures, psychotic disorders, and rheumatoid arthritis.

The FDA gave both manufacturers 15 working days from the receipt of the warning letter to respond with plans on how they intend to correct these violations, threatening legal action — including product seizure and injunction — if they fail to comply.

“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, MD, PhD, in a statement. “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. 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 agency reiterated that, to date, only one CBD product has received FDA-approval. A prescription, oral CBD solution that is indicated to treat seizures associated two rare forms of epilepsy — Lennox-Gastaut syndrome and Dravet syndrome — gained FDA approval in June 2018.

“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 agency wrote. “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.”

John McKenna, Associate Editor, BreakingMED™

Cat ID: 144

Topic ID: 87,144,730,192,144,151,725