FDA issues warnings to 2 companies marketing CBD as opioid alternatives

4/28/2020

The Food and Drug Administration has sent warning letters to two companies it said were marketing products in a way that violates the Food, Drug, and Cosmetic Act. The agency said the action was part of its work to go after companies illegally marketing CBD products with claims that they can treat medical conditions, among them opioid addiction.

"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 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. 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."

Biota Biosciences, based in Washington state, was issued a warning letter for marketing and distributing injectable CBD products, as well as an injectable curcumin product, as an alternative to opioids. The company, which also makes private-label CBD and wholesale CBD extracts, also sells beverages, bulk CBD extracts and water-soluble CBD.

The agency also issued a warning letter to Homero, doing business as Natures CBD Oil Distribution. The New Hampshire-based company was cited for marketing and distributing CBD products as a treatment for opioid addiction, among other diseases. The company is a retailer for Green Roads CBD products and an own-label distributor for CBD products.

The companies have 15 working days to provide a response to the FDA stating how they plan to correct the violations. The FDA said failure to correct the violations promptly could lead to legal action, including product seizure and injunction.