The U.S. Food and Drug Administration (FDA) has directed warning letters to two companies for illicit sale of unapproved products containing CBD. The accusation is that the companies are marketing them in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). 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. The FDA has not approved any CBD products other than GW Pharmaceuticals’ Epidiolex to treat rare, severe forms of epilepsy.
The FDA argues that BIOTA Biosciences and Natures CBD Oil Distribution claim their CBD products represent a viable option to treat opioid addiction. The FDA requested both entities to present responses within 15 working days where they will clarify how they will mend the violations. Were the companies to fail in implementing corrections, the government agency would take legal measures, including product seizure and/or injunction.
The two warning letters went out to:
Specifically, the FDA underlines that Natures CBD website affirmed that its product “Has had success in alleviating severe withdrawal symptoms associated with opiate dependency […], restoring the person back to a quality of life worth living.” “Natures Pure CBD oil works for these medications which all have addictive properties to them: opium, fentanyl, heroin, hydrocodone, oxycodone, methadone, morphine and hydromorphone. Natures Pure CBD Oil has been effective in the treatment and eradication of opiate use.”
As for BIOTA, the FDA pointed out claims on the website like “CBD . . . and its ability to suppress pain and aid in the detoxification processes has highlighted it as a promising therapeutic for a wide array of disorders such as epilepsy, […]. When patients consider trying a new therapeutic like CBD, there are many options for delivery that can be more efficacious to the patient. One delivery option is BIOTA CBD Sterile Vial Therapy.” “Instant relief for patients that are symptomatic of inflammatory auto-immune diseases”.
Although anecdotal evidence exists of THC being a potential solution to curb opioid addicts’ habits to a less dangerous level of consumption, there is no proof backing it as a medically safe alternative, nor did they undergo the FDA evaluation required to introduce the product to the market and legally promote it by means of the aforementioned claims.
Additionally, in the statement issued by the FDA on its website, Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., points out how “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.” She then added that there is no medical evidence of CBD effectiveness 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 marketed in violation of the law.”