As state and federal governments across the country continue to deal with the novel coronavirus known as COVID-19, with the latest figures showing nearly 3 million infections and 200,000 deaths worldwide, other public health issues struggle to remain visible in the public eye. Last year, for example, the United States experienced another record-breaking year for overdose deaths, even though the number had fallen for the first time in almost two decades. But even with 67,000 fatalities and drugs like fentanyl poisoning the street supply, all available resources have been shifted to the current crisis.
Unfortunately, when such a vacuum arises, bad actors will inevitably come in to fill the void. Earlier this week, the Food and Drug Administration sent out warning letters to two CBD companies for violating the Federal Food, Drug, and Cosmetic Act. According to a statement put out by the agency, BIOTA Biosciences, LLC of Washington state and Homero Corp DBA Natures CBD Oil Distribution of New Hampshire marketed their CBD products with the claims that they could either treat opioid use disorder or be used as a replacement for opioids, neither of which is true.
According to the FDA, BIOTA Bioscience put an injectable CBD product on the market, claiming it could be used as an alternative to opioid medications. Homero, on the other hand, sold products under the pretense that they could treat opioid use disorder and “other serious diseases.”
“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, M.D., Ph.D. 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.”
As the FDA has noted on several occasions, under the FD&C Act, products designed to treat diseases or other medical ailments are deemed a drug by the agency. They must follow the rigorous testing procedures needed to be approved as such. To date, the only CBD drug approved for the market is GW Pharmaceutical’s Epidiolex, designated to treat two rare forms of childhood epilepsy.
Homero Corp claimed that its Natures Pure CBD Oil would provide relief from any number of opioid drugs. “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,” the company wrote on its website.
Moreover, the company made unsourced claims about life-saving drugs like Suboxone and methadone. “Suboxone has shown promise in relieving withdrawal symptoms, but there is a chance of dependency, and the length of time one has to be on them is uncertain and often leads to relapse,” the company wrote on its website. “Methadone known as the “green fog” on the street for the drug-induced state it produces, the user is often on it indefinitely.”
According to Harvard doctor Peter Grinspoon, and many more in the recovery community these statements are much more myth than fact.
To date, there have been three classes of drugs approved by the FDA for opioid use disorder. They include methadone, naltrexone, and buprenorphine. Both methadone and buprenorphine are considered the gold standard when it comes to treating opioid use, as they have helped millions of people stop or reduce harmful use, giving them the ability to deal with any traumatic experiences that may have led to their drug use in the first place.
While early-stage trials testing the effectiveness of CBD on opioid use disorder have been performed with some moderate success, their results have been overhyped by many as well. CBD may hold promise, but at this point, it is way too early to tell.
“There are decades of evidence showing that buprenorphine and methadone are the gold standards of treatment for opioid use disorder and that while promising evidence is promising and exciting, in no way should that be seen as replacing or supplementing proven strategies and medications for these disorders,” Dr. Sheila Vakharia told The PotNetwork last year in a discussion about these early-stage trials.
The two companies were given 15 days by the FDA to explain how they will correct the issues.
Images: Bottles of pills, Natures CBD Oil website