By: Carlos Schidlow* and Nabil Rodriguez, Esq.
On March 31, 2020, the FDA issued a warning letter to a CBD company using a particularly predatory marketing technique during the ongoing global heal crisis. Specifically, the claims identified by the FDA indicate that the CBD products in question cure or mitigate the novel virus, COVID-19. The company making these claims is Neuro XPF, which is owned by a former National Football League (NFL) player, Kyle Turley.
The warning letter states that “The FDA has determined that [the] website offers cannabidiol (CBD) products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people… these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). ” Thereby, the FDA asks the company to cease the sale of such unapproved and unauthorized products.
Some of the claims Neuro XPF made on their website that the FDA found problematic include stating that CBD will help strengthen your immune system and “[y]our best defense against the COVID-19 blitz starts with a strong immune system. ”
Turley has continuously touted the alleged benefits of both CBD and his products, from a series of tweets that include stating, “CBD CAN PREVENT AND CURE THE CORONA VIRUS !,” to a phone call with Marijuana Moment, where he mentioned “the immune system will kill the coronavirus if you give your immune system cannabis. It will boost it to its levels where it will kill the coronavirus .”
Turley is not afraid of regulatory enforcement. In fact, he seems to welcome it. In his interview with Marijuana Moment, Turley says “[p]lease shut my company down so I can have another blockbuster press release on how the FDA and the United States government is suppressing truth and information when we have study after study now being driven by major cannabis companies in getting clinical trials to prove what I’m saying is true. ”
Erik Aliteri, executive director of the National Organization for the Reform of Marijuana Laws (NORML), rebutted Turley’s in a statement to Marijuana Moment, “Marijuana and its components do not cure the coronavirus, to say the opposite just to put a few more bucks in your pocket is grotesque .” Thus, affirming that the broader cannabis industry does not condone reckless and unsubstantiated claims such as these.
Yesterday, Turley addressed the claims via Twitter by saying: “OK OK, YOURE ALL RIGHT, ILL ADMIT IT! CHEAP CBD BRAND PRODUCTS WILL NOT PREVENT OR CURE COVID19!… ”
Since 2015, the Food and Drug Administration (FDA) has issued over sixty-five (65) warning letters to companies that market unapproved new drugs allegedly containing CBD. Most common among all letters sent, the FDA shows a primary concern regarding the use of CBD products for medical and/or therapeutic benefits.
Until the FDA updates its guidance and provides regulatory pathways for the lawful marketing of products containing CBD, companies engaged in the sale of CBD products should tread cautiously before making any
If you have questions regarding how to market your CBD products to avoid enforcement action by the FDA or local regulatory authorities, please contact Greenspoon Marder’s Cannabis Law Group.
*Carlos Schidlow is not an attorney
