FDA’s CBD Enforcement Continues

Seth Goldberg
Seth A. Goldberg

On April 20, the FDA issued warning letters to two CBD companies – BIOTA Biosciences and Homero Corp., dba Natures CBD Oil Distribution – directing them to remove statements from their labeling and advertising on websites and social media claiming that CBD can cure opioid addiction among other illnesses.   I am attaching the FDA’s warning letter, as it provides very useful information to the market as to the FDA’s current views of CBD products.  As set forth in the warning letter, the FDA continues to view CBD as (1) an unsafe food additive; (2) not satisfying the definition of a “dietary supplement,” and (3) as unapproved new drugs if marketed as “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.”  In the case of Homero, the CBD products were advertised with the following claims, among others:

  • “Natures Pure CBD Oil has been effective in the treatment and eradication of opiate use.”
  • “CBD Oil Inhibits the reward-facilitating effect of morphine”
  • “Vaping CBD Oil to Treat Asthma . . . Your best best [sic] to combat Asthma is by vaping CBD Oil.”
  • “Natures Pure CBD is a strong anti-oxidant that can alleviate lower epileptic seizures, psychotic disorders, and has neuroprotective qualities.”