Koi CBD, LLC has been hit with a proposed class action in which two consumers allege the California company’s products are illegal given their “prominent systematic” mislabeling for purposes unapproved by the federal Food and Drug Administration.
According to the 42-page complaint, Koi was one of 15 CBD sellers on the receiving end of November 2019 FDA warning letters concerning what the agency described as violations of the federal Food, Drug, and Cosmetic Act. According to the FDA, Koi was among 14 other companies chided for “marketing unapproved new human and animal drugs,” labeling their CBD products as dietary supplements and adding cannabidiol to human and animal foods. The defendant, the FDA stated, used product webpages, online stores and social media to tout its CBD as able to “treat diseases or for other therapeutic uses.”
The lawsuit claims Koi’s CBD healing balm, vape oil, lotion, gummies, pet spray and soft chew products are illegal in that they’re marketed and advertised in contrivance to FDA guidelines. Koi, for instance, cannot legally label its infused CBD shot as a dietary supplement given that the FDA has excluded CBD products from federal dietary supplement guidelines based on available evidence, the suit says. Moreover, Koi’s healing balm, vape oil, lotion and gummies are illegal because, according to the plaintiffs, the company positions the products as “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” The case stresses that new drugs “may not be legally introduced or delivered for introduction into interstate commerce” without FDA approval.
Further still, the lawsuit charges the defendant’s products fail to display on their labeling adequate directions for use, and are misbranded as adulterated human foods considered unsafe under the Food, Drug, and Cosmetic Act.
“There is no food additive regulation which authorizes the use of CBD,” the complaint reads. “The FDA is not aware of any information to indicate that CBD is the subject of a prior sanction.”
Consumers would not have purchased—or would have paid less for—the defendant’s CBD products had they known the products were mislabeled under federal law, the suit claims.