September 22, 2020

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September 21, 2020

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Putative Class Action Alleges Company’s CBD Products for Humans and Animals Violate Federal Law

  • As our readers may recall, on November 25, FDA issued warning letters to 15 companies for illegally selling a variety of FDA-regulated products (for humans and animals) containing cannabidiol (CBD), in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA emphasized that CBD lacks an appropriate regulatory status for use in these products, and in some cases they bear impermissible drug claims, thereby rendering them unapproved new drugs that are also deemed misbranded and adulterated.

  • FDA sent a warning letter to, among others, Koi CBD LLC (Koi), referencing products such as balms, vape oils, tinctures, lotions, gummies, and beverage shots (for humans), and pet sprays and soft chews (for pets). FDA cited claims on the company’s website that CBD could be used to treat diseases and medical conditions such as various cancers, diabetes, multiple sclerosis, post-traumatic stress disorder, schizophrenia, opioid addiction, and Crohn’s Disease.

  • On December 5, 2019, plaintiffs Calley Fausett and Leigh Good filed a putative class action complaint against Koi in California federal court (Central District), alleging the company intentionally marketed and sold illegal products containing CBD. Among other things, plaintiffs allege the marketing and sale of these products constitute false, deceptive, and misleading practices and advertising; that plaintiffs would not have purchased the products (or would have paid less) had they been fully informed; and that the products lack adequate directions for use. The lawsuit is one of a growing number of private actions filed as a result of FDA’s recent warning letters that allege the use of CBD as an ingredient runs afoul of federal regulations. We will continue to monitor this case as well as other CBD-related lawsuits and regulatory actions.

© 2020 Keller and Heckman LLPNational Law Review, Volume IX, Number 347


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...