FDA Letters, Lawsuits Meet the First Generation of CBD Products

Dec. 23, 2019
Without FDA approval of cannabidiol, class-action lawyers are busy filing suits.

If you thought the growing ubiquity of cannabidiol (CBD) gave you license to start making food products with the stuff, think again. If you’re already making CBD-laced gummies or other products, you might want to hire a lawyer.

It’s the Wild West, all right, but in rode the marshal late last year, and not far behind him came the civil lawyers.

The FDA issued warning letters at the end of November to 15 companies for selling products containing CBD. The agency also explicitly stated it is not ready to proclaim CBD “generally recognized as safe” (GRAS). At least not yet.

The agency’s warning letters said the companies were violating the Food, Drug & Cosmetic Act (FDCA). While all appeared to deal primarily in oils and tinctures, all but one also offered some type of human or pet food. Gummies far and away were the most popular food category, with many of the companies offering dog treats, a handful selling other human snacks and one specializing in peanut butter, tea and banana chips.

The companies are: Koi CBD LLC of Norwalk, Calif.; Pink Collections Inc. of Beverly Hills, Calif.; Noli Oil of Southlake, Texas; Natural Native LLC of Norman, Okla.; Whole Leaf Organics LLC of Sherman Oaks, Calif.; Infinite CBD of Lakewood, Colo.; Apex Hemp Oil LLC of Redmond, Ore.; Bella Rose Labs of Brooklyn, N.Y.; Sunflora Inc./Your CBD Store of Tampa, Fla., and Bradenton, Fla.; Healthy Hemp Strategies LLC/Curapure of Concord, Calif.; Private I Salon LLC of Charlotte, N.C.; Organix Industries Inc./Plant Organix of San Bernardino, Calif.; Red Pill Medical Inc. of Phoenix; Sabai Ventures Ltd. of Los Angeles; and Daddy Burt LLC/Daddy Burt Hemp Co. of Lexington, Ky.

“FDA said the warnings were for marketing CBD products in interstate commerce through product webpages, online stores and social media including ways to use them to treat diseases or for other therapeutic uses for humans and/or animals; for marketing CBD products as dietary supplements; and for adding CBD to human and animal foods,” explained food safety and regulatory consultancy The Acheson Group (TAG).

Normally TAG’s URL is, but for topics relating to CBD and other marijuana components – a growing part of their business – they use the playful URL

“Soon after the issuance of FDA’s announcement, the litigation began – and has continued to grow since,” says TAG. “It started with class-action suits against two major CBD companies in California and has hit at least six altogether.”

The Perkins Coie law firm warned, “Manufacturers of CBD products should be aware of the likelihood of increased litigation, especially class actions, resulting from the FDA’s recent actions.

“Consumer class actions are often intertwined with government enforcement activity and proclamations,” the law firm continues. For a number of reasons, those are not likely at the federal level, but “experience from other FDA-regulated industries, particularly food, suggests that state attorneys general and private citizens might use state [consumer protection] laws as a vehicle for class actions against such companies.”

The FDA announced Nov. 25 that it “cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.” The agency cited concerns about potential liver injury, interactions with other drugs, drowsiness, diarrhea and changes in mood. The FDA indicated it will continue to consider CBD a form of medicine and, as such, will not give blanket permission for it to be used in foods and beverages.

As a result, market analysts quickly lowered their predictions for the size of the CBD market and stock prices of companies in the category tumbled.

But the FDA has not shut the door on CBD. In the same Nov. 25 announcement, the agency noted, “Today’s actions come as the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. This includes ongoing work to obtain and evaluate information to address outstanding questions related to the safety of CBD products, while maintaining the agency’s rigorous public health standards.”

The agency also promised an update on its progress regarding the agency’s approach to these products in the coming weeks.

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