WASHINGTON — The U.S. Food and Drug Administration (FDA) has issued warning letters to 15 companies for illegally selling cannabidiol (CBD) products in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act).
According to the warning letters, these companies are marketing CBD products as remedies that treat diseases and for other therapeutic uses in humans and animals. Some have also marketed CBD products as dietary supplements and are adding CBD to human and animal foods, while others have marketed these products for infants and children.
Under the FD&C Act, CBD is an unapproved food additive and drug in all formats, aside from one prescription drug that treats epilepsy.
The companies receiving warning letters:
- Koi CBD LLC, Norwalk, Calif.
- Pink Collections Inc., Beverly Hills, Calif.
- Noli Oil, Southlake, Texas
- Natural Native LLC, Norman, Okla.
- Whole Leaf Organics LLC, Sherman Oaks, Calif.
- Infinite Product Company LLP, dba Infinite CBD, Lakewood, Colo.
- Apex Hemp Oil LLC, Redmond, Ore.
- Bella Rose Labs, New York
- Sunflora Inc., Tampa, Fla./Your CBD Store, Bradenton, Fla.
- Healthy Hemp Strategies LLC, dba Curapure, Concord, Calif.
- Private I Salon LLC, Charlotte, N.C.
- Organix Industries Inc., dba Plant Organix, San Bernardino, Calif.
- Red Pill Medical Inc., Phoenix
- Sabai Ventures Ltd., Los Angeles
- Daddy Burt LLC, dba Daddy Burt Hemp Co., Lexington, Ky.
The FDA has requested responses from each company within 15 working days stating how they will correct the violations. Failure to correct the violations may result in legal action, including product seizure and/or injunction, the warning letters said.
“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns,” said Amy Abernethy, principal deputy commissioner of the FDA. “In line with our mission to protect the public, foster innovation and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate.”
Meanwhile, the FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. Based on the lack of scientific information supporting the safety of CBD in food, the FDA indicated that it cannot conclude that CBD is generally recognized as safe among qualified experts for its use in human or animal food.
CBD’s presence in food and beverages has been debated for months. In May 2019, the FDA held its first public hearing on CBD in food and beverages and created a working group to spearhead these questions and concerns. On the heels of these warnings, the FDA has once again said that CBD is unsafe to be used in human or animal food based on a lack of scientific evidence. The FDA will continue exploring potential pathways for various types of CBD products to be lawfully marketed, it said, and plans to provide an update on this progress in the coming weeks.