November 27, 2019
More than a dozen companies received warning letters from the US Food and Drug Administration (FDA) this week about illegally selling products containing cannabidiol (CBD), the FDA stated in a November 25, 2019, announcement.
“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt,’” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD. “Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA, and we want to be clear that a number of questions remain regarding CBD’s safety—including reports of products containing contaminants, such as pesticides and heavy metals—and there are real risks that need to be considered.”
The companies that received warning letters were:
- Koi CBD LLC, of Norwalk, California;
- Pink Collections Inc., of Beverly Hills, California;
- Noli Oil, of Southlake, Texas;
- Natural Native LLC, of Norman, Oklahoma;
- Whole Leaf Organics LLC, of Sherman Oaks, California;
- Infinite Product Company LLLP, doing business as Infinite CBD, of Lakewood, Colorado;
- Apex Hemp Oil LLC, of Redmond, Oregon;
- Bella Rose Labs, of Brooklyn, New York;
- Sunflora Inc., of Tampa, Florida/Your CBD Store, of Bradenton, Florida;
- Healthy Hemp Strategies LLC, doing business as Curapure, of Concord, California;
- Private I Salon LLC, of Charlotte, North Carolina;
- Organix Industries Inc., doing business as Plant Organix, of San Bernardino, California;
- Red Pill Medical Inc., of Phoenix, Arizona;
- Sabai Ventures Ltd., of Los Angeles, California; and
- Daddy Burt LLC, doing business as Daddy Burt Hemp Co., of Lexington, Kentucky.
According to the FDA, the companies are using websites and social media to sell drops, capsules, food items such as chocolate bars and teas, lotions, and other products that contain CBD. Marketing CBD products to treat diseases or for therapeutic use in humans and animals is a violation of the Federal Food, Drug, and Cosmetic Act, the FDA stated.
Unlike FDA-approved drugs, the companies’ CBD products have not been evaluated for effectiveness, proper dosage, interactions, side effects, and other safety concerns. Along with sending the warning letters, the FDA published a revised Consumer Update for the public explaining current safety concerns about CBD products.
“We recognize the significant public interest in CBD, and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety, and quality of many of these products,” Dr. Abernethy said.
The FDA has requested responses to the warning letters within 15 working days addressing how the violations will be corrected. Failure to do so may result in prompt legal action, the FDA warned.