FDA Sends New Warning Letters Related to CBD Products
November 26, 2019
By Lauren Mendelsohn
On November 25, 2019 the United States Food & Drug Administration (FDA) sent out warning letters to 15 different companies for selling CBD products that violate the Food, Drug, and Cosmetic Act (FD&C Act). In addition to sending these new warning letters, the FDA also published a revised Consumer Update about cannabis and cannabis-derived products, including CBD. We previously discussed the FDA’s authority to regulate such products here.
The FDA has been concerned about CBD products that violate the FD&C Act for several years, as indicated by previous warning letters. However, since the passage of the Agriculture Improvement Act of 2018 (also known as the “2018 Farm Bill”), the CBD market has expanded significantly due to misconceptions about what is actually legal. Thus, far more warning letters have been sent this year than in previous years.
Below are the companies that received warning letters:
- 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
- Daddy Burt LLC, doing business as Daddy Burt Hemp Co., of Lexington, Kentucky
The FDA gave these companies 15 days to state how they will resolve the violations mentioned in the letters, and said in their press release that failure to correct these violations quickly “may result in legal action, including product seizure and/or injunction.”
The latest warning letters echo the sentiments of earlier letters sent by the FDA to alleged violators. Neither CBD or THC are approved by the FDA as a drug; therefore, products containing CBD can’t include any health-related statements that suggest the product (or CBD in general) can diagnose, treat, cure, or prevent any disease. Currently, the FDA has only approved one pharmaceutical medication containing CBD, Epidiolex. The FDA has also not approved the use of CBD as a dietary supplement, so products containing CBD cannot be marketed as such. Additionally, human or animal food products may not contain CBD, since CBD is not an approved food additive. Other concerns that have been raised in warning letters include misbranded drugs, adulterating human or animal food, the use of CBD products on vulnerable populations, and quality control concerns.
As noted above, the FDA also issued a revised Consumer Update which highlights what the FDA perceives as health risks associated with CBD products as well as some areas of current research. For example, the FDA warns of the potential for liver damage, unwanted drug interactions, male reproductive toxicity, and other side effects from using CBD products. The FDA claims that they are looking into the effect of cumulative CBD exposure, the impact of CBD exposure on special populations such as children and pregnant women, and whether CBD can be used safely on animals.
Earlier this year, recognizing the immense scope of the public’s interest in this area, the FDA held a public hearing to gather evidence on how to regulate CBD products. The FDA is still in the process of determining an appropriate regulatory framework for such products, though we expect an update on this sometime soon. As of publication time though, the FDA has refused to conclude that CBD is generally recognized as safe (GRAS) for use in food products.
Stay tuned to our blog for updates regarding FDA’s oversight of CBD products.
This message is provided as an educational public service and is not intended as legal advice. For questions regarding cannabis, hemp or CBD products, contact the Law Offices of Omar Figueroa at (707) 829-0215 or info@omarfigueroa.com to schedule a confidential legal consultation.