February 01, 2020

The Food and Drug Administration announced in November 2019 that the agency had issued warning letters to 15 companies for illegally selling cannabidiol-containing products in ways that violate federal law. Many of the products are intended for animals, particularly pets.

One product, sold by Apex Hemp Oil LLC, is intended for food-producing animals. The agency says it’s concerned about the safety of human food products from animals that consume CBD, as there is a lack of data establishing safe CBD residue levels.

The FDA also published a revised consumer update that more broadly details safety concerns related to CBD products. Given the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating that it cannot conclude that CBD is generally recognized as safe to use in human or animal food.

The 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.

“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 FDA Principal Deputy Commissioner Amy Abernethy, MD, in a statement.

“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,” Dr. Abernethy explained.

The companies receiving warning letters are as follows:

• Apex Hemp Oil LLC of Redmond, Oregon.
• Bella Rose Labs of New York City.
• Daddy Burt LLC, doing business as Daddy Burt Hemp Co., of Lexington, Kentucky.
• Healthy Hemp Strategies LLC, doing business as Curapure, of Concord, California.
• Infinite Product Co. LLLP, doing business as Infinite CBD, of Lakewood, Colorado.
• Koi CBD LLC of Norwalk, California.
• Natural Native LLC of Norman, Oklahoma.
• Noli Oil of Southlake, Texas.
• Organix Industries Inc., doing business as Plant Organix, of San Bernardino, California.
• Pink Collections Inc. of Beverly Hills, California.
• Private I Salon LLC of Charlotte, North Carolina.
• Red Pill Medical Inc. of Phoenix.
• Sabai Ventures Ltd. of Los Angeles.
• Sunflora Inc. of Tampa, Florida/Your CBD Store of Bradenton, Florida.
• Whole Leaf Organics LLC of Sherman Oaks, California.

The FDA has previously sent warning letters to other companies illegally selling CBD products in interstate commerce that claimed to prevent, diagnose, mitigate, treat, or cure serious diseases, such as cancer, or otherwise violated the Food, Drug, and Cosmetic Act. Some of these products were in further violation because CBD was added to food, the agency explained, and some of the products were also marketed as dietary supplements even though products that contain CBD do not meet the definition of a dietary supplement under the Food, Drug, and Cosmetic Act.

According to the FDA, some of the products outlined in the more recent warning letters raise other legal and public health concerns. For instance, some of the products are marketed for infants and children, a vulnerable population that may be at greater risk for adverse reactions because of differences in the ability to absorb, metabolize, distribute, or excrete a substance such as CBD.

The agency has requested responses from the companies stating how the companies will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure or injunction, according to the FDA.

According to market research firm Packaged Facts’ 2019 Survey of Pet Owners, 11% of dog owners and 8% of cat owners have used cannabis supplements or treats for their pets.