FDA Cracks Down on Pet Products Containing CBD After USDA Clears Path for Hemp Production

Although more and more pet owners are turning to CBD products to treat their pets, new action by the FDA is a stark reminder that those CBD pet products found on-line and in stores are considered illegal at the federal level. Less than a month after the USDA published draft final rules to permit the “legal” production and interstate shipment of hemp and CBD throughout the country, the FDA issued warning letters to thirteen companies in nine states for selling various pet food, treats and animal drugs containing CBD. The FDA found that these products were either unapproved animal drugs or adulterated animal foods due solely to the presence of CBD in the products.

Notably, several of these companies are located in states where marijuana sales and possession have been legalized, including California and Colorado. In both the warning letters and an accompanying updated consumer alert, the FDA stated that, based on a lack of supporting scientific information related to use of CBD in food products:

“the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.”

This determination is significant because any animal (or human) food products that contain ingredients or additives that are not GRAS are considered to be adulterated and may not legally be sold. Predictably, this determination has already lead to the filing of a class action lawsuit against a Colorado-based CBD product manufacture that makes CBD dog treats and other products. Moreover, intentionally marketing adulterated human or animal food products may lead to fines or even criminal prosecution for executives of the offending company.

The warning letters identified the offending pet products by name as well as the two specific violations: selling (1) unapproved new animal drugs and (2) adulterated animal food products. The adulterated food violation was based on using CBD as an ingredient or additive when is not GRAS.

With respect to the unapproved animal drugs, the FDA identified numerous disease claims that companies made on their websites and social media (including Instagram, Twitter, and Facebook). The FDA defines disease claims as those indicating that the product “is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of animals.” Examples of disease claims related to these CBD products include relief from anxiety, pain, allergies, seizures, and neurological issues, and treatment of cancer and arthritis. It is noteworthy that all of these warning letters targeted companies that made one or more such explicit disease claims. While this certainly does not suggest any enforcement discretion to allow companies to market CBD-infused pet products without such express disease claims, it does indicate that those who explicitly make such claims are more likely to be the target of enforcement actions. While the FDA’s actions are certainly a blow to the already-growing CBD industry, they expressly recognized “the significant public interest in CBD” and emphasized that it continues to explore pathways for various types of CBD products to be lawfully marketed. To that end, the FDA promised to work together with stakeholders and industry to fill in the knowledge gaps about the quality, science, and safety (including toxicity and drug interactions) of many CBD products.

Somewhat ironically, while the FDA is cracking down on sale of pet products containing CBD, hemp and CBD may be legally produced once the new USDA hemp rules become final.