FDA issues warning letters to companies selling unapproved CBD products

The U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) has issued warning letters to three pet companies accused of selling unapproved cannabis-derived products: Bailey’s Wellness, Holista, and House of Alchemy-Hamet & Love.

The warning letters, issued April 7, were for promoting cannabidiol (CBD) products for use in animals that the FDA has not approved as safe and effective for their intended use under the federal Food, Drug, and Cosmetic Act.

The letters address marketing for various CBD-containing products —including oils, chews, and pellets—that suggest unproven benefits across websites and social media.

In particular, the agency expressed concern about selling unapproved CBD products for food-producing animals and requested immediate action to stop sales of these products.

“In addition to raising potential concerns regarding safety for the animals themselves, CBD products for food-producing animals raise concerns regarding the safety of the human food (meat, milk, and eggs) derived from those animals,” according to an April 7 letter to Bailey’s Wellness, which sold products under the name Bailey’s CBD. “There is currently a lack of data on the formation of residues in edible products of food-producing animals in association with the consumption of CBD products by those animals and on safe levels of any potential residues for the human consumer.”

The FDA’s letters to Holista—which sold products under the name HolistaPet—and to House of Alchemy—which sold as CBD Dog Health, Hamet & Love, and MycoDog—share similar concerns.

The April warning letters gave the companies 15 working days to describe how they planned to address the violations and prevent their recurrence. Failure to comply could result in actions such as product confiscation or court injunctions, the announcement states.