Depending on how that policy ends up, FDA could issue more warning letters to pet product companies using CBD in their formulations. Late last year, 13 companies making CBD products for pets were among the 15 warned by FDA.
The U.S. Food and Drug Administration is in the process of issuing a draft enforcement policy on cannabis-derived compounds, including cannabidiol (CBD). That draft is currently at the White House for review. Pet product companies that formulate with CBD, or are considering it, should mind the outcome of that policy, Emily Lyons, lawyer with Husch Blackwell, said during her presentation at Petfood Forum CONNECT.
“I would expect that this enforcement policy would look very similar to what FDA has included in warning letters to companies,” Lyons said.
Depending on how that policy ends up, FDA could issue more warning letters to pet product companies using CBD in their formulations. Late last year, 13 companies making CBD products for pets were among the 15 warned by FDA that their sales of CBD-containing pet and human items violated the Federal Food, Drug, and Cosmetic Act (FD&C Act).
As with previous warning letters, these may focus on two main alleged violations. First, FDA officials may consider CBD-containing pet products to be adulterated, because the agency ruled that CBD as an ingredient or additive is not generally recognized as safe (GRAS) in animal feed The agency could also view the products as unapproved new animal drugs, which includes reference to disease treatment claims.
“Substantiation is the name of the game in order to make sure that your claims are accurate and truthful on your products,” Lyons said. “FDA has, as I mentioned, addressed some very specific claims related to diseases or disease related conditions.”
Specific CBD-containing product marketing claims addressed by FDA included:
- Works incredibly well for joint pain [and aggression] in pets,
- CBD oil works great for pets [with anxiety, hyperactivity, or
- Adding [our CBD product can] help fight infection and
- CBD Hemp Oil is recommended in [equine anxiety and
- CBD may calm dogs made frantic by fireworks
- CBD stopped [my dog’s] anxiety
- CBD [eases animal epilepsy]