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:
Soon after FDA released those warning letters in 2019, consumers filed more than 15 class actions lawsuits, Michael Annis, partner with Husch Blackwell, said in his portion of the presentation. The defendants have followed found some success arguing “primary jurisdiction” in their responses to the lawsuits’ complaints.
“The principal question in primary jurisdiction is who gets to make the decisions in regard to the legality of the product?” he said. “Is it the courts on one hand, or is it the regulatory agency on the other?”
The defendants argue that FDA has primary oversight over claims involving the illegal sale or marketing of CBD products. Therefore, the FDA, not a court, should determine the legal status of the products.
Whether that defense will hold up after the upcoming policy decision remains to be seen, or if the FDA policy will address consumer complaints.
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