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.
The U.S. Food and Drug Administration is in the process of issuing a draftenforcement policy on cannabis-derived compounds, including cannabidiol (CBD).That draft is currently at the White House for review. Pet product companiesthat formulate with CBD, or are considering it, should mind the outcome ofthat policy, Emily Lyons, lawyer with Husch Blackwell, said during herpresentation at Petfood Forum CONNECT.
“I would expect that this enforcement policy would look very similar to whatFDA has included in warning letters to companies,” Lyons said.
Depending on how that policy ends up, FDA could issue more warning letters topet product companies using CBD in their formulations. Late last year, 13companies making CBD products for pets were among the 15 warned by FDA thattheir 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 allegedviolations. First, FDA officials may consider CBD-containing pet products tobe adulterated, because the agency ruled that CBD as an ingredient or additiveis not generally recognized as safe (GRAS) in animal feed The agency couldalso view the products as unapproved new animal drugs, which includesreference to disease treatment claims.
“Substantiation is the name of the game in order to make sure that your claimsare accurate and truthful on your products,” Lyons said. “FDA has, as Imentioned, addressed some very specific claims related to diseases or diseaserelated 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 PTSD]
- Adding [our CBD product can] help fight infection and inflammation
- CBD Hemp Oil is recommended in [equine anxiety and arthritis]
- CBD may calm dogs made frantic by fireworks
- CBD stopped [my dog’s] anxiety
- CBD [eases animal epilepsy]
Consumer class action lawsuits about CBD pet products
Soon after FDA released those warning letters in 2019, consumers filed morethan 15 class actions lawsuits, Michael Annis, partner with Husch Blackwell,said in his portion of the presentation. The defendants have followed foundsome success arguing “primary jurisdiction” in their responses to thelawsuits’ complaints.
“The principal question in primary jurisdiction is who gets to make thedecisions in regard to the legality of the product?” he said. “Is it thecourts on one hand, or is it the regulatory agency on the other?”
The defendants argue that FDA has primary oversight over claims involving theillegal 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 remainsto be seen, or if the FDA policy will address consumer complaints.
Source: ByTim Wall Petfood Industry
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