Charlie Elrod, Ph.D.
NEAFA Board Member
Natural Biologics, Inc. President & CEO
Among developed nations, the United States has one of the most restrictive regulatory regimes surrounding the claims that can be made for animal feed, ingredients or supplements. Without approval from the FDA’s Center for Veterinary Medicine (CVM) feed ingredients cannot claim to affect methane emissions, animal well-being or pre-harvest food safety. To gain such approval is an arduous process that requires months or years and tens of thousands of dollars, not counting funding the research to support the claim. Two years ago, we began applying for a health claim for one of our products, on which we had a lot of data, but we abandoned the process when CVM wanted data which was experimentally impossible to collect. I’m sure other NEAFA members have had similar experiences.
At this time no claims about altering the microbiome, reducing toxin loads, or improving gut function, immunity, welfare or physiology of the animal are allowed in the U.S. without CVM approval. In fact, there is no regulatory pathway for a feed or ingredient to claim an improvement in production or efficiency! The upcoming listening session is designed to allow for public comment on the proposal to update FDA policy to reflect evolving scientific knowledge and promote innovation. This could allow for a shift from regulating products as drugs to simply regulating them as animal feed.
The deadline for registering to present oral comments has passed, but written comments can be submitted through November 17. More information on the listening session can be found here and information on submitting electronic or written comments can be found here. More context about this topic can be found in this article written by our friend Louise Calderwood at AFIA. Here is a PDF on the subject as well.