The trade group is calling on the agency to modernize its regulatory policy “that currently limits feed ingredients with environmental or production claims from making it to market in a timely way.”
The US Food and Drug Administration (FDA) is reviewing the CVM Policy and Procedures Manual (PPM) 1240.3605, Regulating Animal Foods with Drug Claims, and has been seeking public comments on how the existing policy could be updated to reflect evolving scientific knowledge and promote innovation. It held a virtual public listening session on the policy review last month.
In addition to that event, the CVM sought both electronic and written comments on the policy revision, with November 17 the deadline for receipt of those.
The AFIA submitted formal comments to the CVM yesterday, highlighting why products with environmental and production claims should be regulated as feeds, not drugs; it also explained how a policy revision can be accomplished using existing regulatory pathways.
‘The clock is ticking’
Upon submitting the trade group’s letter to the CVM, AFIA CEO, Constance Cullman, said:
“The FDA is long overdue in allowing US farmers, ranchers, and pet owners to access novel animal food products with environmental, production, animal well-being and pre-harvest food safety benefits claims, which is central to improving the health of animals, incentivizing innovation, and competing in a global marketplace.
"If we are serious about helping the US meet its ambitious 2030 methane reduction goals of 30% below 2020 levels, then these products need to be in the CVM’s review process by 2024, so that they can be approved and make a difference on farms by that deadline. The clock is ticking, and the time to fix this issue is now.”
Feed ingredients with known efficacy to reduce enteric methane emissions in cattle cannot be sold with marketing claims for methane reduction in the US due to current CVM policy, whereas cattle farmers in other markets can knowingly and legally use them for their environmental benefits, putting US producers at a competitive disadvantage, said the industry representatives.
The AFIA said its members are regularly developing new feed ingredients that go beyond the typical taste, aroma, and nutritive value; innovating along the lines of ingredients that act solely on or in the digestive tract of animals, for example. “However, current CVM policy requires that these products be regulated as animal drugs instead of feed ingredients, a costly and cumbersome process, when these products are clearly feed ingredients and should be regulated as such.”
The trade group also outlined how its members have products approved in dozens of other countries that they cannot, or are unwilling to, submit for review at the FDA because of its narrow policy interpretations.
The CVM has the means to make this change, it continued. The agency can use the food additive petition, the generally recognized as safe (GRAS) process and Association of American Feed Control Officials’ ingredient definition pathways to support innovation in feed ingredients that will address existing and emerging issues in animal production, argues the AFIA.