CVM Relaxes Its Stance on Claims for Food Ingredient; Opening the Door for (Some) Novel Food Ingredients

On Feb. 2, 2024, FDA’s Center for Veterinary Medicine (CVM) announced that it will withdraw its Program Policy and Procedures Manual Guide 1240.3605 (PPM). As readers of this blog may recall, this PPM dates from 1998.  It reflects CVM’s narrow interpretation of what constitutes a permissible structure function claim for an animal food.  The PPM has severely limited development of new animal feed ingredients, including ingredients that promote growth, productivity claims, and ingredients with benefits for the environment.

By now, more than a year ago, on October 18, 2022, CVM held a virtual listening session on the regulation of animal foods with certain types of claims. CVM invited the public and stakeholders to comment on FDA’s regulation of animal foods with certain types of claims, that under the now withdrawn PPM, would be considered drug claims.

So what is the consequence of the withdrawal of the PPM?  That remains to be seen.  In its announcement of the withdrawal, CVM recommends that companies that are developing (or planning to develop) products with substantiated claims related to animal production, well-being, food safety, environmental and other benefits consult the agency early in the development process to ensure that products are appropriately reviewed through the right pathways.  In the absence of the policy, there seems a chance that CVM will recognize that certain claims such as production claims are not drug claims.  However, for certain ingredients, including ingredients that work via the gut microbiome, the withdrawal likely will have little to no effect.   As we reported previously, CVM believes that it does not have the authority (under the FDC Act) to regulate as feed ingredients, substances that work within the animal’s gastrointestinal tract with claims that affect the microbiome of the animal, byproducts of the digestive process or human food safety.  According to CVM, before it can consider substances with such claims as food ingredients, an amendment of the FDC Act granting the Agency authority to treat such products as food (ingredients) rather than as drugs is required.  As reported previously, the Innovative Feed Enhancement and Economic Development Act (H.R.6687 and S. 1842) (Innovative FEED Act), introduced in 2023, would amend the FDC Act to provide CVM with the required authority. Unfortunately, despite support bipartisan support and support from industry, this Act has not yet been passed.