Zootechnical Animal Food Substances; a New Category of Animal Food Additives Proposed

On June 8, 2023, bipartisan legislation creating a new category of animal feed ingredients, named zootechnical animal food substances, was introduced.  This legislation, named the Innovative Feed Enhancement and Economic Development Act (Innovative FEED Act), is an effort to create an approval process for ingredients with environmental or food safety claims as food additives rather than as animal drugs. On June 15, 2023, an amendment modeled after the Innovative FEED Act, was proposed as an amendment to S.1844 – Animal Drug and Animal Generic Drug User Fee Amendments of 2023.

The proposed legislation appears to be an effort to resolve issues created by FDA’s Center for Veterinary Medicine’s (CVM) interpretation of the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of food.

In September 1998, CVM published Policy and Procedures Manual (PPM) 1240.3605, Regulating Animal Foods With Drug Claims, which provides guidance on how CVM regulates substances for animals.  Under CVM’s PPM, nutritional ingredients or products with claims of an intended effect on the structure or function (structure/function claims) of an animal’s body would usually be regulated as animal feed or food (“regulated-as-foods”).  Nutritional ingredients or products with production claims and non-nutritive ingredients or products with structure/function claims would be regulated as animal drugs (“regulated-as-drugs”).  CVM’s interpretation, as expressed in the PPM, has severely limited development of animal feed ingredients with benefits for the environment and other benefits.

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, including claims of environmental benefits (e.g., reduced greenhouse gas emissions from animal digestive processes), enhanced animal health, and productivity, as well as claims about an effect on the animal microbiomes.  According to CVM, these claims would constitute drug claims and, therefore, animal foods with these types of claims would be regulated as animal drugs subject to a time-consuming and expensive premarket approval process. CVM held this listening session to get feedback on how it could modernize or improve PPM 1240.3605, what challenges the current approach presents, and what additional types of claims or ingredients should be considered.  CVM maintained that, without new legislation, it does not have the authority to regulate products with these types of claims as feed ingredients.

The proposed amendments to the FDC Act would provide CVM with the needed authority.  They establish a new category of substances, called zootechnical animal food substances, which act in the animal’s gut to provide health benefits, reduce emissions, or address human food safety concerns.  New FDC Act § 201(tt) would define zootechnical animal food substance, in relevant part, as a substance intended to:

(i) affect the byproducts of the digestive process of an animal;

(ii) reduce the presence of foodborne pathogens of human health significance in an animal intended to be used for food; or

(iii) affect the structure or function of the body of the animal, other than by providing nutritive value, by altering the animal’s gastrointestinal microbiome.

The category is limited to substances that achieve their “intended effect by acting solely within the gastrointestinal tract of the animal,” and does not include substances intended to diagnose, cure, mitigate, treat, or prevent a disease, hormones, and ionophores.  The proposed definition also specifically excludes substances approved as a drug under FDC Act § 512, conditionally approved under FDC Act § 571, indexed under FDC Act § 572, or for which “substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.”

These zootechnical animal food substances will be deemed food additives (under FDC Act § 201(s)) subject to approval  under amended FDC Act § 409.  In addition to information about safety, the petition for approval of a zootechnical animal food substance would need to  include data to support the claimed effect of the zootechnical animal food substance.  Furthermore, the label for the zootechnical animal food substance would need to include the statement: “Not for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animal.”

The creation of the new category of animal food additives is intended to provide a route to market for zootechnical animal food substances that is faster than the animal drug approval route and has broad support by industry and trade associations.  Although the FDC Act describes a timeline for FDA’s review of food additive petitions, this timeline often has not been met without repercussions for FDA.

We will be monitoring further developments related to this legislation, as well as other developments concerning the issues brought up during the listening session in 2022.