The U.S. Food and Drug Administration should continue to exercise regulatory discretion to maintain the continued availability of a number of unapproved animal drug products, said the National Grain and Feed Association in a statement to the FDA.  

The types of animal feed and pet food products currently regulated by the FDA that could fall within the category of “unapproved animal drugs” include products formulated from animal feed ingredients that help manage, from a dietary and nutritional standpoint, a specific disease or condition under a licensed veterinarian’s professional supervision, said the NGFA. These products are “generally recognized as safe” or have been authorized under food additive petitions, and have a long history of safe and effective use.

According to the NGFA, pertinent examples of such products include:


  • Diets that provide assistance in supporting the nutritional aspects of the care of animals with certain disease conditions or symptoms.
  • Diets that specifically support urinary tract health, as defined by FDA, and are sold through general retail.
  • Diets developed to reduce the formation and expulsion of hairballs in cats, which are sold through general retail.
  • Electrolyte products that play an important role in meeting the nutritional requirements of livestock and poultry in certain situations.

The FDA put out a request for comments soliciting suggestions for strategies to address the prevalence of animal drug products marketed within the U.S. without approval or other legal marketing status. The agency has said that it is concerned that the safety and effectiveness of some unapproved animal drugs being marketed have not been demonstrated properly, but also recognizes that the continued availability of a number of such products is important to meet the health needs of animals. 

The FDA is looking for comments on approaches that utilize its existing regulatory framework for increasing the number of currently marketed animal drugs that have legal marketing status, as well as the use of enforcement discretion in limited situations, said the agency.