WASHINGTON, D.C., U.S. — The National Grain and Feed Association (NGFA) said on April 25 that it has recommended that the U.S. Food and Drug Administration (FDA) continue its long-standing practice of exercising regulatory discretion if necessary to maintain the continued availability of a number of unapproved animal drug products, provided they have a long history of safe use and do not bear overt drug claims on their labels.

The NGFA’s statement was submitted in response to an FDA request for comments soliciting suggestions for strategies to address the prevalence of animal drug products marketed within the United States without approval or other legal marketing status. When publishing a Federal Register notice requesting comments, FDA stated that the agency is concerned that the safety and effectiveness of some unapproved animal drugs being marketed have not been demonstrated properly. But the agency also indicated it recognized that the continued availability of a number of such products is important to meet the health needs of animals. Therefore, FDA said it was requesting stakeholder comments on approaches that utilize FDA’s 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.

In its statement to FDA, the NGFA said that the types of animal feed and pet food products currently regulated by FDA that potentially 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. The NGFA said that these products are “generally recognized as safe” (GRAS) or have been authorized under food additive petitions, and have a long history of safe and effective use.

The NGFA noted that some 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 NGFA stated that it believed that the use of appropriate enforcement discretion has merit and should continue to be exercised by FDA in cases like the aforementioned where:

• The product provides unquestioned benefit to livestock, poultry and companion animals;

• The product has a history of safe use;

• The product does not bear overt drug claims on the label (that is, it does not purport to treat, prevent, mitigate, diagnosis or cure a disease); and

• The exercise of enforcement discretion is necessary to ensure the continued availability of products necessary to meet the needs of livestock, poultry and companion animals.

The NGFA also stated that it believed FDA should draw a policy parallel regarding the use of enforcement discretion for such animal foods with the enforcement discretion the agency has continued to exercise for the past four decades with respect to human medical foods.