Developments in the Animal Food Ingredient Program at FDA

Written by: Guest   |   August 10, 2020

Federal agencies, Ingredients, Member value, Guest perspective, Member value

Dr. David Edwards
Director of the Division of Animal Feeds, U.S. Food and Drug Administration’s Center for Veterinary Medicine 

Before I dive into this Food and Drug Administration news update, I would be remiss if I didn’t somehow address the COVID-19 pandemic and its implications for the animal food industry. FDA is so grateful for the industry’s cooperation with us during this trying time. We have really relied on animal food trade associations, like the American Feed Industry Association, to help gather information on supply chains and to share critical information with industry. I’m impressed by how well you’ve managed to maintain supply while still protecting your employees. Rest assured, FDA is working with our state partners and agencies, like the Centers for Disease Control and Prevention, U.S. Department of Agriculture, Occupational Safety and Health Administration and Federal Emergency Management Agency, on an all-of-government response to the COVID-19 pandemic. The only way we are going to get through this is if we work together. 

While the COVID-19 pandemic has been a struggle for all of us who work with animal food, fiscal year 2020 has been one of excitement for FDA’s Center for Veterinary Medicine’s (CVM) Division of Animal Feeds. This is because we received new appropriation funding that is allowing us to ramp up our new animal food ingredient review capabilities by rapidly expanding our team. We are grateful for the support and energy the animal food industry gave to ensure that the FDA received more funding in this critical area. 

We acknowledge that greater predictability with regards to timing, deadlines and consistency in submission review is needed for the industry. We are excited about the innovation that you are all bringing to the animal food industry, but we know that we need to play a part, too, in working to be timelier and more predictable in our reviews. In addition to the funding increase, we have also reorganized our Division to improve the process of review from both the scientific aspect and the administrative part, too. These process improvements have become possible due to the increase in funding. As we move forward, we hope that funding for these important processes can continue to keep pace with the exciting new innovations that you are bringing to CVM. 

After conducting a worldwide search, CVM has hired incredibly talented new reviewers from a variety of scientific disciplines, including biology, animal science, chemistry, toxicology and food technology. Despite the challenges of the COVID-19 pandemic, we remain on schedule with our hiring and are onboarding these staff members this summer. While their training starts on day one, training them to be reviewers will take some time.

We are looking forward to the day, in the not-too-distant future, when the addition of the new staff will result in those timelier and more predictable reviews for the industry. It will not happen overnight, but once our newly-expanded team of reviewers is trained, I am confident that you’ll be truly pleased with the changes we have made to FDA’s Division of Animal Feeds.

By restructuring the Division, we are better able to make sure the necessary review process facilitates getting innovative animal food products to market.  

We want to help industry bring new ingredients that improve safety, quality and nutritional value of animal food to the market quickly and safely. As always, but especially in these unpredictable times, we strongly urge firms to contact FDA early and often so we can help you navigate the regulatory landscape and ensure that your pre-market animal food submissions don’t face any unnecessary delays.  We want the review process to go just as quickly and smoothly as you do!  

This is doubly important for anyone interested in pursuing an animal food additive intended to mitigate African swine fever (ASF). Preventing ASF infection and spread, as well as finding treatments for infections that may occur, are key priorities for the U.S. government, pig producers, animal drug and food industries and academia. FDA has the regulatory authority to evaluate any animal drug intended to treat ASF or any ASF virus mitigant intended to be added to animal food. FDA is committed to working with sponsors to facilitate the development and approval of products intended to prevent ASF infection and spread. Remember, both new animal drugs and animal food additives require pre-market review and approval by the FDA prior to being legally marketed. Because there are several pathways to consider, we encourage sponsors interested in bringing such products to the marketplace to consult with our experts by emailing AskCVM@fda.hhs.gov early in your development process. While FDA is committed to ushering all food additive petitions through the review process as expeditiously as possible, we are prepared to prioritize reviews for food additives that are meant to mitigate ASF. 

Through all the disruption that has faced our nation during this COVID-19 pandemic, the animal food industry has remained resilient in getting the nutrients to our animals. We appreciate the hard work you have done to meet this challenge. We, here at CVM, have also continued to work through this time, and it has even given us some ideas on how to streamline and improve our processes. These improvements, along with our staffing increase and changes to our business processes, will lead to a more dynamic review process as we move forward here at DAF. Thank you for the work you do.