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FDA and NIH Announce Innovative Joint Nutrition Regulatory Science Program

FDA and NIH Announce Innovative Joint Nutrition Regulatory Science Program

Today, the U.S. Food and Drug Administration and the National Institutes of Health (NIH) announced a new, joint innovative research initiative that will serve as a key element in fulfilling U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr.’s commitment to Make America Healthy Again. With diet-related chronic diseases continually rising, it is imperative that the FDA and NIH work in lockstep to invest in gold standard science, prioritize a better understanding of the root causes to end the diet-related chronic disease crisis and safeguard the health of America’s children.

Under the new Nutrition Regulatory Science Program, the FDA and NIH will implement and accelerate a comprehensive nutrition research agenda that will provide critical information to inform effective food and nutrition policy actions to help make Americans’ food and diets healthier. The initiative will aim to answer questions such as:

  • How and why can ultra-processed foods harm people’s health?
  • How might certain food additives affect metabolic health and possibly contribute to chronic disease?
  • What is the role of maternal and infant dietary exposures on health outcomes across the lifespan, including autoimmune diseases?

Answering these questions and many others will enable effective policy development and help promote the radical transparency Americans deserve about the foods they are eating and how those foods can impact their health.

“The FDA is focusing resources on the greatest contributors to the staggering health care crisis: chronic diseases,” said FDA Commissioner Martin A. Makary, M.D., M.P.H, “Mirroring the highly successful FDA and NIH Tobacco Regulatory Science Program, we’re bringing together scientific expertise from both agencies to transform nutrition and food-related research.”

The FDA will provide its critical expertise in regulatory science and NIH will provide the infrastructure for the solicitation, review and management of scientific research. The initiative will bring together experts in many disciplines—including chronic disease, nutrition, toxicology, risk analysis, behavioral science, and chemistry—all with the goal to advance the gold standard of nutrition and food science.  

“Nutrition has always been a priority at NIH. By teaming up with the FDA, we’re taking a major step toward answering big questions about how food affects health—and turning that science into smarter, more effective policy. It’s time to tackle the chronic disease crisis head-on. That’s why NIH is making this investment alongside the FDA,” said NIH Director Jay Bhattacharya, M.D., Ph.D.

The FDA and NIH will work together to develop a research agenda for the Nutrition Regulatory Science Program and are committed to ensuring all research conducted under the Program is fair, independent and free of conflicts of interest. 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

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I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.
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