FDA and NIH introduce new joint Nutrition Regulatory Science Program

The US FDA and National Institutes of Health (NIH) will invest in science to better understand the root causes of diet-related chronic diseases. They aim to implement and advance a comprehensive nutrition research agenda in the Nutrition Regulatory Science Program. This agenda will provide information to inform effective food and nutrition policy and help make US food and diets healthier. 

The FDA and NIH note that their joint research initiative will be key to fulfilling Health and Human Services Secretary Robert F. Kennedy Jr.’s commitment to “Make America Healthy Again.” 

“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,” comments NIH Director Jay Bhattacharya, Ph.D. 

“It’s time to tackle the chronic disease crisis head-on. That’s why NIH is making this investment alongside the FDA.”

Key research questions

The organizations state that answering key questions on nutrition will enable effective policy development and help promote the “radical transparency” that US citizens deserve about the foods they eat and how these can impact their health.

The initiative aims 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?

In the joint program, the FDA will provide its expertise in regulatory science, and the NIH will provide an infrastructure for soliciting, reviewing, and managing scientific research. 

The organizations say their initiative will include experts in various disciplines, such as chronic disease, nutrition, toxicology, risk analysis, behavioral science, and chemistry, to “advance the gold standard of nutrition and food science.” 

The nutrition research agenda aims to help inform effective food and nutrition policy and make food healthier.“The FDA is focusing resources on the greatest contributors to the staggering health care crisis: chronic diseases,” adds FDA Commissioner Martin Makary. “We’re bringing together scientific expertise from both agencies to transform nutrition and food-related research.”

FDA nutrition advances

To help US consumers choose more nutritious foods, the FDA updated its definition of “healthy” at the beginning of this year. The updated rule sets new criteria on food groups and limits thresholds in saturated fat, sodium, and added sugars. 

At the same time, the organization has also received stark criticism in recent months. For example, experts are warning that the FDA is failing to protect infant formula safety, pointing to inaction on toxic contaminants and citing regulatory conflicts of interest. 

Moreover, experts caution that recent budget and staff costs at the FDA will undermine the organization’s effectiveness. 

A legal analysis published last month urged boosting FDA funding and closing food safety loopholes such as the self-approved GRAS rule (generally recognized as safe). The researchers and the Center for Science in the Public Interest (CSPI) cautioned that FDA underfunding and understaffing threaten the organization’s oversight of food supply safety. 

The CSPI has also urged FDA Commissioner Makary to halt ongoing and future staff reductions and safeguard scientific expertise in food safety.