MOU 225-26-002

MEMORANDUM OF UNDERSTANDING BETWEEN DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH AND THE FOOD AND DRUG ADMINISTRATION CONCERNING Coordinated Efforts on NIH-FDA NUTRITION REGULATORY SCIENCE PROGRAM ("PROJECT")

PURPOSE

This Memorandum of Understanding (MOU) sets forth an overarching framework of partnership between The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) (individually referred to as “Party” and collectively referred to as the “Parties”), which are components of the United States Department of Health and Human Services (HHS) and also described herein as fellow agencies within HHS. To effectuate this purpose, the Parties enter into a non-exclusive, non-binding MOU to promote the generation of evidence and data using existing and novel approaches to inform food-related policy and regulatory decision making and to foster coordination and additional collaborations between NIH and FDA in supporting research that addresses priority nutrition research gaps. The Parties share common interests and goals in developing novel methodologies and approaches to generate the evidence needed to inform regulatory decision-making. Moreover, an expected output of shared interest to both Parties is the use and development of New Approach Methodologies (NAMs) for evaluating complex food matrices.

Each Party, operating under its own authority, intends to have specific roles in promoting this shared research interest (outlined below). This MOU provides a framework between the NIH and the FDA for coordination and collaborative efforts between the Parties to maintain and enhance effectiveness. It also provides the principles and procedures by which the Parties intend to manage and share expertise and information in order to increase collaboration and strategic planning.

BACKGROUND

The NIH-FDA Nutrition Regulatory Science Program (NRSP): Nutrition plays a pivotal role in health, yet poor dietary habits are now the leading risk factor for illness and death. In the United States (U.S.), diet-related conditions such as heart disease, cancer, diabetes, and obesity are leading contributors to the nation’s $4.5 trillion in health care. Addressing these issues requires coordinated efforts across society with support from government agencies. The NIH and the FDA are essential partners in this endeavor. A strong foundation of scientific research, coupled with effective, practical, and real-world regulatory activities, is critical to inform consumers and support a healthier food environment. In December 2024, the NIH and FDA convened a workshop to advance nutrition science for food-related policy decision-making. The event brought together researchers, policymakers, industry leaders, and more to share individual perspectives to help identify research gaps, explore strategies for enhanced NIH-FDA collaboration, and highlight emerging technologies in nutrition science, with a particular focus on the topic of ultra-processed foods. The workshop objectives included: (i) identifying critical research gaps and priorities in nutrition regulatory science; (ii) enhancing scientific collaboration between NIH and FDA; (iii) exploring how scientific evidence informs food-related policies and regulations; and (iv) highlighting emerging technologies and data resource needs for nutrition research. The NRSP was informed by the workshop.

SCOPE/SUBSTANCE OF UNDERSTANDING

This MOU will be subject to the applicable policies, rules, regulations, and statutes under which FDA and NIH operate.

The NIH and FDA intend to coordinate efforts that will promote the generation of evidence and data using existing and novel approaches to inform food-related policy and regulatory decision making and to foster additional collaborations between NIH and FDA in supporting research that addresses priority nutrition research gaps.

Types of collaborative efforts that are expected to be undertaken under the NRSP may include:

• FDA providing regulatory and scientific expertise to help support, refine, and advance NIH-sponsored research projects with regulatory potential within the NRSP. The knowledge of which may help facilitate NIH’s review of grant applications and the conduct of intramural research. Research topics to be investigated may include:
  • 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?
• Holding regular joint NIH-FDA workshops and/or meetings to ensure progress with NRSP and to develop new policies and initiatives as needed.

The Parties agree that before any specific collaborative project is initiated or implemented, the Parties shall identify topics of mutual interest, and develop separate, written agreements for collaboration and sharing of resources to the extent authorized by law. Where applicable, these agreements shall incorporate by reference this MOU.

ACTIVITIES AND RESPONSIBILITY OF EACH PARTY

The NIH and the FDA intend to assume the following respective roles and responsibilities under this MOU, such as:

The NIH staff, management, and investigators, are to assume the roles and responsibilities as described in any NIH Notice of Funding Opportunities (NOFOs) related to this MOU. Additionally, the NIH is expected to initiate a project entitled "Nutrition Ecology of Early Development (NEED)" to inform the NRSP.

Each Party may engage in data sharing as deemed necessary and appropriate between the NIH and FDA. The FDA and HHS have announced "Operation Stork Speed," a component of which includes collaborating with the NIH and other scientific bodies to address priority scientific research gaps regarding short- and long-term health outcomes associated with infant formula feeding in infancy and childhood across the lifespan. Each Party may use the expertise and relationships of the other to increase their own capability and responsiveness to the scope of NRSP and additional collaborations under this MOU.

GENERAL PROVISIONS

1. Term, Termination, and Modification. This MOU becomes effective on the date of the last signature and shall remain in full force and effect for a period of ten (10) years, unless modified or terminated. The Agreement may be modified or terminated by mutual written consent the Parties. No amendment or modification of this MOU shall be valid unless made in writing and signed by authorized representatives of both parties. Either Party may unilaterally terminate this MOU by providing a ninety (90) day advance written notice to the other Party of its intent to terminate the MOU.
2. Resource Obligations. All activities undertaken pursuant to this MOU are subject to the availability of personnel, resources, and funds. The FDA and NIH will not exchange or transfer funds. If transfer of funds is deemed to be required in the future, the Partie(s) may enter an interagency agreement by Section 601 of the Economy Act of 1932, as amended (31 U.S.C. 1535). This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties. This MOU does not create binding, enforceable obligations against any Party.

3. Information Sharing Guidelines. As fellow agencies within HHS, FDA and NIH can generally share information in the possession of either agency with each other, subject to applicable law and authorities.  The Parties agree that the following principles and procedures will govern the exchange of nonpublic information between the two agencies.

   Both agencies agree to protect non-public information that is shared, whether in writing or orally, between FDA and NIH from unauthorized disclosure. See e.g., 21 U.S.C. § 331; 18 U.S.C. § 1905; 21 CFR Parts 20 and 21; 5 U.S.C. § 552 and 552a; 45 CFR Parts 5 and 5b; 45 C.F.R. Part 46; 42 U.S.C. § 242m (d), and 42 U.S.C. § 241(d). Safeguards are important to protect the interests of, among others, owners and submitters of trade secrets and confidential commercial information; patient identities and other personal privacy information; privileged and/or pre-decisional agency records; and information protected for national security reasons. Such safeguards also help ensure FDA's and NIH’s compliance with applicable laws and regulations.

   The agencies agree to comply with the following:

   1. The agency requesting information (the “Requesting Agency”) will limit the dissemination of shared information it receives to internal agency offices that have a need to know. The agency official who makes the request will be responsible for ensuring that there are no other recipients of the information. If the request for information is sent electronically, then the sender should have the requisite responsibility and authority. If the request for information is sent in a “letter” then there should be a signature and date provided.
   2. The Requesting Agency shall agree not to publicly disclose any shared information in any manner including in publications and at public meetings without the approval of the agency that shared the information (the “Sharing Agency”). If the Requesting Agency wishes to disclose shared information, including information that it believes is publicly releasable, it shall obtain the permission of the Sharing Agency. The Requesting Agency shall promptly notify the appropriate office of the Sharing Agency when there is any attempt to obtain shared information by compulsory process, including, but not limited to, a Freedom of Information Act request or judicial order.
   3. The Sharing agency will indicate (orally or in writing depending on whether it’s a routine or non-routine request) whether the type of information being shared is nonpublic (e.g. confidential commercial information, trade secret information, personal privacy, or pre-decisional) and indicate to the Requesting Agency the limitation on sharing. Example text: “This information is nonpublic and shall not be further disclosed external to the agency without permission from [FDA or NIH] (Whichever is the applicable sharing agency) Applicable laws and regulations may prohibit further disclosure of this information. See, e.g., 21 U.S.C. § 33l(j); 18 U.S.C. §1905; 21 CFR Parts 20 and 21; 45 CFR Parts 5 and 5b; 42 U.S.C. § 242m(d); and 42 U.S.C. § 241(d).”
   4. Any unauthorized disclosure of shared confidential information by the agency receiving the information shall be the responsibility of that agency, so long as the Sharing Agency conveys the confidential nature of the information to the receiving agency, in accordance with the terms of this MOU, or the receiving agency otherwise has knowledge that such information is confidential.
   5. Non-Public Information Exchanges: Public Health Emergency:
      In cases where a Party to this MOU needs to obtain certain information as soon as possible due to emergency circumstances, such as an outbreak of an illness, the Requesting Agency shall so indicate orally or through informal written communication, e.g., email, to the other Party.  The Requesting Agency shall agree to protect any such information from unauthorized disclosure. In the case of emergency circumstances, as soon as is practicable, the Parties to this MOU shall document their sharing of any non-public information.

4. FOIA And Other Third-Party Requests for Shared Information. If any Party to this MOU receives a FOIA request for information shared by the other Party, it shall: (a) if the request implicates documents from the Sharing Agency in their original form, refer the FOIA request to the Sharing Agency for a response, without indicating to the FOIA requester whether the Sharing Agency has responsive records or releasable records;  or (b) if the request implicates documents received from the Sharing Party and then incorporated into document[s] by the Receiving Agency, the Parties shall consult about how best to respond to the FOIA request. All actions taken under this paragraph must be in compliance with 45 C.F.R. 5.25.

   Any Party to this MOU shall promptly notify the other Party if there is any attempt by a third party, including requests by Congress, the Office of Inspector General, or the Government Accountability Office, to obtain shared non-public information by processes, including, but not limited to a voluntary request, subpoena, discovery request, or litigation complaint or motion. The Parties shall consult before complying with any request to obtain shared non-public information, so that the Parties may determine the appropriate measures to take, including, where appropriate, legal action.

5. Points of Contact. The following individuals are designated points of contact for the MOU. The names of NIH and FDA staff listed below represent the current persons in these assigned roles at the date of signing of this MOU.

   FOOD AND DRUG ADMINISTRATION

   Robin A. McKinnon, PhD, MPA
   Acting Director
   Nutrition Center of Excellence
   Human Foods Program
   U.S. Food & Drug Administration
   (p): 240-402-1888
   (e): robin.mckinnon@fda.hhs.gov

   Dorn Carranza, PhD, MBA
   Senior Science Advisor
   Office of the Commissioner
   U.S. Food and Drug Administration
   (p): 301-796 8338
   (e): Dorn.Carranza@fda.hhs.gov

   NATIONAL INSTITUTES OF HEALTH

   Andrew A. Bremer, MD, PhD, MAS
   Director
   Office of Nutrition Research
   National Institutes of Health
   (p): 301-402-7886
   (e): andrew.bremer@nih.gov

   Nicole C. Kleinstreuer, PhD 
   NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives 
   Office of the Director
   National Institutes of Health
   (p): 301-402-9852
   (e): nicole.kleinstreuer@nih.gov

APPROVED AND ACCEPTED BY
Food and Drug Administration

/s/
Martin A. Makary, MD, MPH
Commissioner of Food and Drugs
Date: 01/26/2026

APPROVED AND ACCEPTED BY
National Institutes of Health

/s/
Matthew J. Memoli, M.D., M.S.
Principal Deputy Director
Date: 02/23/2026