MOU 225-19-032

MOU 225-19-032 has been amended, effective August 1, 2025.

MEMORANDUM OF UNDERSTANDING
Between the U.S. Food and Drug Administration and the National Institutes of Health National Institute of Environmental Health Sciences and the Health and Environmental Sciences Institute Botanical Safety Consortium

I.  PURPOSE

We seek to continue this Memorandum of Understanding (MOU), which was established in 2019, to enhance public health protection by providing scientific approaches to support the safety assessment of complex botanical mixtures used in foods and dietary supplements. This MOU delineates the partnership of the U.S. Food and Drug Administration (FDA), National Institute of Environmental Health Sciences (NIEHS), and Health and Environmental Sciences Institute (HESI) as participating members of the Botanical Safety Consortium (BSC).

II.  BACKGROUND

Initially established in 2019, this MOU has served as a framework to support the scientific collaboration and resourcing of scientific efforts related to improving the quality and safety assessment of botanical dietary supplements. Programmatic activities conducted or supported as part of this MOU have included chemical characterization of complex botanical products, identification of fit-for-purpose toxicity testing approaches, and the development of a public database of toxicity outcomes for select botanical ingredients. All of the outputs of this collaboration are made publicly accessible.

In the years since the enactment of the Dietary Supplement Health and Education Act (DSHEA) of 1994, P.L. 103-417, the dietary supplement marketplace has grown significantly in both size and complexity. The U.S. dietary supplement market currently is estimated to be worth more than $60 billion and contain 100,000+ different products; significantly larger than the $4 billion market that was estimated to contain 4,000 products in 1994. Additionally, today’s marketplace is more complex with a global supply chain and precisely formulated products, many of which contain novel ingredients. This growth, along with significant variation in current approaches to quality and safety assessment of botanicals, warrants increased focus on the quality and safety of complex botanical mixtures in foods and dietary supplements to better protect public health.

The BSC was formed in 2019 as a forum for scientists from consumer health groups, academia, industry, non-profit organizations, and the federal government to work collaboratively to generate a sound scientific basis for evaluating botanical safety using the latest toxicology tools integrated with existing safety data. With implementation of this MOU in 2019, the Parties established specific guidelines for membership and participation in the BSC with input from additional stakeholders. Since 2019 HESI has served as a convener and facilitator for the BSC.

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act), as amended (21 U.S.C. 301, et seq.). In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, and medical devices, as well as the safety and security of foods, dietary supplements, cosmetics, and radiological products. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. To accomplish its mission, FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues. Increased development of research, education, and outreach will contribute to FDA’s mission.

NIEHS, part of the National Institutes of Health, is authorized by Section 463 of the Public Health Service Act (42 U.S.C. 285l) to conduct and support research, training, health information dissemination, and other programs with respect to factors in the environment that affect human health, directly or indirectly. In addition to intramural research activities, the NIEHS has carried out comprehensive toxicological studies in rodents on a number of botanical dietary supplement ingredients through its participation in the National Toxicology Program.

HESI is a non-profit 501(c)(3) charitable scientific organization whose mission is to develop science for a safer, more sustainable world. HESI achieves its mission by serving as a neutral and skilled convener of scientists from academic, government, foundations, research institutes, and the commercial sector. Since 1989, HESI programs have helped to build scientific evidence on human and environmental health issues through collaborative and efficient research and expertise-sharing platforms.

III.  COMMON UNDERSTANDING OF THE PARTIES

In this MOU, FDA, NIEHS, and HESI are referred to individually as a “Party” and collectively as the “Parties.” This MOU states the shared understanding of the Parties as to how they expect to proceed in working together on the Botanical Safety Consortium. This MOU is not a binding agreement. Any joint projects between the governmental parties (FDA and/or NIEHS) and HESI will be governed by a separate agreement that must comply with applicable laws and regulations governing agreements between federal governmental and non-governmental entities.

As part of the BSC, the parties intend to continue to engage in a number of collaborative projects leveraging their individual and pooled expertise and resources. Relevant activities of the Parties could include managerial and logistical support, intellectual input, laboratory investigation, data analysis, manuscript writing, and public engagement. In their shared efforts to educate and build consensus across governmental, academic, clinical, non-governmental, and industry stakeholders, the Parties may elect to share with each other information that is in the public domain and considered non-confidential. Activities contemplated under this MOU are not intended to include group advice to FDA or NIEHS NTP that would be subject to the Federal Advisory Committee Act (FACA), 5 U.S.C. App.

In furtherance of this MOU:
A.  FDA expects to:

1. Engage in the scientific program design, execution, evaluation, and implementation efforts described in this MOU.

B.  NIEHS expects to:

1. Engage in the scientific program design, execution, evaluation, and implementation efforts described in this MOU.

C.  HESI expects to:

1. Engage in the scientific program design, execution, evaluation, and implementation efforts described in this MOU.
2. Provide scientific program leadership, management and administration, teambuilding and stakeholder engagement, and communications support for MOU-related efforts by serving as a convener for the BSC.

IV.  GENERAL PROVISIONS

1. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort and will comply with current U.S. Government patent law and any other applicable statutes and regulations. Institutions within each party may decide to enter into Cooperative Research and Development Agreements (CRADAs) specific to particular collaborative projects. The terms of such CRADAs will address relevant Intellectual Property rights.
2. Any financial support provided by FDA and/or NIEHS for these efforts will be formalized through a separate agency process, consistent with applicable law and subject to the availability of funds.
3. This MOU does not authorize the sharing of FDA non-public information (NPI). The reference to “non-public information” covered by this agreement includes any information protected from public disclosure under Federal law and regulations, including the Freedom of Information Act (FOIA) and 21 CFR part 20. See also 21 U.S.C. § 331(j), 21 U.S.C. § 360(j), 5 U.S.C. § 552a(i)(1), 18 U.S.C. § 1905. This may include confidential commercial information, trade secret information, personal privacy information, pre-decisional information, deliberative information, and law enforcement records. Each Party will comply with the other Parties’ security procedures and policies regarding access to and use of facilities.
4. Under this MOU, joint efforts will be undertaken to support collaborative research and training as permitted under appropriate statutory authority. Before any specific collaboration is initiated or implemented, the Parties shall identify priorities, topics of mutual interest, and develop separate, written supplemental agreements for collaboration and sharing of resources. Where applicable, these agreements may reference this MOU. The terms and conditions of any such agreements will comply with applicable Federal law and regulations and shall be negotiated and executed by appropriate representatives among parties under procedures that comply with applicable laws and regulations that govern contracts between government agencies and non-governmental entities.
5. Nothing in this MOU should be interpreted to imply that the United States, Department of Health and Human Services, FDA, or National Institute of Health endorses the products or services of HESI or its affiliates.

V.  RESOURCES OBLIGATIONS

This MOU represents the broad outline of the intent by FDA, NIEHS, and HESI to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds. This MOU does not create binding, enforceable obligations against any Party. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU.

VI.  LIAISON OFFICERS

A.  For FDA:
Name:  Hellen Oketch-Rabah, Ph.D.
Organization:  U.S. Food and Drug Administration
Title:  Deputy Director, Office of Dietary Supplements Program
Address: 5001 Campus Dr, College Park, MD 20740
Telephone Number:  301-796-2024

B.  For NIEHS:
Name:  Cynthia Rider, Ph.D.
Organization:  National Institute of Environmental Health Sciences 
Title:  Toxicologist
Address:  111 T. W. Alexander Dr, Research Triangle Park, NC 27709 
Telephone Number:  987-287-3111

C.  For HESI:
Name:  Syril Pettit, Dr.P.H., MEM
Organization:  Health and Environmental Sciences Institute
Title:  Executive Director
Address:  740 15th St, NW, 6th Floor, Washington DC 20005
Telephone Number:  202-659-8404

Each Party may designate new liaisons by notifying the other Parties’ administrative liaison in writing. If, at any time, an individual designated as a liaison under this MOU becomes unavailable to fulfill those functions, the Party will name a new liaison within two (2) weeks and notify the other Parties through the designated administrative liaisons.

VII.  DURATION, TERMINATION, AND MODIFICATION

Activities under this MOU will start upon the signature by authorized officials of each Party, and continue for five (5) years from the date that all Parties have signed, unless the MOU is modified or terminated. Each Party may terminate this MOU with or without cause. Each party agrees to provide written notice to the other Parties at least sixty (60) days in advance of their intent to modify or terminate this MOU.

VIII.  STATUTES, REGULATIONS, RULES AND POLICIES

This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules and policies under which FDA, NIEHS, and HESI operate.

APPROVED AND ACCEPTED FOR THE NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

/s/
Heather Patisaul, Ph.D.
Scientific Director, Division of Translational Toxicology
NIEHS
Date: 08/01/2025

APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION

/s/
Kyle Diamantas, J.D.
Deputy Commissioner for Human Foods
FDA
Date: 2025/08/01

APPROVED AND ACCEPTED FOR THE HEALTH AND ENVIRONMENTAL SCIENCES

/s/
Syril Pettit, Dr.P.H., MEM  Date
Executive Director
HESI
Date: 08/01/2025