MEMORANDUM OF UNDERSTANDING
BETWEEN THE U.S. FOOD AND DRUG ADMINISTRATION
CENTER FOR TOBACCO PRODUCTS
The U.S. Food and Drug Administration (FDA)’s Center for Tobacco Products and Truth Initiative have a shared interest in youth and young adult tobacco use prevention and public education efforts. The purpose of this collaboration is to foster and improve that shared interest. FDA and Truth Initiative are referred to individually as “Party” and collectively as the “Parties”. This Memorandum of Understanding (MOU) establishes the framework for collaboration between the Parties to promote this shared interest.
II. Background and Authority:
FDA CTP is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), which was signed into law in 2009 (Public Law 111-31 [H.R. 1256]). The purposes of the Tobacco Control Act include ensuring that FDA has the authority to address the use of tobacco by young people and that consumers are better informed regarding the health and dependency effects or safety of tobacco products. FDA is authorized to collaborate with experts in science, medicine, and public health to, among other things, promote the public health. See Federal Food, Drug, and Cosmetic Act (FD&C Act), section 1003(b)(4), 21 U.S.C. § 393(b)(4). Additionally, FDA is authorized to conduct educational and public information programs related to the responsibilities of the FD&C Act. See FD&C Act, section 1003(d)(2)(D), 21 U.S.C. § 393(d)(2)(D).
Truth Initiative® is America’s largest nonprofit public health organization committed to making tobacco use a thing of the past. Truth Initiative is dedicated to achieving a culture where all youth and young adults reject tobacco. Truth Initiative is best known for its award-winning truth® youth smoking prevention campaign.
The MOU seeks to further the missions of both Parties. The goals of the public education collaboration
(described below) are to:
- Increase understanding of electronic nicotine delivery systems (ENDS) and new and emerging tobacco use prevention research approaches;
- Increase scientific knowledge around the health consequences of use of ENDS and other new and emerging tobacco products;
- Increase understanding of effective youth ENDS cessation tools; and
- Increase understanding of effective approaches for measuring youth awareness and reactions to ENDS prevention messaging.
The Parties intend to achieve these goals through sharing of topline findings from campaign formative and outcome evaluation studies from CTP’s and Truth Initiative’s flagship ENDS prevention campaigns as well as research surrounding new and emerging tobacco products.
IV. Substance of the Agreement:
1. FDA intends to establish a mechanism to share publicly available information regarding: CTP’s formative and evaluation findings related to ENDS and new and emerging tobacco products research; relevant target audience formative research; and pre-market testing of advertisements, findings from outcome evaluation studies, digital measurement and tracking. This MOU does not authorize FDA to, and FDA does not intend to, share any confidential commercial, trade secret, or personal privacy information with Truth Initiative pursuant to this MOU.
2. Truth Initiative intends to establish a mechanism to share information regarding formative and evaluation findings related to ENDS and new and emerging tobacco products research findings; relevant target audience formative research, Pre-market testing of advertisements,findings from outcome evaluation studies, digital measurement and tracking, and results from Pixel tracking. This MOU does not authorize Truth Initiative to, and Truth Initiative does not intend to, share any confidential commercial, trade secret, or personally identifiable information with FDA pursuant to this MOU.
3. FDA CTP intends to collaborate with Truth Initiative (where appropriate) to accomplish the following:
a) Share the information referenced above (i.e., in 1. and 2.) early to help both FDA CTP and Truth Initiative combat the sharp rise in ENDS use among youth and young adults;
b) FDA CTP and Truth Initiative will each identify dedicated staff members responsible to serve as the points of contact for this MOU. Each party will identify one staff member as the primary decision-maker for the collaboration (the “Liaison Officer”) and a second staff member to serve as a back-up or alternative contact and source of information (“Alternative Liaison Officer) (See Liaison Officers below for additional details).
4. With respect to any information gained as a result of the collaboration established by this MOU, neither Party may use information in any way so as to suggest the other Party’s endorsement of any third-party product, program, person and/or initiative without the explicit written consent of the other Party.
V. General Provisions:
This MOU represents the broad outline of the Parties’ intentions to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to the availability of personnel and resources. This MOU does not affect or supersede any existing or future understandings or arrangements between the Parties and does not affect the ability of the Parties to enter into other understandings or arrangements related to this MOU. This MOU does not create binding, enforceable obligations against either Party. This MOU and all associated agreements will be subject to the applicable policies, regulations, and statutes under which FDA and Truth Initiative operate. Nothing in this MOU alters the statutory authorities or obligations of FDA CTP. The Parties recognize that this MOU is not intended to and may not be relied on to create any right or benefit, substantive or procedural, enforceable by law by any Party or against any Party.
VI. Information Sharing:
Access to any deliberative, pre-decisional, confidential, non-public information shall be governed by separate Confidential Disclosure Agreements in which the Parties will agree and certify in writing that they shall not further release, publish or disclose such information, except as required by law, and that they shall protect such information in accordance with the provisions of 21 U.S.C. § 331(j), 21 U.S.C. § 360j(c), 18 U.S.C. § 1905, and other pertinent laws and regulations governing the confidentiality of such information. No proprietary data, trade secrets or patient confidential information shall be disclosed among the Parties unless the Parties have executed a Confidential Disclosure Agreement covering such data and such disclosure is permitted by applicable law. Such Confidential Disclosure Agreements may be part of, or be executed pursuant to, Supplemental Agreements covering specific collaborations.
VII. Term, Termination, and Modification:
1. This MOU, when accepted by both Parties, will have an effective period from the date of the latest signature until five years from the date of such signature, unless earlier terminated under the terms of this MOU;
2. This MOU may be terminated by either Party upon a 30-day advance written notice to the other Party;
3. FDA CTP reserves the right to terminate this MOU immediately when, in FDA CTP’s sole judgment, immediate termination is necessary to prevent fraud or malfeasance, to protect public health and safety, or to prevent harm to FDA CTP resources and reputation.
4. This MOU may be extended, renewed, or modified only by mutual, written consent by both Parties.
5. This MOU creates a non-exclusive relationship between the parties. Either party may collaborate with multiple organizations on any given public education campaign with no exclusive collaboration association, implied or actual; and
6. This MOU is not a contractually-binding agreement between the parties, nor is it a funds obligating document.
VIII. Dispute Resolution
The Parties agree that in the event of a dispute between them, FDA CTP and Truth Initiative shall promptly use their best efforts to resolve the dispute in an informal fashion through communication and consultation, or other forms of non-binding alternative dispute resolution that are mutually acceptable to the Parties.
IX. Liaison Officers:
The Liaison Officer for each Party will be responsible for facilitating exchanges of information and expeditiously informing other interested persons within each respective organization on matters requiring prompt attention. Each Party may designate a new Liaison Officer or Alternative Liaison Officer at any time by notifying the other Party's Liaison Officer in writing (which may be provided by electronic mail). If, at any time, a Party’s Liaison Officer becomes unavailable to fulfill those functions, the Party will name a new Liaison Officer within two (2) weeks and notify the other Party of its new Liaison Officer. If a Party’s Liaison Officer is temporarily unavailable, the other Party’s Liaison Officer may communicate with the first party’s Alternative Liaison Officer to advance the work envisioned by this MOU.
FDA CTP Liaison Officer:
Name: Tesfa Alexander, PhD.
Title: Director, Division of Research and
Organization: Center for Tobacco Products, FDA
Truth Initiative Liaison Officer:
Name: Elizabeth C. Hair, Ph.D.
Title: Sr. Vice President, Schroeder Institute
Organization: Truth Initiative
FDA CTP Alternative Liaison Officer:
Name: Matthew Walker, PhD.
Title: Team Lead, Division of Research and
Organization: Center for Tobacco Products, FDA
Truth Initiative Alternative Liaison Officer:
Name: Jessica Rath, Ph.D.
Title: Managing Director, Schroeder Institute
Organization: Truth Initiative
Executed in duplicate on the dates indicated below:
Signature: /s/ Date: 10/13/2020
Printed Name and Title: Kathy Crosby, Director, Office of Health Communications and Education
Center for Tobacco Products, U.S. Food and Drug Administration
Signature: /s/ Date: 11/2/2020
Printed Name and Title: David Dobbins, Chief Operations Officer