Botanical Safety Consortium Principles & Rules of Engagement

November 2021

These Principles & Rules of Engagement establish standards for Membership in the Botanical Safety Consortium (“BSC”). All Members of the BSC Steering Committee, Technical Working Groups, and Stakeholder Council must acknowledge that they have read, understood, and will abide by this information.

The BSC is a program operated under the auspices of the Health and Environmental Sciences Institute (HESI), and thus all Members of the BSC must comply with HESI’s bylaws, codes of conduct, ethical standards, and policies as published here as well as these BSC Rules of Engagement and the BSC Organizational Framework. Additional information on the general structure and governance of the BSC is contained in the BSC Organizational Framework Document.

HESI BSC About Us Structure wg

Background

The Botanical Safety Consortium (BSC) was established in October 2019 by a Memorandum of Understanding (“MOU”) between the U.S. Food and Drug Administration (“FDA”), the National Institutes of Health National Institute of Environmental Health Sciences (“NIEHS”), and the Health and Environmental Sciences Institute (“HESI”).

The parties to the MOU designated HESI to serve as the convener and facilitator for the BSC. HESI, a non-profit scientific organization based on Washington, DC USA, is recognized as a charity under Section 501(c)(3) of the U.S. Internal Revenue Code. The BSC is funded by a federal grant from FDA and NIEHS provided to HESI through a subcontract agreement with a federal contractor and in part by charitable contributions from industry Members of the BSC.

aloe plant

Purpose

The BSC is a forum for scientists from consumer health groups, academia, industry, non-profits, and government (collectively, the “Members”) to generate a scientifically based integration of existing safety data and toxicology tools to evaluate botanical safety. BSC Members will work collaboratively on a variety of issues, including chemical characterization of complex botanical products and identification of fit-for-purpose assays for evaluating risks such as genotoxicity, hepatotoxicity, developmental and reproductive toxicity, cardiotoxicity, and systems toxicity. Based on this research, the BSC will provide recommendations to enhance the botanical safety toolkit and bring clarity to botanical dietary ingredient assessments for manufacturers and regulators.

Membership

Membership in the BSC is limited to those individuals who meet the requirements to be Members of the HESI Assembly and entities that meet the requirements to become HESI Sponsors or Affiliate Sponsors, as set forth in the HESI bylaws and the BSC Organizational Framework document. In joining as Members of the BSC, individuals and entities represent that they are eligible for such Membership and agree to be bound by these Rules of Engagement, the HESI bylaws, and the BSC Organizational Framework, and those documents may be modified from time to time by the BSC Steering Committee or (in the case of the HESI bylaws) by the HESI Board of Trustees. Per the HESI bylaws and BSC Organizational Framework, all private sector (industry) Members must become and remain HESI Sponsors or HESI Affiliate Sponsors in order to participate in the BSC. All public sector participants in the BSC must meet the eligibility requirements described in the HESI bylaws, and the BSC Organizational Framework.

Trade associations or other business associations classified as tax-exempt under Section 501(c)(6) of the U.S. Internal Revenue Code who are not eligible to be HESI Sponsors or Affiliate Sponsors, as set forth in the HESI bylaws but who do meet the requirements specified in the BSC Organizational Framework document can be Members of the BSC. In joining as Members of the BSC, individuals and entities agree to be bound by these Rules of Engagement and the Organizational Framework. Although not eligible to be HESI Sponsors, these individuals and entities agree to be bound by the HESI bylaws “as if” they were Sponsors.

Requirements to Join the BSC. Eligible individuals and entities should complete a BSC application form. Upon confirmation of eligibility to participate in the BSC Stakeholder Council, private sector Members will be required to pay applicable Fees in accordance with the fee schedule set forth in the BSC Organizational Framework document. All individuals will be required to acknowledge that they have read and agree to comply with the terms of Membership.

The Health and Environmental Sciences Institute (HESI), and the HESI Botanical Safety Consortium (BSC) by extension, is committed to upholding high ethical, scientific, and legal standards.   This includes a commitment to preserving the integrity of the Memorandum of Understanding between the U.S. Food and Drug Administration (FDA), National Institute of Environmental Health (NIEHS), and HESI that serves as the founding basis for the Consortium.  In support of these guidelines and principles, the BSC will not knowingly admit any private company that manufactures or distributes a botanical dietary product for which the FDA has:

  • affirmatively determined the product cannot be sold as a dietary supplement (e., CBD or THC products)
  • warned consumers not to use the product in any form for safety reasons (e.g., Kratom); or
  • banned the product as a dietary supplement (e.g., ephedrine alkaloids)

Role of HESI

HESI will serve as the convener and facilitator of the BSC. In that role, HESI shall: (i) recruit Members to join the BSC, (ii) engage in the scientific program design, execution, evaluation, and implementation efforts described in the MOU, and (iii) provide scientific program leadership, management, administration, team-building, stakeholder engagement, and communications support for the BSC. The primary contact for the BSC is Dr. Michelle Embry, Associate Director, (“Administrator”) who can be reached by phone at (202) 659-8404 or at botanicalsafety@hesiglobal.org

Additional Terms

Term and Termination. These Rules of Engagement are effective as of 01 March 2020 and shall remain in effect until such time that the BSC is concluded or a new or modified set of Rules of Engagement are adopted by the BSC Steering Committee.

Limitation of Liability. Neither HESI nor any Member shall be liable to any other Member for any indirect, consequential, compensatory, lost profits, punitive, exemplary or any similar damages. The maximum liability of HESI to any Member shall not exceed the total amount of Fees paid to HESI by such Member as specified in the BSC Organizational Framework.

Confidentiality. Generally, Members of the BSC will not share confidential information with other Members in the course of BSC activities. If a Member desires to share any confidential information in the context of BSC activities, the Member must contact HESI prior to disclosing any such confidential information and make the appropriate arrangements to protect the confidentiality of such information.

Intellectual Property.

  • Trademarks. All BSC trademarks and/or service marks (including but not limited to marks associated with the name or logo of the BSC) shall be owned by HESI and used for the purposes of the BSC.
  • BSC IP. It is not anticipated that the BSC will develop any patentable inventions identified in subsection A. In the event that any intellectual property (including but not limited to works of authorship that are susceptible of copyright protection) is developed as a result of the work done through the BSC (“BSC IP”), such BSC IP shall, subject to any provisions in the Subcontract or federal rules or regulations to the contrary, become the property of HESI. HESI shall be responsible for filing for any intellectual property rights related to any such BSC IP, with the costs of such filing being paid from BSC funds.

Use of BSC and Member Names and Logos. No Member shall use the name, logos or trademarks of the BSC, HESI, or any other Members to promote their products and services, to imply endorsement of products or services, or for any other purposes. Notwithstanding the foregoing, HESI may use Member names on BSC marketing and informational materials.

BSC Communications. All statements on behalf of the BSC must be made through HESI in coordination with the Administrator. Members shall not make any public statements on behalf of the BSC without the written consent of the Administrator. BSC Members and staff shall avoid making public statements that are inconsistent with BSC policies, such as statements that amount to lobbying, advocacy of policy positions, or endorsement of commercial interests.

Compliance with Law. Each Member agrees that in the course of participating in BSC activities, the Member will comply with all applicable laws, rules and regulations, as well as any federal program requirements that apply to the BSC.

Governing Law. This Agreement shall be governed by and construed in accordance with the internal laws of the District of Columbia, without reference to its conflict of laws principles.

Ethics

The BSC is committed to enhance public health protection by providing scientific approaches to support the safety assessment of botanicals used in dietary applications. We believe that achieving this goal requires open, active, and ethical collaborations involving scientists with diverse technical and professional expertise. Our collaborators share a commitment to producing science for public benefit and a mutual respect for human, animal, and environmental health and safety.

We understand that the BSC’s scientific credibility and impact is the product of the high ethical standards of our Members and our staff. As such, BSC Members commit themselves to pursuit of the following values:

  • Collaboration: Respectful interactions that recognize differences and leverage synergies in perspective, approach, and interpretation of scientific issues are core to the BSC mission. By supporting this diversity and interaction, we enrich the BSC’s ability to generate relevant and rigorous science.
  • Respect: The BSC is committed to a safe and collegial work environment, so that all BSC activities take place in a climate of understanding and mutual respect for the dignity and worth of each individual.
  • Transparency: Access to quality information and contemporary methods is essential to public and environmental health decision-making. All of the BSC’s scientific programs are committed to the generation of robust and publicly-accessible resources and activities.
  • Independence: In the context of the BSC programs and efforts, all BSC Members must act in the interest of the BSC mission to improve the science that underpins botanical safety. The BSC does not promote legislative policy changes or advocate for individual stakeholders or products.
  • Integrity: The BSC’s Technical Working Group programs and organizational activities will be conducted to the highest standards of ethical conduct and scientific rigor. As BSC Members and staff, we will exhibit a respect for laws, regulations, ethical standards for human and animal research, and for our colleagues around the world. BSC Members must adhere to HESI’s operating policies with regard to disclosing conflicts and solely to produce science for public benefit.
  • Opportunity: The BSC provides equal opportunity and equal consideration to all Members and staff without regard to sex, gender identity or expression, race, color, national or ethnic origin, religion or religious belief, age, marital status, sexual orientation, disabilities, veteran status, or any other ground on which discrimination is prohibited by applicable law.

Antitrust

No activity or discussion at any meeting of BSC may be engaged in for the purpose of bringing about any understanding or agreement among Members to (a) raise, lower, or stabilize prices; (b) regulate production; (c) allocate markets; (d) encourage boycotts; (e) foster unfair trade practices; (f) assist monopolization, or (g) in any way, violate applicable antitrust, anti-monopoly, or competition laws.

BSC meetings shall not be occasions where participants:

  • Discuss prices or pricing policies, or any marketing policy with a direct or indirect effect on pricing or any other terms of sale;
  • Confer about division or allocation of sales territories or customers;
  • Establish blacklists or boycotts of suppliers, purchasers, or competitors;
  • Coerce Members to implement particular programs or policies;
  • Resolve problems unique to a single Member or a small, select group of Members;
  • Exchange or disseminate information relating to costs of production, distribution, or marketing or
  • Conduct or plan any lobbying activities.