FOR IMMEDIATE RELEASE
November 10, 2026
Colorado Springs, Colo. – S3 Collective, a 501(c)(3) nonprofit focused on Botanical Standards, Science, and Safety, is calling for standardized testing and ingredient transparency alongside valid medical studies to establish the safety and efficacy of botanical treatments. Its November 3, 2026 submission to the U.S. Food and Drug Administration draws on clinical, laboratory and standards expertise in response to the agency’s request for information (Docket No. FDA-2026-N-9550) on botanical drug development.
S3 Collective recommends supplementing the FDA’s 2016 botanical drug guidance to clarify how active ingredients should be identified and measured to help establish the minimal safety testing parameters for all botanical drug products. Beyond these safety parameters, further characterization would be tailored to the material and research question.
S3 Collective’s Medical Advisory Committee (MAC) has developed baseline testing guidelines, including recommended safety parameters for botanical products with medical claims. S3 Collective’s MAC emphasizes accurate labeling of active-ingredient amounts and safety testing for hazards such as heavy metals and pesticides. Dr. Leah Johnson and the committee she chairs were primary contributors to the submission, alongside experts in laboratory science, botanical product characterization and standards development.
To connect product information with clinical findings, S3 Collective asks FDA to encourage a minimum framework for describing complex botanical materials used in clinical studies, tailored to the material and research question. It asks the FDA to require disclosure of all active and inactive ingredients.
Because sampling and testing procedures can make laboratory results difficult to compare, the MAC also supported the creation of voluntary consensus standards and validated test methods to help laboratories produce comparable results for the materials tested.
The MAC practitioners report that, in their clinical and research experience, isolating a single compound from a botanical product is often associated with reduced therapeutic benefit, higher dosing requirements, and increased risk of adverse effects. While acknowledging that single-molecule medicines can be highly effective, S3 Collective recommends a development pathway for whole-plant and minimally purified products that recognizes their complexity and retains standardized testing, transparency, and valid studies.
“A study of one botanical preparation does not necessarily predict what we can expect from another. Clear product characterization, including ingredient verification and safety testing, along with appropriate standardized testing methodologies are essential to identifying the potential benefits, safety, and efficacy of different botanical products.”
Read S3 Collective’s full submitted comment.
About S3 Collective
S3 Collective is a 501(c)(3) nonprofit think tank focused on Standards, Science, and Safety. Our work follows a research-to-standards-to-adoption model: we identify measurement and quality problems, gather data, engage stakeholders, conduct research, and translate findings into standards-based outcomes. We draw on a cross-sector network of experts in laboratory testing, manufacturing, product characterization, clinical research, clinical practice, and voluntary consensus standards development. S3 Collective is proud to be the only organization accepted into FDA’s Network of Experts in the area of cannabis and cannabinoids.
About S3 Collective’s Medical Advisory Committee
The S3 Collective Medical Advisory Committee (MAC) is a collaborative medical advisory group composed of physicians, nurses, and clinical pharmacists who provide advice and guidance for federal regulation for use of botanical entities, specifically focused on medical cannabis. MAC members are practicing clinicians who work directly with patients and in research. The MAC has developed baseline testing guidelines, including minimum safety parameters for botanical products with medical claims.
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