Re: FDA Request for Public Comment on the Scope of Dietary Supplement Ingredients

Introduction

The American Society for Microbiology (ASM) appreciates the opportunity to provide comments in response to the U.S. Food and Drug Administration’s request for public input regarding the scope of dietary supplement ingredients. ASM is the world’s largest professional organization devoted to the microbial sciences, representing more than 38,000 scientists working globally across academia, industry, clinical medicine and public health. Through its scientific unit, ASM Health (ASM-H), ASM is focused on translating advances in microbial science into real-world diagnostics, preventive strategies and therapeutics. ASM-H’s Microbiome to Medicine Initiative brings together researchers, clinicians, regulators and industry partners to facilitate responsible clinical translation of microbiome science. From this perspective, ASM-H has a strong interest in how FDA interprets section 201(ff)(1)(E), particularly as applied to microbial products that could have the potential for causing confusion amongst consumers seeking these products for either dietary supplement or therapeutic purposes.

ASM advocates for public policies rooted in evidence-based science. To account for the rapid evolution of microbiome science into both consumer products and medical therapies, ASM recognizes that FDA regulation must balance 1) protecting the public from unsafe or misleading products and 2) avoiding unnecessary barriers that delay access to beneficial products. As such, ASM views the mission of FDA’s Office of Dietary Supplement Programs (ODSP) as essential to ensuring that dietary supplements contribute positively to public health.

Regulatory Interpretation and Clinical Intent

ASM supports a modern, science-based interpretation of DSHEA that evaluates microbial dietary ingredients based on identity, manufacturing controls, exposure and the totality of available safety data, rather than relying on historical dietary presence alone. Restricting dietary ingredients solely to substances with a documented history of consumption risks driving innovation into less transparent pathways. In the same vein, ASM does not advocate for simply excluding all novel microbial ingredients from the dietary supplement category. Instead, ASM supports DSHEA interpretations that align the regulatory pathway with intended use, biological activity and supporting evidence to substantiate labelling claims.

Strengthening Oversight Through Data Infrastructure

To reduce and prevent confusion around how DSHEA should be interpreted to keep pace with innovation, ASM suggests that FDA shift from reliance on the “grandfather clause” toward a dynamic, evidence-based infrastructure. ASM recommends the development of a centralized, searchable database that integrates non-confidential components of New Dietary Ingredient
 
Notification (NDIN) master files with relevant Generally Recognized as Safe (GRAS) determinations and associated evidence used to substantiate permitted claims. Among other things, dietary substances and dietary ingredients should be cataloged to specify the production methodology, identity, composition, potential byproducts or impurities, structural or functional variations, etc. This includes genomic data, colony forming units (CFU), pharmacokinetic and pharmacodynamic profiles, manufacturing process and quality controls, and other characteristics that may alter assessments for similarity or evidentiary requirements.

Conclusion and Call to Action

In closing, ASM respectfully urges FDA to interpret section 201(ff)(1)(E) in a manner that reflects contemporary microbiome science. We further encourage FDA to actively promote the use of drug and biologics pathways for microbiome products seeking health- or disease-related claims, where the medical potential of microbiome science can be fully and responsibly realized. Aligning regulatory pathways with scientific and clinical intent will protect the public, reward responsible innovation and ensure that microbiome-based products deliver genuine, evidence-based benefits to human health. ASM Health stands ready to serve as a scientific resource to FDA as it considers next steps arising from this public dialogue.