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I recently submitted a public comment to FDA, following its public meeting on the scope of dietary supplement ingredients, providing input on the regulatory framework as it applies to microbial products and probiotics.

https://www.regulations.gov/comment/FDA-2026-N-2047-0009

Over the last 20 years, advances in microbiome science have significantly expanded our understanding of the diversity of microorganisms that are routinely ingested through the food supply and that actively participate in human gut physiology. As a former Principal Investigator at the U.S. Food and Drug Administration (FDA), a former group leader at the National Institute of Standards and Technology (NIST), and a former member of the USP Probiotics Expert Panel, my work over the past 25 years has focused on microbial genomics, molecular genetics, analytical measurement science, and the development of standards to support regulatory and industry decision-making. In this context, thousands of microbial species, many only recently characterized through genomic methods, are now recognized as components of the normal dietary and gastrointestinal landscape. A growing body of scientific literature demonstrates that greater microbial diversity in the gut is associated with improved resilience, metabolic function, and overall health, while reduced diversity has been linked to a range of adverse outcomes. Diet is a primary driver of this diversity, serving not only as a source of nutrients for the gut microbiome, but also as a direct source of microorganisms[1]. This includes microbes associated with fermented foods as well as those naturally present on fresh fruits and vegetables and other environmental sources[2]. These observations underscore the importance of microbial exposure as a component of human nutrition. In this context, these organisms also represent a substantial and largely untapped pool of candidates for next-generation probiotic products.

Modern analytical methodologies, including whole genome sequencing, comparative genomics, and MALDI typing, provide robust and reproducible frameworks for establishing strain-level identity, assessing purity, and evaluating safety of microbial products[3]. These tools enable a level of precision and standardization that was not available at the time DSHEA was enacted and should be recognized as fit-for-purpose for supporting the responsible development of microbial dietary ingredients.

In this context, interpreting DSHEA, which was enacted in 1994, to limit dietary ingredients only to substances with a documented history of dietary presence is unnecessarily restrictive, particularly given that our understanding of the microbiome of the food supply and the human gut was extremely limited at the time. Such an interpretation does not reflect the intent of Congress to foster a dynamic and evolving dietary supplement marketplace, nor does it account for the transformative impact of modern biotechnology on ingredient discovery and characterization. A more appropriate framework would allow for the inclusion of novel microbial ingredients that can be rigorously defined and demonstrated to be safe using contemporary scientific standards[4]. Adopting this approach would support innovation, promote economic development, and enable the delivery of evidence-based probiotic products to consumers, while maintaining appropriate regulatory boundaries between supplements and therapeutic products.

It is also important to recognize that microbial dietary supplements (i.e., probiotics) and live biotherapeutic products (LBPs or “bugs as drugs”) serve distinct and complementary roles within the broader microbiome ecosystem, and both should be supported within an appropriate regulatory framework. Regulatory precedent demonstrates that closely related substances can appropriately exist in both drug and dietary supplement frameworks. For example, prescription omega-3 products such as icosapent ethyl are derived from the same underlying compounds found in fish oil supplements, with differentiation driven by purity, dose, and intended use rather than entirely distinct identity. Therapeutic applications of live microbes, where products are intended to diagnose, treat, or prevent disease, are appropriately developed and regulated under drug authorities, while dietary supplements are intended to support general health and nutrition. Preserving these parallel pathways enables innovation while ensuring that regulatory oversight is aligned with product intent and risk.

In summary, FDA should adopt a modern, science-based interpretation of DSHEA that supports innovation in microbial dietary ingredients while maintaining clear, risk-appropriate distinctions between supplements and therapeutic products. Such an approach will enable continued scientific advancement, promote responsible product development, and better serve public health.

Sincerely,
Scott A. Jackson
Founder and Principle

The NEST: A Biotechnology Consulting Firm

https://thenest.consulting/

About the author: 

I am a microbiome scientist and former FDA and NIST research leader with over 25 years of experience in microbial genomics, analytical method development and validation, standards development, and regulatory science. I have published over 70 scholarly articles related to these topics. In 2015, I co-founded the International Microbiome and Multi’omics Standards Alliance (IMMSA) which has grown to include over 900 international members from academia, industry, and government. Through The NEST, I advise companies on the development, validation, and regulatory positioning of microbiome and biotechnology products, including quality systems for biomanufacturing and analytical assurance. I would welcome the opportunity to engage further with FDA and stakeholders as these important policy considerations evolve.

[1] Frame LA, Costa E, Jackson SA. Current explorations of nutrition and the gut microbiome: a comprehensive evaluation of the review literature. Nutr Rev. 2020;78(10):798-812. doi:10.1093/nutrit/nuz106

[2] Wicaksono WA, Cernava T, Wassermann B, et al. The edible plant microbiome: evidence for the occurrence of fruit and vegetable bacteria in the human gut. Gut Microbes. 2023;15(2):2258565. doi:10.1080/19490976.2023.2258565

[3] Jackson SA, Schoeni JL, Vegge C, et al. Improving End-User Trust in the Quality of Commercial Probiotic Products. Front Microbiol. 2019;10:739. Published 2019 Apr 17. doi:10.3389/fmicb.2019.00739

[4] Roe AL, Boyte ME, Elkins CA, et al. Considerations for determining safety of probiotics: A USP perspective. Regul Toxicol Pharmacol. 2022;136:105266. doi:10.1016/j.yrtph.2022.105266