Coming soon... highlights of the CRN team's work so far in 2026. See 2025 reports.
Presenting data that will help define the dietary supplement category
At a pivotal moment for the future of dietary supplement innovation, two voices from CRN helped bring clarity—and urgency—to the conversation at FDA's March 27 public meeting on the evolving scope of dietary ingredients (Docket FDA-2026-N-2047).
CRN SVP and Chief Science Officer Andrea Wong, Ph.D., and SVP and General Counsel Megan Olsen delivered testimony that, together, bridged science, law, and practical reality in a way that reflects the unique value CRN provides.
Dr. Wong grounded the discussion in what innovation actually looks like today. From precision fermentation to next-generation probiotics, the science has moved far beyond 1994—but regulatory interpretation hasn’t always kept pace. Her message was clear: we cannot define “dietary substance” so narrowly that it excludes the very innovations DSHEA was designed to accommodate.
As she put it, responsible industry isn’t looking for shortcuts—it’s “knocking at the front door,” ready to demonstrate safety through the appropriate pathways, not forced into inefficient or impractical workarounds.
Ms. Olsen then reinforced that position with legal precision. The statute’s language—“to supplement the diet by increasing the total dietary intake”—was intentionally expansive. It does not require prior presence in the food supply, nor does it limit innovation to what existed decades ago. Legislative history confirms this was a conscious choice by Congress to allow the category to evolve alongside science. The path forward, as she emphasized, is not to rewrite the law—but to interpret it as written, in a way that supports both innovation and safety.
Together, their testimony reflects what CRN has consistently stood for:
✔️ Science-based policy
✔️ Regulatory clarity
✔️ Responsible innovation
✔️ A viable pathway (NDI) that actually works
As Dr. Wong noted, the detailed questions FDA is asking about identity, manufacturing, and composition are absolutely valid—but they belong in the evaluation of safety, not as a gatekeeping mechanism for whether an ingredient qualifies in the first place.
This distinction matters.
Because when the framework is too narrow, innovation doesn’t stop—it just moves elsewhere, often outside the very oversight system designed to protect consumers. A more inclusive, science-aligned interpretation does the opposite: it brings innovation into the regulatory system, where it can be properly evaluated.
That’s the opportunity in front of FDA now. And it’s why this moment feels different.
📌 The comment period is open through April 27 (FDA-2026-N-2047). CRN with its Regulatory Affairs Committee is preparing a submission. The outcome will shape both regulatory policy and the trajectory of innovation across proteins, enzymes, microbials—and beyond.
Additional Q1 activity reporting coming soon...