In the ever-evolving world of dietary supplements, staying ahead of regulatory changes is crucial for manufacturers, retailers, and consumers alike. The U.S. Food and Drug Administration (FDA) has long been working on finalizing its guidance for New Dietary Ingredients (NDI), but recent developments under the Trump administration's push to slash regulations are throwing a wrench in the process. According to FDA official Cara Welch, Ph.D., Director of the Office of Dietary Supplement Programs (ODSP), the final NDI guidance could be stalled until 10 older regulations are eliminated. This revelation, shared at a recent industry event, highlights the broader implications of Trump's "war on regulations" for the supplement sector.

As a leading provider of AIDEVI solutions in the nutrition and wellness space, we're committed to keeping our readers informed about these critical updates. In this article, we'll break down what this means for the industry, explore unanswered questions, and discuss potential pathways forward.

Understanding the NDI Guidance Delay: Trump's Two-for-One Rule in Action

The Trump administration's executive order, often referred to as the "two-for-one" rule (now expanded in practice), mandates that agencies eliminate multiple existing regulations before issuing new ones. For the FDA's ODSP, this translates to scrapping at least 10 outdated rules, guidances, or policies to pave the way for the final NDI document.

Cara Welch addressed this during the Council for Responsible Nutrition's (CRN) Legal, Regulatory & Compliance Forum in New York City. She emphasized that even though the NDI guidance has been in draft form since 2011, it's still treated as a "new" issuance under the policy. "My understanding is, yes, we are going to be looking at 10 regulations, guidances and so forth to get rid of if we are going to have a new guidance," Welch stated. She even invited industry stakeholders to suggest which regulations could be axed, opening the door for collaborative input.

This delay comes at a time when the dietary supplement industry is booming, with innovations in manufacturing driving demand for clearer rules. The original Dietary Supplement Health and Education Act (DSHEA) of 1994 laid the groundwork for NDI notifications, but advancements like precision fermentation and synthetic biology have outpaced the framework.

A Decade of Drafts: Why the NDI Guidance Remains Controversial

The first NDI draft guidance in 2011 sparked widespread industry backlash for its strict interpretation of DSHEA. Critics argued it created unnecessary barriers to bringing new ingredients to market. Since then, the FDA has revised and reissued drafts multiple times, but core issues persist.

Here are some of the fundamental questions still unanswered:

• Bioidentical Molecules: Are factory-synthesized versions of natural compounds (e.g., via synthetic biology) acceptable as dietary ingredients, or do they require separate NDI notifications?
• Manufacturing Innovations: How does switching extraction methods—like from solvent-based to supercritical CO2—affect an ingredient's status? Does it make it "new" enough to trigger additional filings?
• Proprietary Protections: Can companies safeguard trade secrets in NDI submissions to prevent competitors from copying their innovations?

These ambiguities have left supplement companies in limbo, potentially stifling innovation and increasing compliance costs. For businesses in the U.S. and Europe, where regulatory harmony is key for international trade, resolving these could unlock new opportunities in the global market.

The Future of Self-Affirmed GRAS: A Potential Loophole Under Scrutiny

Another hot topic at the forum was the Self-Affirmed Generally Recognized as Safe (GRAS) pathway, which some ingredients use to enter the supplement market. U.S. Health and Human Services Secretary Robert F. Kennedy Jr. has labeled it a "loophole" and pushed for its elimination through rulemaking.

While GRAS applies to food ingredients that can crossover to supplements, Welch redirected focus to NDI as the primary route for dietary supplements. "For supplements, the pathway to market really is NDI," she said. "What I would like to hear more from our stakeholders is about what the barriers are to using the NDI process. Why aren’t people using it, and what can we do to fix it?"

This shift could force more companies to rely on NDI notifications, amplifying the urgency for finalized guidance. Industry leaders should prepare by reviewing their portfolios and engaging in FDA consultations to address these barriers.

FDA Staffing Concerns: Is ODSP Equipped to Handle the Load?

Amid broader Trump-era efforts to downsize the federal workforce, questions arose about ODSP's capacity. Welch reassured attendees that no staff were lost to mandatory reductions in force (RIF). However, some employees opted for early retirement buyouts.

"We did lose a few people to early retirement. But I actually think we are in a pretty good position," Welch maintained. This stability is vital as ODSP tackles not only NDI but also other regulatory priorities in the supplement space.

What This Means for the Dietary Supplement Industry Moving Forward

The delay in NDI guidance underscores the tension between deregulation and innovation in the Trump administration. For supplement manufacturers and distributors targeting the U.S. and European markets, this could mean prolonged uncertainty—but also a chance to influence outcomes. By providing feedback on regulations to eliminate, the industry can help shape a more efficient framework.

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This article is for informational purposes only and does not constitute legal advice. Always consult with regulatory experts for your specific situation.