Why Regulatory Strategy Is Becoming the Most Important Part of Supplement Development

TL;DR

The global supplement industry is booming, but regulators in both the US and EU are tightening oversight of ingredients, safety claims, and novel food technologies. In the US, the FDA is closing the Self GRAS loophole and stepping up enforcement of New Dietary Ingredient (NDI) notifications. In Europe, EFSA is raising the bar on health claim evidence, and the proposed EU BioTech Act signals stricter governance of precision fermentation and microbial ingredients. For supplement brands, regulatory strategy is no longer an afterthought; it must be embedded in product development from day one. The brands that adapt now will build stronger, more trusted products and gain a meaningful edge.

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The Industry Is Entering a New Phase

The global dietary supplement market has grown faster than the regulatory frameworks designed to govern it. Valued at over USD $167 billion in 2023 and projected to exceed $300 billion by 2030, the sector has attracted unprecedented investment and innovation.¹ But 2026 may mark the moment that regulators finally catch up.

Consumer expectations are shifting. Retailers are demanding cleaner labels. And regulatory agencies on both sides of the Atlantic are tightening their grip on ingredient safety, health claims, and novel food technologies. For supplement brands, the era of compliance as an afterthought is drawing to a close.

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The US Regulatory Shift

Closing the Self-GRAS Loophole

Under the US Food, Drug, and Cosmetic Act, ingredients deemed 'Generally Recognised as Safe' (GRAS) may be used in food and supplements without formal FDA pre market approval. Historically, companies could make this determination themselves, a process known as self-affirmation of GRAS, without ever notifying the FDA.²

This long standing loophole is under increasing scrutiny. The FDA's voluntary GRAS notification programme has revealed that a significant proportion of safety determinations are made internally, with no external review. A 2023 report by the Government Accountability Office (GAO) called on the FDA to strengthen oversight of the GRAS pathway, highlighting systemic gaps.³

Brands should anticipate higher documentation requirements, more robust safety substantiation, and increased pressure to submit formal notifications, particularly for novel or synthetic ingredients.

New Dietary Ingredient (NDI) Guidance

Any dietary ingredient not marketed in the United States before October 15, 1994, is considered a New Dietary Ingredient (NDI) and requires a pre-market safety notification to the FDA at least 75 days before launch.⁴ Yet enforcement has historically been uneven, and many companies have marketed NDI containing products without ever submitting a notification.

The FDA has signalled its intent to provide clearer NDI guidance and to increase enforcement activity. A 2022 FDA discussion paper acknowledged that the current framework is underutilised and outlined proposals for more defined submission requirements.⁵ Brands launching products containing novel or modified botanical extracts, biofermented actives, or synthetic analogues of natural compounds should proceed with particular caution.

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Europe's Increasing Scientific Oversight

EFSA's Expanding Role

The European Food Safety Authority (EFSA) is the scientific backbone of food and supplement regulation across the EU. Its role has grown substantially in recent years, both in the depth of evidence it demands and the breadth of ingredients it reviews.

Health claims authorised under Regulation (EC) No 1924/2006 must now be substantiated by robust clinical evidence, with EFSA's opinions carrying significant weight in Commission decisions.⁶ Brands making structure-function or health claims in the EU must ensure those claims are either on the approved list or supported by sufficiently powered, well-designed human trials. Novel food ingredients, including many plant extracts, bioactive peptides, and algae-derived compounds, require full EFSA safety assessments under Regulation (EU) 2015/2283 before they can legally enter the market.⁷

The Proposed EU BioTech Act

The European Commission's proposals for a dedicated biotechnology regulatory framework, often discussed under the banner of an 'EU BioTech Act', reflect growing policy ambitions around precision fermentation, synthetic biology, and microbially derived ingredients.⁸

While legislation is still developing, the direction is clear: the EU wants stronger scientific governance of emerging food technologies. Brands working with fermentation derived proteins, bioengineered actives, or microbial metabolites should anticipate more defined approval pathways, longer regulatory timelines, and higher evidence thresholds.

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Why This Matters for Supplement Brands

Regulation now touches every part of the product lifecycle. Consider what each major regulatory development means in practice:

• Formulation: Ingredient selection must account for GRAS status, NDI history, novel food classification, and permitted dosage limits across target markets.

  
  

• Health claims: Marketing language must be tied to approved claim lists or supported by credible evidence; aspirational copy is no longer sufficient.

  
  

• Ingredient sourcing: Supply chain transparency and traceability are increasingly required, both for regulatory submissions and retailer compliance audits.

• Manufacturing: GMP compliance, third-party testing, and documentation standards are subject to growing regulatory attention.

The contrast between reactive and proactive approaches is stark. A brand that develops a product first and checks compliance later risks costly reformulation, delayed launches, or enforcement action. A brand that integrates regulatory strategy from the outset makes better decisions at every stage.

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The Growing Need for Integrated Expertise

One of the most common and costly mistakes in supplement development is treating formulation and regulatory strategy as separate workstreams. In practice, they are deeply interdependent.

A high-quality ingredient may fail regulatory review if it exceeds permitted dosage limits in a target market. A health claim may be unsupportable if the clinical evidence comes from a population or format that regulators do not accept. Even a novel fermentation derived active could trigger a novel food review, potentially adding 18–24 months to the launch timeline.

Effective supplement development requires simultaneous expertise across three domains:

• Formulation science: Ingredient compatibility, bioavailability, dose optimisation, and stability.

  
  

• Regulatory strategy: jurisdiction-specific requirements for safety notifications, health claims, and novel food status.

• Ingredient sourcing: supply chain verification, certificate of analysis review, contaminant testing, and traceability.

At Balkin Nutrition, we integrate all three into a single development process so regulatory considerations inform formulation decisions from the outset, rather than appearing as obstacles at the end.

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What Brands Are Doing Now

The brands best positioned for the regulatory environment ahead are already taking concrete steps:

• Reviewing ingredient dossiers for GRAS status, NDI history, and novel food classification across target markets before finalising formulations.

• Assessing health claims, early mapping intended claims to approved lists or identifying the evidence needed to substantiate them.

• Auditing supply chains for traceability, third-party testing standards, and compliance with EU and US import requirements.

• Engaging regulatory consultants or integrated development partners at the concept stage, not after product sign-off.

• Monitoring regulatory developments, including FDA NDI guidance updates and emerging EU biotechnology legislation, as part of their commercial planning.

These are not precautionary measures taken by risk averse companies. They are strategic investments being made by the brands most serious about long term growth.

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Conclusion

The supplement industry is entering a new era, one where scientific credibility and regulatory preparedness will increasingly define which brands succeed and which fall behind.

The GRAS and NDI frameworks in the US are tightening. EFSA's evidence expectations in Europe are rising. Emerging biotechnology regulations will reshape how novel ingredients are developed and approved. Retailers and consumers are demanding greater transparency and substantiation than ever before.

The brands that adapt early will not only remain compliant, but they will build stronger, more trusted products, access more markets, and command greater loyalty from both retailers and consumers.

Regulatory strategy is no longer a back end function. It is the foundation of effective supplement development.

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Need Help With Compliance?

As regulatory frameworks tighten on both sides of the Atlantic, ensuring your supplement listings meet evolving compliance standards is no longer optional. We help brands audit product listings, review label claims against applicable regulatory requirements, and organise third-party testing so you stay compliant, protect your market access, and avoid costly disruption to your business.

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References:

1. Grand View Research. (2024). Dietary Supplements Market Size, Share & Trends Analysis Report. https://www.grandviewresearch.com/industry-analysis/dietary-supplements-market

2. US FDA. (2023). Generally Recognized as Safe (GRAS). https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras

3. US Government Accountability Office. (2023). FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be GRAS. GAO-23-104501. https://www.gao.gov/products/gao-23-104501

4. US FDA. (2022). New Dietary Ingredients in Dietary Supplements. https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/new-dietary-ingredient-ndi-notification-process

5. US FDA. (2022). New Dietary Ingredients: Regulatory Framework and Enforcement Priorities. FDA Discussion Paper.

6. European Commission. (2006). Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32006R1924

7. European Commission. (2015). Regulation (EU) 2015/2283 on novel foods. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015R2283

8. European Commission. (2023). EU Biotechnology and Biomanufacturing Initiative. https://ec.europa.eu/commission/presscorner/detail/en/ip_22_6118

9. Holland & Barrett. (2024). Supplier Quality Standards. Internal trade documentation.

10. Council for Responsible Nutrition. (2024). CRN Consumer Survey on Dietary Supplements. https://www.crnusa.org/resources/2024-crn-consumer-survey-dietary-supplements

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Disclaimer

The information contained in this article is intended for general informational and educational purposes only. It does not constitute legal, regulatory, or professional advice and should not be relied upon as such. Regulatory frameworks vary by jurisdiction and are subject to change; readers are strongly encouraged to seek independent legal or regulatory counsel before making decisions relating to product development, ingredient safety, health claims, or market entry. Balkin Nutrition accepts no liability for actions taken or not taken based on the contents of this article. Reference to third-party sources, legislation, or organisations does not imply endorsement or guarantee of accuracy beyond the date of publication.