Confident View Ahead: Dietary Supplements — From Wellness Choice to Healthcare Infrastructure

May 2026

The dietary supplement category — known across markets as food supplements, herbal or complementary medicines, natural health products or nutraceuticals — is at a quiet inflection point. Nearly three-quarters of Americans now take a dietary supplement, eighty-three per cent of supplement users say they trust the industry, and the global market is on a trajectory from roughly US$218 billion in 2026 to around US$430 billion by 2035.^{¹ ² ³} Those numbers represent something more important than commercial scale. They reflect the steady migration of dietary supplements from discretionary wellness purchase to a core component of how citizens engage with their own health.

That migration is now being formally recognized. In the United States, the most coherent supplement-specific policy agenda in three decades is taking shape under the Make America Healthy Again (MAHA) priority set at the Department of Health and Human Services — covering DSHEA modernization, mandatory product listing, GRAS reform, and federal regulatory uniformity. In parallel, a broad industry coalition is advancing the Dietary Supplements Access Act to include supplements within the tax-advantaged Health Savings Account and Flexible Spending Account framework. And from India to Australia, Canada to Brazil, regulators are simultaneously tightening requirements on ingredients for which safety evidence has changed and opening positive frameworks for science-led categories such as prebiotics — work that distinguishes companies that can substantiate what is in the bottle from those that cannot.

These movements are sometimes read inside the industry as a tightening of regulation. Read at a system level, they are something different. They are the policy recognition of what supplements have already become for many citizens, and the necessary infrastructure to make that role safer, more credible, and more equitable. The strategic question for senior leaders is not how to defend the category against this evolution, but how to participate constructively in shaping it — alongside the regulators, legislators, and trade associations who will do the writing.

This edition of Confident View Ahead sets out the policy environment, the access agenda, and the global signals shaping the next decade of the dietary supplement category, and articulates Confident Strategy Group’s three convictions about what leaders should do now.

1. A modernization agenda, not a tightening cycle

The legislative environment in the United States represents the most coherent supplement-specific package since DSHEA was passed in 1994. Senator Dick Durbin reintroduced the Dietary Supplement Listing Act as S.3677 in January 2026, with a House companion (H.R. 8370) introduced by Representative Maxine Dexter in April. The bills would require every responsible person to list dietary supplements with the FDA before marketing.^{⁴ ⁵} The decisive difference from earlier attempts in 2022 and 2024 is that the Council for Responsible Nutrition, having declined to endorse earlier versions based on specific objections, now publicly supports it — after amendments that preserve the DSHEA framework, avoid pre-market approval, and protect confidential business information on proprietary blends.^⁶ CRN’s argument — that a mandatory listing gives FDA the tools to identify and act against products that operate outside the responsible mainstream — has reframed the political conversation around transparency rather than oversight.

Two further bills round out the cluster. Representative Mike Lawler’s GRAS Oversight and Transparency Act (H.R. 7291) would establish a federal review board to vet legacy “generally recognized as safe” designations made before 2000 that were never formally notified to the FDA. Representative Nick Langworthy’s Dietary Supplement Regulatory Uniformity Act (H.R. 7366) would clarify federal preemption against the growing patchwork of state-level dietary supplement requirements, including age-of-sale restrictions on weight-management and muscle-building supplements that have proliferated in recent years.^⁷ The House Energy and Commerce Committee’s 29 April 2026 “Healthier America” hearing considered all three bills, alongside the FRESH Act, in a single sitting — signaling that DSHEA modernization is being approached as an integrated framework rather than as discrete reforms.

The administrative track is equally consequential. FDA’s Human Foods Program 2026 Priority Deliverables, released on 23 January 2026, name dietary supplement oversight modernization as a specific 2026 deliverable, alongside GRAS reform, streamlining of New Dietary Ingredient notifications, and targeted enforcement against violative products.^⁸ The Spring 2026 Unified Agenda has flagged the long-awaited proposed rule formally authorizing N-acetyl-L-cysteine (NAC) as a dietary ingredient. NAC itself is a small market, but the rulemaking is significant because it would be the first use of formal notice-and-comment rulemaking under DSHEA’s drug-preclusion provision in the law’s thirty-year history — establishing a procedural precedent that the industry could in principle invoke for other ingredients caught in similar preclusion disputes. The strength of that precedent will depend on whether the final rule withstands a legal environment in which agency interpretations face closer judicial scrutiny. On 27 March 2026, the FDA’s Office of Dietary Supplement Programs convened a public meeting, Exploring the Scope of Dietary Supplement Ingredients, to examine how the 1994 DSHEA framework should apply to precision-fermented, recombinant, and other modern ingredient methodologies. The public comment window closed on 27 April.^⁹

Read individually, each of these is a regulatory adjustment. Read together, they constitute the most thoughtful supplement-specific modernization program in a generation — one that recognizes the responsible industry’s track record while equipping the FDA with tools the agency itself has signaled it needs. The companies best placed to thrive in this environment are those that already operate in accordance with current Good Manufacturing Practice, with documented supply chains and substantiated claims; for them, listing and modernized oversight reinforce the value of investments already made. The CEO question is no longer whether to support modernization, but where and how to engage constructively within it. The Council for Responsible Nutrition’s recalibration of the Listing Act is a working model.

2. The global shift toward proven ingredients

The same logic is visible, simultaneously, across the international ingredient and quality landscape.

On 15 April 2026, India’s Ministry of Ayush prohibited the use of Withania somnifera (Ashwagandha) leaves in all Ayush products and extracts. India’s Food Safety and Standards Authority extended the restriction the following day to health supplements, nutraceuticals, and food for special dietary use, citing higher concentrations of withaferin-A in the leaves than in the roots.^¹⁰ In Australia, the Therapeutic Goods Administration opened consultation on 21 April to remove Andrographis paniculata from the permitted ingredients list for listed medicines, following sustained anaphylaxis reporting that label warnings had not reduced.^¹¹ Health Canada’s Natural and Non-Prescription Health Products Directorate published its first prebiotics monograph on 30 April, formally adopting the 2017 International Scientific Association for Probiotics and Prebiotics definition and listing accepted prebiotic ingredients.^¹² Brazil’s ANVISA shortly afterward cleared NutriLeads’ precision prebiotic. The European Commission is progressing Article 8 measures under Regulation (EC) 1925/2006 covering berberine, hydroxycitric acid, and fennel seed preparations, and the long-stalled work on harmonized maximum vitamin and mineral levels in food supplements appears closer to resolution than it has in two decades.^¹³

Above national regulators, the Codex Alimentarius Commission — the joint FAO/WHO standard-setting body whose texts are referenced by the World Trade Organization in resolving international food trade disputes — is approaching a substantive moment for supplement-relevant work. The Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) is scheduled to convene its 45^th session in Autumn 2026 after a two-year intersessional period. Three workstreams stand out for supplement businesses. First, the Committee is progressing nutrient reference values (NRVs-R) for children aged six to thirty-six months — relevant for fortified foods and supplements targeting that age group. Second, in October 2024, the Committee took up a discussion paper on harmonized probiotic guidelines for use in foods and food supplements, and despite support from thirteen Codex members representing close to three-quarters of the world’s population, declined for the moment to develop a dedicated standard — leaving probiotic identity, labeling, and minimum viable count claims still to be addressed by future work.^¹⁴ Third, the long-standing Codex Guidelines for Vitamin and Mineral Food Supplements (CXG 55-2005) remain the reference text that GCC member states and many Asia-Pacific regulators adopt directly into national law. Any future revision of that guideline — including in maximum-level provisions — propagates rapidly into national supplement frameworks. In January 2026, the World Customs Organization announced that dietary supplements would be formally recognized as a distinct category within the Harmonized System, which classifies goods for international trade, reducing classification disputes and providing governments with more consistent trade data for the category.^¹⁵

Running underneath the regulatory activity is the growing weight of third-party verification. The USP Dietary Supplement Verification Program, NSF International‘s product certification and NSF Certified for Sport, and ConsumerLab‘s testing programs have shifted over the past several years from differentiators to baseline expectations in retailer scorecards, healthcare-professional recommendations, and athlete-channel listings. NSF Certified for Sport is recognized by Major League Baseball, the NHL, and the United States Anti-Doping Agency, and recommended by the NFL, NBA, and PGA, among other organizations seeking to manage the risk of contaminated supplements.^{¹⁶ ¹⁷} Consumer Reports, the NIH Office of Dietary Supplements, and nutrition associations now reference third-party certification as a baseline trust signal for the consumer.

Read together, the regulatory and verification signals are converging on a single direction of travel: a global, multi-regulator shift from acceptable ingredients toward substantiated ones, and from what the label says toward what has been independently verified. For senior leaders, three implications follow. Ingredient selection now carries direct portfolio-value implications. Standardized extracts and validated species and plant-part documentation become procurement priorities. And credible third-party certification translates into measurable shelf and channel advantage. The portfolios most exposed are those resting on opaque sourcing, unstandardized botanical inputs, or claims that cannot withstand the substantiation standards now being written. The portfolios best placed to grow are those that have already invested in identity, purity, and substantiation as core operating disciplines.

3. The access agenda is the under-discussed growth story

If regulatory modernization lifts the quality floor for the category, the access agenda determines how widely the benefit of that quality is shared. It is the area in which the responsible industry has the strongest evidence base and the broadest internal coalition — and, in our view, the most strategically valuable conversation underway.

The Dietary Supplements Access Act would amend the Internal Revenue Code to allow Americans to use funds from Health Savings Accounts, Flexible Spending Accounts, and Health Reimbursement Arrangements for dietary supplements. At present, only prenatal vitamins and a narrow set of supplements supported by a Letter of Medical Necessity qualify; the majority of high-quality, FDA-regulated supplements do not. The bill — first introduced in the 118th Congress as H.R. 4794 and a CRN 2026 legislative priority for reintroduction in the current Congress — is supported by an unusually broad industry coalition: the Council for Responsible Nutrition, the Consumer Healthcare Products Association, the American Herbal Products Association, the Natural Products Association, and the United Natural Products Alliance.^{¹⁸ ¹⁹}

The economic case has been documented. The CRN Foundation’s Frost & Sullivan study, Supplements to Savings: U.S. Health Care Cost Savings from the Targeted Use of Dietary Supplements, 2022–2030, concluded that only approximately US$59 billion of identifiable preventive healthcare savings are currently being captured. For coronary artery disease alone, targeted use of omega-3 fatty acids, magnesium, vitamin K2, and soluble fiber at preventive intake levels in at-risk populations could prevent between 81,000 and 302,000 avoidable medical events annually, delivering up to US$17.74 billion in net savings.^²⁰ The full study extends the analysis to osteoporosis, age-related macular degeneration, cognitive decline, irritable bowel syndrome, and maternal–child cognitive development, at a comparable scale. These are independent econometric analyses, not advocacy estimates, and they place dietary supplements squarely within the cost-effectiveness conversation that increasingly drives healthcare policy in the United States and beyond.

Further access dynamics deserve close attention. The Natural Products Association continues to advocate for the inclusion of dietary supplements in SNAP and WIC, which would expand access for lower-income and food-insecure populations, who often have the largest nutrient gaps.^²¹ Internationally, the affordability conversation runs in different directions. In India, an NGO petition seeks to bring nutraceuticals under the Central Drugs Standard Control Organization, citing both quality and pricing concerns. In Indonesia, BPOM’s draft regulation on the labeling of ingredient origin and alcohol content will increase documentation costs. In the European Union, a future move toward harmonized maximum vitamin and mineral levels — currently a patchwork of national rules — will reduce formulation flexibility and probably push reformulation costs into 2027 in member states with more permissive current regimes.

A less-discussed but commercially material dynamic is the operation of formal price-setting regimes for dietary supplements in parts of the Middle East. In Saudi Arabia, food supplements registered through the health-products track of the Saudi Food and Drug Authority are subject to the SFDA’s pricing rules, which include the submission of a Saudi price certificate (Form 16), the comparison of proposed prices to registered alternatives and to international reference prices, and a defined process for periodic re-evaluation of registered prices. In the United Arab Emirates, the Federal Decree-Law No. 38 of 2024 brought food supplements explicitly within the scope of medical products regulation, and the newly empowered Emirates Drug Establishment — which took over the relevant services from MOHAP on 29 December 2025 — issues the “Single Medical Product Pricing Certificate” for food supplements, alongside price lists for medicines and medical products registered in the UAE.^{²² ²³} Other GCC members typically reference the Saudi or UAE positions through the Gulf Standardization Organization framework. The practical implication is that pricing strategy in the Gulf is part of the regulatory dossier, not a downstream commercial decision; companies that approach Gulf registration without an integrated pricing position frequently encounter material commercial constraints once authorization is granted.

The strategic prize in the access agenda is larger than the tax savings on supplement purchases, important though those are for consumers. It is the formal reframing of dietary supplements from discretionary wellness consumables to evidence-based preventive healthcare infrastructure (for certain populations and conditions) — a category recognized by tax policy, healthcare policy, and clinician practice alike. That reframe, supported by the Supplements to Savings evidence base, is among the most strategically valuable narratives available to the industry in the next decade. It belongs at the center of public affairs, communications, and investor relations strategy.

The CSG Perspective

Drawing on these signals, Confident Strategy Group offers three convictions about how senior leaders should approach the next twelve months.

1. Regulatory modernization is a system-level opportunity, not a sector defense. Mandatory listing, GRAS reform, streamlined New Dietary Ingredient notifications, ingredient-specific rulemakings such as NAC, and the FDA’s broader oversight modernization are happening regardless of industry posture. The decision facing each company is whether to participate constructively in the design — through CRN, CHPA, AHPA, NPA, UNPA, and direct dialogue with regulators — or to manage the consequences of work shaped by others. Constructive participation is more demanding than opposition, but it is more durable, and it is the posture senior leaders adopt in every other mature consumer-health category.
2. Verifiable quality is a strategic brand asset, not an operational line item. As regulators and consumers converge on verified quality, third-party certification — USP Verified, NSF Certified, NSF Certified for Sport, where the channel demands it, ConsumerLab Approved — shifts from a procurement decision to a brand investment that compounds as the standard rises. The communications and retailer-engagement work to convert certification into consumer-visible quality positioning should be underway now, not after the next regulatory milestone.
3. The access agenda is where the responsible industry has the most to gain. The Dietary Supplements Access Act, the SNAP and WIC inclusion conversation, and the international parallel work positioning supplements as preventive infrastructure are the most strategically valuable narratives the industry has. They are anchored in independent evidence, supported by a broad coalition, and aligned with the cost-effectiveness pressures every healthcare payer now faces. Public affairs investment calibrated solely to defensive battles leaves the larger opportunity unattended.

Why Confident Strategy Group

Confident Strategy Group works at the intersection of policy, science, regulation, and reputation in consumer health. We have advised senior leaders on dietary supplement strategy, access, and policy for more than fifteen years across the United States, Europe, Asia-Pacific, Latin America, and the Gulf. Our client work in this space includes reshaping market access for an innovative nutrition company, repositioning a menopause symptom relief product to expand women’s access globally, leading the policy and communications strategy behind a “self-care saves lives” advocacy campaign, verifying SPF claims to address misleading marketing in adjacent self-care categories, and the foundational Filling Dietary Gaps Shouldn’t Be So Hard work on the food-versus-medicine classification question that remains live in every regulatory environment described above. We bring expertise across all the supplement classifications — food supplements in Europe, dietary supplements in the United States, health supplements in Asia, complementary medicines in Australia, natural health products in Canada, nutraceuticals in India and Latin America — together with standing relationships with the trade associations and regulators shaping the next chapter, and a strategy practice through Confident ForeFront™ and ConfidentAccess™ that translates regulatory complexity into commercial and policy decisions a senior leader can act on.

Bottom line for decision-makers

Dietary supplements are no longer a discretionary category at the periphery of healthcare. They are increasingly recognized by consumers, clinicians, regulators, and the evidence base as a meaningful part of how citizens prevent disease, maintain health, and reduce avoidable demand on stretched healthcare systems. The policy modernization underway in the United States, the quality and ingredient discipline emerging globally, and the access agenda gaining coalition support are, in our view, complementary movements toward a single outcome: a dietary supplement category that is more transparent, more substantiated, more accessible, and more trusted.

The senior leaders who engage that movement constructively — supporting modernization where it lifts the floor, investing visibly in verified quality, and championing the access and economic-case conversation — will be remembered as having helped shape it. They will also be operating from the strongest commercial position when the next decade opens. The choice is not between regulation and freedom, nor between industry and oversight. It is between participating in the design of a more credible category and inheriting the consequences of a design shaped without you.

If you would like to pressure-test your supplement portfolio strategy against the policy, quality, and access agenda described here, and translate it into priorities for your next board or executive committee, contact Confident Strategy Group. We work with senior leaders in dietary supplements, broader consumer health, and the surrounding regulatory ecosystem in every region that matters.

References

1. Council for Responsible Nutrition / Ipsos. 2024 CRN Consumer Survey on Dietary Supplements. crnusa.org
2. Ipsos. Nine in ten dietary or nutritional supplement users agree that dietary supplements are essential to maintaining their health. ipsos.com
3. Precedence Research. Dietary Supplements Market Size to Hit USD 430.39 Billion by 2035, 2026. precedenceresearch.com
4. US Congress. S.3677 — Dietary Supplement Listing Act of 2026, 119th Congress. Introduced 15 January 2026. congress.gov
5. Office of US Senator Dick Durbin. Durbin Introduces Legislation to Improve Transparency and Safety of Dietary Supplements, 15 January 2026. durbin.senate.gov
6. Council for Responsible Nutrition. CRN-Backed Product Listing Proposal Reintroduced, Advancing Long-Standing Push for Transparency, 15 January 2026. crnusa.org
7. Council for Responsible Nutrition. CRN Announces 2026 ‘Day on the Hill’ to Advance Key Legislative Priorities, April 2026. crnusa.org
8. US Food and Drug Administration. Human Foods Program 2026 Priority Deliverables, 23 January 2026. fda.gov
9. US FDA. Public Meeting: Exploring the Scope of Dietary Supplement Ingredients, 27 March 2026, docket FDA-2026-N-2047. fda.gov
10. Food Safety and Standards Authority of India. Advisory regarding non-use of Ashwagandha (Withania somnifera) leaves in food products, 16 April 2026. fssai.gov.in
11. Therapeutic Goods Administration (Australia). Stakeholders to be consulted on proposal to remove Andrographis paniculata as a low-risk ingredient, 21 April 2026, and updated safety review. tga.gov.au
12. Health Canada, NNHPD. Prebiotics Monograph, 30 April 2026; adopts the 2017 ISAPP definition (Gibson G.R. et al., Nat Rev Gastroenterol Hepatol 14:491–502). canada.ca
13. European Commission, DG Sante. Food supplements (Directive 2002/46/EC) and Article 8 of Regulation (EC) 1925/2006. food.ec.europa.eu
14. Codex Alimentarius Commission. Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) — Report of the 44th Session, Dresden 2–6 October 2024 (REP24/NFSDU); CCNFSDU45 scheduled Autumn 2026. Codex Guidelines for Vitamin and Mineral Food Supplements (CXG 55-2005). fao.org/fao-who-codexalimentarius (CCNFSDU)
15. World Customs Organization. Recognition of dietary supplements as a distinct category in the Harmonized System, announced 23 January 2026. wcoomd.org
16. United States Pharmacopeia. Dietary Supplement Verification Program. usp.org
17. NSF International. NSF Certified Dietary Supplements and NSF Certified for Sport. nsf.org
18. US Congress. H.R.4794 — Dietary Supplements Access Act, 118th Congress; expected reintroduction in 119th Congress. congress.gov
19. Consumer Healthcare Products Association. Dietary Supplements Access Act. chpa.org
20. CRN Foundation. Supplements to Savings: U.S. Health Care Cost Savings from the Targeted Use of Dietary Supplements, 2022–2030, Frost & Sullivan analysis. crnusa.org/Supplement-Savings
21. Natural Products Association. Advocacy for SNAP and WIC inclusion of dietary supplements. npanational.org
22. Saudi Food and Drug Authority. Pricing Rules for Pharmaceutical Products; Food Supplements Registration in the SFDA Drug Sector (health-product track). sfda.gov.sa
23. United Arab Emirates. Federal Decree-Law No. 38 of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (effective 2 January 2025); Ministry of Health and Prevention transfer of services to the Emirates Drug Establishment (effective 29 December 2025), including the Single Medical Product Pricing Certificate covering food supplements. uaelegislation.gov.ae; ede.gov.ae

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