Introduction and Context
Dietary supplements—vitamins, minerals, botanicals, probiotics, amino acids, and other orally consumed products—are part of everyday life for more than half of U.S. adults. Yet for three decades the United States has regulated these products under a food-oriented law, the Dietary Supplement Health and Education Act (DSHEA) of 1994, which does not require routine premarket safety or efficacy review by the U.S. Food and Drug Administration (FDA). In July 2026, the American College of Physicians (ACP) published a position paper calling for substantial modernization of the U.S. regulatory framework to reduce harms, improve product quality, and align policy with contemporary markets and science (Cline et al., Ann Intern Med. 2026). This article summarizes the ACP’s recommendations, explains why change is needed, and highlights implications for clinicians, health systems, and patients.
Why this statement matters now
– The supplement marketplace has exploded: tens of thousands of products, globalized supply chains, and heavy promotion on social media.
– Postmarket-only oversight under DSHEA has repeatedly failed to keep adulterated, mislabeled, or unsafe products off shelves.
– Consumers and many clinicians mistakenly assume FDA premarket review; limited reporting and clinician documentation blunt adverse-event detection.
The ACP argues that the current approach is no longer fit for purpose and sets out concrete, actionable policy and practice recommendations.
New Guideline Highlights
The ACP’s position paper presents ten core recommendations focused on regulatory modernization, enforcement capacity, data infrastructure, clinical tools, and research. Major themes include:
– Shift from a purely postmarket approach to a risk-based premarket registration and evidence review of dietary supplement products (including many already on the market).
– Require adherence to recognized quality standards such as those from the United States Pharmacopeia (USP).
– Strengthen FDA and Federal Trade Commission (FTC) funding and mandatory enforcement tools (including stronger recall authority and marketing oversight).
– Build a single, searchable national database of supplements with unique product identifiers and linked evidence summaries and drug-interaction data.
– Equip clinicians and electronic health records (EHRs) with better supplement data and interaction alerts, and broaden clinician and patient education.
Key takeaways for clinicians
– Expect a policy push toward mandatory product listing and more rigorous quality/label standardization.
– Be prepared for improved information resources and EHR integration that will make documenting and checking supplement use easier.
– Continue proactively asking patients about supplement use and reporting suspected adverse events.
Updated Recommendations and Key Changes from DSHEA
What the ACP proposes that would change the DSHEA-era status quo:
– Premarket review: instead of the current model—manufacturer responsibility with limited FDA premarket power—the ACP calls for product registration and evidence-based review and approval by FDA. This would be a substantial reversal of DSHEA’s default presumption that supplements are food products not requiring premarket agency approval.
– Mandatory quality standards: ACP supports requiring manufacturers to meet USP standards (now voluntary for many supplements).
– Greater enforcement: the ACP wants stronger mandatory recall authority and improved adverse-event reporting and data sharing (e.g., better integration of poison center reports with FDA data systems).
– Centralized product database: a public national registry with unique identifiers—akin to drug NDCs—covering label claims, ingredients, and evidence.
Why these changes now: the evidence base and market environment have shifted since 1994. Fortmann and colleagues’ systematic evidence review for the U.S. Preventive Services Task Force (Ann Intern Med. 2013) and ongoing federal data collection demonstrate that many common supplements have limited disease-prevention benefits while certain product classes (weight-loss, bodybuilding, sexual enhancement) have disproportionate risks. The ACP frames these proposals as aligning regulatory oversight with contemporary public-health risk.
Topic-by-Topic Recommendations
Below are the ACP’s core recommendations organized for clinicians, policymakers, and health systems.
1) Premarket registration and evidence-based review (ACP call to Congress)
– Recommendation: Amend DSHEA to require dietary supplement products (including many already marketed) to register with the FDA and undergo risk-based, evidence-focused review.
– Rationale: Product listing enables FDA visibility over what’s on the market and prioritization for review; evidence review can identify products with clear safety concerns or unsupported disease claims.
– Practical implication: A phased, risk-prioritized approach is likely—high-risk categories (e.g., stimulants, weight-loss products) first.
2) Quality standards and manufacturing
– Recommendation: Require adherence to Current Good Manufacturing Practices (21 CFR Part 111) and to USP compendial standards for identity, purity, and potency.
– Rationale: Third-party standards reduce contamination and batch variability.
3) Strengthened enforcement and surveillance
– Recommendation: Increase FDA resources; give the agency stronger mandatory recall authority and better tools to act quickly on adulterated or mislabeled products.
– Recommendation: Improve adverse-event systems (FDA CAERS) and data sharing (poison control centers, EHRs).
4) Marketing and misinformation control
– Recommendation: Bolster FTC resources to police inaccurate or misleading advertising (including social-media influencer sponsorships and undisclosed paid endorsements).
– Rationale: Consumers often encounter unsubstantiated health claims online; aggressive enforcement can reduce harm.
5) Centralized, public product database
– Recommendation: Create an FDA-run national database with unique product identifiers, full label contents (ingredients and quantities), links to evidence and safety data, and interaction warnings.
– Clinical benefit: EHR integration of this database would allow clinicians to scan or search supplements and receive interaction alerts.
6) Clinical documentation and clinician tools
– Recommendation: EHR vendors should add discrete fields for supplement documentation and integrate interaction-checking tools.
– Recommendation: Health care organizations should collect supplement use similarly to prescription histories.
7) Research and funding
– Recommendation: Increase funding for the NIH Office of Dietary Supplements (ODS) and for clinical research on safety, efficacy, and interactions.
Expert Commentary and Insights
What the ACP committee and experts emphasized
– Burden of proof should tilt toward ensuring safety: ACP argues manufacturers should substantiate safety and label accuracy before broad marketing.
– Risk-based pragmatism: ACP acknowledges that bringing tens of thousands of products under premarket review is a large undertaking and suggests a phased, high-risk-first approach.
Areas of controversy
– Industry opposition: Mandating premarket approval and product listing has historically drawn strong industry pushback and political resistance; earlier bipartisan legislative attempts have stalled.
– Scope of regulation: Some stakeholders worry that more regulatory burden could stifle innovation or push consumers to illicit supply lines; regulators must balance access and safety.
– Resource needs: Achieving these reforms requires substantial new funding for FDA, FTC, and NIH ODS; ACP recommends industry user fees as a partial funding mechanism.
Expert voices (paraphrased)
– Public-health experts: Many welcome stronger oversight to reduce adulteration and international supply-chain risk.
– Clinicians: Most want better tools and data but emphasize the need for practical EHR workflows and educational support.
Practical Implications
For frontline clinicians
– Ask routinely: Document supplement use much like medication history; patients often do not volunteer this information.
– Report events: Increase reporting of suspected supplement adverse events (FDA CAERS) to strengthen postmarket surveillance.
– Be skeptical: Counsel patients about limited evidence for most disease-prevention claims and potential drug interactions (e.g., warfarin–herbal interactions).
For health systems and EHR vendors
– Implement discrete fields for supplement entry and integrate interaction-checking databases.
– Develop previsit questionnaires to collect supplement lists and flag high-risk products.
For policymakers and regulators
– Consider targeted, risk-based product listing and premarket review, align enforcement resources, and mandate transparent product identifiers and labeling.
Patient Vignette
Mary, a 68-year-old woman with atrial fibrillation on warfarin, reports taking an over-the-counter “herbal energy” supplement promoted online. Under the ACP-recommended system, a clinician could rapidly query the national supplement database via the EHR, see a flagged interaction risk with warfarin or an identified undisclosed stimulant in that branded product, counsel Mary, and report the event. That actionable information—currently often unavailable—could prevent bleeding or arrhythmia.
What’s Next: Research and Policy Roadmap
– Legislative action: ACP calls on Congress to update DSHEA to enable product listing and premarket review.
– Agency implementation: FDA and FTC will need expanded statutory authority and appropriations to enforce mandatory standards and marketing rules.
– Data infrastructure: Building a national, open supplement registry with unique identifiers and publicly linked evidence will be foundational.
– Clinical integration: Funding and technical standards for EHR integration and clinician education are required to translate policy into safer care.
References
1. Cline K, Beachy MW, Carr PW; Health and Public Policy Committee of the American College of Physicians. Modernizing the Regulatory Framework for Dietary Supplements: A Position Paper From the American College of Physicians. Ann Intern Med. 2026 Jul 14. doi:10.7326/ANNALS-26-01119.
2. Dietary Supplement Health and Education Act of 1994, Pub.L. 103–417, 1994.
3. Code of Federal Regulations. 21 CFR Part 111—Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (final rule, 2007).
4. U.S. Food and Drug Administration. CFSAN Adverse Event Reporting System (CAERS) — Dietary Supplements. https://www.fda.gov/food/dietary-supplements/cfsan-adverse-event-reporting-system-caers
5. Dietary Supplement and Nonprescription Drug Consumer Protection Act, Pub.L. 109–462, 2006.
6. National Institutes of Health Office of Dietary Supplements. https://ods.od.nih.gov/
7. United States Pharmacopeia. Dietary Supplements Compendium. https://www.usp.org/products/dietary-supplements-compendium
8. Federal Trade Commission. Dietary Supplements: An Advertising Guide for Industry. https://www.ftc.gov/tips-advice/business-center/guidance/dietary-supplements-advertising-guide-industry
9. Fortmann SP, Burda BU, Senger CA, Lin JS, Whitlock EP. Vitamin and Mineral Supplements in the Primary Prevention of Cardiovascular Disease and Cancer: An Updated Systematic Evidence Review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013;159(12):824–834.
(For readers: the ACP paper includes many additional source citations and an appendix outlining the detailed rationale for each recommendation.)
Bottom line
The ACP’s 2026 position paper is a clear, evidence-grounded call to modernize U.S. dietary supplement regulation: move beyond a postmarket-only approach, require product registration and quality standards, strengthen enforcement and surveillance, and give clinicians the tools they need to safeguard patients. For clinicians and health systems the near-term steps are practical: ask about supplements, document them, report adverse events, and advocate for the data and EHR integrations that will make safer care possible.
