U.S. Physicians' Group Demands Congress Overhaul DSHEA, Require Pre-Market Approval for All Dietary Supplements

The U.S. dietary supplement market is a $200 billion global juggernaut, offering consumers everything from daily multivitamins and protein powders to exotic botanical extracts and specialized probiotics. Yet, unlike prescription medications or even over-the-counter pain relievers, these products routinely hit pharmacy shelves and online storefronts without ever proving to the federal government that they actually work—or that they are fundamentally safe to consume. Now, the nation's largest medical specialty organization is demanding a fundamental rewrite of the rules, arguing that the current system leaves millions of Americans vulnerable to ineffective and potentially dangerous products.[4]

In a sweeping position paper published this week in the prestigious Annals of Internal Medicine, the American College of Physicians (ACP) called on Congress to completely overhaul the Dietary Supplement Health and Education Act of 1994, commonly known as DSHEA. The influential medical group is urging lawmakers to require all dietary supplements, including the estimated 100,000 products that are already available on the market today, to undergo rigorous, evidence-based pre-market review and approval by the Food and Drug Administration. This would effectively hold supplements to a standard much closer to that of pharmaceutical drugs.[1][4][5]

The proposal represents a seismic shift in how vitamins, minerals, and botanicals would be regulated in the United States. Under the current DSHEA framework, which has governed the industry for three decades, dietary supplements are legally classified as a subcategory of food, rather than as drugs. This critical distinction means that manufacturers do not need explicit FDA authorization before selling their products to the public. Instead, the system relies almost entirely on 'post-market surveillance,' a reactive approach where the government only intervenes, investigates, or issues recalls after a product is already on shelves and has been proven harmful to consumers.[1][4][6]

For the American College of Physicians, that reactive approach is no longer tenable in a rapidly expanding market. The organization argues that the 30-year-old law has created an inadequate regulatory framework that routinely allows adulterated, mislabeled, and potentially dangerous products to reach consumers. The data underscores their concern: between 2004 and 2021, the FDA received more than 79,000 reports of adverse events linked to dietary supplements. Furthermore, public health experts widely believe this figure represents only a small fraction of actual incidents, as adverse reactions to supplements are notoriously underreported by both patients and physicians.[1][2]

"The reliance on postmarket surveillance in the regulation of dietary supplements is inadequate to protect public health and safety," the ACP stated unequivocally in its policy paper. The physicians' group emphasized that while some supplements—particularly essential vitamins and minerals used to treat specific nutritional deficiencies—are backed by strong safety data and clinical evidence, thousands of others lack robust scientific backing. Many of these unvetted products carry hidden risks, including the potential to interact dangerously with prescription medications or exacerbate underlying health conditions without the patient's knowledge.[1][2][5]

The scale of the issue is massive, touching the lives of a majority of the population. More than 57 percent of U.S. adults report using at least one dietary supplement in the past 30 days, a significant jump from 51 percent in 1999. Yet, according to the ACP's findings, only about a quarter of those consumers are taking products explicitly recommended by a healthcare professional. This dynamic leaves millions of Americans navigating a complex, highly marketed, and largely unvetted marketplace on their own, often relying on social media influencers or packaging claims rather than medical advice.[2][4]

To address these systemic vulnerabilities, the ACP's ten-point reform plan goes significantly beyond simply mandating pre-market approval. The organization is demanding that all supplements meet stringent, standardized quality metrics established by the United States Pharmacopeia (USP) to ensure purity and accurate dosing. They also want Congress to grant the FDA expanded mandatory recall authority for mislabeled or contaminated products, and to significantly boost funding for the Federal Trade Commission (FTC) so the agency can crack down aggressively on deceptive marketing and illegal disease claims made online.[2][3][4]

Furthermore, the physicians are calling for the creation of a publicly accessible, comprehensive national database of dietary supplements, complete with unique product identifiers for every item sold in the United States. Crucially, this registry would be integrated directly into electronic health records (EHRs) used by hospitals and clinics. This technological integration would automatically alert doctors and pharmacists to potential interactions between a patient's self-reported supplements and their prescribed medications, closing a dangerous blind spot in modern patient care.[1][4]

Unsurprisingly, the dietary supplement industry has mounted a fierce and immediate defense of the current regulatory system, rejecting the ACP's proposals as draconian and fundamentally misunderstanding the nature of nutritional products. Trade groups representing thousands of manufacturers argue that treating vitamins, minerals, and botanicals like pharmaceutical drugs would devastate the industry, stifle natural product innovation, and drastically drive up costs for everyday consumers who rely on these products for their baseline health and wellness. They maintain that the vast majority of supplements are perfectly safe and that the industry is already heavily regulated under existing laws.[3][5]

Daniel Fabricant, president and CEO of the Natural Products Association (NPA), stated that the ACP's demands would "eviscerate the regulatory distinctions between pharmaceuticals and dietary supplements." He argued that such a sweeping move would undermine the original congressional intent of DSHEA, which was explicitly designed to ensure Americans had unfettered access to safe, beneficial nutritional products without the bureaucratic bottleneck and billion-dollar costs associated with FDA clinical drug trials. The NPA insists that the current framework, if properly enforced, is more than sufficient to protect the public.[3][5]

The Council for Responsible Nutrition (CRN), another major industry trade group, echoed these strong sentiments. While the CRN agreed with the physicians on the urgent need to remove adulterated products from the market and supported increased congressional funding for FDA enforcement actions, they firmly rejected the call for universal pre-market approval. "The solution is not to regulate vitamins, minerals, probiotics, and other dietary supplements like prescription drugs," the organization countered, warning that such a paradigm shift would force countless safe and effective products off the shelves.[4][5]

Instead of pharmaceutical-style approval, industry leaders are pointing to more targeted legislative compromises that are already circulating in Washington. The most prominent alternative is the Dietary Supplement Listing Act of 2026, a bipartisan bill introduced by Representative Maxine Dexter and Senator Dick Durbin. Rather than requiring clinical trials for efficacy, this legislation would mandate a comprehensive product registry, requiring manufacturers to submit basic label, ingredient, and sourcing information to the FDA before a product can legally go to market.[4]

CRN President Steve Mister has characterized this mandatory listing approach as a "commonsense solution" that balances consumer safety with market access. Proponents of the registry argue it would finally give the FDA clear visibility into exactly what products are on the market and who is manufacturing them. This transparency would theoretically allow the agency to swiftly identify and remove illegal, tainted, or dangerous items without subjecting standard, well-established vitamins and minerals to the prohibitive costs of full pre-market clinical trials.[3][4][6]

The escalating debate highlights a persistent point of confusion for American consumers: the subtle but critical legal difference between "structure/function" claims and "disease" claims. Under DSHEA, supplement makers are strictly prohibited from claiming their products can diagnose, treat, cure, or prevent any specific disease. They can, however, legally claim that a product supports normal bodily functions—such as "supports immune health" or "promotes joint flexibility"—provided they include a mandatory disclaimer stating that the FDA has not evaluated the statement.[6]

For practicing physicians, this nuanced legal distinction is often completely lost on patients, who may substitute unproven dietary supplements for necessary, evidence-based medical treatments based on clever marketing and influencer endorsements. The ACP's push for reform is fundamentally an effort to close this dangerous knowledge gap, ensuring that the products Americans ingest daily are held to a standard of scientific evidence that matches the health benefits they implicitly promise to deliver. Doctors argue that without pre-market proof of efficacy, consumers are essentially participating in an uncontrolled, nationwide clinical trial.[3][5]

Whether Congress has the political appetite to reopen the fiercely contested DSHEA framework remains highly uncertain. The original 1994 law was born out of a massive, industry-backed grassroots campaign by supplement users who feared losing access to natural remedies—a political force that remains highly mobilized and vocal today. However, with the supplement market having grown tenfold since the law's passage, and with the nation's largest group of internists now demanding action, the pressure to modernize oversight and prioritize consumer safety is reaching an unprecedented boiling point.[4][6]