Washington, D.C.—The American College of Physicians (ACP) has published a paper in the Annals of Internal Medicine, titled Modernizing the Regulatory Framework for Dietary Supplements: A Position Paper From the American College of Physicians, calling on Congress and federal policymakers to modernize the U.S. regulatory framework for dietary supplements. Among ACP's recommendations are:

• Modernize the regulatory framework established under the Dietary Supplement Health and Education Act of 1994 (DSHEA) by requiring dietary supplements—including products already on the market—to undergo evidence-based FDA review, registration, and approval, while meeting United States Pharmacopeia quality standards.
• Strengthen post-market surveillance by expanding mandatory recall authority for adulterated or mislabeled products and improving adverse event reporting.
• Ensure supplement marketing is evidence-based and address health misinformation by providing the Federal Trade Commission with adequate resources to monitor advertising and enforce violations.

ACP also recommended standardizing dietary supplement information and improving healthcare professionals' ability to counsel patients who use dietary supplements.

ACP's rationale, as outlined in the paper: "Dietary supplement use is common, and although there is some evidence of benefits from specific dietary supplements, particularly for persons with nutritional deficiencies, use may be accompanied by health harms that are not always well known to physicians or the public. Further, there are gaps in both pre- and postmarket regulation that do not adequately protect the public from adulterated or mislabeled products."

ACP added that its recommendations aim "to bolster the regulation of dietary supplements, improve standardization and centralized access to supplement information, and improve physician knowledge and monitoring of patient supplement use to protect public health and safety."

NPA and CRN respond to ACP's paper on dietary supplements

NPA strongly opposes ACP recommendations

The Natural Products Association (NPA) called ACP's proposal an effort to dismantle the U.S. regulatory framework governing dietary supplement products under the guise of protecting public health, noting that the proposed reforms would:

• impede access to safe products;
• kill dietary ingredient innovation;
• increase consumer costs;
• regulate “dietary supplements”— a distinct FDA-regulated category of foods created by Congress in 1994 — as pharmaceuticals.

“The dietary supplement industry is more than adequately regulated, and it has a long-established track record of safety,” said Daniel Fabricant, Ph.D., President and CEO of NPA. “Congress has delegated authority to FDA to routinely inspect manufacturing facilities, assess the safety of new dietary ingredients, and review serious adverse event reports, which could trigger FDA actions to protect the public, including mandatory recalls, seizures of products, injunctions and criminal prosecutions. ACP’s proposals would eviscerate the regulatory distinctions between pharmaceuticals and dietary supplements, undermining congressional intent in DSHEA and depriving American consumers of unfettered access to safe, beneficial nutritional products.” 

Citing growing recognition of nutrition and dietary supplements within federal health initiatives, NPA pointed to a June announcement from the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Education. As NPA shared, the agencies hosted eight of the nation's leading accreditors, assessors, and medical organizations to announce an initiative to increase nutrition requirements throughout U.S. medical education, competency evaluation, training, and residency. NPA also noted that 19 U.S. medical schools signed the Nutrition Education Pledge, committing to incorporate 40 hours of nutrition education—or an equivalent competency requirement—into graduation requirements beginning this fall.

In announcing the nutrition requirements, HHS Secretary Robert F. Kennedy, Jr. said: “Poor diets are the primary driver of America’s chronic disease epidemic, and today’s announcement reflects the shifting landscape toward placing nutrition and prevention at the core of patient health. Still, more work remains, and I look forward to seeing nutrition play an increased role as the latest science, data, and best practices develop.”

Given this, Dr. Fabricant noted, “It’s ironic that the American College of Physicians wants to treat dietary supplements as FDA-approved drugs during an administration that has recognized the urgent need for formal medical education about the value of nutrition and prevention. Consumers who use supplements and engage in self-care achieve better health outcomes. Unfortunately, ACP is tone-deaf to the growing role of dietary supplements as part of a healthy lifestyle focused on nutrition and prevention of disease. NPA will continue to fiercely oppose any proposals to dismantle the strong regulatory framework under DSHEA.”

CRN calls for targeted modernization

The Council for Responsible Nutrition (CRN) also issued a statement, offering a mixed review of ACP's paper. "We share many of the objectives outlined in the paper...including removing adulterated products from the marketplace, strengthening FDA oversight, improving physician-patient communication about dietary supplements, expanding nutrition research, and ensuring consumers have access to accurate, science-based information," CRN shared. "Where we fundamentally disagree is the paper's conclusion that these goals require replacing the Dietary Supplement Health and Education Act (DSHEA) with a pharmaceutical-style premarket approval system for dietary supplements. The primary problems identified throughout the paper—adulterated products, unlawful disease claims, fraudulent marketing, and products containing illegal pharmaceutical ingredients—are already prohibited under existing law. These examples do not demonstrate that DSHEA has failed; they demonstrate the need for stronger enforcement against companies that violate it."

The solution is not to regulate dietary supplements like prescription drugs, CRN stressed, adding that "misinformation and fear-mongering directed toward a category of products that enjoys a tremendous legacy of safe use only shut down productive conversations between patients and their healthcare providers."

Instead, CRN is calling for targeted modernization of the existing framework. "We strongly supported passage of the 2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act, a law requiring dietary supplement companies to report serious adverse effects to FDA. CRN also consistently urges Congress to increase funding for FDA’s Office of Dietary Supplement Programs to provide the necessary resources to ensure regulatory compliance and take aggressive enforcement actions against companies that intentionally violate the law.  In addition, we have repeatedly called for a dietary supplement product registry as a commonsense modernization of FDA oversight, supporting congressional efforts—including the recently introduced Dietary Supplement Listing Act of 2026. These practical reforms would provide FDA with greater visibility into the marketplace and strengthen its ability to identify and remove illegal products without disrupting responsible manufacturers or limiting consumer choice."