Published in the Annals of Internal Medicine on July 14, the physician organization’s paper argues that the current regulatory framework for dietary supplements does not adequately protect consumers from unsafe, ineffective or misleadingly marketed products and recommends sweeping reforms.
“ACP calls on Congress to modernize the regulatory framework for dietary supplements under DSHEA to require premarket approval by the FDA, bolster post-market surveillance, and ensure that marketing is evidence-based while combatting the proliferation of harmful misinformation on social media,” the authors wrote.
Leading US dietary supplement trade associations have pushed back against the proposal, arguing that many of the ACP’s concerns could be addressed through stronger enforcement of existing law and targeted updates to DSHEA, rather than a pharmaceutical-style approval system.
Common ground on enforcement
The Council for Responsible Nutrition (CRN) said it shared several of the ACP’s broader objectives while drawing a clear distinction over how those objectives should be achieved.
“We support stronger and swifter action by FDA to remove adulterated and illegally marketed products, more effective FDA oversight, better communication between physicians and patients about supplement use, greater investment in nutrition research, and improved access to accurate, science-based information,” Jeff Ventura, vice president of communications at CRN, told NutraIngredients.
The organization also agreed that companies making unlawful disease claims, deceptive marketing claims or selling products adulterated with pharmaceutical ingredients should face enforcement, noting those activities are already prohibited under DSHEA.
One area of overlap is product registration. While ACP recommends mandatory FDA registration and approval of dietary supplements, CRN also called for a mandatory dietary supplement registry to improve FDA’s visibility into the marketplace, although the association stopped short of supporting premarket approval.
Premarket approval draws opposition
Despite that agreement, CRN said the ACP’s proposal to replace DSHEA’s food-based regulatory framework with a premarket approval system represented a fundamental point of disagreement.
“Vitamins, minerals, probiotics, botanicals, and other supplements are not prescription drugs, and they should not be required to demonstrate drug-like efficacy before reaching the market,” Ventura said.
He argued that the violations highlighted in the ACP paper already violate existing law and demonstrate a need for stronger enforcement rather than a new regulatory framework.
Instead, CRN called for additional funding for FDA’s Office of Dietary Supplement Programs, greater use of third-party audit data to focus on inspections and clearer implementation of the new dietary ingredient notification process.
The American Herbal Products Association (AHPA) also distinguished between updating DSHEA and replacing it.
“AHPA respects the commitment of the American College of Physicians to patient wellness and public health, and we welcome its constructive interest in the dietary supplement marketplace,” Graham Rigby, president and CEO of AHPA, told NutraIngredients. “However, we strongly oppose the premarket approval system proposed by the ACP, which does not exist for other food products or cosmetics.”
Rigby said AHPA has long advocated for targeted modernization of DSHEA through clearer and more consistent pathways for ingredient innovation alongside strong enforcement of existing requirements.
He added that a pharmaceutical-style review process could limit access to safe herbal products and dietary supplements and said the association would continue working with policymakers on reforms designed to improve transparency, protect consumers and support responsible marketplace innovation.
NPA says FDA already has the tools
The Natural Products Association (NPA) argued that many of the ACP’s recommendations overlook authorities FDA already has under existing law.
“I’m unaware of any situation where FDA hasn’t addressed unsafe products in the marketplace... ACP doesn’t even know which tools FDA has,” Daniel Fabricant, PhD, president and CEO of NPA, told NI.
He pointed to FDA’s existing mandatory recall authority for foods, including dietary supplements, as well as the agency’s serious adverse event reporting system, which manufacturers are already required to use.
“Companies are required to report SAERs to FDA...it’s the exact and identical MedWatch that is used on the drug side of FDA, so doesn’t that mean the system for detecting post-market problems for drugs is inadequate as well according to ACP?”
Dr. Fabricant also argued that products adulterated with active pharmaceutical ingredients should not be considered dietary supplements.
“ACP’s paper focuses on adulterated products, products that aren’t supplements at all, rather they include active pharmaceutical ingredients (APIs) or derivatives of APIs. This makes them illegal drugs, not ‘dietary supplements,’ and NPA has always expressed support for swift enforcement against them.”
Going forward, Dr. Fabricant said FDA should continue to prioritize inspections, laboratory testing and enforcement against products that pose genuine risks to consumers, including adulterated products and counterfeit supplements sold through online marketplaces.
