American College of Physicians Calls for Stricter Regulation of Dietary Supplements

The American College of Physicians (ACP), an organization comprised of internal medicine physicians, recently published a paper calling for stricter regulations around manufacturing and marketing of dietary supplements. The position paper, “Modernizing the Regulatory Framework for Dietary Supplements: A Position Paper from the American College of Physicians,” was published in Annals of Internal Medicine.

“Dietary supplement use continues to grow among the public. When taken as directed by a physician, dietary supplements can have material health benefits. However, under the current regulatory framework, supplements are not evaluated for their safety before going to market, unlike drugs and food additives. As a result, patients are vulnerable to potentially dangerous products and drug interactions. Skewed public perception of the safety of supplements and low rates of reporting their use to physicians and other health care professionals only contribute to making the public more at risk for severe adverse outcomes. ACP’s recommendations directly address this problem from a public health policy perspective,” said Jan K. Carney, MD, president of ACP.

ACP called on Congress to make several specific changes to the Dietary Supplement Health and Education Act (DSHEA). The first change they requested is a mandate for all supplements to undergo a pre-market approval process involving evidence-based review and registration. The organization also called for a requirement that all supplements meet quality standards set by the U.S. Pharmacopeia (USP). ACP also called on Congress to amend DSHEA to give FDA authority to bypass voluntary recall procedures when notified of adverse events or mislabeled products, so that the agency could remove products it finds in violation from the market more quickly.  

ACP also called for more resources to be dedicated to the U.S. Food and Drug Administration (FDA) for the purpose of strengthening post-market oversight and enforcement of manufacturing, quality, safety, and labeling requirements. Similarly, more resources need to be dedicated to the Federal Trade Commission (FTC) to monitor marketing and advertising of supplements, specifically by social media influencers, ACP said.

ACP urged FDA to create a national, public, searchable database of dietary supplements that includes their ingredients and scientific research on health impacts and drug interactions with standardized language and data sharing; this can ensure safety and label accuracy, while also facilitating integration into electronic health records. Because there are no standardized supplement documentation procedures, patients are susceptible to adverse events rising form drug interactions with dietary supplements, ACP reported, especially with how often they self-initiate a supplement that can interact with drugs without disclosing it to their physician.

CRN: DSHEA Doesn’t Need an Overhaul

The Council for Responsible Nutrition said in response to ACP’s paper that it shares many objectives with ACP, “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. Where we fundamentally disagree is the paper’s conclusion that these goals require replacing [DSHEA] with a pharmaceutical-style premarket approval system for dietary supplements.”

Further, adulteration, disease claims, fraudulent marketing, and products containing illegal pharmaceutical ingredients are prohibited by existing law. “These examples do not demonstrate that DSHEA has failed; they demonstrate the need for stronger enforcement against companies that violate it.”

Congress intentionally created a regulatory framework for dietary supplements that is distinct from prescription drugs, limiting the kind of ingredients that can be used and restricting the types of claims that can be made, CRN noted. “Requiring FDA premarket approval for every supplement would create an enormous regulatory burden, reduce consumer access to products with long histories of safe use, stifle innovation, and divert FDA resources away from the bad actors who pose the greatest public health risk,” CRN stated.

At the same time, CRN reported that it has advocated for certain modernization measures, such as the 2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act, which mandates adverse event reporting, as well as the dedication of resources to FDA’s Office of Dietary Supplement Programs to ensure sufficient enforcement measures are taken against violating products. CRN also called attention to its longstanding advocacy for mandatory product listing. “The choice is not between today’s regulatory framework and pharmaceutical regulation. It is between the targeted modernization that strengthens FDA’s ability to enforce the law and a sweeping overhaul that would burden responsible companies while doing little to deter those already operating outside the law.”

NPA: ACP is ‘Tone-Deaf’ to Growing Role of Preventive Care

The Natural Products Administration (NPA), in response to ACP’s position paper, noted that such proposed reforms would impede consumer access to safe, natural products, kill dietary ingredient innovation, increase costs, and effectively regulate supplements as pharmaceuticals, rather than as a distinct category of food products as they have been since DSHEA was passed in 1994.

“The dietary supplement industry is more than adequately regulated, and it has a long-established track record of safety,” said Daniel Fabricant, PhD, president and CEO of NPA, who oversaw FDA’s Division of Dietary Supplement Programs during the Obama administration. “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,” he said.

NPA noted that the current administration is recognizing the value of supplements as part of a strategy to promote health and wellness, and HHS Secretary Robert F. Kennedy Jr.’s emphasis on improving nutrition and preventive health knowledge in medical education.

In June, for instance, HHS and the U.S. Department of Education hosted eight of the nation’s leading accreditors, assessors, and medical organizations to announce plans to increase nutrition requirements at every level of U.S. medical education, competency evaluation, training, and residency. Nineteen U.S. medical schools signed a pledge vowing to incorporate 40 hours of nutritional education or its competency equivalent into graduation requirements starting this fall.

“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,” said Fabricant. “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.”