AMA is strongly urging Congress to modify and modernize the Dietary Supplement Health and Education Act (DHSEA) to allow FDA the authority to establish a mandatory product registry.
The American Medical Association (AMA; Chicago, IL) recently released a statement calling for increased regulation of dietary supplements. This is part of a new policy adopted by physicians at the Special Meeting of the American Medical Association House of Delegates to expand AMA’s existing policy calling for more stringent federal regulation of dietary supplements. More specifically, under the new policy AMA is strongly urging Congress to modify and modernize the Dietary Supplement Health and Education Act (DSHEA) to allow FDA the authority to establish a mandatory product registry. AMA is also calling for increasing FDA’s authority and resources to implement and enforce policies related to dietary supplements, such as mandatory recall, risk-based inspections of manufacturing facilities, and strengthening adverse event reporting systems.
“Patients and physicians expect the dietary supplements they purchase and recommend to be safe, quality products that are accurately labeled with their contents. As the dietary supplement industry continues to grow with little oversight, many more people will use supplements without having a clear understanding of what’s contained in these products potentially putting their health at risk,” said AMA Immediate-past Board Chair Jesse M. Ehrenfeld, MD, MPH, in a press release. “We need the federal government to step up its regulation and enforcement of the dietary supplement industry to remove unsafe products from the market and protect public health.”
In response to AMA’s statement, the Consumer Healthcare Products Association’s (CHPA; Washington, D.C.) vice president of scientific affairs and dietary supplements, John Troup, PhD, released his own statement, speaking in support of AMA. “Today’s American Medical Association (AMA) call for more stringent regulation and more FDA enforcement has many parallels to calls from the supplement industry – including members of the Consumer Healthcare Product Association (CHPA) – who believe DSHEA needs to be modernized and strengthened,” said Troup. “More than 25 years after the passage of DSHEA, the dietary supplements market has outgrown and outpaced the regulatory framework. Modernization is an important public health issue as bad actors continue to sell adulterated or misbranded dietary supplement products.
“CHPA is also advocating for increased resources for FDA to support more enforcement and new regulatory tools,” he continued. “Improvements such as mandatory product listing and other modernizations can help FDA to quickly identify and remove potentially hazardous and adulterated products from the market while also ensuring products meet quality standards. We look forward to collaborating with FDA and other stakeholders, including AMA, on proposals to enhance quality and oversight.”
Mandatory product registration is a topic of debate within the industry, with groups such as CHPA and the Council for Responsible Nutrition (CRN; Washington, D.C.) viewing it favorably, and groups such as the American Herbal Products Association (AHPA; Silver Spring, MD) and the Natural Products Association (NPA; Washington, D.C.) showing skepticism. CRN, for its part, has launched a voluntary registry called the Supplement OWL as a tool for industry self-regulation, and to provide an existing framework should FDA mandate a product registry.