CHICAGO — Given the insufficient regulation of and lack of transparency in the growing dietary supplement industry, physicians adopted new policy at the Special Meeting of the American Medical Association (AMA) House of Delegates meeting. The new policy expands upon the AMA’s existing policy to call for more stringent federal regulation of dietary supplements—including increased oversight of manufacturing, marketing, product labeling, and adverse event reporting.
While reports estimate that 75,000 new dietary supplement products have been introduced since 1994, the U.S. Food and Drug Administration (FDA) has only received adequate safety data for fewer than 250 new ingredients and has no mechanism to know all of the products on the market or their ingredients. Under the new policy, the AMA strongly urges Congress to modify and modernize the Dietary Supplement Health and Education Act to allow the FDA the authority to establish a mandatory product registry to help identify and remove dangerous dietary supplement products from the marketplace. The new policy also calls 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, M.D., M.P.H. “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.”
To help ensure manufacturers adhere to quality and safety standards, the new policy strongly urges dietary supplement manufacturers and distributors to clearly label all products with truthful and not misleading information. The AMA is also calling for specific requirements for product labels, including replacing “proprietary blends” with a full listing of all ingredients, adding advisory statements on potential supplement-drug interactions, and including accurate and useful ingredient measurements.
AMA’s new policy also supports efforts to increase patient, health care practitioner, and retailer awareness of resources to help patients select quality supplements, including educational efforts to build label literacy. The AMA also strongly urges physicians to ask their patients about their use of dietary supplements and have risk-based conversations with them about using these products.
Medications undergo a rigorous FDA approval process before entering the market and are considered unsafe until evidence shows they are safe, however dietary supplements do not undergo the same rigorous approval process and are considered safe until proven unsafe. The AMA will continue to support policies that promote increased oversight of and innovation in the dietary supplement industry and efforts to safeguard the public from unsafe and illegal products.
ph: (312) 464-4443
About the American Medical Association
The American Medical Association is the physicians’ powerful ally in patient care. As the only medical association that convenes 190+ state and specialty medical societies and other critical stakeholders, the AMA represents physicians with a unified voice to all key players in health care. The AMA leverages its strength by removing the obstacles that interfere with patient care, leading the charge to prevent chronic disease and confront public health crises and, driving the future of medicine to tackle the biggest challenges in health care.