The AMA announced in a press release that the association is expanding on its existing policy of calling for more stringent federal regulation of dietary supplements, which already includes increased oversight of manufacturing, marketing, product labeling, and adverse event reporting.
The problem, as identified by the AMA: Since 1994, reports estimate that 75,000 new dietary supplement products have been introduced. However, FDA has only received adequate safety data for fewer than 250 new ingredients, and has no way of knowing all the products on the market or their ingredients.
AMA’s solution is to urge Congress to “modify and modernize” DSHEA to allow 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 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.
On the manufacturer end, AMA’s policy urges manufacturers and distributors to clearly label all products with truthful and not misleading information. AMA also calls for updated label requirements, including replacing “proprietary blends” with a full listing of all ingredients, adding advisory statements on potential supplement-drug interactions, and including useful and accurate ingredient measurements.
“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., in the 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.”
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In NPA’s press release, Daniel Fabricant, Ph.D., President and CEO, argued that there’s no need for that level of regulation. “Nutritional supplements are strongly regulated in the United States and their safety record is far superior to prescription and over the counter drugs, and even conventional foods: we don’t have a Vitamin C crisis in America, we do have an opioid crisis,” he said. “Granted, there is no substitute for a healthy diet, exercise and good choices, and people should always speak to their doctor before deciding to take a supplement. But the truth is that few of us get enough nutrients from food alone and nutritional supplements are essential to millions of Americans who use them each and every day to support their health.”The press release noted that aWorld Health Organization reporthas shown benefits of zinc supplementation, andpoints to data showingthat 95% of adults and 98% of teens have an inadequate vitamin D intake, and that 61% of adults and 90% of teens do not get enough magnesium.
With regards to adverse effects, NPA’s press release points out that the system to which healthcare providers report adverse effects—CAERS—is the same as MedWatch, FDA’s reporting program for FDA-regulated products. NPA haswritten a letterto medical societies, including the AMA, urging healthcare providers to provide more detailed information for adverse effects related to nutritional supplements, to help policymakers and healthcare providers better understand how they occur. However, given the data we have, Dr. Fabricant notes: “Adverse events from supplements are extremely low given their widespread usage, and most of these are the result of three factors: accidents, people not consulting with their doctor, or misuse of a product combined with other health factors.”
Dr. Fabricant concluded: “We agree that the FDA can do a better job by using all of the enforcement tools it has available to protect consumers but regulating vitamin C like a drug isn’t the answer. Rather than opining about regulations and misleading Americans about the safety of nutritional supplements, the AMA would be better off urging its members to do a better job reporting adverse events associated with nutritional supplements.”
