Durbin & Blumenthal Optimistic FDA's New Online Reporting System Will Better Detect Unsafe Dietary Supplements
[WASHINGTON, D.C.] - U.S. Senator Dick Durbin (D-IL) and U.S. Senator Richard Blumenthal (D-CT) today expressed optimism that the Food and Drug Administration (FDA)’s new online adverse event reporting system will improve submission of reports from dietary supplement consumers and members of the industry and help FDA better detect dietary supplements that pose health risks. Previously, only voluntary reports could be submitted online while mandatory adverse event reports associated with dietary supplements could only be submitted over the phone or on paper.
“Reporting serious concerns with dietary supplements just became easier today,” said Durbin who led a bipartisan effort in 2006 to enact legislation requiring manufacturers to report serious adverse events related to dietary supplements. “Yet, we’ve got a long way to go when it comes to making sure FDA has the resources it needs to act quickly when a product on the market is found to be unsafe and to have the information it needs to keep those products off the market in the first place. I commend the FDA for taking this step today and I am encouraged by their commitment to improving the adverse event reporting system.”
“The online adverse event reporting system, while far from perfect, will give the FDA the resources it needs to respond more quickly when a dietary supplement is found to be unsafe and unreliable,” Blumenthal said. “I applaud the FDA for taking this practical and purposeful step, and I look forward to additional improvements to the new system. Consumers of dietary supplements should have more peace of mind as a result of today’s announcement.”
Investigative reports by “USA Today”, “Rock Center”, “Chicago Tribune” and others have exposed the lack of information about dietary supplement products while they are on store shelves. With no authority to require information about a dietary supplement before it is put on the market, the first FDA often learns about a product is when a consumer becomes sick or worse.
In August 2013, Durbin and Blumenthal introduced the Dietary Supplement Labeling Act which would improve the information available to consumers by requiring more information on product labels, give more authority to the FDA to require manufacturers to register their products and ingredients and provide proof of any health benefit claims, and curb the prevalence of drinks and foods that are masquerading as dietary supplements as a means of avoiding reviews and regulation by the FDA. Durbin and Blumenthal first introduced a version of the Dietary Supplement Labeling Act in June 2011.
Mandatory reporting of serious dietary supplement adverse event reports went into effect in December 2007, a year after the passage of the Dietary Supplement and Nonprescription Drug Consumer Protection Act authored by Durbin. The legislation required manufacturers to report serious adverse events related to consuming dietary supplements, enhancing the FDA's ability to identify and respond more quickly to potential health problems. The Dietary Supplement Labeling Act would build on that by requiring dietary supplement manufacturers to register their products with the FDA and display a mandatory warning if the product contains a dietary ingredient that may cause potentially serious adverse events.
A March 2013 Government Accountability Office (GAO) report found that between 2008 & 2011, the FDA received an average of 2,100 dietary supplement adverse event reports a year compared to fewer than 400 in 2007. The report also suggested that there is underreporting of adverse events to the FDA because consumers and health care practitioners are more likely to call poison control centers than they are to report a problem to the FDA or manufacturer.
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