GAO: FDA Needs to Get to Work Tracking Adverse Events Related to Dietary Supplements
Senator Durbin (D-Illinois) and Representative Waxman (D-California) requested late last year that the Government Accountability Office (GAO) examine steps taken by the Food and Drug Administration (FDA) to enhance the regulatory oversight of the multibillion dollar dietary supplements market. The GAO undertook the review and recently issues its findings. The full report can be found here.
Specifically, the GAO was asked to examine the FDA Adverse Event Reporting System (FAERS) in overseeing dietary supplements. The GAO found that from 2008-2011, the FDA received 6,307 adverse event reports for dietary supplements. Of those, approximately 70 percent were submitted by companies and most were related to products with a combination of ingredients. Notably, the GAO indicated that the FDA is likely not obtaining a significant portion of all adverse events. The report states that because consumers and others may not be voluntarily reporting the events to the FDA, but rather to other sources such as poison centers, FAERS may underestimate the adverse events related to dietary supplements.
As part of its regulatory obligations, the FDA has increased its inspections of dietary supplement companies and, in fact, has taken some actions against firms that don’t meet their FAERS reporting obligations. Notably, the FDA increased the number of inspections from 120 in 2008 to 410 during the first nine months of 2012.
Companies in the dietary supplements business need to be aware of the evolving role of the FDA in overseeing their products and ensure they are complying with rules and regulations. Currently, the FDA is not required to publicize potential safety concerns from supplement adverse event reports. However, according to the GAO report, making such information public could expand the FDA’s use of adverse event reports and improve consumer awareness of health issues reported after dietary supplement use.
When dealing with FAERS, companies must meet their reporting obligations while at the same time being wary that plaintiffs’ attorneys will attempt to use the information to establish causality between the product and the health problem. While the FDA recognizes the limits of using an adverse event report (that contains limited information) for establishing causality, plaintiffs’ attorneys do not.
In a tell of things to come, Senator Durbin has indicated that he intends to introduce the Dietary Supplement Labeling Act later this year. That bill would reportedly require supplement companies to register products with the FDA, providing ingredients, descriptions and product labeling.