The health and consumer marketplace is an evolving network, constantly transforming with the addition of new medications and products. In a breakthrough decision to improve overall market transparency, the Food and Drug Administration (FDA) will publish adverse event data on products outside the drugs and medical device category.
In Dec. 2016, the FDA announced the agency will make reported data related to foods, supplements and cosmetics available to the public. The goal of the shift is to better alert consumers to products that could be hazardous, answering a long-awaited call from critics of the previous system.
“Transparency in the actions we take as an agency, and our reasons for taking them, is an important value for FDA in its mission to protect public health,” according to FDA Voice.
What is adverse event data?
The FDA uses adverse events as a catch-all term for issues that arise from a negative interaction with a product. According to the FDA, this includes a “number of poor outcomes, including bad reactions, illnesses or deaths.”
An adverse event could include life-threatening complications, or mild allergic reactions. In addition, consumer complaints, such as packaging problems, will also fall into this category.
The CFSAN Database
Initially, the adverse reports were only available through a Freedom of Information Act (FOIA) request, which can be expensive and untimely. Now, adverse event data related to food and other items will be available through the site’s Center for Food Safety and Applied Nutrition (CFSAN). The information can be reported or accessed by researchers, consumers, and health professionals, according to the FDA.
The current data archive includes reports from 2004 through September 2016. The most recent data will be updated on a quarterly basis.
Improved Regulation
The FDA believes the adverse event data will lead to better targeting of investigations, product testing and recalls, in addition to more effective alerts, warnings and actions. In the FDA’s announcement, the agency listed previous recalls and investigations sparked from adverse event reporting, including HydroxyCut, OxyElite, EOS lip balm and Brazilian BlowOut.
The agency acknowledges because the data is reported by outside parties, the information may be incomplete -- noting a report does not equal causation. Though reporting is voluntary, the FDA will continue updating the system to improve user experience in an effort to gather more complete and impactful data reports.
“We’re hoping that this increased transparency will result in more detailed and complete reports that will help us to more rapidly identify red flags about a possible safety issue with products we regulate,” according to FDA Voice.