October 22, 2018
Making business connections

New Transparency on FDA Adverse Event Reports

by Health After 50  

As part of a push to improve transparency, the FDA is making adverse event report data about food, supplements, and cosmetics available to the public for the first time.

This information, received by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), had previously been available only through requests via the Freedom of Information Act. Now, the data will be readily available to consumers, healthcare professionals, and researchers.

The first posting of information from CFSAN’s Adverse Event Reporting System (CAERS) consists of data about adverse events provided by consumers, medical professionals, and the healthcare industry from 2004 through September 2016.

“Adverse events” include unexpected reactions, illnesses, and deaths. The FDA plans to update this information every three months to ensure consumers have the most current information available.

The goal of this program is to alert healthcare consumers and medical professionals to potential product hazards. Information from CAERS can lead to investigations into the safety of conventional foods, dietary supplements, and cosmetics. Those, in turn, may prompt the FDA to take actions to improve product safety, communicate safety information to the public, and, in rare cases, remove a product from the market.

There is a caveat, however: The adverse events reports about a product in CAERS are not scientifically vetted, so they do not prove a cause-and-effect relationship between a product and the reported outcomes. For example, an event may have been related to an underlying condition or activity, to consumption of a different product, or simply be due to chance.

What you can do

You can access the newly public data on adverse event reports for food, supplements, and cosmetics at this FDA web page. To report a problem you've experienced with a food, supplement, or personal care (cosmetic) product—as well as with a prescription or over-the-counter drug—go to the FDA's user-friendly portal.

This article was adapted from HealthAfter50.