Primary tabs

Why FDA Is Making Data Extracted from Reports of Adverse Events for Foods and Cosmetics Available to the Public

By: Susan Mayne, Ph.D., and Katherine Vierk, M.P.H.

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.
Susan Mayne
—Susan Mayne, Ph.D., is Director of the FDA’s Center for Food Safety and Applied Nutrition

That is why we are, for the first time, making public the data that FDA’s Center for Food Safety and Applied Nutrition (CFSAN) receives about adverse events related to foods, including conventional foods and dietary supplements, and cosmetics regulated by FDA. This is information that was once only available through Freedom of Information Act (FOIA) requests, but will now be easily available to researchers, consumers, and health professionals.

This first posting of data from CFSAN’s Adverse Event Reporting System (CAERS) includes data from reports submitted by consumers, medical professionals and industry from 2004 through September 2016. The term “adverse event” is an umbrella term for a number of poor outcomes, including bad reactions, illnesses or deaths. We plan to update this information quarterly to ensure that the public has the most current information available.
Katherine Vierk
—Katherine Vierk, M.P.H., is the Director of the Division of Public Health Informatics and Analytics at FDA’s Center for Food Safety and Applied Nutrition

The goal of CAERS is to provide indications, or “signals” of potential hazards. FDA uses these adverse event reports to monitor the safety of foods, including conventional foods and dietary supplements, and cosmetics. This information can, and has, led to investigations of specific products, targeted inspections and product testing, import alerts, warning letters, and enforcement actions.

Examples of how adverse event data has been used to support multiple actions by FDA include recalls of HydroxyCut and OxyElite Pro dietary supplements, and investigations of cosmetic products, such as EOS lip balm and Brazilian BlowOut hair smoothing treatment.

A few caveats about CAERS: The data from the reports is what was reported to the agency. FDA has not necessarily determined that the events reported were actually caused by the product in question. And there often are gaps in the information provided, which should ideally include the product name, symptoms, outcome, consumer’s sex and age, and the date the adverse event was experienced.

Going forward, FDA intends to modernize the system to make reporting adverse events as user-friendly as possible. You can expect to hear more about that in about a year. But in the meantime we didn’t want to delay giving the public access to data we have. The CAERS data will be posted on fda.gov and is also available through OpenFDA, launched in 2014 to make it easier to access the agency’s publicly available information.

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. Anyone can report a safety or quality issue with an FDA-regulated food (conventional foods and dietary supplements) and cosmetics. To do so, visit fda.gov.

Susan Mayne, Ph.D., is the Director of FDA’s Center for Food Safety and Applied Nutrition

Katherine Vierk, M.P.H., is the Director of the Division of Public Health Informatics and Analytics at FDA’s Center for Food Safety and Applied Nutrition

Cross posted from December 6, 2016 by FDA Voice