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December 09, 2016

FDA's Public Posting of Food Safety Adverse Event Reports: Four Things to Know

As part of a new initiative, the U.S. Food and Drug Administration (FDA) will begin publicly posting all consumer reports of adverse events related to food, dietary supplements and cosmetics. Here are four things companies in these industries should know about the new reporting system and how to prepare for the FDA’s continued efforts at increased transparency.

What is FDA Doing That’s New?

On December 6, 2016, FDA announced that for the first time, it will make public reports that FDA’s Center for Food Safety and Applied Nutrition (CFSAN) receives about consumer adverse events associated with food and dietary supplements, as well as for cosmetics. FDA posted initial data (redacted to protect consumer privacy) from January 2004 through March 2016. Going forward, the agency will begin posting reported data on a quarterly basis to a dedicated space on fda.gov.

What is the Adverse Event Data to be Posted? Where Does It Come From?

The posted data will be extracted from the CFSAN Adverse Event Reporting System (CAERS). CAERS is a database that contains reports submitted voluntarily by consumers, healthcare professionals and others about food and cosmetics, as well as mandatory reports for adverse events involving dietary supplements. The reports include quality complaints such as off-taste or defective packaging, but the majority of reported events involve minor to major medical concerns that the consumer or other reporting individual believes may be linked to consumption or use of a conventional food, dietary supplement or cosmetic product. The posted data will include:

  • demographic and administrative information and the CAERS report ID number;
  • product information from the case reports;
  • symptom information from the reports;
  • patient outcome information from the reports.

How Should This Public Data Be Interpreted?

CAERS contains information exactly as reported to FDA, therefore the agency offers this critical caveat:

“The adverse event reports about a product and the total number of adverse event reports for that product in CAERS only reflect information AS REPORTED and do not represent any conclusion by FDA about whether the product actually caused the adverse events. For any given report, there is no certainty that a suspected product caused a reaction. Healthcare practitioners, firms, agencies, consumers, and others are encouraged to report suspected reactions; however, the event may have been related to a concurrent underlying condition or activity or to co-consumption of another product, or it may have simply occurred by chance at that time.”

What Does This Mean for My Business?

The posted data may be searched by the public to identify reports against certain types of food and dietary supplements or against certain manufacturers or brands. Most consumers, however, are unaware of CAERS, and in the near term, that level of awareness may not change simply because reporting data is now publicly available. If inquiries are received, media relations and consumer services divisions can remind the public that the information in these reports has not been scientifically, medically or otherwise verified and that FDA repeatedly warns it is not safe to assume that a product listed in a report actually caused an adverse event.

In the longer term, FDA plans to modernize its reporting system to encourage submissions and improve data quality. FDA hopes this increased transparency will lead to more detailed reporting that will help the agency better identify potential safety issues with the products it regulates.

The material contained in this communication is informational, general in nature and does not constitute legal advice. The material contained in this communication should not be relied upon or used without consulting a lawyer to consider your specific circumstances. This communication was published on the date specified and may not include any changes in the topics, laws, rules or regulations covered. Receipt of this communication does not establish an attorney-client relationship. In some jurisdictions, this communication may be considered attorney advertising.

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