Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                CFSAN Constituent Updates

CFSAN Constituent Updates Home
          Food
          News & Events from CFSAN
          CFSAN Constituent Updates
          FDA Begins Posting Adverse Event Report Data for Foods and CosmeticsCFSAN Constituent Updates FDA Begins Posting Adverse Event Report Data for Foods and Cosmetics
  
  	
    Share
    Post
    Linkedin

    Email
    PrintWhat's New

January 3, 2017

The CAERS data file made available on December 6, 2016 included data reported by consumers, health care practitioners, and mandatory reports by industry from January 2004 through March 2016. Data voluntarily reported by industry were not included in this data file, but will be made available during the next quarterly update in February 2017. In the interim, these reports are available through Freedom of Information (FOI) requests to FDA.

Original Constituent Update

December 6, 2016

The U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN) will now post on a quarterly basis data extracted from adverse event reports,including conventional foods and dietary supplements, and cosmetics, in order to increase transparency and improve access to government data for consumers, health care providers, researchers and academics. The agency is also making available raw data files that can be downloaded in .csv format or through OpenFDA.gov as an application program interface (API).

The CFSAN Adverse Event Reporting System (CAERS) is one of the post-market surveillance tools that the FDA uses to monitor the safety of foods and cosmetic products. Adverse event reports related to conventional foods, dietary supplements, and cosmetics come primarily from consumers and health care providers: of these products, only dietary supplement manufacturers have a legal obligation to report adverse events to the agency.

The FDA uses adverse event reports as part of its overall strategy to help monitor the safety of foods and cosmetics. The FDA anticipates that this increased transparency will help to spur the submission of more detailed and complete reports from consumers, health care providers and other members of the public. Complete and detailed reports are immensely helpful to the agency when identifying safety signals and choosing particular products for further scrutiny.

CAERS captures any adverse events or complaints related to foods or cosmetics. These can include minor to major medical events, but also complaints about off-taste or color of a product, defective packaging, and other non-medical issues. However, it’s also important to understand the information in the database is exactly as reported to the FDA, and the agency has not necessarily determined if the products(s) in question were the actual cause of the events reported.

From January 1, 2004 through September 30, 2016, the FDA received 56,574 adverse event reports. Of these, 26,840 adverse events were reported for conventional food; 25,412 were reported for dietary supplements; and 4,322 were reported for cosmetic products. FDA staff reviewed each of these reports and, collectively, initiated follow-up on hundreds of complaints to investigate potential safety signals.

The FDA is currently modernizing CAERS, improving the process for consumers, health care providers, and other members of the public to provide information to the agency, and expects to have a more user-friendly platform in one to two years. The move to post these data now is an important first step in increasing public access to such information, and the public can expect improved access to even better data in the future.

For additional information:

Federal Register Notice: Posting Adverse Event Report Data Associated with Conventional Foods, Dietary Supplements, and Cosmetics on the Internet
	CFSAN Adverse Event Reporting System (CAERS)
	Frequently Asked Questions
	Blog: Why FDA Is Making Data Extracted from Reports of Adverse Events for Foods and Cosmetics Available to the Public
	MedWatch (FDA’s site for reporting adverse events)

                                                                                  Content current as of:
      12/07/2017
              
              
Regulated Product(s)
		 Food & BeveragesCFSAN Constituent Updates
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop