ARTICLE
22 December 2016

FDA Starts Publishing Adverse Event Report Data For Foods And Cosmetics

JD
Jones Day
Contributor
Jones Day is a global law firm with more than 2,500 lawyers across five continents. The Firm is distinguished by a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.
On December 6, 2016, FDA announced that the Center for Food Safety and Applied Nutrition ("CFSAN") will post on a quarterly basis data extracted from adverse event reports...
United States Food, Drugs, Healthcare, Life Sciences
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On December 6, 2016, FDA announced that the Center for Food Safety and Applied Nutrition ("CFSAN") will post on a quarterly basis data extracted from adverse event reports related to the use of conventional foods (including dietary supplements) and cosmetics, in order to "increase transparency and improve access to government data for consumers, health care providers, researchers and academics."

The FDA uses adverse event reports to help monitor the safety of foods and cosmetics. The CFSAN Adverse Event Reporting System, or CAERS, captures minor to major medical events, as well as complaints about off-taste or color of a product, defective packaging, and other non-medical issues. The information in the database has not been edited or (in many cases) evaluated by the FDA; the agency has not necessarily determined if the product or products in question were the actual cause of the events reported. In addition, only adverse events related to the use of dietary supplements are required to be reported to FDA. Adverse event reporting is voluntary for food and cosmetic companies. 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."

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ARTICLE
22 December 2016

FDA Starts Publishing Adverse Event Report Data For Foods And Cosmetics

United States Food, Drugs, Healthcare, Life Sciences
Contributor
Jones Day is a global law firm with more than 2,500 lawyers across five continents. The Firm is distinguished by a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.
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