Letter to FDA re: Adverse event reporting

Letter to FDA re: Adverse Event Reporting image


CSPI writes to draw FDA’s attention to our new publication in the journal Annals of Allergy, Asthma, & Immunology titled “Adverse Events and Labeling Issues Related to Suspected Sesame Allergy Reported in an Online Survey.” This study adds to the body of literature documenting under-reporting of adverse events related to foods to FDA. We request a meeting with the Center for Food Safety and Applied Nutrition (CFSAN) to discuss our findings and, more generally, our recommendations for an improved adverse event reporting system.

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