Monday, March 21, 2016

Filing Adverse Reaction Report with the FDA

A couple of years ago I had difficulty submitting an adverse reaction report to the FDA; since they claimed that until Congress declares corn an official allergen, companies are not required to list corn/corn derivatives on their labels. They have since become more receptive to corn-related adverse reaction reports. Remember to save packaging information in order to record the UPC code, best if used by date, and lot number; and as I just discovered recently, a photo of the product package is required (front and back of product package).

https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home

http://www.fda.gov/Safety/ReportaProblem/ucm059044.htm

http://www.fda.gov/Safety/ReportaProblem/ucm055676.htm

http://www.fda.gov/cosmetics/complianceenforcement/adverseeventreporting/default.htm


Corn Allergy Advocacy/Resources
@CornAllergy911

No comments:

Post a Comment

The intentional endangerment of corn-allergic citizens by U.S. regulatory agencies. [DOCUMENTED]

I was diagnosed with an IgE-mediated allergy to corn in 2011, and have been a full-time corn allergy advocate/researcher since 2014. My pu...