Go to https://www.regulations.gov/document/FDA-2026-N-1304-0001
And upload your comment stating that FDA should not adopt a threshold that leaves out 1.6 Million Americans, (ie the ED05 level) and instead delay guidance until the food allergic consumers understand what thresholds mean, how to learn what their threshold is, and whether they believe the FDA should switch from a hazard based assessment to a risk based one with regard to precautionary allergen labeling. Further, the FDA should survey food allergic consumers about those issues as well as conduct a survey of food manufacturers to determine the allergen preventative controls they utilize and whether other controls are needed to further reduce recalls especially regarding mislabeled or cross contaminated foods. Finally, if the FDA believes the time is ripe to move to a risk assessment approach, it should adopt the level that protects 99% of the food allergic community at ED01, not the level excluding 1.6 million Americans from protection (ED05). Thank you!
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