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Where’s my coconut?!
FDA revised its food allergen labeling guidance.
On 7th January 2025, the US Food and Drug Administration (FDA) revised for the fifth time its food allergen labeling guidance.
As a guidance, this document is not amending the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) but is updating the FDA thinking on its interpretation. However the FDA view is changing substantially: therefore, despite the non-binding nature of guidance documents, it is better for the food industry to be updated about such changes.
Let’s see the more impactful Q&A.
- FDA does not intend to move forward with the thresholds for the declaration of food allergens or to ease the use of PAL (precautionary allergen labeling, e.g. may contain, not regulated under FALCPA)
“A.4 Do the food allergen labeling requirements of the FD&C Act require FDA to set so called “thresholds” for any food allergen?
No, the food allergen labeling requirements of the FD&C Act do not require FDA to establish a threshold level for any food allergen. FDA has previously examined the topic of thresholds but has not established specific thresholds for any food allergens. See https://www.fda.gov/food/food-labeling-nutrition/approaches-establish-thresholds-major-foodallergens-and-gluten-food.”
