FDA grants temporary labeling flexibility for non-allergen minor ingredients

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The goal “is to provide regulatory flexibility, where appropriate, to help minimize the impact of supply chain disruptions on product availability associated with the current COVID-19 pandemic​,” said the FDA in a guidance document​ issued Friday.

“The food industry has requested flexibility when manufacturers need to make such minor formulation changes that may cause the finished food label to be incorrect, but that do not pose a health or safety issue and do not cause significant changes in the finished food.​”

Minor formulation changes should be consistent with the factors listed below:

  • Safety​: the ingredient being substituted does not cause adverse health effect (including allergens, gluten, sulfites, or other foods known to cause sensitivities in some people such as glutamates) 
  • Quantity​: present at 2% or less by weight of the finished food
  • Prominence​: the ingredient being omitted or substituted for the labeled ingredient is not a major ingredient in the product
  • Characterizing ingredient​: the ingredient being omitted or substituted for the labeled ingredient is not a characterizing ingredient; for example, omitting raisins, a characterizing ingredient in raisin bread
  • Claims​: an omission or substitution of the ingredient does not affect any voluntary nutrient content or health claims on the label
  • Nutrition/Function​: an omission or substitution of the labeled ingredient does not have a significant impact on the finished product, including nutritional differences or functionality.

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