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.
Examples contained in the guidance include a vegetable quiche with green peppers temporarily reduced or omitted, and substituting canola oil for sunflower oil, or malic acid for citric acid.
Given the current shortages of bleaching agents used to bleach flour, the FDA is also allowing temporary flexibility for the substitution of unbleached flour for bleached flour without a corresponding label change.
The FDA is also allowing vending machine operators to waive requirements for calorie labeling on products on a temporary basis, and relaxing rules about labeling of the origin of some ingredients.
“For example, if a food states that it is made with California raisins and the manufacturer needs to substitute raisins from another domestic or international location, FDA does not intend to object.”
The move was welcomed by the American Bakers Association: “In the few instances where there might be isolated supply chain challenges due to sourcing or logistical delivery, the flexibility will enable our members to continue the steady delivery of major food staples to America’s families even if some ingredients are temporarily unavailable.”