FDA Allowing Ingredient Substitutions During COVID-19

May 26, 2020
Agency gives temporary flexibility for ingredients in short supply without labeling changes.

The FDA issued a guidance document May 22 providing temporary flexibility in food labeling requirements when ingredients are substituted for or eliminated entirely due to supply chain disruptions associated with the current COVID-19 pandemic.

“Minor formulation changes in certain circumstances” are allowed “without updating the ingredient list on the packaged food,” the agency explained. “For example, an ingredient could be temporarily reduced or omitted (e.g. green peppers) from a vegetable quiche that contains small amounts of multiple vegetables without a change in the ingredient list on the label.”

Substitution of certain oils also may be appropriate without a label change, such as canola oil for sunflower oil, because they contain similar types of fats.

Another temporary formulation change involves substituting for bleached flour. “FDA is aware that currently there is a shortage of the bleaching agent used to bleach flour. Given significant supply chain disruptions for this ingredient during this time, FDA is providing temporary flexibility for the substitution of unbleached flour for bleached flour without a corresponding label change while there continue to be bleached flour shortages.”

The agency says minor formulation changes should be consistent with these general factors:

  • Safety: The ingredient being substituted for the labeled ingredient does not cause any adverse health effect (including food allergens, gluten, sulfites, or other foods known to cause sensitivities in some people, for example, glutamates).
  • Quantity: Generally present at 2 percent 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.

The guidance also reminds processors of existing flexibilities in food labeling regulations, such as the flexibility to exchange spices when the label declares the generic term “spice.”

Other temporary flexibilities that FDA has issued address nutrition labeling on food packages, menu labeling, packaging and labeling of shell eggs and the distribution of eggs to retail locations.

The agency also is providing temporary flexibility to the vending machine industry “and will not object if covered operators do not meet vending machine labeling requirements to provide calorie information for foods sold in the vending machines at this time.”

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