So, what's considered a minor formulation change? According to FDA guidelines, all changes should be consistent with the following six general factors:

Safety. The ingredient being substituted for the labeled ingredient must not cause any adverse health effect (including allergens, gluten, sulfites or other foods known to cause sensitivities in some people, for example, glutamates).
Quantity. The change should represent only 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 or ingredient in name. The ingredient being omitted or substituted for the labeled ingredient is not a characterizing ingredient, such as raisins 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 FDA guidance document also provides information regarding flexibilities already in food labeling regulations so that manufacturers/businesses understand that these options are readily available for use. An example is a flexibility to declare flavors, spices and certain food colors generically and, in limited cases, to use "and/or" in ingredient labeling. Other temporary flexibilities that the FDA has issued as a result of the COVID-19 pandemic address further the nutrition labeling on prepackaged foods, ingredient labeling on menus, labeling of shell eggs and safety guidelines on the distribution of eggs to retailers.

Special Reports /

Temporary FDA policies food industry clients should know

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