First, the FDA is providing flexibility for manufacturers to make minor formulation changes in certain circumstances without making conforming label changes, such as making a change to product ingredients, without updating the ingredient list on the packaged food when such a minor change is made. For purposes of this guidance, minor formulation changes should be consistent with the general factors listed below, as appropriate:
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; and
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.