The U.S. Food and Drug Administration (FDA) has issued a new guidance document to provide additional but temporary flexibility in food labeling requirements to manufacturers and vending machine operators. The goal, says FDA, 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. 

The guidance, entitled “Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines,” is one of several that FDA has issued during the pandemic to provide temporary flexibility to the food industry and to help support the food supply chain meet customer demand.

Within the guidance, 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. Also within this specific guidance, minor formulation changes should be consistent with the following general factors, 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. 

The guidance does include some specific examples of scenarios when labeling may or may not need altering, such as:

  • … if the label of a spaghetti sauce makes the statement “made with mushrooms” and the ingredient statement declares portobello mushrooms as an ingredient, we do not intend to object if the firm temporarily needs to use button mushrooms rather than portobello mushrooms. However, if the label of a spaghetti sauce makes the statement “made with portobello mushrooms,” a substitution with button mushrooms should not be made unless accompanied by a corresponding label change.
  • … substitution of canola oil for sunflower oil may be appropriate without a label change (both are vegetable sourced and have similar fatty acid profiles), but the substitution without a label change of beef tallow for sunflower oil would be outside the scope of this policy because the oils are from different categories (one is animal-sourced and the other is vegetable-sourced) and have different fatty acid profiles.

Another formulation change for which FDA is providing temporary flexibility is the substitution of “bleached flour.”  Some flours require the word “bleached” wherever the name of the food appears on the label. 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.

FDA is also providing temporary flexibility to the vending machine industry and the guidance document outlines how operators can address business practices during the current pandemic as it relates to calorie information for foods sold in vending machines. 

See FDA’s 12-page guidance document on temporary labeling at FDA.gov. 


Author(s): Staff