A Label Update, or Not

By Joan Mantini

As more countries begin to find their new normal after facing temporary shutdowns brought on by the global pandemic caused by the Cornona virus, the U.S. Food and Drug Administration (FDA) announced a temporary flexibility policy regarding certain labeling requirements for foods for humans during the COVID-19 pandemic.

The issued guidance document provides additional temporary flexibility in food labeling requirements to both manufacturers and vending machine operators, with 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.

Entitled “Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines,” this guidance is just one of several that the FDA issued providing temporary flexibility to help the food supply chain meet consumer demand while supplies are in short.

What does the new policy entail?  According to the FDA, first, it 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.

According to its announcement on the new policy, the FDA states that 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.

Specific examples are contained in the guidance. 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 may temporarily be appropriate without a label change, such as canola oil for sunflower oil, because they contain similar types of fats.

Another formulation change for which the 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. Given that there is a shortage of the bleaching agent used to bleach flour, creating supply chain disruptions for this specific ingredient, the FDA is providing temporary flexibility for the substitution of unbleached flour for bleached flour without a corresponding label change.

Second, the FDA 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.

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.