May 22, 2020
The U.S. Food and Drug Administration is issuing a guidance document to provide additional temporary flexibility in food labeling requirements to manufacturers and vending machine operators. 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 one of several the FDA has issued to provide temporary flexibility to the food industry to help support the food supply chain and meet consumer demand during the pandemic.
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.
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 we are 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.
The guidance also provides examples of existing flexibilities in food labeling regulations so that manufacturers know these are already available. One example is the flexibility to exchange spices when the label declares the generic term “spice.”
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. As a result of the COVID-19 pandemic, vending machine operators may need to change business practices, and there may be temporary disruptions in the supply chain for foods sold in vending machines. Where possible, FDA encourages covered vending machine operators to continue to comply with the vending machine labeling requirements.