On May 22, 2020, the Food and Drug Administration (FDA) released Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines to provide temporary labeling flexibility for food manufacturers that make temporary minor formulation adjustments due to unforeseen shortages in certain ingredients, as well as vending machine operators that may not be able to display calorie information for vended foods. The goal of the temporary policy is to meet consumer demand by minimizing the impact of supply chain disruptions on product availability due to COVID-19.
Specifically, the temporary policy permits food manufacturers to continue using existing labels where a minor formulation change is made. A “minor formulation change” should be consistent with the general factors listed below:
- SAFETY – Substitute ingredient must not cause any adverse health effects (including food allergens, gluten, sulfites, and other ingredients known to cause sensitivities in some people).
- QUANTITY – Substitute ingredient generally must be present at 2% or less by weight of the finished food.
- PROMINENCE – Omitted/substitute ingredient must not be a major (prominent) ingredient or subject of a label statement (e.g., “made with real butter”).
- CHARACTERIZING OR INGREDIENT IN NAME - Omitted/substitute ingredient must not be a characterizing ingredient where the ingredient has a material bearing on consumer purchasing decisions.
- CLAIMS – Omitted/substitute ingredient must not affect any voluntary nutrient content or health claims on the label.
- NUTRITION/FUNCTION – Omitted/substitute ingredient must not have a significant impact on the finished product (e.g., nutritional or functional differences).
Foods that involve a food standard (21 CFR parts 130 through 169), except bleached flour, are not covered by the temporary policy.
The guidance includes several helpful examples. FDA also notes that it does not intend to object to the following:
- Using different varieties of the same ingredient as a substitute, as long as the ingredient list uses a general term to declare the ingredient on the label.
- Omission or reduction of the amount of a minor, non-characterizing ingredient, as long as it does not significantly change the order of predominance in the ingredient list.
- With respect to voluntary geographical origin claims for certain ingredients, FDA will not object to temporary substitutions of similar ingredients of different origin if the substitution is not for the food itself, though the Customs and Board Protection (CBP) and U.S. Department of Agriculture’s Agricultural Marketing Service (USDA/AMS) should be consulted regarding specific country of origin labeling inquiries.
FDA recommends that manufacturers use alternative ways of communicating to consumers any changes not reflected on the product label, such as posting information on their website or through point of sale labeling.
In addition, FDA is also providing temporary labeling flexibility to vending machine operators who own or operate 20 or more vending machines. FDA recognizes that vending machine operators may be changing business practices as a result of the COVID-19 public health emergency, which may affect their ability to disclose accurate calorie information through labeling or signage. Therefore, FDA encourages vending machine operators to comply with the labeling requirements but has stated that it will not object if operators are unable to meet the labeling requirements during the duration of the COVID-19 public health emergency.
For additional information, please consult the following resources:
- Food Safety and the Coronavirus Disease 2019 (COVID-19)
- COVID-19-Related Guidance Documents for Industry, FDA Staff and Other Stakeholders
As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.