One of These Things Is Not Like the Others: FDA Flexibility With Food Ingredients During COVID-19

June 1, 2020

During the COVID-19 pandemic and national emergency, the U.S. Food and Drug Administration (FDA) has taken a relatively relaxed approach to some of the more concrete regulations governing the nation’s food supply. This month, FDA released its “Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines.” In this new guidance, FDA recognizes that supply chains have been disrupted and may need time to bounce back to “regular order.”

Under Sec. 403 of the Federal Food Drug and Cosmetics Act and 21 C.F.R. 101, a food is misbranded unless the label truthfully represents a complete list of ingredients and the big eight allergen information (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soy) and, if selling food in Illinois, sesame. While allergens must still be listed, FDA is allowing flexibility in “minor ingredient” variations from the label. FDA encourages the industry to consider first if the minor ingredient change would impact safety, quality, prominence, characterizing ingredient, claims and nutrition.

Besides allowing industry to swap out minor ingredients, FDA has stated it would not object to a product using less of an ingredient, such as a reduction or omission of an ingredient or flavor in the context of a multi-ingredient recipe or flavor profile for a food. FDA gives the following examples:

  1. Substitution of one artificial flavor for another or substituting one natural flavor for another
  2. Substitution of colors
  3. Substitution of acids
  4. Substitution of varieties of the same ingredient (e.g., substituting chili pepper for habanero pepper and changing the label accordingly)

FDA also will temporarily relax regulations regarding the accuracy of labels related to geographic origin. For example, a product whose labeling information declares that it is made with “Georgia peaches” or “Illinois corn” may temporarily substitute for “South Carolina peaches” or “Iowa corn,” provided it is not a single-ingredient food consisting solely of the substituted ingredient. For a complete list of examples, review the FDA’s guidance.

Finally, FDA recognizes the need of existing vending machine operators struggling with sourcing products in the machines. While FDA has encouraged operators to comply with existing regulations as much as possible during the COVID-19 emergency, it will not object if the operator temporarily is unable to comply with vending machine labeling requirements in 21 CFR 101.8.

With these flexibilities in mind, it is important to still remember the rules of the road and to compare with other guidance documents FDA has released. FDA has not implemented a free-for-all, but instead has directed very explicit flexibility to specific circumstances. Normal food rules should still govern whenever possible, and consumer labeling litigation remains a very real risk. Accordingly, labels still should strive to convey a truthful and not misleading message.

McGuireWoods has published additional thought leadership analyzing how companies across industries can address crucial business and legal issues related to COVID-19.