This is the fifth time since the start of the pandemic that FDA announced flexibility regarding labeling regulations for foods. The temporary policies are intended to ease manufacturers’ problems due to supply-chain issues associated with the pandemic.
FDA’s latest action addresses FDA’s position regarding manufacturers’ substitution of certain hard-to-get ingredients in their products without changing the label. Under the temporary guidance, manufacturers may make some minor formulation changes without changing the labeling provided the changes do not pose a health or safety issue and do not cause significant changes in the finished food.
The guidance discusses various factors that FDA will consider and provides several examples illustrating when FDA would not object to substitution without a conforming label change. Not surprisingly, the formulation change can not cause any potential adverse health effect, e.g., the replacement ingredient may not be a major allergen, a sulfite, or another ingredient associated with food sensitivity, e.g., aspartame. Replacement of a characterizing ingredient, e.g., cinnamon in cinnamon rolls, would not be appropriate either.
With the exception of bleached flour, minor formulation changes to food(s) that involve a food standard are not covered under this guidance. Bleached flour is subject to a standard of identity. However, because of a shortage of the bleaching ingredient, benzoyl peroxide, FDA will not object to substitution of unbleached flour for bleached flour without a corresponding label change.
The labeling flexibilities associated with formulation changes set out in this guidance remain in place only as long as needed to help ensure an adequate food supply during and after the pandemic. FDA encourages manufactures to use digital disclosures, stickers and point of sale labeling as alternative ways to inform consumers about the formulation changes.
In the same guidance, FDA also provides flexibility regarding disclosure of calorie declaration for food from vending machines under 21 C.F.R. § 101.8. This flexibility applies for the duration of the pandemic.
As noted above, this is not the first time that FDA provided flexibility regarding food labeling rules. Previous guidances address nutrition labeling on food packages intended for restaurants and food manufacturers that may not be labeled for retail sale, menu labeling at chain restaurants, and the packaging and labeling of eggs during the pandemic.
In addition, separate from any guidance, FDA announced in March 2020, that it would work “cooperatively with manufacturers for the remainder of the year [i.e., Dec. 31, 2020] regarding using updated Nutrition and Supplement Facts labels and will not focus on enforcement actions during this time.” Previously, FDA had announced that it would do so until July 1, 2020.