FDA announced a draft guidance to update the agency’s Questions and Answers Regarding Food Allergen Labeling. The draft guidance generally does not substantially change current practices, but rather largely documents FDA’s existing practices. In addition, the draft guidance updated the existing questions and answers to include sesame as a major food allergen, ahead of the January 1, 2023 compliance date for sesame labeling.
FDA’s proposed updates include limiting the “milk” and “egg” allergens to milk from cows and eggs from chickens. Additionally, the update now clarifies that required allergen labeling applies to bulk food intended for other food manufacturers, in addition to food packaged for consumers.
FDA additionally addressed newer technologies in the draft guidance, indicating that when a protein from a major food allergen is included in a food, the allergen must be declared. This includes proteins produced through other sources or means, such as milk protein produced through fermentation of a non-milk food source. FDA will permit modified allergen declarations, such as “contains milk-derived protein” in these circumstances.
In the draft guidance, FDA also addresses the use of a “contains” statement to declare other ingredients to which individuals are sensitive, such as gluten or mustard. Here, FDA indicated that the “contains” statement can only be used to declare the presence of major food allergens as defined in the FD&C Act as the use of the “contains” statement to include any other information may lead to consumer confusion. However, FDA included in the draft guidance that the agency will permit the use of additional voluntary statements, as long as those statements are truthful, not misleading, and are separate from the required allergen declaration. These statements could include “other allergen information” or “other information," for example.
FDA is currently accepting comments on the draft guidance, which can be submitted until January 30, 2023. Comments can be submitted through Regulations.gov.
Liz Presnell is a food industry consultant and lawyer, and has worked in the food industry for nearly a decade. She can be reached at presnell@foodindustrycounsel.com.