On February 28, 2018, FDA issued final guidance on Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments: Guidance for Industry Small Entity Compliance Guide. This Guidance is written in simple language to help small entities comply with the rules established in 21 CFR 101.9 and 101.12, which involve, among other things, labeling of food packages that contain up to 300% as much food as the established single serving.

As of July 26, 2016, all food manufacturers that are subject to the FDA’s nutrition labeling requirements were required to begin specially label foods sold in smaller packages. Foods that are sold in a package that contains up to 200% of the established serving size for that food must be labeled as single serving. For example, if two cookies are considered a single serving, but they are sold in packages of four cookies, the package must be labeled as a single serving container and provide nutritional information for the entire container. If the package contains 150-200% of the established serving size, then the manufacturer is allowed to add a column of nutritional information for the established serving size to the left of the required nutritional information for the entire container.

Foods that are packaged in containers holding 200-300% of the established serving size are generally required to use dual-column labeling, which provides nutrition information for the established single serving of food in the left column and the nutrition information for the entire container in the right column. Some foods exempt from this requirement include products that are allowed to use the smaller tabular or linear format labels, raw fruits and vegetables with voluntary labels, and products that require further preparation (e.g., pancake mix).

The Guidance provides detailed guidance on complying with the new labeling regulations, and covers other minor points of the Rules (for example, a breath mint serving size should be labeled as “1 unit”).