Under 21 CFR 101.9(g)(10), food manufacturers must make and keep records to support
certain nutrient declarations on their product labels. We recognize that a manufacturer may
contract with a firm to label a product that is then returned to the manufacturer for
distribution, may sell a product to a firm that labels the product under the firm’s own brand
name for distribution (e.g., “private labeler”), or may engage in some other similar
arrangement with a packager, labeler, or distributor. A firm that labels the product, whether
the manufacturer or a private labeler must know, for each nutrient declared, the amount of a
nutrient in a serving of food to ensure the label is truthful and accurate and does not misbrand
the product. We would expect a firm that does not manufacture the product, but that is
responsible for labeling the product, to have access to records that are sufficient to verify the
nutrient declarations for which records are required in the final rule and make the records
available during an inspection.
