"NONFUNCTIONAL SLACK-FILL" DEFINED BY FDA

"NONFUNCTIONAL SLACK-FILL" DEFINED BY FDA as the "empty space in a package that is filled to substantially less than its capacity," according to a final regulation published in the May 12 Federal Register. The final reg is the same as a Jan. 6 proposed regulation defining the circumstances in which the slack-fill within a food package is nonfunctional and therefore misleading. Devising official slack-fill definitions is part of the agency's ongoing implementation of the Nutrition Labeling & Education Act. FDA outlined circumstances under which an empty package can be filled to less than its capacity. They include: "protection of the contents of the package"; "requirements of machines used for enclosing the contents in such a package"; "normal product settling during shipping and handling"; the "need for the package to perform a specific function (e.g. where packaging plays a role in the preparation or consumption of a food), where such function is inherent to the nature of the food and is clearly labeled"; or if the "product is a gift product consisting of a food or foods combined with a reusable gift container, where the container is intended for further use after the food is consumed." Under the reg, a product is deemed to be misbranded if its container is "misleading." A container, in turn, is considered to be misleading if it contains nonfunctional slack-fill, FDA explained. The NLEA stipulated that FDA had to publish a final regulation implementing the slack-fill provision by May 8, 1993 or the proposed rule would be considered a final rule. The agency decided not to publish a final rule before May 8 and let its Jan. 6 proposal remain as a final rule. Comments received by FDA on the slack-fill proposal included a March letter from Perrigo, whose subsidiary, Perrigo of South Carolina, manufactures private label dietary supplement products. Perrigo argued that the definition for nonfunctional slack-fill should not apply to dietary supplements "when a minimum package size is needed to accommodate a label bearing information required by FDA, by other state or federal law, or by commercial necessity" ("The Tan Sheet" March 22, p. 14). The final rule did not specifically address dietary supplements.