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This article was originally published in The Tan Sheet

Executive Summary

FDA PROPOSES TO REVOKE NONFUNCTIONAL SLACK-FILL REGULATION that was published in May and replace it with a new final rule published in the Dec. 6 Federal Register. FDA explained in the Dec. 6 Federal Register that the agency is publishing a second final regulation in order to "clarify many issues that have been raised by public comments during the past few months, and for the agency to both address and respond to these issues so as to ensure adequate implementation of misbranding regulations as well as facilitate their compliance." The Dec. 6 Federal Register includes both the new final rule and a proposed rule that would revoke a May 12 final regulation defining conditions under which the slack-fill within a food package is nonfunctional and, therefore, misleading ("The Tan Sheet" May 17, p. 6). FDA had indicated shortly after issuing the final rule in May that it was working on another regulation that would supersede the May 12 reg ("The Tan Sheet" May 24, In Brief). FDA noted that it was required "by operation of law" to publish the final rule in May and that the reg "did not have the benefit of public comment." In the Dec. 6 proposal, FDA said it "tentatively finds that [the new] regulation is better able to ensure adequate implementation" of the slack-fill requirements than the reg published in May. "Because [the new final rule] is a clearer regulation," FDA said it will "facilitate compliance." The agency also said that replacing the May regulation with the new final rule "will not result in any hardship to manufacturers who have relied" on the earlier reg. The Dec. 6 regulation, the agency concluded, "in most respects is consistent" with the May regulation. The Dec. 6 final rule becomes effective on Jan. 5 "for all affected products initially introduced or initially delivered for introduction into interstate commerce on or after this date." Interested parties are given the opportunity to comment on the revocation of the May 12 rule only until Dec. 17 to allow the rulemaking to "proceed as expeditiously as possible." The definition of nonfunctional slack-fill is essentially the same in the Dec. 6 final rule as in the regulation published in May. The new final rule defines nonfunctional slack-fill as "the empty space in a package that is filled to less than its capacity for reasons other than: (1) protection of the contents"; (2) the "requirements of the machines used for enclosing the contents"; (3) "unavoidable product settling during shipping and handling"; (4) the "need for the package to perform a specific function" that is "clearly communicated to consumers"; (5) the container is "part of the presentation of the food"; and (6) the "inability to increase level of fill or to further reduce the size of the package (e.g., where some minimum package size is necessary to accommodate required food labeling" and to "discourage pilfering, facilitate handling, or accommodate tamper-resistant devices." The earlier reg had define nonfunctional slack-fill as the empty space in a package that is filled to 11 substantially less" than its capacity, and did not include a sixth exclusion criterion. Slack-fill is defined in the final rule as the "difference between the actual capacity of a container and the volume of product contained therein." A container "that does not allow the consumer to fully view its contents shall be considered to be filled as to be misleading if it contains nonfunctional slack- fill," the agency explained. In the final reg, FDA also rejected a request by Perrigo that dietary supplements be exempt from the definition of nonfunctional slack-fill ("The Tan Sheet" March 22, p. 14). Perrigo, according to FDA, had argued that "consumers do not make the same types of value comparisons with respect to dietary supplements that they make for conventional food products" and therefore "consumers cannot be misled as to the amount of product they are purchasing." The agency said it is "not convinced by the comment that there is any reason to treat dietary supplements differently from other conventional food items." While some dietary supplement packages may be subject to the "small package exemption," dietary supplements "are food and, as such, must comply" with the slack- fill regulations, FDA declared.

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