FDA Law Blog: FDA Extends Menu Labeling Compliance Date and Announces Forthcoming Guidance
FDA Extends Menu Labeling Compliance Date and Announces Forthcoming Guidance
FDA Extends Menu Labeling Compliance Date and Announces Forthcoming Guidance
Posted: 10 Jul 2015 12:46 PM PDT
By Etan J. Yeshua –
Last week, FDA announced that it will be extending by one year the compliance date for its menu labeling rule. This means that restaurants and other establishments covered by the rule, and by the menu labeling provisions of the Affordable Care Act (ACA), now have until December 1, 2016 to post calories and other information on their menus and menu boards, provide full written nutrition information in-store, and come into compliance with the rule’s other requirements. The Agency also announced that it plans to issue a draft guidance document to provide “answers to some of the more frequently asked and crosscutting questions that the agency has received” about the rule. The announcement followed requests by some in industry and on Capitol Hill for such a delay and for additional guidance.
Earlier, FDA had rejected requests for delaying enforcement past December 1, 2015. In its proposed rule, FDA specified that the final rule would become effective six months from the date of its publication. When the final rule was published on December 1, 2014, the Agency said it agreed with comments it received that called for a later enforcement date, and it announced a one-year compliance window, ending on December 1, 2015. In that preamble, the Agency said it believed a compliance date longer than one year was unnecessary: “We disagree that an effective date over 1 year (such as 18 months or 2 years, as suggested by [some] comments) is necessary. Many comments seeking a longer effective date focused on the need to train employees. Such training does not need to wait until all implementation activities are complete.” The Agency added that “we have no information that could assist us in considering whether or how much additional time might be appropriate.”
Since then, there have been repeated calls for FDA to delay enforcement and/or to revise or clarify certain of the rule’s requirements. For example, in May 2015, 32 U.S. Senators sent a letter to FDA requesting a one-year delay citing “outstanding questions regarding the details of how the final rule will be applied to certain covered entities” and the need for “clear and consistent guidance” as well as “adequate time to understand and come into compliance with the regulations.” In addition,legislation that would both delay enforcement of the rules and revise the statutory requirements of the ACA’s menu labeling provisions has been introduced in Congress. More recently, language was added to a draft House Appropriations bill (pages 84-85) and report (page 67) that “directs the FDA to implement the final rule no earlier than December 1, 2016, and at least one-year following agency publication of related guidance to newly regulated stakeholders.” Some in industry have been calling for a delay as well, and in its announcement last week, FDA cited its “extensive dialogue with chain restaurants, covered grocery stores and other covered businesses.”
FDA noted that specific information in four requests it received from “large retailer and trade and other associates” justified the compliance date extension:
Last week, FDA announced that it will be extending by one year the compliance date for its menu labeling rule. This means that restaurants and other establishments covered by the rule, and by the menu labeling provisions of the Affordable Care Act (ACA), now have until December 1, 2016 to post calories and other information on their menus and menu boards, provide full written nutrition information in-store, and come into compliance with the rule’s other requirements. The Agency also announced that it plans to issue a draft guidance document to provide “answers to some of the more frequently asked and crosscutting questions that the agency has received” about the rule. The announcement followed requests by some in industry and on Capitol Hill for such a delay and for additional guidance.
Earlier, FDA had rejected requests for delaying enforcement past December 1, 2015. In its proposed rule, FDA specified that the final rule would become effective six months from the date of its publication. When the final rule was published on December 1, 2014, the Agency said it agreed with comments it received that called for a later enforcement date, and it announced a one-year compliance window, ending on December 1, 2015. In that preamble, the Agency said it believed a compliance date longer than one year was unnecessary: “We disagree that an effective date over 1 year (such as 18 months or 2 years, as suggested by [some] comments) is necessary. Many comments seeking a longer effective date focused on the need to train employees. Such training does not need to wait until all implementation activities are complete.” The Agency added that “we have no information that could assist us in considering whether or how much additional time might be appropriate.”
Since then, there have been repeated calls for FDA to delay enforcement and/or to revise or clarify certain of the rule’s requirements. For example, in May 2015, 32 U.S. Senators sent a letter to FDA requesting a one-year delay citing “outstanding questions regarding the details of how the final rule will be applied to certain covered entities” and the need for “clear and consistent guidance” as well as “adequate time to understand and come into compliance with the regulations.” In addition,legislation that would both delay enforcement of the rules and revise the statutory requirements of the ACA’s menu labeling provisions has been introduced in Congress. More recently, language was added to a draft House Appropriations bill (pages 84-85) and report (page 67) that “directs the FDA to implement the final rule no earlier than December 1, 2016, and at least one-year following agency publication of related guidance to newly regulated stakeholders.” Some in industry have been calling for a delay as well, and in its announcement last week, FDA cited its “extensive dialogue with chain restaurants, covered grocery stores and other covered businesses.”
FDA noted that specific information in four requests it received from “large retailer and trade and other associates” justified the compliance date extension:
[T]he requests describe steps involved in developing software, information systems, and other technologies for providing nutrition information in ways that better correspond to how foods are offered for sale in covered establishments and allow for more efficient and product specific nutrition labeling. In addition, the requests describe steps involved in training staff, implementing standard operating procedures, and developing and installing updated and consistent menu boards across all locations within a chain. Most requests sought to extend the compliance date by 1 year. In light of these requests, we have decided to extend the compliance date for the final rule to December 1, 2016.
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