October 15, 2019

October 15, 2019

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October 14, 2019

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FDA: No Plans to Reopen Nutrition Facts Label Rule

  • In May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products was initially slated for July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales).  As covered on this blog last week, however, FDA announced that the compliance dates for the new nutrition labeling requirements will now be extended, although the Agency has not yet specified the length of the extension.

  • Yesterday, FDA Commissioner Scott Gottlieb assured the Senate appropriations subcommittee that although the Nutrition Facts label rule is being delayed, FDA has no plans to reopen the rule.  Gottlieb explained that the delay was implemented simply as a means to carve out additional time to develop and provide “additional guidance to sponsors on how to interpret aspects of the new Nutrition Facts label.” Gottlieb further stated that: “This is a time-limited delay. This is not a suspension of the regulation. We are not reopening the regulation.” Gottlieb’s remarks mean that FDA has no intention of changing the substance of the nutrition labeling requirements as currently drafted.

  • In the lead up to FDA’s decision to delay the rule, many food industry leaders have urged the administration to align the compliance dates for changes to the Nutrition Facts Label and USDA’s GMO labeling disclosure requirements.  USDA AMS is required by law to publish a final rule by July 2018 but the compliance date for GMO labeling disclosure requirements will likely be well beyond July 2018.  It remains to be seen how or whether FDA will ultimately elect to delay the nutrition labeling compliance date to align with the compliance date of USDA’s GMO labeling disclosure requirements.

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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...