March 23, 2023

Volume XIII, Number 82

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FDA Issues Procedural Notice on Front-of-Package Labeling Research

  • On January 26, 2023, FDA issued a 60-day notice in the Federal Register of its intention to conduct an experimental study on consumer responses to front-of-package (FOP) labeling. Any collection of information conducted or sponsored by an agency requires such notice and solicitation of public feedback prior to submission to the Office of Management and Budget (OMB) for approval.  44 U.S.C. 3506(c)(2)(A)

  • FDA continues to explore options to create a healthier food supply and to empower consumers to make healthier choices including through FOP labeling. FOP labeling has already been adopted in both Canada and Mexico and the development of FOP labeling was included as part of the White House’s Hunger, Nutrition, and Health Strategy. In 2022 FDA conducted a review of the literature on FOP nutrition-related labels and conducted a set of focus groups to test FOP concepts and draft FOP schemes, and the results of this work will inform the experimental study.

  • The experimental study will test 3,000 adult consumer responses to a set of draft FOP schemes over 3 mock food products without providing any explanation of the FOP scheme. Further details regarding the study are available in the Federal Register notice.

  • As required by statute FDA is seeks comment on:

  1. whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;

  2. the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

  3. ways to enhance the quality, utility, and clarity of the information to be collected; and

  4. ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

  • Comments are due by March 27, 2023. 

© 2023 Keller and Heckman LLPNational Law Review, Volume XIII, Number 31
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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...

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