February 18, 2019

February 18, 2019

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FDA to Begin Process of Modernizing Certain Standards of Identity

  • On January 11, 2018, the U.S. Food and Drug Administration released its Strategic Policy Roadmap for 2018.

  • As part of its Strategic Policy Roadmap, FDA has signaled its intent to modernize certain standards of identity to address current barriers to the development of healthier products while making sure consumers have accurate information about the foods they eat. To accomplish this goal, FDA intends to issue a request for information to identify and help prioritize which potential standards of identity should be modernized based on their public health value.

  • The modernization of certain standards of identity could conceivably lead the FDA to wade into the controversial plant-based milk and cheese debate this year.  It remains to be seen which standards the Agency ultimately decides to tackle. Finally, we estimate that the process will take many years to complete as it involves formal notice and comment rulemaking possibly including revisions to existing regulations and promulgation of new regulations.

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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...