February 18, 2019

February 18, 2019

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New DOJ Policy Says Government Lawyers Cannot Base Enforcement Actions on Guidance Documents

  • As our readership is well aware, the U.S. Food and Drug Administration (FDA) frequently issues guidance documents for all areas under its regulatory purview, including foods. These guidance documents seek to clarify and supplement existing regulations.

  • On November 16, 2017, Attorney General Jeff Sessions ostensibly expressed a distaste for binding private parties to provisions in guidance documents that have not undergone the rulemaking process.

  • On January 25, 2018, the U.S. Department of Justice changed its policy such that government lawyers will no longer be able to rely on guidance documents to establish civil law infractions.  In other words, going forward under the current Administration, “noncompliance with any guidance document cannot be used to prove violations involving federal civil enforcement actions.”

  • This policy change could have a substantial effect on regulatory actions brought against FDA-regulated entities.

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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...