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The Department of Justice and the Yates Memo: Heightened Focus on Individual Liability

Written by Michael A. Walsh on October 13, 2015

Last month, in what is known as the “Yates Memo,” the United States Department of Justice (DOJ) set a new course on “Individual Accountability for Corporate Wrongdoing” identifying six “keys steps” in its prosecutions. When coupled with the Food and Drug Administration’s (FDA) renewed interest in applying the “Park Doctrine” to implicate individuals for others’ Read More…

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Vermont is “Naturally” Genetically Modified

Written by Michael A. Walsh on September 22, 2015

The state of Vermont was not one of the original 13 colonies and did not join the union until 1791, the year the First Amendment was ratified. That tardiness may explain its inability to interpret the First Amendment correctly. Vermont was settled by the French from whence its Ver (green) mont (mountain) name emerged as Read More…

Michael A. Walsh

Strasburger Partner Mike Walsh Calls for Clarity in FDCA Enforcement

Written by Michael A. Walsh on September 18, 2015

As appears in For The Defense (September 2015) “Unless or until the Supreme Court or Congress brings clarity to limit state law claims for conduct under the FDCA, courts may follow the government’s permissive approach to parallel claims, imperiling manufacturers.” The tracks of “parallel claims” are often federal claims treated as parallel state law claims Read More…

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Ninth Circuit Opens Floodgates for Duplicative Mislabeling Claims in California

Written by Amanda Loughmiller on September 16, 2015

In Sarah Samet, et al v. Procter and Gamble Co., the court dismissed Plaintiffs’ unjust enrichment claims as duplicative because the Unfair Competition Law (UCL), False Advertising Law (FAL) and Consumer Legal Remedies Act (CLRA) already provided for restitution as a remedy for the facts alleged in Plaintiffs’ complaint (The order is available here.)  Plaintiffs Read More…

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The FDA is getting PCQI: New FSMA Rules Issued

Written by Michael A. Walsh on September 14, 2015

On September 10, 2015, the Food and Drug Administration issued Final Rules on Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and for Animal Food. The Food Safety Modernization Act (FSMA) was signed into law in January 2011, and is regarded by the FDA as “the most sweeping reform of Read More…