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FDA’s Off-Label Hearing Set for the Day after the 2016 Election

Written by Michael A. Walsh on September 6, 2016

On September 1, 2016 the Food and Drug Administration (FDA) issued its Notice of Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (FDA’s Off-Label Hearing). The FDA’s Off-Label Hearing is scheduled for November 9-10, 2016, the Wednesday and Thursday immediately following the 2016 national election. The FDA’s Off-Label Hearing Read More…

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Mitigation Strategies Protect Food Against Intentional Adulteration

Written by Michael A. Walsh on May 27, 2016

On May 27, 2016, the Food and Drug Administration (FDA) published the seventh and final rule required under the Food Safety Modernization Act (FSMA), imposing new duties on domestic and foreign food companies to prevent intentional adulteration of food. The new rule, like all of the new FSMA rules, is preventative and thus requires implementation Read More…

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FDA is KIND about Healthy and Tasty

Written by Michael A. Walsh on May 11, 2016

As the self-appointed protector of consumers’ ability to understand product labels, the FDA has again attempted to demonstrate what Mel Brooks made famous in his movie The History of the World, it’s “good to be the king.” In a March 2015 Warning Letter, the FDA threatened KIND LLC with, among other things, an enforcement action Read More…


Sanitary Food Transportation: New Rules May Require a Fresh Look

Written by Michael A. Walsh on April 25, 2016

Prompted by the Sanitary Food Transportation Act of 2005 and the Food Safety Modernization Act of 2011 (FSMA), the Food and Drug Administration (FDA) issued a new rule entitled “Sanitary Transportation of Human and Animal Food” (the SFT Rule). The SFT Rule establishes the requirements for sanitary transportation practices that will apply beginning April 6, Read More…


Two Cases: Wineries and Regulators Are a Unique Blend

Written by Michael A. Walsh on April 19, 2016

Regulatory enforcement can threaten the existence of wineries and small producers. First, the financial costs of regulatory inspection can be high, and new laws and regulations have given the government significant new authority. Further, when the regulator determines that a winery’s products are “adulterated,” the specter of civil and criminal penalties is significant. Governmental inspections Read More…