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In Hair Supplement Case, Ninth Circuit Rejects Bald Attempt to Escape Preemption

Federal law expressly authorizes manufacturers of dietary supplements to make “structure/function” claims—that is, claims about the effect of particular nutrients on the structure or function of the human body.  (Think:...more

Liability Immunity Under The PREP Act: A Potent New Defense Against COVID-Related False Advertising Claims

Our national response to the COVID-19 pandemic has been made more difficult by a shortage of personal protective equipment and lifesaving drugs and medical devices. Some evidence suggests that manufacturers’ fear of lawsuits...more

Paradise Lost: Court Dismisses Class Action Alleging Gin “Adulteration”

Grains of paradise (aframomum melegueta), pictured above, are a peppery, citrusy spice indigenous to West Africa, related to ginger and cardamom. ...more

FDA Withdraws Proposed Rule Abolishing Generic Preemption; Recognizes “Downsides” Of Expanded Tort Liability

On December 13, 2018, the FDA withdrew a proposed rule that would have authorized manufacturers of generic drugs to use the Changes Being Effected (CBE) procedure to add new safety information to their labeling—something that...more

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