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“Fit” For Dismissal: SDNY Rejects Class Action Misapplying FDA’s “Healthy” Regulation

When is a food “healthy”?  And who gets to decide?  A recent decision from the Southern District of New York touched on these questions in the context of an implausible consumer class action—though the court ultimately didn’t...more

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

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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