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
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
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