FDA Drug Promotion Enforcement Update

It has been an interesting week from the perspective of an FDA drug promotion attorney. On the one hand, we have a federal district court expanding how drug companies can promote drugs; on the other, we have FDA’s Office of Prescription Drug Promot… Read More
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Warning Letters Update

This past week FDA made a number of Warning Letters available on its website, with issues ranging from Juice HACCP to cGMPs for finished pharmaceuticals. A Warning Letter is informal and advisory, with the aim to achieve voluntary compliance and to e… Read More
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What’s New at CDRH?

Since January 1, it seems that the Center for Devices and Radiological Health (CDRH) has been out of the agency’s spotlight, and even FDA’s “News & Events” webpage has been lacking in its reporting of medical device related activity. This… Read More
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Dealing With FDA Warning Letters

By Casper E. Uldriks The FDA issues Warning Letters to provide firms notice that unless they achieve voluntary correction of the violations noted in the letter, the agency is prepared to initiate an enforcement action without further notice. Enforcem… Read More
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Increased FDA Testing of Pet Foods May Provide More Support for the FSMA Proposed Rule on “Preventive Controls for Animal Food”

When I was growing up on a farm in Pennsylvania, my twin sister and I always savored the sweet feed that we fed to our horses. We would also occasionally “chew on the oats,” but Sis and I never found our way to eating the dog or cat food. This wa… Read More
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DMAA Dietary Ingredient Withdrawn from Market

FDA’s publication last week, on April 11th, of a warning to consumers about dietary supplements containing dimethylamylamine (DMAA) (a/k/a 1,3-dimethylamylamine, methylhexanamine or geranium extract) followed up on Warning Letters issued on Apr… Read More
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Food Labeling Politics – What the Election Results May Mean for Your Company

The election is over and the current Administration will stay in the White House. Food labeling may not have been among the top issues on the minds of American voters. But the election results will have an impact on food manufacturers, retailers, and… Read More
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Mirror, Mirror on the Wall: Nothing Magical about FDA Warning Letters for Cosmetics with Age-Related Claims

The evil queen sucks the life out of young maidens to sustain her flawless complexion in the movie Snow White and the Huntsman. If you are wondering how the U.S. Food and Drug Administration (FDA) might regulate the claims for a product with such reg… Read More
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Class Action Consumer Litigation: A Rising Enforcement Risk for Aggressive Food Labeling Claims

The number of class action lawsuits targeting food labeling claims has risen dramatically over the past few years. These are cases alleging that a food product’s labeling (and/or advertising) violates state consumer protection laws. As a result, wh… Read More
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