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U.S. Food & Drug Administration

Appeals Court Denies Motion to Stay May 2020 Substantial Equivalence, Schedules Appeal Hearing for March 18

The U.S. Court of Appeals for the Fourth Circuit has denied a motion by cigar trade groups to grant a stay on the May 12, 2020…

FDA: Not Enforcing Tobacco 21 Yet

The U.S. Food & Drug Administration (FDA) has clarified its position on a new federal that bans those under 21-years-old from purchasing tobacco products. While…

PCA & Others Seek Clarification on Federal Tobacco 21 Age Increase Implementation

The Premium Cigar Association (PCA) and other trade groups have asked the U.S. Food & Drug Administration (FDA) to clarify the implementation of the new…

Eight Things: FDA’s Planned Ban on Flavored Vaping Pods & Premium Cigars Being the “Lowest Priority”

Earlier today, the U.S. Food & Drug Administration unveiled draft guidance that would effectively lead to a ban on flavored vaping and e-cigarette pods/cartridges. In…

FDA: Premium Cigars Are Our Lowest Priority

The U.S. Food & Drug Administration (FDA) has announced plans to more aggressively regulate e-cigarettes and vaping products, specifically flavored pods or cartridges. At the…

Ten Questions for 2020

Welcome to the 10th version of Ten Questions. In December 2009, I decided to write an editorial that previewed some of the big topics for the following…

Graded: Ten Questions for 2019

It’s in the mid-50s, the skies are gray and the space heater is fired up on the balcony, which means only one thing: it’s time…

FDA Declares Tobacco Purchasing Age Increase to 21 in Effect; PCA Advises Stores to Stop Selling to Persons Under 21

Less than a week ago, President Trump signed a government spending bill that included an increase in the minimum age to purchase tobacco products from…

Dr. Stephen Hahn Confirmed as FDA Commissioner

Dr. Stephen Hahn is the new commissioner of the U.S. Food & Drug Administration (FDA). Earlier today, Hahn was confirmed by the Senate by a…

Micallef Launching PredX, Trade Exchange for FDA Predicate Blends

In a world of strict FDA regulation of cigars, there will likely be some process where companies trade or sell the rights to FDA-approved blends…

Senate Committee Approves Stephen Hahn’s Nomination as FDA Head

Dr. Stephen Hahn is just one step away from becoming the next commissioner of the U.S. Food & Drug Administration (FDA). The Senate Health, Education,…