Turns out, if you put a new band on a cigar, it’s still the same cigar after all. Yesterday, the U.S. Food & Drug Administration (FDA) lost its court fight over whether a change to a label would be considered a new product. Judge Amit Mehta of the D.C. District Court ruled in favor of Altria, Lorillard and Reynolds America—i.e. the three largest American tobacco companies—in a lawsuit regarding whether changes to packaging would deem a tobacco product new and as such make it applicable for substantial equivalence, a process of FDA approval that is expected to cost upwards of $20,000 per individual cigar due to legal and testing fees. Mehta ruled for FDA over whether a quantity change—i.e. the amount of cigars or cigarettes in a package—would qualify as a new product. The agency had said it would count as a new product, something that was upheld in the ruling. As for the packaging changes, the agency has previously stated that it considered any “major” packaging changes to constitute as a new product. It put out guidelines as to what it defined as minor, changing the font or logo size slightly, and major, changing a color on the packaging from red to blue or changing a logo. ...
↧