Judge Sides With Tobacco Companies In FDA Labeling Lawsuit
- August 17, 2016 |
- By Andrew Nagy
Tobacco companies have won a partial victory in the fight against U.S. Food and Drug Administration regulation, as a federal judge on Tuesday ruled that a label change on a tobacco product does not mean the agency should consider it to be new.
U.S. District Judge Amit Mehta in Washington D.C. ruled in favor of Altria Group Inc., Lorillard Inc. and Reynolds American Inc., who along with their subsidiaries, had filed a lawsuit against the FDA in September 2015. The tobacco companies, which are the three largest in the United States, claimed that the FDA's requirements violate the First Amendment protections of commercial free speech. Additionally, the companies argued that the rules under the 2009 Tobacco Control Act are too restrictive.
At the heart of the lawsuit was whether significant changes to a tobacco product's packaging—such as a change in color or logo—would deem the product new, and thus make it a candidate for the FDA's costly and time-consuming Substantial Equivalence pre-market approval process.
In his ruling, Mehta wrote that under the act, "a modification to an existing product's label does not result in a new tobacco product, and therefore such a label change does not give rise to the act's substantial equivalence review process."
However, Mehta did rule that a change in quantity of the product in the packaging—such as switching the number of cigars in a box from 20 to 10 per box—does constitute a new tobacco product that would need FDA approval.