In mid-April 2015, the FDA was sued on Free Speech grounds by major tobacco companies including R. J. Reynolds, Philip Morris, Lorillard Tobacco, Altria Group Inc., U.S. Smokeless Tobacco Company, American Snuff Company and Santa Fe Natural Tobacco Company.
Filed in U. S. District Court in Washington, the suit alleges that FDA labeling guidelines preemptively restrict free speech, exceed the FDA’s scope of authority and do not advance a substantial government interest.
The FDA was given authority over the tobacco industry by the Tobacco Control Act of 2009. Since that time, leading tobacco companies have repeatedly challenged the FDA’s authority, sometimes with resounding success. Do you remember hearing several years ago that tobacco packs would be required to show graphic images of smoking’s danger? That was a real FDA guideline challenged by a 2011 lawsuit and eventually dropped by the government. The tobacco industry jealously guards its labeling Free Speech rights, especially after the government limited their advertising in magazines, billboards and TV.
This recent fight involves FDA guidelines issued in March 2015 regarding “new products” requiring FDA review. The guidelines state that if substantial changes are made to a product’s label, the product requires new FDA approval, even if the product was previously approved.
The tobacco industry predictably reacted with the recently filed federal suit.
The suit is obviously in its earliest stages and the FDA will not comment on the pending action.
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