On August 16, 2016, the U.S. District Court for the District of Columbia ruled on a lawsuit brought to the court by Philip Morris USA Inc. and other tobacco manufacturers against the Food and Drug Administration (FDA) (FUFDA). The lawsuit challenged two portions of the FDA’s latest tobacco regulations.
First Philip Morris challenged the FDA regulation requiring FDA approval prior to marketing an existing product, if the manufacturer changes the product’s label. Second, Philip Morris challenged the FDA regulation stating that a change in the quantity of an existing product creates a “new tobacco product” and as such is subject to FDA approval.
The lawsuit was brought by Philip Morris USA Inc.; U.S. Smokeless Tobacco Company LLC; R.J. Reynolds Tobacco Company; American Snuff Company, LLC; Santa Fe Natural Tobacco Company, Inc.; and ITG Brands, LLC. Not exactly a who’s who of cigar manufacturers but at least in this case, big tobacco was fighting with the cigar industry instead of against it.
The Court ruled in a somewhat strange way, siding with Philip Morris USA Inc., et al, regarding label modification and with the FDA on quantify changes.
The court stated, “. . . 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. Accordingly, the FDA’s Guidance as it relates to labeling changes is contrary to the law and cannot stand.”
However, in regard to changing the packaging quantity, the Court ruled in favor of the FDA, stating, “On the other hand, the Court concludes that a change to an existing product’s quantity does result in a ‘new tobacco product’ and therefore does trigger the Act’s substantial equivalence review process. Accordingly, in regards to quantity change, the Court concludes that the Guidance need not be vacated.”
So, in sum, a cigar manufacturer can change the label on a box of cigars without obtaining FDA approval but must obtain FDA approval to change the quantity of cigars in the box from 24 to 25 cigars. Are you friggin’ kidding me?
For those legal geeks that want to read “the rest of the story”, the entire ruling is HERE.