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 Plaintiffs including R.J. Reynolds Co, Lorillard Tobacco Co and
Altria Group Inc's Philip Morris USA Inc filed the lawsuit in the
U.S. District Court for the District of Columbia to try to block the
directive, which was issued in March.
If the guidance is left intact, the companies say, they could be
exposed to substantial financial and legal penalties if they make
changes to how they package or market already-approved tobacco
products without the FDA's permission.
The FDA issued the guidelines to help clarify what changes require
regulatory approval under the 2009 Tobacco Control Act.
But the tobacco companies said the FDA’s authority to regulate
labeling was limited to products that claim to reduce
tobacco-related harm or other circumstances addressed by formal
rulemaking.
The guidelines go far beyond that authority, the plaintiffs said, by
requiring FDA authorization to make any labeling changes that would
render a product already on the market “distinct,” like a name
change.
Although the FDA has framed the guidelines as non-binding
recommendations, they create "specific legal obligations with clear
and draconian consequences for violations,” including civil or
criminal penalties, the lawsuit said.
The companies said the guidelines violated First Amendment
protections for commercial speech by presumptively blocking certain
labeling statements until they receive FDA approval. They also
accused the FDA of depriving stakeholders of the chance to weigh in
on the directive by issuing it as guidance and not through formal
rulemaking.
The lawsuit also challenges portions of the guidance that call for
companies to seek approval for changes to product quantity, such as
putting more cigarettes in a pack.
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An FDA spokesman declined to comment, citing the pending litigation.
In the March directive, the FDA said that significant modifications
to a product's label that make it distinct from the original
version, such as a logo or recognizable color pattern, could require
the agency's approval.
Altria spokesman Brian May said the company wanted the court to
resolve the issues so it would know how to proceed.
Several smokeless tobacco companies are also plaintiffs, including
U.S. Smokeless Tobacco Co and American Snuff Co. A spokesman for
Reynolds American, the parent company of R.J. Reynolds and two
smokeless tobacco plaintiffs, said companies had a right to
"truthful, non-misleading speech."
(Reporting by Jessica Dye; Editing by Alexia Garamfalvi, Lisa Von
Ahn and Bernard Orr)
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