By Tripp Mickle
The biggest U.S. tobacco companies on Tuesday filed a federal
lawsuit against the Food and Drug Administration, challenging an
alleged effort to assert authority over labels on tobacco
products.
Tobacco subsidiaries of Altria Group Inc., Reynolds-American
Inc. and Lorillard Inc. argue a recent FDA requirement violates
free speech by requiring them to submit labels for approval.
The FDA in March issued an update regarding new tobacco products
and said changing the background color of an existing product from
green to red, changing its logo or adding words such as "premium
tobacco" would make it a new product requiring agency approval.
The cigarette makers claim the 2009 Tobacco Control Act, which
gave the FDA authority to regulate tobacco, restricts the FDA from
preapproving tobacco labels of Marlboro, Camel and Newport
cigarettes. As a result, the manufacturers say they should be able
to change the color or look of tobacco packaging as they wish.
The lawsuit doesn't challenge the Surgeon General's Warning
labels, which are required by law and warn about the health risks
of smoking.
"We disagree that FDA's new requirements that manufacturers must
obtain agency authorization before changing certain product labels
when the actual physical tobacco product remains exactly the same,"
said Brian May, an Altria spokesman. "We're asking the court to
resolve these issues."
The FDA said it doesn't comment on litigation.
The lawsuit is the latest skirmish between tobacco companies and
the FDA over labels. In 2011, Reynolds and Lorillard sued the FDA
after the agency introduced rules that would have put graphic
images like cancerous lungs on the top half of cigarette packages.
The companies won that suit, arguing the labels would violate their
free speech rights.
This latest suit also comes as governments around the world look
to exert more control over cigarette labels. Last month, the U.K.
Parliament voted in favor of a so-called plain-packaging law that
would require cigarettes to be sold in uniform packs stripped of
the distinctive logos and colors that make them easily
identifiable. International tobacco companies like Japan Tobacco
International Inc. and Imperial Tobacco Group PLC said they plan to
challenge the proposed law in court.
Previously, U.S. tobacco companies only had to submit new
tobacco products, like a new brand of cigarettes, and accompanying
labels for FDA for approval. But under the March FDA requirement,
tobacco companies argue, the FDA now will require them to get
approval if they change an existing product's label.
For example, Newport-maker Lorillard submitted a new product and
secured FDA approval in 2013 for its Non-Menthol Gold Box
cigarettes. But under the new rules, a Lorillard spokesman said, if
the company wanted to change the color of the product from gold to
white nationally, it would have to submit it for FDA approval.
The companies argue that process has harmed them by "restricting
[their] ability to modify their product labels without FDA
pre-authorization and by chilling and restricting" free speech.
The tobacco companies say that if the FDA wants to require label
approval, it should go through "notice-and-comment rule making"
process. Doing so would take months and involve the FDA introducing
a rule, the companies commenting on that rule, and the FDA
reviewing those comments before completing the regulation.
A similar process for rules regarding e-cigarettes began nearly
a year ago and measures still haven't been introduced.
Write to Tripp Mickle at tripp.mickle@wsj.com
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