Big Tobacco Fires on New ‘Draconian’ FDA Rules

WASHINGTON (CN) - Regulating changes to the labels of all tobacco products subjects the industry to "draconian" rules, manufacturers claim in Federal Court.

Philip Morris and five other tobacco giants filed a federal lawsuit Tuesday to overturn recent U.S. Food and Drug Administration changes to tobacco labeling requirements.

Congress enacted the Family Smoking Prevention and Tobacco Control Act in 2009, letting the FDA regulate the manufacture, marketing and sale of cigarettes and smokeless tobacco products.

That law, which the agency rejiggered last month, required tobacco makers to seek FDA preapproval for any changes to their products. With a few narrow exceptions, however, the pre-existing law did not require pre-authorization of changes to labels for those products.

Now the FDA wants pre-authorization for "any change to a label that would render a tobacco product 'distinct' - as defined under FDA's vague standards - from the predecessor version of the product," even if the characteristics of the product stay the same, according to the lawsuit.

Manufacturers says the new rules require them to seek FDA preapproval before changing the labels of tobacco products or the quantity of a tobacco product in a package, under threat of civil and criminal penalties.

The agency has 90 days to review the changes and decide if a new label makes the product "distinct."

Philip Morris and its fellow plaintiffs say the new rule violates the Tobacco Control Act and gives them inadequate notice about which label changes fall under the new requirements.

They say the criteria for determining whether a label change makes a tobacco product "distinct" and thus a "new tobacco product" requiring FDA pre-approval are vague and subjective.

Moreover, the FDA's position that relabeling a tobacco product makes it a new product even if it has the same characteristics as before is at odds with federal law and with the agency's previous interpretation of it, the lawsuit states.

The rule is not limited to modified risk tobacco products, as originally intended by Congress, the manufacturers claim.

It was also improper for the FDA to adopt the rule, a "final agency action," without opportunity for comment, as required under the Administrative Procedure Act, the plaintiffs say.

Although disguised as "guidance," the FDA rule described in the complaint as the "SE directive" imposes legal obligations that manufacturers must follow or face penalties, including seizure of an entire product line, they continue.

"Moreover, by imposing this broad pre-approval requirement for label changes, the SE Directive also violates the First Amendment's strict limitations on prior restraints as well as its protections for commercial speech and the prohibition against vague speech restrictions," the complaint states.

The original rule allowed the FDA to do a premarketing review of labels that claim that a tobacco product presents a "modified risk," and the FDA could also require preapproval of labels for limited purposes, but only after proper notice and opportunity for comment, the industry says.

As a general rule, the Tobacco Control Act asks manufacturers to file reports with the FDA every six months, showing material changes made to the labeling of their tobacco products. If the FDA finds a change false or misleading, it may pursue civil or criminal remedies.

Philip Morris and co-plaintiffs, which manufacture hundreds of tobacco products, claim the rule interferes with their marketing process by making them wait at least 90 days before introducing label changes.

The agency could take months or years to rule on reports seeking preapproval for label changes, according to the lawsuit.

The manufacturers want the directive vacated.

They are represented by Robert Weiner with Arnold & Porter.

The plaintiffs are Philip Morris USA, U.S. Smokeless Tobacco, R.J. Reynolds Tobacco Co., American Snuff Co., Santa Fe Natural Tobacco Co. and Lorillard Tobacco Co.

A spokesman for the FDA said the agency does not comment on possible, pending or ongoing litigation.

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