US: Fed Agencies Want Tobacco Packaging Lawsuit Tossed

Source from:  Winston-Salem Journal 12/10/2015

Two federal health agencies have filed - as expected - for the dismissal of a lawsuit by the Big Three tobacco manufacturers that aims to prevent implementation of new packaging guidelines.

The U.S. Food and Drug Administration and U.S. Department of Health and Human Services on Tuesday submitted their motion for dismissal, as well as a motion for summary judgment.

It is the latest development in the pursuit of a permanent injunction against the FDA by Altria Group Inc., Lorillard Inc. and Reynolds American Inc., along with their subsidiaries. Lorillard has been replaced by ITG Brands LLC since Reynolds' $29.25 billion purchase of Lorillard on June 12.

The manufacturers sued on April 14 over rules for packaging labels that they consider too restrictive under the federal Tobacco Control Act of 2009. The FDA issued an interim enforcement policy May 29 on new tobacco products that appeared to be a response to the lawsuit.

The manufacturers agreed to drop the lawsuit June 2 based on the FDA's willingness to consider regulatory comments and delay enforcing the initial guidelines.

The FDA's revised guidelines were issued Sept. 8. The manufacturers said in the revived lawsuit, filed Sept. 30, that the guidelines imposed similar restrictions.

The FDA has wanted to broaden its power of prior restraint on the companies' marketing communications, foremost by saying that its approval is required for changes to the labeling of tobacco products and the quantities of products within a package under substantial equivalent standards.

That includes being able to declare any tobacco product whose label is modified as a new "distinct" product - even if the product's ingredients and characteristics are not changed.

For example, a modified label could be simply changing the background color.

According to the lawsuit, "Over the past four years, FDA has suggested varying interpretations of the act that would improperly broaden the agency's regulatory authority over tobacco product labels and product quantities.

"Each time, when challenged, FDA devised a new rationale for the same predetermined conclusion that the changes create a new tobacco product subject to premarket review under the act - a results-oriented approach that is antithetical to proper agency decision-making and inconsistent with the plain language of the act," the lawsuit says.

The FDA and DHHS motion says the lawsuit should be dismissed in part because the guidelines are just that and do not represent final agency action. The agencies say the manufacturers "cannot show that they will suffer significant hardship if review is withheld."

The federal agencies argue they are not acting arbitrarily in issuing the substantial equivalence guidance "simply because it reconsidered whether a 'label' is 'part' of a tobacco product."

The agencies also say they believe that "the guidance does not implicate the First Amendment and, in any event, does not impose an unconstitutional restriction on commercial speech. It is also not unconstitutionally vague."

Reynolds spokesman David Howard said on Sept. 30 that the FDA "is trying to do an end run around these other mechanisms by using the substantial equivalence pathway to regulate packaging and labeling."

Tobacco companies increasingly rely on packaging to build brand loyalty and grab consumers - one of the few advertising avenues left to them after the government curbed their presence in magazines and on billboards and TV.

Some manufacturers changed their packaging labels to associate a certain color with a certain style after the FDA banned the words "light," "mild," "medium" and "low tar" in advertising in June 2010. For example, the blue packaging associated with Camel Lights has become the main identifier of the style; the same with gold and Marlboro Lights. Enditem