The Big Three tobacco manufacturers are pushing their request for a permanent injunction against the Food and Drug Administration to prevent the implementation of new packaging guidelines.
Altria Group Inc., Lorillard Inc. and Reynolds American Inc., along with subsidiaries, filed their latest request for summary judgment Friday — two days after federal Judge Amit Mehta declined to recuse himself from the case over potential conflict-of-interest issues.
Mehta’s former law firm, the Washington office of Zuckerman Spaeder LLP, provided legal counsel to anti-tobacco advocacy group Campaign for Tobacco-Free Kids “relating to the comments that it submitted” to the FDA advocating the regulatory action that plaintiffs are challenging. Mehta’s wife has been a law firm partner since 2008.
Mehta said his former law firm’s advice to the advocacy group is not likely “to become an issue in this litigation” because the advocacy group “is unlikely to become a party or witness in this matter.”
The FDA wants to broaden its power over the companies’ marketing communications, foremost by saying that FDA approval is required for changes to labeling of tobacco products and the quantities of products within a package.
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.
The FDA has said “failure to conform will bring adverse consequences” in enforcement actions.
The companies sued the FDA on April 14, saying the rules are too restrictive under the federal Tobacco Control Act of 2009 and the First Amendment.
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 new guidelines were issued Sept. 8. The lawsuit was revived Sept. 30, with ITG Brands LLC taking the place of Lorillard. The manufacturers said the guidelines imposed similar restrictions.
The plaintiffs said in Friday’s motion that the FDA’s second substantial equivalent directive “disregards the clear statutory distinction between the regulation of tobacco products and regulation of tobacco product labels.” A new tobacco product must be substantially equivalent to an existing product to avoid heightened FDA regulations.
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