WASHINGTON -- Altria Group Inc., Reynolds American Inc. and ITG Brands LLC are moving forward with a lawsuit to legally prevent the U.S. Food and Drug Administration’s (FDA) new packaging guidelines. Last Friday, the Big Three tobacco companies filed a request for a summary judgment on the matter, the Winston-Salem Journal reported.
The new packaging guidelines would require tobacco manufacturers to get FDA approval in order to change any aspect of a products' label. Under this directive, any changes to a product’s packaging—such as a new background color—would result in the manufacturer needing to submit a substantial equivalence (SE) application to the FDA for that “distinct” product, even if the changes were only made to the packaging, not the product itself.
The FDA said “failure to conform will bring adverse consequences” via enforcement actions.
Altria, Reynolds and Lorillard Inc. first sued the FDA in April 2015, arguing the rules were not in line with the Tobacco Control Act and the First Amendment. The manufacturers agreed to drop the suit in June, after the FDA issued an interim enforcement policy that indicated a willingness to consider regulatory comments and delay enforcement of the initial directive.
The lawsuit was revived in September—with ITG taking Lorillard’s place—after the FDA issued updated packaging guidelines that more or less reverted back to the original restrictions the companies objected to.
In Friday’s summary motion, Altria, Reynolds and ITG said the updated guideline “disregards the clear statutory distinction between the regulation of tobacco products and regulation of tobacco product labels.”
The summary judgment request comes after federal Judge Amit Mehta declined to recuse himself due to a potential conflict of interest. Zuckerman Spaeder LLP, the law firm for which Mehta once worked and his wife is currently a partner, gave legal counsel to the Campaign for Tobacco-Free Kids for the comments the organization submitted supporting the FDA’s new packaging guidelines.
Mehta said Zuckerman Spaeder’s history with Tobacco-Free Kids is not likely “to become an issue in this litigation” because the group “is unlikely to become a party or witness in this matter.”
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