WASHINGTON — The Big Three tobacco manufacturers have revived a lawsuit seeking a permanent injunction against the U.S. Food & Drug Administration (FDA) to prevent implementation of new packaging guidelines, reported The Winston-Salem Journal.
Altria Group Inc., Lorillard Inc. and Reynolds American Inc. sued 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 report said.
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 September 8. The manufacturers said in the revived lawsuit that the guidelines imposed similar restrictions.
In the revival of the lawsuit, ITG Brands LLC has taken the place of Lorillard, said the newspaper. Most of Lorillard went to Imperial Tobacco Group in a deal related to the Reynolds American-Lorillard merger. ITG Brands is Imperial’s U.S. subsidiary.
The FDA has wanted to broaden its power of prior restraint on the companies’ marketing communications by saying that they require the agency’s approval for changes to labeling of tobacco products and the quantities of products within a package.
A modified label could be simply changing the background color, the report said.
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.”
“Reynolds American’s operating companies are in compliance with the act, and believe that FDA does not have the authority to impose the restrictions outlined in the guidance,” David Howard, a Reynolds spokesperson, told the Journal. “The act’s substantial equivalence [SE] provisions regulate the introduction of new tobacco products into the market. These provisions address the characteristics of the product itself, not how the product is described. Congress provided different mechanisms for changes to how the product is described in its packaging and labeling.”
He added, “FDA is trying to do an end run around these other mechanisms by using the substantial equivalence pathway to regulate packaging and labeling.”
On September 15, the FDA prohibited the sale of four brands of R.J. Reynolds Tobacco Co.’s cigarettes: Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13.
On August 27, it sent warning letters to a Reynolds American subsidiary and ITG Brands, saying that advertising traditional cigarette products as “additive free” or “natural” is in violation of federal regulations. The brands are Santa Fe Natural Tobacco Co.’s Natural American Spirit, ITG’s Winston and Sherman’s 1400 Broadway N.Y.C. Ltd.’s Nat Sherman.