Clear The Air News Tobacco Blog Rotating Header Image

Tobacco manufacturers revive lawsuit against FDA

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 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. Although Reynolds spent $29.25 billion to buy Lorillard — essentially to get top-selling menthol brand Newport — the bulk of Lorillard went to Imperial Tobacco Group Plc in a $7.1 billion side deal. ITG Brands is Imperial’s U.S. subsidiary.

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 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.

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 FDA did not comment Wednesday on the revival of the lawsuit, citing a policy of not commenting on pending litigation.

“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 spokesman, said.

“The act’s substantial equivalence 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.

“FDA is trying to do an end run around these other mechanisms by using the substantial equivalence pathway to regulate packaging and labeling,” Howard said.

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.

The revival of the lawsuit comes as the FDA has stretched its regulatory muscles in recent weeks.

On Sept. 15, the FDA prohibited the sale of four brands of R.J. Reynolds Tobacco Co.’s traditional-style cigarettes: Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13.

On Aug. 27, the FDA sent warning letters to a Reynolds American Inc. subsidiary and ITG Brands LLC, saying that advertising traditional cigarette products as “additive free” or “natural” is in violation of federal regulations. The brands are Natural American Spirit for Santa Fe Natural Tobacco Co., Winston for ITG Brands and Nat Sherman for Sherman’s 1400 Broadway N.Y.C. Ltd.

When asked if the two decisions had anything with the revival of the lawsuit, Howard said, “not at all; completely separate issues.”

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>