FDA Bans Sale of New R.J. Reynolds Cigarettes

Products didn't meet requirement that they be substantially the same as existing cigarettes, agency says

Tuesday, September 15, 2015

TUESDAY, Sept. 15, 2015 (HealthDay News) -- The U.S. Food and Drug Administration has ordered the R.J. Reynolds Tobacco Co. to stop selling four new cigarette brands because they violate provisions of the 2009 tobacco control law.

The agency determined that the cigarettes are substantially different from existing Reynolds tobacco products on the market and need a full agency review before they can be marketed. The cigarettes are Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13.

These new cigarettes contain higher levels of some ingredients and ingredients that were not in the comparison products, the agency said Tuesday. Camel Crush Bold, for example, contains a menthol capsule in its filter that the agency believes would make it more attractive to younger smokers.

"These products had been provisionally marketed while our scientific review has taken place," Mitch Zeller, director of FDA's Center for Tobacco Products, explained during a morning news conference.

But going forward, these products can no longer "be sold, distributed, imported or marketed in interstate commerce," Zeller said. Selling or distributing these brands could result in FDA enforcement action, including seizure, the agency said.

Retail stores, however, have 30 days to dispose of any inventory on hand.

A senior executive with R.J. Reynolds disagreed with the FDA's ruling.

"We believe that our substantial equivalent applications fully satisfied the guidance the agency provided, and we respectfully disagree with their evaluations of the products in question," Jeffery Gentry, executive vice president of operations and chief scientific officer for the company, said in a statement released Tuesday.

"Our submissions to the agency on these brands were comprehensive and we believe we effectively demonstrated substantial equivalence. We're examining all of our options at this time," Gentry said.

Zeller explained that the four brands of cigarettes were put on the market during a "grace period" granted under the 2009 Tobacco Control Act, which gave the FDA oversight authority for tobacco products. This grace period covered products that entered the market after February 2007 and before March 2011.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, said the FDA order is precedent-setting.

"For the first time since being granted regulatory authority over tobacco products by a 2009 law, the FDA today ordered a tobacco company to pull a major cigarette brand off the market," Myers said in a statement.

He said tobacco manufacturers have a long history of modifying their products to make them more attractive and more addictive. They also target new brands and styles to specific segments of the market, including children, he said.

"Today's decision sets an important precedent that almost certainly will apply to other brands," he said.

For the products to be marketed in the future, the Winston Salem, N.C., tobacco company has to reapply to the FDA, Zeller said.

Zeller said that all four cigarette products have different characteristics than the comparison cigarettes that preceded them.

"The company did not adequately show that those differences did not cause these products to raise different questions of public health," he said.

Speaking at the news briefing, David Ashley, director of the Office of Science at FDA's Center for Tobacco Products, said that harmful ingredients in the new products included increased amounts of the chemicals formaldehyde and toluene, and dyes. There were also high levels of menthol and new ingredients that could affect toxicity, Ashley said.

SOURCES: Sept. 15, 2015, news conference, Mitch Zeller, J.D., director, Center for Tobacco Products, and David Ashley, Ph.D., director, Office of Science, Center for Tobacco Products, U.S. Food and Drug Administration; Sept. 15, 2015, media release, Campaign for Tobacco-Free Kids, Washington, D.C.; Sept. 15, 2015, statement, R.J. Reynolds Tobacco Co.

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