FDA review of tobacco products grinds to a halt

By Michael Felberbaum

Associated Press

Published: Thursday, Dec. 13 2012 12:00 a.m. MST

And though they say they only market to smokers, if cigarette makers can't lure new ones, their business will die.

They also can't look for growth overseas. All of the companies sell cigarettes only in the U.S. Their brands are sold in other countries by different companies.

"You try to introduce new products to keep some excitement and freshness out there," tobacco analyst Jack Russo of Edward Jones said. "There are just so many hurdles and regulations and battles to get new products approved. ... It's kind of like you have a new sheriff in town, and you're trying to figure out what the new rules are."

In an interview with the AP, Dr. Lawrence Deyton, director of FDA's Center for Tobacco Products, said the agency is working with companies to get more information about products and hopes the industry will be more transparent about its reasoning that product changes don't affect public health.

Small changes in ingredients or additives can make a cigarette more addictive or harmful, Deyton said. "Though cigarettes seem like a very simple product — chopped-up tobacco rolled in paper ... we know that cigarettes are highly engineered. They're technologically incredibly sophisticated," said Deyton.

The center has an annual budget of more than $450 million, funded by the industry, and more than 365 employees, about 115 of whom work on the application reviews.

"This is new for them ... and this is new for FDA as well. ... We're not playing gotcha," Deyton said.

The FDA isn't exercising common sense, Murray Kessler, CEO of Newport cigarette maker Lorillard Inc., said in an interview.

"These are cigarettes. They haven't changed in 50 years. They've had the most minor changes," Kessler said. "I don't think the spirit of the law ever envisioned this type of cumbersome scrutiny."

For example, Kessler said that under the FDA's guidelines, if the nation's third-biggest tobacco company wanted to take a Kent brand cigarette and rename it "Newport," it would be subject to review even though "it's not substantially equivalent — it's exactly equivalent."

Lorillard petitioned the agency in June seeking to speed the reviews. The FDA has until around the end of the year to respond.

The slowdown has caused a split in the industry as well. Smaller companies like Lorillard say larger companies like Philip Morris USA were able to put more products in test markets before the FDA deadline. That let them stay on the market while being reviewed by the FDA.

At a mid-November analyst conference in New York, Kessler reiterated his frustration with the process but said the FDA is communicating with Lorillard on two of its applications for new products and its petition.

Lars-Erik Rutqvist, senior vice president of scientific affairs at smokeless tobacco maker Swedish Match, said the frustration lies in "the fact that it takes so long and there's no explanation why."

"I think there's suspicion within industry that this is how it's going to be in the future and this is more or less a way of punishing the industry," Rutqvist said.

Other industry observers like Richard A. Daynard, professor of law at Northeastern University and chairman of the Tobacco Products Liability Project, say the process wasn't "intended to be a black hole."

"There's certainly a tension in having the FDA regulate a deadly product that has no compensating benefits, but that's their job under this thing and they need to get with it," he said.

Despite the tug-of-war, government processes taking longer than expected isn't new ground, said Ira Loss, an analyst with Washington Analysis who has covered the FDA for three decades.

"This would not be the only division at FDA that has trouble meeting deadlines for review," he said, citing a backlog of applications for generic drugs. "(The industry has) a right to gripe. ... There probably should be (an avenue for recourse), but there isn't. What are you going to do, put people in jail?"

Michael Felberbaum can be reached at http://www.twitter.com/MLFelberbaum .

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