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The Food and Drug Administration blocked the sale of four cigarette brands Tuesday, saying retailers will have to pull them off the shelves and telling the maker, R.J. Reynolds, that they cannot sell them any longer.
The agency used its new, limited authority over tobacco products to say the four new brands don’t meet what’s called substantial equivalence. FDA doesn’t want to be seen “approving” a tobacco product, but can refuse an application to market something new.
The four products — Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes — are new formulations.
“Today’s actions reflect the FDA’s ability to use its legal authority under scientific review,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, told reporters in a telephone briefing. “Tobacco use continues to be the leading cause of preventable disease and death.”
“These four tobacco products are now considered misbranded and adulterated."
The FDA said the Camel Crush product has a little capsule of menthol in the filter that’s new. After “considerable back and forth” R.J. Reynolds was unable to show that the menthol capsule didn’t change the product’s risk and didn’t change how consumer might view the brand. As for the Pall Mall products, the company wouldn’t give FDA enough information about sweeteners and other flavors added to the cigarettes, Zeller said.
Retailers will have 30 days to remove the products, after which FDA says it can seize them.
“These four tobacco products are now considered misbranded and adulterated,” the FDA’s Ann Simoneau said.
Advocates celebrated the decision.
"They are taking on major brands with lots of market appeal," said David Dobbins of the Truth Initiative, a non-profit group devoted to fighting tobacco use.
“Today’s decision sets an important precedent that almost certainly will apply to other brands. The FDA’s action is a critical step in preventing the introduction of tobacco products that may be more appealing to youth, more addictive or more harmful,” Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in a statement.
“Tobacco manufacturers have a long history of continually modifying their products to make them more attractive and more addictive and introducing new brands and styles designed to appeal to specific segments of the market, including children. These tactics have been spectacularly successful in attracting new smokers, most of whom are children, and in discouraging current smokers from quitting.”
Congress gave the FDA partial authority to regulate tobacco products in 2009 but the agency has moved very slowly and cautiously. It cannot ban products outright. Its first official action didn't come until 2014, when it ordered a company to stop selling cigarette-like products called bidis.
“Before the 2009 law, tobacco companies were free to change their products in secret, and no government agency had the information or authority to do anything about it. The FDA now has the authority to stop these harmful tobacco industry actions, and the agency’s action today is a much-needed step forward,” Myers said.
"The FDA’s action is a critical step in preventing the introduction of tobacco products that may be more appealing to youth, more addictive or more harmful."
Zeller said the FDA has allowed 257 products to be marketed under “substantial equivalence” and has blocked 113.
“FDA doesn’t approve tobacco products,” added FDA’s David Ashley. “We will authorize them for marketing according to standards in the statute. Even products that we authorize for marketing are deadly products, so we stay away from that word.”
"R.J. Reynolds Tobacco Company strongly disagrees," the company said. It said it clearly showed the cigarettes were equivalent to older products already on the market. "We supplied the agency with extensive information on each of the products, and responded to all of the agency’s questions," it said.
Smoking kills more than 400,000 Americans a year, according to the Centers for Disease Control and Prevention.
Dobbins said the FDA is using its limited authority in the best way it can. "The FDA is going to make the tobacco industry play by the rules," he said.
"They are doing exactly what the law tells them they have to do."
So companies will have to either tweak an existing product so it's "substantially equivalent", or go for a new approval of a new product.
And, Dobbins said, FDA will force them to show that the new products are somehow safer than the old ones.
"Tobacco products have done nothing but get more addictive and more toxic," Dobbins told NBC News.