XXII .87 is looking much better after this FDA decision against R.J. Reynolds on Sept.15th!!! XXII has the ability to genetically alter nicotine and tar levels in tobacco while the huge tobacco companies rely on chemical additives and or filters to try to achieve improvements but not anything close to the nearly ZERO nicotine XXII has shown. Here is the article in it's entirety. Well worth reading if you want some significant news that may and I believe will have a huge impact on the growth of XXII "healthier" cigarettes, plus other products to improve results for quitting smoking!! Here is the article:
FDA orders R.J. Reynolds to stop selling some of its cigarette brands
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By Brady Dennis September 15
(AP/Matt Rourke)
The Food and Drug Administration on Tuesday ordered tobacco giant R.J. Reynolds to pull several types of its cigarettes from the market, the latest example of the agency exercising powers it received under a 2009 tobacco control law.
Before Congress passed the far-reaching legislation, which gave the FDA authority to regulate everything from cigarettes to smokeless tobacco, companies could introduce new products without the blessing of federal regulators. But since the law's passage, companies must prove that any new products they sell are "substantially equivalent" to what already was on the market years ago.
The FDA said Tuesday that Reynolds hadn't adequately made that case for four of its cigarette brands: Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13. Agency officials said those cigarettes "have different characteristics than the predicate products" and, therefore, could raise a different set of public health concerns.
"These decisions were based on a rigorous, science-based review designed to protect the public from harms caused by tobacco use," Mitch Zeller, director of the FDA's Center for Tobacco Products, said in an announcing the action. "The agency will continue to review product submissions and exercise its legal authority and consumer protection duty to remove products from the market when they fail to meet the public health bar set forth under law.
[Government quits legal battle over graphic cigarette warnings]
The FDA said the four brands at issue Tuesday differed in meaningful ways from the Reynolds products that preceded them. For instance, in some cases they contained higher loads of potentially harmful ingredients, higher menthol levels or new ingredients altogether. In its applications for approval, Reynolds failed to prove that such changes don't raise new public health questions, the agency said.
Reynolds is not alone in wrestling with the intricacies of the new tobacco legislation. The FDA said that since the law's enactment, it has received thousands of applications for products that companies claimed were “substantially equivalent” to ones already on the market. While some applications initially lingered for years, officials said Tuesday it has acting on a growing number of them.
Two years ago, the agency made its first approvals for two types of non-menthol cigarettes made by Lorillard after determining that the cigarettes, while slightly different than previous products, wouldn’t pose new public health worries. Since then, it has resolved hundreds of other applications, approving some and rejecting others, officials said.
[FDA approves marketing of two new cigarette brands]
But Tuesday's decision is significant because it marks the first time the FDA has ordered a company to pull a major brand off the market, namely Camel Crush Bold, said Matthew Myers, president of the Campaign for Tobacco-Free Kids.
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," Myers said in a statement, noting that Camel was among the most popular cigarette brands among youth smokers, according to a 2013 government-funded survey on drug use and health.
Camel Crush Bold, in particular, has a capsule in its filter that releases menthol when crushed. FDA cited that feature in its order, saying it made the product different in potentially significant ways from its predecessor.
Tuesday's order means that the four Reynolds brands can no longer be legally sold or distributed in the United States. The FDA said that because some retailers might have difficulty disposing of products already on their shelves, the agency doesn't intend to take enforcement actions for 30 days.
Reynolds said Tuesday that it “strongly disagrees” with the FDA’s decision, and it stopped short of saying it would pull the four brands from store shelves.
“We supplied the agency with extensive information on each of the products, and responded to all of the agency’s questions,” Jeffery S. Gentry, the company’s chief scientific officer, said in a statement. “Our product stewardship process is rigorous and ensures that we are producing the highest quality products that meet regulatory requirements.” He said company officials are “examining all of our options at this time.”
Reynolds said Tuesday the brands targeted by the FDA represent a “very small portion” of the company’s overall business.
Tobacco use remains the leading cause of preventable death in the United States, killing nearly a half million Americans each year, according to the Centers for Disease Control and Prevention.
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