22nd Century Uniquely Positioned To Take Advantage Of New FDA Regulations

22nd Century Uniquely Positioned To Take Advantage Of New FDA Regulations

22nd Century Uniquely Positioned To Take Advantage Of New FDA Regulations

The US Food and Drug Administration (FDA) has announced a comprehensive new roadmap for regulation of tobacco products, shifting focus to nicotine addiction.

So the plan is to reduce nicotine levels in cigarettes, while leaving it in other products, like aids to quit smoking and e-cigarettes. Tobacco use causes more than 480,000 deaths every year, and a 2015 study showed that smokers who were given cigarettes with nicotine smoked less and showed fewer signs of addiction, which could cut down the death rate considerably, Stat reports.

"Despite the initial anxiety, we do not see the FDA's landmark decision as a frontal attack on the industry (only on combustibles) as we do not think the FDA will eventually ban nicotine across all tobacco products", the bank said.

"Most of the harm associated with smoking is related not to the nicotine but everything else in the smoke", Eric Donny, Ph.D., a researcher who has studied the effects of smoking, told the Houston Chronicle.

Even though e-cigarettes or vapes have helped smokers to reduce smoking or helped them in quitting, it is still not clear whether it's a safe option for them for using it.

British American Tobacco, which recently completed its £41.7 billion ($54.7 billion) of Reynolds American Inc., saw cigarette volumes in its Americas business fall 5.4% to 53 billion, the company said Friday, although profits rose 12.2% to £616 million.

Cigarette smoking is the leading cause of preventable disease and death in the United States, according to the U.S. Centers for Disease Control and Prevention. "What we are seeing here is that FDA, under the framing of a new approach, is weakening public health protection for e-cigarettes and cigars, and they are punting protection for kids down the road for five years". One of the biggest: the addictive component of cigarettes will have to go away. Big Tobacco players are going to need a plan of action to navigate this changing regulatory landscape and 22nd Century Group has the proprietary technology to make it happen.

But, the Campaign said the FDA's new agenda also delays implementation of a 2016 regulation that was set to expand the agency's regulatory jurisdiction to e-cigarettes and cigars; and that the delay would allow sales of kid-friendly flavored products to continue.

As a complementary step - to make the process of product reviewing more predictable, efficient and transparent for the manufacturers while maintaining its public health mission - the FDA has plans to provide foundational rules.

According to Commissioner Gottlieb, the approach to nicotine must be accompanied by a strict base of rules and standards for newly-regulated products which should be done in concert and not in isolation, if it is to be successful.

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