FDA Tobacco Policy Is A Winner And Loser

FDA Commissioner Scott Gottlieb MD

"We are thrilled that FDA is now moving to lower nicotine in combustible cigarettes to non-addictive levels; this is a technically achievable standard whose time has come", explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. Nicotine, however, is the addictive element. Furthermore, nicotine is a powerful, risky and addicting drug. This plan is expected to serve as a roadmap that can be implemented through multiple years in improving the protection of kids as well as reducing the diseases and deaths related to tobacco. It is delaying for several years a major regulation that affects cigars and e-cigarettes, including flavoured vaping products that studies have shown are especially enticing to the American youth.

"Because almost 90 percent of adult smokers started smoking before the age of 18 and nearly 2,500 youth smoke their first cigarette every day in the United States, lowering nicotine levels could decrease the likelihood that future generations become addicted to cigarettes and allow more now addicted smokers to quit", the USA agency said. "Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use", FDA Commissioner Scott Gottlieb said, adding that rules to govern the tobacco industry "must be done in concert and not in isolation". If we reduce the level of the stimulus, we reduce the craving.

And the data support this plan.

Demonstrating a better awareness that nicotine, which is highly addictive, embodies a range of risks when delivered through products is a key piece of the approach by the FDA. It will also explore the role of e-cigarettes and other products in lowering harm from smoking.

The FDA is considering a plan to cut the amount of nicotine in cigarettes to "non-addictive" levels. Together, the products 22nd Century sells are low to high nicotine cigarettes. 22nd Century is the only company in the world capable of producing the Very Low Nicotine SPECTRUM brand styles. Based on the FDA's press release last week, the strong trend is likely to continue.

Public opinion had been turning against Big Tobacco. Approximately 18% of American's smoke.

In addition, the FDA is delaying implementation of last year's rules on cigars and e-cigarettes now on the market until 2021 and 2022, respectively. The FDA says it intends to develop product standards to "protect against known public health risks such as electronic nicotine delivery systems (ENDS) battery issues and concerns about children's exposure to liquid nicotine". Instead, the less nicotine, the less addictive it is, leading to less smoking. Again, 22nd Century looks uniquely poised to benefit from this potential mandate.

For e-cigarettes, the agency extended the deadline by up to four years, and up to three years for cigar companies, to comply with a 2016 rule that gave the FDA oversight over the products, giving them more time on the market without regulation.

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