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The Buffalo News Op-ed: 22nd Century CEO Urges FDA to Proceed with Plan to Limit Nicotine Levels in Cigarettes

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22nd Century Group advocates for FDA regulation of nicotine levels in cigarettes to reduce addiction and save lives. CEO James A. Mish emphasizes that lowering nicotine can lead to over 8 million fewer deaths by century’s end. The proposal aligns with the FDA's prior plans to combat smoking-related diseases, which result in over 480,000 deaths annually in the U.S., costing $300 billion in healthcare. The company urges Congress to support this vital public health initiative.

Positive
  • The FDA's proposed nicotine reduction aligns with 22nd Century's mission to lower addiction levels with their reduced nicotine content tobacco products.
  • Potential for regulatory support could enhance 22nd Century's market positioning in tobacco harm reduction.
Negative
  • The previous administration's failure to implement nicotine reduction policies may delay progress.
  • Cigarette addiction remains a significant public health issue, potentially impacting the company's growth in tobacco products.

The FDA Can Save 8 Million Lives and Prevent 1,600 Kids From Becoming Addicted Every Day

WILLIAMSVILLE, N.Y., Jan. 26, 2021 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc., a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, announced today that the Buffalo News, the largest newspaper in Western New York, published an op-ed from James A. Mish, 22nd Century’s Chief Executive Officer.

Mish writes that the Biden Administration has a historic opportunity to address cigarette addiction by dramatically reducing the nicotine in cigarettes.

Requiring all cigarettes to be made minimally or non-addictive is a primary objective of the U.S. Food and Drug Administration (FDA) as stated in its previously published Comprehensive Plan for Tobacco and Nicotine Regulation. Public health researchers estimate that by reducing the nicotine in cigarettes to such low levels will “help addicted adult smokers quit” and “significantly reduce tobacco-related disease and death in the U.S. in the years to come.” 22nd Century stands ready to help the FDA achieve this goal and improve public health.

“While the country has made progress in the battle against cigarette addiction over the last decades, now is the time to enact policies that will allow us to take that fight to the next level. Specifically, requiring cigarettes to be minimally or non-addictive would put us in a strong position to help end this epidemic,” Mish writes.

The article is reprinted below in its entirety:

Another Voice: FDA can save lives by targeting tobacco addiction
By James A. Mish
Published 1/26/2021

President Biden campaigned on reversing much of former President Donald Trump’s legacy. Let’s hope that pledge extends to cigarette smoking.

Trump’s Food and Drug Administration unveiled an ambitious plan in 2017 to regulate tobacco and nicotine consumption, promising to “better protect kids and significantly reduce tobacco-related disease and death."

This multi-year roadmap focused on nicotine reduction and included consideration of “a product standard to lower nicotine in cigarettes to minimally addictive or non-addictive levels.” Notably, the FDA stated that reducing nicotine in cigarettes could “…result in more than 8 million fewer tobacco-caused deaths through the end of the century.”

Their goal was laudable, and the plan the agency announced was sound. But the proposal failed to gain traction. And in the fall of 2019, Trump’s FDA confirmed what many surmised by formally dropping the mandate from its unified agenda, effectively punting on a policy priority the agency introduced with much fanfare just two years earlier. The decision was another victory for Big Tobacco.

The Biden administration has a chance to embrace this agenda after Trump’s FDA abandoned it. Ending Covid-19 is their top priority, and rightfully so. But the new administration will hopefully recognize that combating cigarette addiction and Covid-19 go hand-in-hand and both should be pillars of their overall public health agenda.

Cigarette addiction continues to take a serious toll on millions of Americans, causing about one in five deaths in the United States, or more than 480,000 deaths annually, and costs $300 billion in healthcare expenses each year. In New York alone, smoking kills 28,000 adults annually and costs the state more than $17 billion in health-related costs and lost productivity.

I lead a dynamic biotechnology company based right here in Western New York that has a solution to help the FDA achieve its goal of solving cigarette addiction, which remains one of the world’s largest preventable health crises.

While the country has made progress in the battle against cigarette addiction over the last decades, now is the time to enact policies that will allow us to take that fight to the next level. Specifically, requiring cigarettes to be minimally or non-addictive would put us in a strong position to help end this epidemic.

We are asking our congressional representatives and Sens. Schumer and Gillibrand to work with the FDA to require all cigarettes be made minimally or non-addictive.

About The Buffalo News
The Buffalo News is Western New York’s largest newspaper in the Buffalo–Niagara Falls metropolitan area. The newspaper provides comprehensive coverage from Buffalo, to New York’s state capital, Albany, Washington D.C., and beyond. Buffalo News covers various subject areas including, local, national and world news, politics, business, sports, lifestyle, and culture.

About 22nd Century Group, Inc.
22nd Century Group, Inc. (NYSE American: XXII) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing, and modern plant breeding. 22nd Century’s primary mission in tobacco is to reduce the harm caused by smoking through the Company’s proprietary reduced nicotine content tobacco cigarettes – containing 95% less nicotine than conventional cigarettes. The Company’s primary mission in hemp/cannabis is to develop and commercialize proprietary hemp/cannabis plants with valuable cannabinoid profiles and desirable agronomic traits.

Learn more at xxiicentury.com, on Twitter @_xxiicentury and on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in “Risk Factors” in the Company’s Annual Report on Form 10-K filed on March 11, 2020 and in its subsequently filed Quarterly Report on Form 10-1. 22nd Century undertakes no obligation to publicly update or revise any forward-looking statement as a result of new information, future events, or otherwise, except as otherwise required by law.

All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

Investor Relations & Media Contact:
Mei Kuo
Director, Communications & Investor Relations
22nd Century Group, Inc.
(716) 300-1221
mkuo@xxiicentury.com


FAQ

What is 22nd Century Group advocating in relation to the FDA's tobacco regulations?

22nd Century Group is advocating for the FDA to require cigarettes to have minimal or non-addictive nicotine levels to reduce addiction and save lives.

How many lives could be saved by FDA nicotine regulation according to 22nd Century Group?

22nd Century Group claims that the FDA's nicotine regulation could save over 8 million lives by the end of the century.

What are the annual smoking-related deaths in the U.S.?

Smoking causes over 480,000 deaths annually in the U.S.

What is the cost of cigarette addiction to the U.S. healthcare system?

Cigarette addiction costs the U.S. healthcare system approximately $300 billion each year.

How does 22nd Century Group plan to help reduce tobacco addiction?

22nd Century Group plans to reduce tobacco addiction by developing and promoting reduced nicotine content tobacco products.

22nd Century Group Inc.

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