22nd Century Group, Inc. (NYSE American: XXII), 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 Morning Consult, a global data
intelligence company with an editorial division that issues an
influential newsletter reaching more than 300,000 audience members
on the Hill and within federal agencies, published a powerful op-ed
article penned by John Pritchard, 22nd Century’s vice president of
regulatory science.
In the article, Pritchard calls for the U.S. Food and Drug
Administration (FDA) to accelerate implementation of its
Comprehensive Plan on Tobacco and Nicotine Regulation, in
particular to impose the mandate requiring all cigarettes sold in
the United States to contain minimally or non-addictive levels of
nicotine. The proposed rule was removed abruptly from the agency’s
agenda late last year without warning or significant explanation.
Yet, smoking remains the number one preventable cause of death in
America, killing near half a million people a year or, 1,300 deaths
per day. The serious direct and indirect harm caused by cigarette
addiction is irrefutable. Furthermore, the COVID-19 pandemic has
further accelerated the need to promote and protect respiratory
health.
“Despite the obvious harm of smoking, the staggering public
health costs, and the millions of lives lost, we have never
mustered the fortitude to enact policies that would make cigarettes
less addictive and end this public health disaster. This is the
perfect time to take that step,” wrote John Pritchard, vice
president of regulatory science of 22nd Century Group.
Pritchard stressed the importance of a timely decision by the
FDA, “Companies like the one where I work have developed technology
to decrease the chances that future generations become addicted to
cigarettes and to provide alternatives for smokers of highly
addictive cigarettes…Yet we continue to wait almost a year for a
further authorization to allow us to communicate this breakthrough
to adult smokers. The faster this can be achieved, the sooner and
greater the public health benefit in the United States.”
The article is reprinted below in its entirety:
It’s Time for the Government to Refocus on Respiratory
Health
BY JOHN PRITCHARDPublished November 19, 2020
Americans have historically applied science and technology to
advance the nation and its public health. We developed advanced
diagnostic tools, removed lead from gasoline, limited harmful
substances in our food and drink and countless other examples.
There is, however, one tragic exception to such success:
cigarettes.
Despite the obvious harm of smoking, the staggering public
health costs and the millions of lives lost, we have never mustered
the fortitude to enact policies that would make cigarettes less
addictive and end this public health disaster. This is the perfect
time to take that step.
The COVID-19 pandemic has brought into sharp focus the
importance of respiratory health: We all need air that is not
harmful. For people addicted to the nicotine in cigarettes, this
pandemic brings yet another specter related to their already
compromised respiratory health.
The serious direct and indirect harm caused by cigarette
addiction is irrefutable. Smoking causes almost half a million
deaths a year or 1,300 deaths per day. Compare that to COVID-19,
which tragically takes about 1,200 lives per day, and there’s
little doubt that smoking is a never-ending pandemic.
Further, 16 million Americans are currently living with
smoking-related disease, leading to about $300 billion in annual
economic costs. The outlook remains truly horrific; the Centers for
Disease Control and Prevention estimates 5.6 million children alive
today will die from smoking-related diseases.
The U.S. Food and Drug Administration responded to these
alarming statistics by developing the landmark Comprehensive Plan
for Tobacco and Nicotine Regulation in 2017. The plan was
straightforward: create a roadmap to better protect youth and help
addicted adult smokers quit, significantly reducing tobacco-related
disease and death in the United States in the years to come.
At the time, then-FDA Commissioner Dr. Scott Gottlieb called it
an opportunity to save millions of lives. “The overwhelming amount
of death and disease attributable to tobacco is caused by addiction
to cigarettes – the only legal product that, when used as intended,
will kill half of all long-term users,” Gottlieb said at the
time.
Then, late last year, without warning or significant
explanation, the FDA abruptly removed the proposed rule-making to
reduce nicotine levels in cigarettes from its regulatory agenda.
Even before the COVID-19 pandemic struck, policymakers decided
there were more immediate priorities than cigarette addiction and
the roughly half-million Americans who die from it each year.
And so, here we are still; the cycle continues. The tobacco
industry promotes an addictive product and gains financially from
smokers’ life-long compulsive consumption, the costs of which are
largely borne (like COVID-19) by individuals and families in lower
socio-economic communities and regions. Deaths are offset by
“replacement smokers” – our children.
But the facts remain. There are approximately 34 million smokers
in the United States, 70 percent of whom have expressed a desire to
quit. In fact, a recent survey found that 8 in 10 adult smokers
favor requiring cigarette makers to lower nicotine levels in
cigarettes so that they are less addictive.
By mandating the reduction of nicotine levels in cigarettes to
minimally or non-addictive levels and by introducing a pragmatic
regulatory approach to alternative methods of nicotine delivery, we
have the opportunity to reduce the harm caused by addiction and to
save millions of lives. But we continue to delay the steps needed
to make that a reality.
This is where science comes in. Companies like the one where I
work have developed technology to decrease the chances that future
generations become addicted to cigarettes and to provide
alternatives for smokers of highly addictive cigarettes. Our
product, based on years of research by the FDA, the National
Institutes of Health and the CDC, dramatically reduces the amount
of nicotine in tobacco. The FDA has already authorized our product
for sale as “appropriate for the protection of public health” in
2019. Yet we continue to wait almost a year for a further
authorization to allow us to communicate this breakthrough to adult
smokers. The faster this can be achieved, the sooner and greater
the public health benefit in the United States.
Too many Americans pay a fatal price for cigarette addiction and
for too long; the global pandemic has accelerated the need to
promote and protect respiratory health. The FDA’s comprehensive
plan on tobacco and nicotine deserves and demands to be a national
priority. The FDA should revisit their plan and accelerate its own
actions. But even before that, the agency should provide
authorizations to those products that can begin to change the
trajectory of disease and death in the United States. The impact of
these actions will go a long way towards protecting public health
and the lives of individual Americans now and for generations to
come.
We have the science. Now, we just need the will.
About Morning ConsultMorning
Consult is a global data intelligence company established in 2014.
The company provides global survey research tools, data services
and news to organizations in business, marketing, economics, and
politics. Morning Consult’s editorial division covers various
subject areas including, Washington, Brands, Tech, Energy, Finance,
Health, Sports, and Entertainment. The company produces original
reporting, as well as daily email newsletter briefings that reach
300,000 subscribers.
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 StatementsExcept 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 KuoDirector, Communications & Investor
Relations22nd Century Group, Inc.(716)
300-1221mkuo@xxiicentury.com
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