22nd Century’s Vice President of Regulatory Science Publishes Important Public Policy Article
22nd Century Group, Inc. (NYSE American: XXII) is urging the FDA to expedite its Comprehensive Plan on Tobacco and Nicotine Regulation to mandate lower nicotine levels in cigarettes. The company highlights the urgent need for such reforms, citing that smoking causes nearly 500,000 deaths annually in the U.S. The ongoing COVID-19 pandemic emphasizes the critical importance of respiratory health. John Pritchard, the company's VP of regulatory science, stresses that products developed by 22nd Century can help reduce addiction and improve public health, yet authorization delays hinder their potential impact.
- 22nd Century's products promise significant public health benefits by reducing nicotine levels in cigarettes.
- A large percentage of smokers support nicotine level reductions, indicating market readiness for 22nd Century's offerings.
- The FDA removed the proposed rule on nicotine reduction from its agenda without explanation, delaying potential reforms.
- 22nd Century is facing authorization delays that prevent them from marketing their reduced nicotine products.
Article Urges the FDA to Accelerate Implementation of its Plan to Limit Nicotine Levels in All Cigarettes and to Provide Less Harmful Alternatives for Smokers of Highly Addictive Cigarettes
WILLIAMSVILLE, N.Y., Nov. 24, 2020 (GLOBE NEWSWIRE) -- 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 PRITCHARD
Published 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
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 Consult
Morning 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
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
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