Becerra Confirmation Boosts 22nd Century’s Position to Disrupt Tobacco Industry

Rhea-AI Summary

22nd Century Group (XXII) congratulates Xavier Becerra on his appointment as Secretary of HHS, believing it could revitalize the FDA's plan to regulate nicotine levels in cigarettes. Becerra’s advocacy for a nicotine cap aligns with 22nd Century's mission to reduce harm from smoking. The company highlights that its VLN® product, engineered to contain 95% less nicotine, complies with proposed regulations. The FDA is anticipated to grant a Modified Risk Tobacco Product designation for VLN®, enabling the company to market it effectively to help smokers reduce nicotine exposure.

Positive

• Potential FDA support for nicotine cap could enhance market position.
• 22nd Century's VLN® product may benefit from FDA Modified Risk Tobacco Product designation.
• Public health research suggests a nicotine cap could save millions of lives.

Negative

• None.

Confirmation of Becerra as New HHS Secretary May Reignite FDA’s Plan to Eliminate Addictive Cigarettes

WILLIAMSVILLE, N.Y., March 19, 2021 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, biotechnology company focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, today congratulated Xavier Becerra as the new Secretary of the U.S. Department of Health and Human Services (HHS). The Company believes that Becerra’s confirmation may reignite the U.S. Food and Drug Administration’s (FDA) ground-breaking Comprehensive Plan for Tobacco and Nicotine Regulation, in particular the Agency’s plan to render all cigarettes “minimally or non-addictive.”

“We congratulate Secretary Becerra on his well-deserved confirmation to this critically important role,” said James A. Mish, chief executive officer of 22nd Century. “Among his many accomplishments, Secretary Becerra has demonstrated leadership when it comes to one of the most important public health crises of our time: tackling cigarette addiction. 22nd Century urges the HHS to continue this important work by implementing a nicotine cap for all combustible cigarettes to a ‘minimally or non-addictive’ level. We look forward to joining Secretary Becerra, the HHS, and the FDA on tackling the pressing public health tragedy caused by addictive cigarettes that is costing millions of Americans lives and billions of dollars each year.”

Secretary Becerra is a long-time proponent of a reduced nicotine cap for cigarettes and tougher regulation for the tobacco industry. While serving as the attorney general of California in 2018, Becerra and five other attorney generals wrote a letter in response to the FDA’s Advance Notice of Proposed Rulemaking (ANPRM), strongly supporting a tobacco product standard for nicotine level of combusted cigarettes. In the letter, Becerra, and others highlighted their “extensive interest in and engagement with tobacco policy, regulation, and enforcement” and their “substantial experience and expertise regulating the tobacco industry”. They also “applaud[ed] FDA for considering a nicotine product standard” and stated that “[t]he nicotine standard should apply to all combusted products.” The appointment of Becerra as Secretary of HHS is yet another signal from the Biden Administration that points to a favorable political climate for the renewal of the reduced nicotine mandate and a continued outsized focus on improving public health. Public health researchers project that the enactment of a nicotine cap will help more than five million people to quit smoking within the first year of implementation and will save more than eight million American lives by the end of the century.

Engineered by 22nd Century to contain 95% less nicotine than traditional cigarettes, VLN® is the only combustible product that complies with the FDA’s proposed nicotine cap. Numerous independent scientific studies, funded largely by the FDA, the (NIH), and other U.S. federal government agencies, have demonstrated that using reduced nicotine content tobacco cigarettes helps smokers reduce their nicotine exposure and dependence; smoke fewer cigarettes per day; increase their number of smoke-free days; and double their quit attempts – all with minimal or no evidence of nicotine withdrawal or compensatory smoking.

The Company believes that it is in the final stages of the FDA’s application process to obtain a Modified Risk Tobacco Product (MRTP) designation for VLN®. The designation will allow 22nd Century to communicate key features of VLN® King and VLN® Menthol King, including, a headline claim of “95% less nicotine”. Although it contains just 0.5 milligrams of nicotine per gram of tobacco, VLN® tastes, smells, and smokes like a conventional cigarette. This disruptive product is an alternative to addictive, traditional cigarettes and will help adult smokers reduce their exposure to nicotine. 22nd Century is fully prepared and eager to launch its VLN® cigarettes within 90 days of receiving authorization from the FDA and believes that a MRTP designation will serve as a catalyst for its VLN® brand and tobacco franchise. The Company remains committed to licensing its technology to every cigarette manufacturer so that Big Tobacco can join in the effort to reduce the harm caused by smoking and protect future generations from ever becoming addicted to cigarettes.

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, 2021. 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 does 22nd Century Group (XXII) think about Xavier Becerra's confirmation as HHS Secretary?

22nd Century Group believes that Becerra's confirmation could reignite the FDA’s plan to regulate nicotine in cigarettes.

How does 22nd Century Group (XXII) plan to reduce harm from smoking?

The company aims to reduce smoking harm through its VLN® cigarettes, which contain 95% less nicotine than traditional cigarettes.

What are the implications of a nicotine cap for 22nd Century Group (XXII)?

A nicotine cap could improve 22nd Century's competitive edge and market acceptance of its reduced nicotine products.

What is the projected impact of a nicotine cap on public health according to 22nd Century Group (XXII)?

Public health researchers project that a nicotine cap could help over five million people quit smoking in the first year.

When does 22nd Century Group (XXII) expect to launch its VLN® cigarettes?

22nd Century is prepared to launch its VLN® cigarettes within 90 days of receiving FDA authorization.