22nd Century Group (XXII) Supports FDA Policy Advancements, Proposed Menthol Ban Now at OMB

BUFFALO, N.Y., Oct. 26, 2023 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a leading biotechnology company focused on utilizing advanced plant technologies to improve health and wellness with reduced nicotine tobacco, hemp/cannabis and hops, announced that it supports the recent move by the US Food and Drug Administration to send final rules aimed at banning menthol in cigarettes and banning flavored cigars to the White House Office of Management and Budget for review, a key regulatory step toward the rules becoming federal policy.

In April 2022, the FDA stated that these proposed policies had the potential to reduce disease and death associated with smoking and support smoking cessation. Stop smoking experts largely agree such policies could save lives and mitigate the creation of new smokers, as well as help to address racial disparities in the harms of smoking. The policy submissions, originally expected earlier this year, are more than a decade in the making. The FDA officially began exploring the concept of a menthol ban in July 2013.

FDA’s April 28, 2022 press release announcing its rule making stated that the proposed menthol standard will “reduce the appeal of cigarettes, particularly to youth and young adults, decreasing the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking” and “improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation.”

Tobacco use is widely regarded as the number one cause of preventable death in the US, and menthol cigarettes are widely documented to increase the addictive nature of cigarette smoking, as well as target minority communities. Flavored cigar products are known to be particularly appealing to youth and have been shown to be popular among younger or underage smokers.

“The FDA has taken a significant step forward to enact federal enforcement on these important public health policies,” said John Miller, Interim Chief Executive Officer of 22nd Century Group. “The FDA has closely studied these issues for years, accumulating a wealth of scientific and clinical research data in support of these advances. Submission of the FDA’s proposals to the OMB is a key step ahead of publishing the final rules, which we believe could be the most transformative proactive public health policies of a generation. We are eager to see the final rules, and how FDA proposes to handle products with modified risk designations, which are designed to reduce the harms associated with smoking.”