22nd Century Group Urged Federal Nicotine Standards

The company has petitioned federal regulators to finalize a rule capping nicotine levels in all combusted tobacco products.

Updated on Sept. 24, 2026 in Substance Abuse

Bold flat-color editorial illustration of a stylized tobacco leaf and beaker, symbolizing federal nicotine regulation standards. — 22nd Century Group has petitioned the FDA to finalize a long-pending regulation that would limit nicotine content in all combusted tobacco products. AI Illustration. Upload story photo >

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Should federal regulators prioritize implementing a mandatory nicotine reduction standard for cigarettes?

22nd Century Group is calling on the FDA to implement a proposed standard that would limit nicotine content in cigarettes to 0.70 milligrams per gram. The firm argues the measure is a critical tool for reducing national tobacco-related mortality.

Why it matters

The company states that the rule has remained pending for more than eight years since the FDA first signaled its intent to act. Proponents believe the policy could significantly shift public health outcomes by preventing millions of Americans from becoming addicted to nicotine.

The proposed FDA rule limits nicotine to 0.70 milligrams per gram, which represents a 95% reduction compared to traditional tobacco products. Federal models estimate this change could avert 1.8 million tobacco-related deaths by 2060.

The players

22nd Century Group

A biotech company that uses patented technology to regulate the alkaloid content in tobacco plants.

FDA

The federal agency responsible for overseeing tobacco product standards and public health regulations.

The details

The policy relies on regulating alkaloid biosynthesis to achieve lower nicotine levels in combusted tobacco products. 22nd Century Group, which currently produces VLN cigarettes at its 60,000 square foot manufacturing facility in Mocksville, North Carolina, advocates for the immediate adoption of this standard.

March 16, 2018: FDA issued advance notice of proposed nicotine rulemaking.
January 15, 2025: FDA issued the formal proposed nicotine rule.
September 15, 2025: Public comment period for the proposed rule closed.
May 2026: FDA opened public docket for VLN cigarette renewal applications.
September 24, 2026: 22nd Century Group issued a call for rule implementation.

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The Big Picture

This effort follows a pattern set by the FDA Tobacco Product Standard for nicotine levels by pushing for its finalization after years of agency deliberation.

If implemented, this standard would require all combusted tobacco products to significantly lower their nicotine content, fundamentally altering the addiction profile of available cigarettes. Consumers would likely see a transition in product availability as manufacturers comply with the new federal limits.

The takeaway

The move highlights the ongoing tension between private industry innovation and the pace of federal regulatory rulemaking. Readers should note that current nicotine-reduced products represent a specific segment of the tobacco market that may become the universal standard under federal proposals.