FDA Eyes Renewal for 'Safer' Cigarettes—Smokers, Weigh In!
Published Date: 5/13/2026
Notice
Summary
The FDA is inviting the public to comment on the renewal of special approval for two cigarette products by 22nd Century Group Inc. These products claim to lower health risks compared to regular cigarettes. If approved, the renewal keeps these products on the market with their modified risk status, affecting smokers and the tobacco industry starting May 13, 2026.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Renewal Must Meet Section 911(g)(2) Tests
The applicant seeking renewal is pursuing an order under section 911(g)(2) of the FD&C Act and must demonstrate several statutory points, including that the order would promote public health, that claims are limited to reduced exposure or reduced levels of substances, that available scientific evidence reasonably predicts measurable and substantial reductions in morbidity or mortality, and that consumers will not be misled. These statutory demonstrations are required for the renewed modified-risk authorization.
Possible Continued Sale of 'Modified Risk' Cigarettes
The company 22nd Century Group Inc. has applied to renew FDA authorization to market VLN® King and VLN® Menthol King as modified risk tobacco products. These products previously received authorization on December 23, 2021; if the renewals are granted they would remain on the market with modified-risk claims (public comment for the applications opened May 13, 2026).
Public Comment Period and Document Posting Rules
FDA posted redacted application documents for public comment beginning May 13, 2026 and will set a closing date that is at least 120 days after this notice and at least 30 days after final documents are posted; the Agency will announce the final closing date at least 30 days in advance. Comments submitted electronically to regulations.gov will be posted publicly unless submitted as confidential written/paper submissions following FDA instructions.
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