Federal Register #FDA-2019-N-0994

FDA Requests Public Comment on Renewal Applications for VLN King and VLN Menthol King Modified Risk Tobacco Products

The Food and Drug Administration (FDA) is seeking public comment on renewal applications for two modified risk tobacco products: - VLN King and VLN Menthol King cigarettes - Submitted by OEM/vendor: 22nd Century Group Inc. - Renewal is for continued authorization to market these products as modified risk tobacco products under section 911(g)(2) of the Federal Food, Drug, and Cosmetic Act - FDA will make application documents available for public review and comment - No specific purchase quantities or part numbers are provided, as this is a regulatory solicitation for comment - Notable requirements: - Scientific and regulatory standards must be met for renewal - Public comment period will be established

Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services

OEMs and Vendors: - 22nd Century Group Inc.

Products/Services Requested: - VLN King Cigarette - VLN Menthol King Cigarette

Unique Requirements: - Renewal of modified risk tobacco product orders - Regulatory review and public comment process

Places of Performance/Delivery: - FDA offices in Rockville, MD and Silver Spring, MD

Description

The Food and Drug Administration (FDA) is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) for renewal of existing MRTP orders for two cigarette products submitted by 22nd Century Group Inc. The applicant seeks renewal of authorization to market VLN King and VLN Menthol King as modified risk tobacco products under section 911(g)(2) of the FD&C Act. The FDA will post application documents for public comment and establish a closing date for the comment period. Comments can be submitted electronically or in writing starting May 13, 2026.

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