The U.S. Food and Drug Administration (FDA) announced on May 12, 2026, that it had filed two Modified Risk Tobacco Product (MRTP) renewal applications submitted by 22nd Century Group for scientific review. The applications cover the VLN® King and VLN® Menthol King cigarette products, which contain reduced nicotine levels compared to conventional cigarettes. The products previously received FDA MRTP authorization in 2021, allowing the company to market them with modified risk claims. Those authorizations are scheduled to expire in December 2026. To continue marketing the products with MRTP claims beyond the expiration date, the company submitted renewal applications for FDA review. The FDA also opened a public docket through Regulations.gov beginning May 13, 2026, allowing stakeholders to submit scientific data, research, and public comments related to the applications. The agency stated that redacted application materials and future amendments will be made publicly available on a rolling basis during the review process.
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