Regulatory report: US FDA assesses MRTP application for VLN cigarettes



1 Executive summary
2 Scope of report
3 Introduction
4 FDA’s advanced notice of proposed rulemaking
5 Potential benefits and harms of a nicotine product standard
6 FDA’s plans withdrawn
7 22nd Century Group’s VLN MRTP application
8 Conclusion


In March 2018 the US Food and Drug Administration (FDA) issued a notice to interested stakeholders to comment on a proposed rule to create a tobacco product standard for nicotine. Over a year later, the FDA accepted for substantive review a modified risk tobacco product (MRTP) application for 22nd Century Group’s VLN (very low nicotine) product. This report analyses the advantages and disadvantages associated with very low nicotine products and considers their impact on the tobacco industry as a whole.

No. of pages: 6

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