Special Report | From CrossBar 20K to 6-Methyl Nicotine KUMI: Two Routes Into U.S. State Vape Directories?

2Firsts
A 2Firsts special report examines how CrossBar and KUMI products entered U.S. state vape directories via historical PMTA amendments and FDA exemption classifications for nicotine analogues.

Summary

Several U.S. states, including Pennsylvania and Louisiana, have adopted vape product directories that use the September 9, 2020 historical PMTA filing deadline as a key eligibility criterion, creating obstacles for newer high-capacity disposables. Pennsylvania's 163-entry directory includes four CrossBar 20K disposables with 13mL capacity and up to 20,000 advertised puffs; related CrossBar registrations also appear in North Carolina, Virginia, Mississippi, Alabama, Nebraska and Louisiana. Separately, KUMI and CROSSBAR SIX products registered by Blue Nine LLC and VR Products I LLC appear across Louisiana, Nebraska and Wisconsin, totaling 171 KUMI-related entries. Louisiana classifies 56 KUMI SIX and four CROSSBAR SIX entries as FDA EXEMPTION, while related CrossBar ENDS and some KUMI SCENIC entries are listed as under FDA review. KUMI markets its NoNic6 ingredient as 6-methylnicotine, a nicotine analogue it argues falls outside conventional FDA tobacco PMTA requirements. Corporate records link Scott Silverman to both VR Products I LLC and Blue Nine LLC. PMTA compliance expert Mr. K told 2Firsts that two routes may explain these listings: amendments to acquired historical PMTA applications (potentially relevant to CrossBar 20K) and FDA exemption classifications for nicotine-analogue products (relevant to KUMI). Neither mechanism has been confirmed in these specific cases. The report concludes that as more states implement directories, historical PMTA filings, brand assets and nicotine-analogue formulations are increasingly central to market-access strategies.

(Source:2Firsts)

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