Tobacco Asia

Tobacco Asia 31 Erstwhile research brand goes commercial Well, fast forward to the present. SPECTRUM proved a success with re- searchers, but 22nd Century aimed at going further with it and making it avail- able for regular retail with a product called VLN ® – which contains the same level of very low nicotine content as the lowest line of SPECTRUM cigarettes used in reduced nicotine cigarette research. It wasn't an easy endeavor to commercialize VLN, of course, thanks to extremely complex tobacco regula- tions in the US. "We are not only under FDA regulations, but also subject to FTC regu- lations, state and local regulations, as well as the Master Settlement Agree- ment [MSA] with the National Association of Attorneys General [NAAG]," explained John Miller, 22nd Century's president of the tobacco division. "Any new cigarette brand to launch in the US must meet the full set of requirements under all of these [regulations]," Miller said. But while the regulatory environ- ment was "challenging for smaller companies like 22nd Century Group," the firm managed to negotiate the gauntlet nevertheless. Even more amazingly, VLN, by then a registered trademark, became the first combustible cigarette product in the US to ever having successfully gone through both the pre- market tobacco product application [PMTA] and the modified risk tobacco product [MRTP] processes. The advantages of MRTP authorization MRTP authorization allows VLN to make specific claims in its marketing materials (including printed on the packaging) that other brands are barred from, such as "95% Less Nicotine" or "Helps Reduce Your Nicotine Con- sumption". But whenever these authorized claims are used, FDA also re- quires VLN to include the additional message "Helps You Smoke Less". It is worth noting at this point that presently there exist only four authorized MRTP products in the US. VLN ® retail shelf display in the United States.

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