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As required by the rule, all new tobacco products must comply with a host of TCA regulatory requirements such as registration, ingredient listing, warnings, age-restrictions and, most critically, premarket authorization for any new products first marketed or modified after the February 15, 2007 grandfather date. With respect to premarket authorization, because there are no known grandfathered ENDS, all such products, including those that have been on the market for years, are required to obtain FDA marketing authorization through the Premarket Tobacco Product Application (PMTA) process

We note that, on average, in any case where the impact on the direct cost for a particular refinement is $0.35 or less, the refinement has no impact on the PE RVUs

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