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May 26, 2016

 HR 2058 summary

Keller Heckman | The Cole-Bishop Amendment to the Agricultural Appropriations Bill Amending the Grandfather Date for “Deemed” Tobacco Products Passes House Committee – What Next?

The Deeming Regulation, as proposed, would treat all deemed products in essentially the same manner as the currently regulated products under a one-size-fits-all regime, subjecting the newly covered products to the same requirements including, among other things, facility registration, product and ingredient disclosures, Harmful and Potentially Harmful Constituent (HPHC) testing and reporting and, critically, the premarket authorization requirements for “new” products. Under the Tobacco Control Act, any regulated tobacco product not marketed on or modified after the February 15, 2007 grandfather date is a “new” product that requires FDA marketing authorization – via either a Premarket Tobacco Application (PMTA) or Substantial Equivalence (SE) Report – before it can enter the market. For more on the Tobacco Control Act requirements that will apply to deemed products including e-vapor products, see “FDA Regulation of E-Cigarettes – Are You Prepared?”  

Source: Keller Heckman | The Cole-Bishop Amendment to the Agricultural Appropriations Bill Amending the Grandfather Date for “Deemed” Tobacco Products Passes House Committee – What Next?

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