Instead, we are now faced with the "deeming regulations," a disastrous proposal under which most of the existing e-cigarette market may be destroyed and the market essentially handed over to Big Tobacco, which are the only companies large enough to successfully complete the new product applications which will be required for every single e-cigarette product on the market.

1. Altria Client Services (on behalf of Nu Mark): "Nothing in the FSPTCA [Family Smoking Prevention and Tobacco Control Act] requires FDA to engage in all-or-nothing deeming for all purposes. Rather than deem an entire class of tobacco products categorically subject to the FSPTCA for all purposes, FDA has multiple options for proceeding in a reasoned, scientifically sound, and incremental manner. For example, FDA should exercise its statutory authority to deem e-vapor products commercially marketed before the Final Rule for certain purposes under the FSPTCA. Such products would be subject to age restrictions, warning labels, and disclosure requirements, without subjecting them to premarket authorization. Only those e-vapor products commercially marketed after issuance of the Final Rule would be subject to ... premarket authorization."

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