FDA is Out of Its Mind: Deeming Regulations Should Be Called "The Cigarette Protection Act of 2015"; Regs are an Embarrassment to Public Health and Will Decimate the Vaping Industry

OMB Should Be Called Upon to Disapprove the Regulations and to Require Changes to Protect the Public's HealthThe Tobacco Vapor Electronic Cigarette Association (TVECA) has obtained a copy of the FDA electronic cigarette deeming regulations that were sent to the Office of Management and Budget (OMB) for final approval before promulgation, as well as a draft of the guidance that the agency intends to release in conjunction with the deeming regulations. The guidance relates to the recommended procedure for filing pre-market tobacco product applications (PMTA's). The TVECA has made the PMTA guidance publicly available on its web site, but did not make the deeming regulations available upon the request of the FDA.The following commentary is based on my review of the PMTA draft guidance document. Although I have not yet reviewed the actual deeming regulations, it is possible, from analyzing the guidance, to infer the basic approach that the FDA has decided to take regarding the regulation of electronic cigarettes and vaping products. Once the deeming regulations are released, I will continue to analyze them and provide additional commentary, including any clarifications of the following commentary if they are necessary. However, the approach the FDA is taking appears clear from the draft guidance.Caveat: This commentary is based solely on my review of the PMTA draft guidance. It is possible, although unlikely, that the actual deeming regulations include exemptions or modified provi...
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