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PMTA\u00a0<\/strong>D<\/strong>EADLINE ARRIVES: This is a\u00a0BIG DAY<\/u>\u00a0for the vapor technology industry. The day that so many said could not come has arrived. And, just like with every other deadline imposed by the FDA, the vapor industry has stepped up to the task.<\/p>\n Once thought impossible,\u00a0already reports are coming in of many manufacturers filing their Pre-Market\u00a0Tobacco Applications (PMTAs) covering what is sure to be\u00a0thousands of products.\u00a0Congratulations to all those companies who dug in, did the hard work, gathered the science and submitted their\u00a0PMTAs by the deadline. Yes, companies had to make some tough decisions along the way, but that was always expected as we headed into the final phase of the Deeming Regulation.<\/p>\n Last week, the FDA confirmed it will take each applicant’s\u00a0individual circumstances into account during the review process.\u00a0To be sure, FDA already has been quickly replying\u00a0to early applicants\u00a0and\u00a0issuing initial acceptance letters\u00a0accepting applications for a variety of products.<\/p>\n While this may feel like a finish line, it is really only the beginning of an ongoing process with FDA as CTP reviews each application submitted and engages with further questions of the applicants.<\/p>\n VTA will continue our existing dialogue with FDA to strongly advocate for our members participating in the process.\u00a0 To that end, the process rolls out as follows:<\/p>\n Phase 1<\/u>:\u00a0 Administrative Review.\u00a0<\/strong>\u00a0FDA initially reviews the application to make sure that basic requirements are in the application, it is in English, it includes required contact information and that it contains product identifying information.\u00a0If these basic elements are included, a company should receive a letter from FDA accepting their application for further action.\u00a0If not, FDA will send a \u201crefuse to accept\u201d letter.<\/p>\n Phase 2:<\/strong><\/u>\u00a0\u00a0Filing.<\/strong>\u00a0 FDA engages in a preliminary scientific review to make sure that everything required by the statute is included, such as health risk data, HPHC studies, descriptions of components, ingredients, additives, and principles of operation, description of facility controls, manufacturing, etc.\u00a0 If FDA finds these elements, a company will receive a letter accepting the application for filing.\u00a0 If not, FDA will send a \u201crefuse to file\u201d letter.<\/p>\n Phase 3:<\/u>\u00a0 Substantive Review:\u00a0<\/strong>\u00a0This is FDA\u2019s full-blown evaluation of all the science and data presented in each application.\u00a0 FDA will take recommendations from TPSAC and will engage with the applicant with questions.\u00a0 This process could take up to 12 months and\u00a0during this time FDA may send the applicant a deficiency letter, giving them 90 days to provide missing or deficient information.\u00a0 If FDA has made a scientific decision to issue a marketing order, FDA will send an environmental information request letter before it can issue a final marketing order. Otherwise, FDA will send a \u201cno marketing order\u201d letter.<\/p>\n Phase 4:<\/u>\u00a0 Post Marketing Reporting.<\/strong>\u00a0 As part of its approval process, FDA may require that the sale and distribution of your product is restricted (i.e., to protect kids).\u00a0 Or FDA may require the applicant to establish and maintain certain records and make certain reports available to FDA.\u00a0 Post market reports will vary based on submission and may include a requirement that the applicant engages in serious or unexpected adverse experience reporting or any manufacturing deviations.<\/p>\n VTA\u2019s full, in-depth analysis summarizing the important developments for those impacted by the PMTA deadline, particularly as it relates to FDA\u2019s enforcement now that the PMTA deadline has been reached,\u00a0can be found\u00a0here<\/a>.<\/p>\n
\nVAPOR INDUSTRY RESPONDS<\/strong>
\nSeptember 9, 2020<\/strong><\/p>\n
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