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The FDA’s proposed product approval process for vaping industry

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The vaping industry is currently engaged in a multi-front war, battling Congress on one side, the FDA on another, and HUD coming at us from seemingly out of nowhere. With all of this fighting going on, it’s sometimes difficult for the average vaper to keep up with all of the hullabaloo. Unfortunately, this is precisely what our combatants want.

The news cycle of the last few weeks is focusing on HUD and their attempts to ban e-cigs and vaping devices in the private dwellings of public housing. Meanwhile, the FDA has secretly authorized the selling of new tobacco products through the PMTA (Premarket Tobacco Application). Immediately after the authorization, the marketing of eight new Swedish Match snus products (“snus” tobacco products are very much like “snuff” tobacco in America) was essentially placed on hold indefinitely until FDA approval is granted. How long will this take? No one can be sure.

The PMTA document is over 100,000 pages in length. It is so massive and complex that many government agencies cannot quite figure out what it means. In fact, the FDA’s summary of its decision to authorize the new product approval process is a whopping 67 pages in itself. One professor from Boston University is so confused by the document that he recently issued a statement in the Tobacco Analysis blog regarding the potential negative impacts that this new legislation will have on the vaping industry.

“What the FDA did not readily reveal is that the (PMTA) application was incredibly complex, rigorous, burdensome, comprehensive, and extensive, weighing in at a total of more than 100,000 pages… It demonstrates that successfully submitting a PMTA is a…burdensome and highly expensive project that can only be completed successfully by…the absolutely largest e-cigarette companies,” states Mark Siegel, Professor of Community Health Sciences at the Boston University School of Public Health. “This is simply not something that a vape shop owner, the owner of a small e-cigarette business, or the owner of a small e-liquid business is going to have the capability or resources to carry out. This backs up my point made yesterday that the FDA deeming regulations amount to a de facto prohibition of all or most electronic cigarettes currently on the market.”

Siegel also goes on to say that the manner in which the FDA is trying to regulate the vaping industry is simply “insane.” E-cigarettes and vaping devices are the “safest products on the market.” If the regulations continue on this current path, the entire industry will essentially be eliminated by over-taxation and mountains of paperwork that have no clear deadline in place for FDA approval.

(Michael Siegel)

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