The Food and Drug Administration’s claim that it’s almost 500-page rule book, which could wipe out 99 percent of e-cigarette products, will increase innovation in the sector is being mocked by experts as “ridiculous.”
The centerpiece of the FDA regulations is the requirement for all vapor products released after Feb. 17, 2007, (predicate date) to go through the notoriously onerous and expensive Pre-Market Tobacco Application process (PMTA).
PMTA’s can cost millions of dollars per product and the FDA itself admits it will take around 1,700 hours of paperwork. Almost no vape businesses will be able to withstand this regulatory onslaught. FDA analysis estimates 99 percent of products on the market won’t even be put through this process.