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.
“The most ridiculous FDA claim is that these regulations will lead to increased innovation—even though the agency admits that 99 percent of the market will not be able to comply,” writes Jared Meyer, Fellow at the Manhattan Institute. “This is a nonsensical claim that could only be made by a government agency,” Meyer adds.
“While the FDA repeatedly claims that its regulations will lead to ‘significant public health benefits,’ what the regulations will actually do is consolidate the sprawling, dynamic vaping industry into the hands of two tobacco giants, Altria Group (the parent company of Phillip Morris) and R.J. Reynolds.”
Such an industry-wide consolidation would be disastrous for innovation, according to Michelle Minton, Fellow at the Competitive Enterprise Institute (CEI).
“With fewer companies and products to compete with each other and onerous pre-approval rules, innovation will slow to a crawl. Where once intense competition prompted vaping companies to reduce prices and introduce safety features, like heavy metal-free e-liquid and adjustable nicotine levels, the new rules will freeze the technology in time,” says Minton.
There’s one bright spot for the industry. An amendment sponsored by Rep. Tom Cole and Rep. Sandford Bishop, which passed the House Appropriations committee, would alter the predicate date to ensure products already on the market won’t be pulled off the shelves in two years time. The amendment will need to pass through the House of Representatives to become law. (RELATED: Vapers Win Big: House Committee Passes Amendment To Save E-Cigarettes)
“In order to preserve this growing market and allow continued innovation in the vapor-product industry, it’s essential that Congress act to amend the grandfather date set out in the 2009 FDA Tobacco Law.” said R Street Policy Analyst Caroline Kitchens in a press release.
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