GOP Senator Challenges FDA On Crushing E-Cig Regulations

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Guy Bentley Research Associate, Reason Foundation
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Sen. [crscore]Ron Johnson[/crscore] is demanding the Food and Drug Administration (FDA) justify devastating regulations that could wipe-out the e-cigarette industry.

“Unfortunately, the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences,” Johnson wrote in a letter to the agency Wednesday. (RELATED: FDA Announces Rule To Ban 99 Percent Of E-Cigarettes)

“The costly impact the rule will have on e-cigarette manufacturers will stifle innovation and make it harder for e-cigarette companies to continue to offer products that serve as an alternative to smoking. It is possible that without a cost-effective alternative, some consumers will resort to traditional cigarettes,” Johnson continued.

The rule that most concerns the e-cigarette industry is the so-called “predicate date” of Feb. 17, 2007. All vapor products that came on the market after this date, which is almost all of them, will have to go through the notoriously onerous and expensive Pre-Market Tobacco Application process (PMTA).

PMTAs can cost millions of dollars per product and around 1,700 hours of paperwork. Industry experts and the FDA’s own analysis from 2014 estimate 99 percent of products on the market won’t even be put through this process and will be taken off the market within two years.

Johnson asked the FDA whether it will revise its rules if there is sufficient data that finds e-cigarettes are a safer alternative to traditional cigarettes. Two of the UK’s leading medical institutions, the Royal College of Physicians and Public Health England, believe e-cigarettes are 95 percent less harmful than tobacco cigarettes. (RELATED: Game Changer: World Leading Medical Group Backs E-Cigarettes)

“How is the FDA’s regulation of e-cigarettes not a premature restriction on an industry given the FDA’s admission that it does not have “sufficient data” about e-cigarettes to determine the effects on the public’s health?,” Johnson said in the letter.

The GOP senator also wants to find out how many businesses will be affected by the FDA’s 499-page rule book and whether any analysis was undertaken to see if smoking rates might increase if the e-cigarette market is decimated.

Johnson cites the Chief Executive Officer of Johnson Creek Vapor Company, who said the FDA deeming regs would “extinguish a multi-billion dollar industry and put tens of thousands of people out of business.”

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