The Food and Drug Administration Thursday proposed establishing the first federal regulations on electronic cigarettes, banning sales to minors and requiring FDA approval of the products. Electronic cigarette makers would be required to disclose the chemicals used in the nicotine delivery devices – which replace cigarette smoke with vapor – and note on product labels that nicotine can be addictive.
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“First, for America’s 44 million smokers, most of whom want to quit yet cannot with the currently available FDA-approved products, the continued availability of electronic cigarettes is reassuring, as this method provides addicted smokers with their best chance of quitting.
“Second, the rules will stifle innovation in the e-cigarette marketplace. They are unduly onerous and are not based on sound science, requiring 99 percent of the current products to apply for FDA approval. Many smaller e-cig companies will either go under or seek ‘protection’ from the major tobacco companies via buyout/takeover.
“Third, while these proposed regulations will in the best of circumstances take three to four years to become fully implemented, the likelihood of litigation will prolong even that interval. During this period and at its end, Big Tobacco will come out the winner – by either absorbing small companies unable to bear the FDA approval expense, or just by waiting it out.”
“For several years, public health advocates familiar with the Family Smoking Prevention & Tobacco Control Act have warned that FDA regulation of electronic cigarettes would cripple much of the industry and protect cigarette markets. With the release of the FDA’s proposed deeming regulations, it is clear that these advocates were correct.
“By requiring the manufacturer of every single electronic cigarette product on the market to file a ‘new tobacco product’ application, the FDA has all but guaranteed the closure of tens or hundreds of small and medium-sized businesses that have no connection to Big Tobacco. The FDA estimates that just one application will require over 5,000 man hours to complete, meaning that the true cost of a single application is likely in the millions.
“Additionally, with the Government Accountability Office strongly criticizing the FDA last year for its spectacular failure to meet deadlines with relation to regulatory decisions on the tobacco products it already regulates, why is the FDA now attempting to give itself even more responsibility and power?”
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