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Washington, D.C. / New York, NY - The Food and Drug Administration's Center for Tobacco Products will soon publish its so-called "Deeming Regulations," the framework for regulating e-cigarettes at the federal level.
The Hill reports the rule's release may be "imminent."
According to National Center for Public Policy Research Risk Analysis Director Jeff Stier, "the regulation could require all e-cigarettes that came to market after February 15, 2007, which is essentially all of them, to be removed from the market unless they win onerous pre-market approval."
"This," Stier warns, "would give deadly old-school combustible cigarettes an almost insurmountable competitive advantage."
"The regulation would have the effect, intended or not, of taking e-cigarettes away from former smokers who quit smoking by using these less harmful alternatives," Stier added.
"This," says Stier, "is exactly the opposite of what government should be doing, which is to create a regulatory environment that encourages smokers to switch to e-cigarettes, the dramatically less harmful way to get nicotine."
Stier explains that the 2007 date, known as the "predicate date," was established by Congress with cigarettes and other tobacco products in mind. "E-cigarettes were in their infancy when Congress gave FDA authority to regulate tobacco. There's just no public health way of making sense of applying a 2007 predicate date to e-cigarettes, as the FDA stubbornly insists it must."
According to Stier, "the most immediate thing Congress can do to stop the FDA from killing off the most viable alternative to cigarettes for smokers is to change the predicate date to the effective date of the new FDA rule, likely later this year."
Stier says "the House Appropriations Committee can change the predicate date, literally giving everyone more breathing room, but it wouldn't completely rein in the FDA, because the FDA would still seek to hold e-cigarettes that go on the market after that date to innovation-stifling pre-market rules."
"E-cigarettes are innovative products. Health regulators should put reasonable safety standards in place, rather than put e-cigarettes at a disadvantage to deadly cigarettes, already entrenched in the market," Stier insists.
Stier met with White House and FDA officials twice as the Obama Administration was considering the Deeming Regulations. He has also given talks at leading conferences around the world on the role of tobacco harm reduction. Stier has also offered his expertise on the matter at the United Nations, as well as in city, state and federal regulatory and legislative hearings around the country. Video of Stier testifying to the Los Angeles City Council is available here and at the United Nations, here.
As Mr. Stier told WCBS TV in New York City last year, "E-cigarettes are a free-market solution to the problem of smoking because people are willfully switching from a very harmful product to dramatically less harmful products."
Stier is concerned that "if, in the name of public health, federal regulations inhibit much-needed innovation in the e-cigarette market, public health will actually suffer, as fewer adult smokers will be likely to switch from smoking."
In an op-ed for USA Today, Stier argued, "E-cigarettes aren't threatening the progress of continued smoking reduction. They are helping even hard-core cigarette smokers quit."
In an interview with Al Jazeera America's Ali Velshi, Stier called e-cigarettes "a boon to public health" and a threat to the old way tobacco companies did business.
According to Stier, "It is appropriate for the federal government to regulate e-cigarettes, but as even the FDA's own chief tobacco regulator has repeatedly acknowledged, the law requires the agency to use science to weigh the potential benefits of e-cigarettes against any potential health risk for both the individual user, as well as the population as a whole."
When the FDA initially issued the proposed Deeming Regulation in 2014, Stier warned, "If the regulations are too heavy-handed, they'll have the deadly effect of preventing smokers from quitting by switching to these dramatically less harmful alternatives."
Stier predicts, "If the Deeming Regulations apply overly-burdensome rules, the industry, consumer groups, and health advocates will come together to challenge the rules in court, as well as in the legislature."
The National Center for Public Policy Research, founded in 1982, is a non-partisan, free-market, independent conservative think-tank. Ninety-four percent of its support comes from individuals, less than four percent from foundations, and less than two percent from corporations. It receives over 350,000 individual contributions a year from over 96,000 active recent contributors. Sign up for free issue alerts here or follow us on Twitter at @NationalCenter.