US: Deeming Rules Could Spell Disaster

Source from:  Tobacco Reporter 04/18/2016

The National Center for Public Policy Research (NCPPR) is calling on Congress to act quickly to halt the Food and Drug Administration's upcoming regulation that would kill off electronic cigarettes in the US.

In a press note issued yesterday, the NCPPR said the FDA's Center for Tobacco Products would soon publish its so-called Deeming Regulations, the framework for regulating e-cigarettes at the federal level. The Hill, it said, had reported that the rule's release might be 'imminent'.

According to NCPPR's risk analysis director, Jeff Stier, the regulation could require all electronic 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 said, "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.

"This 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 said 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," he said. "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 could do to stop the FDA from killing off the most viable alternative to cigarettes for smokers was to change the predicate date to the effective date of the new FDA rule, likely later this year. "The House Appropriations Committee can change the predicate date, literally giving everyone more breathing room, but it wouldn't completely reign 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 met with White House and FDA officials twice as the Obama Administration was considering the Deeming Regulations. He has given talks at leading conferences around the world on the role of tobacco harm reduction. And he has 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.

On WCBS TV in New York City last year, Stier made the point that electronic cigarettes were a free-market solution to the problem of smoking because people were willfully switching from a very harmful product to dramatically less harmful products. But he has expressed concern that if, in the name of public health, federal regulations inhibit much-needed innovation in the electronic cigarette market, public health will actually suffer, because fewer adult smokers will be likely to switch from smoking.

In an op-ed for USA Today, Stier said electronic cigarettes weren't threatening the progress of continued smoking reduction; they were helping even hard-core cigarette smokers quit. And in an interview with Al Jazeera America's Ali Velshi, Stier called electronic cigarettes "a boon to public health" and a threat to the old way tobacco companies did business. Enditem