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Trump’s Charge for FDA Regulatory Reform Could Be Good News for Snus

Friday, March 3, 2017 12:54
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If President Donald Trump is serious about reforming how the Food and Drug Administration operates, he could start by requiring the agency to use common sense when regulating alternatives to smoking.

Alternatives like snus, for example. The Swedish-made tobacco product consists of a small packet, similar to a tea bag, that’s filled with tobacco powder and placed in the upper lip. It delivers a jolt of nicotine but doesn’t come with the same health risks as smoking or using chewing tobacco.

But you wouldn’t know that by looking at the label. Swedish Match, the company that makes snus, has been trying since 2014 to get permission from the FDA to identify its product as a safer alternative to smoking. In Sweden, where snus is marketed that way, its popularity is credited with cratering smoking rates and associated diseases, and Swedish Match executives believe they could reshape the American tobacco market (and improve smokers’ health) in much the same way.

In December, the FDA ruled that snus would have to continue carrying a warning about the potential for causing tooth decay and gum disease, but punted on the more important question: whether snus could be marketed in the U.S. as less dangerous than cigarettes.

“Because there is already a warning label, they’re not inclined to remove it no matter how much evidence we present,” says Jim Solyst, vice president for federal regulatory affairs for Swedish Match, in an interview published by Tobacco Reporter, a trade publication.

That’s where Trump enters the picture. In his address to a joint session of Congress on Tuesday, the president specifically identified the FDA as a target for his administration’s regulatory reform effort.

The FDA’s “slow and burdensome approval process,” Trump said, prevents too too many advances from reaching those in need.

He was talking specifically about the FDA’s approval process for new drugs—an area where FDA foot-dragging can literally cost lives, as Reason’s Ron Bailey pointed out earlier this week—but the same logic makes a case for changing how the administration regulates tobacco, with an eye towards improving Americans’ health.

Slow and burdensome certainly describes what Swedish Match has gone through. The company has filed more than 130,000 pages of applications with the FDA since May 2014, according to Tobacco Reporter, in trying to become the first product to gain the coveted “modified-risk tobacco product” designation.

“We think that telling smokers that these products are 97 percent safer than similar products is the key message; this message is getting lost,” Solyst told the trade publication.

Swedish Match sees the obvious marketing benefit of earning that designation, but that doesn’t cancel out the very real public health benefits that could be realized if snus was more widely used.

The research continues to pile up. A peer-reviewed study published in Tobacco Control found that snus “does not appear to cause cancer or respiratory diseases” and cardiovascular risks from using snus were lower than with smoking. A study conducted in Norway and published in Nicotine and Tobacco Research found that using snus was much more effective at getting smokers to quit using cigarettes than nicotine replacement products like patches and gum. Snus-ers were three times as likely to quit smoking as smokers using nicotine gum, the researchers found. They believed snus was so effective because it delivered a nose of nicotine that was almost the same as cigarettes and provided a “sensory effect that medicinal nicotine products perhaps lack” because snus smells and tastes like tobacco. Researchers at the University of Alabama at Birmingham reported in 2007 that 200,000 smoking-related deaths per year could be prevented if tobacco uses across the whole of the European Union adopted snus at the same level as Swedes.

While there hasn’t been any official announcement of changes in FDA policy towards tobacco, there’s good reason to believe the agency’s new boss is open to changing tobacco regulations.

Tom Price, the orthopedic surgeon and former Georgia congressman appointed by Trump to run the Department of Health and Human Services (Price was confirmed by the Senate in a party-line vote last month) is on the record as being skeptical of the FDA’s history of regulating all tobacco products equally. In fact, as a member of the Senate, he twice voted against bills allowing the FDA to regulate tobacco—both bills passed despite his opposition.

Price heading the Department of Health and Human Services, combined with Trump’s focus on streamlining the FDA’s permitting process, could be good news for snus—and for anyone who’s been unable to quit smoking using other means.



Source: http://reason.com/blog/2017/03/03/trump-fda-regulatory-reform-snus

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