Concerns over FDA snus delay

In a Hit & Run Blog on reason.com, Eric Boehm asks a pertinent question that has long bothered Tobacco Reporter and others.

Boehm reports that it’s been a year since the Food and Drug Administration signaled that it was nearing a decision on whether a Swedish Match snus brand could be marketed in the US as a less-harmful alternative to smoking.

‘What’s taking them so long?,’ he asks.

His answer, in part, says that if the FDA were to deny Swedish Match’s application to advertise snus as a safer alternative to smoking, it would have to explain why it believed that consuming snus was equally as dangerous as smoking – despite all evidence to the contrary.

‘By sitting on its hands for a year, Zeller [Mitch Zeller, director of the FDA’s Center for Tobacco Products] and the rest of the FDA has avoided committing to being on the side of science or on the side of Big Pharma,’ he writes.

Boehm’s piece is at: http://reason.com/blog/2016/10/24/why-is-the-fda-dragging-its-feet-on-auth

Boehm isn’t the only commentator to be looking at this matter. Writing on October 15 on hotair.com, Jazz Shaw said that for some reason the FDA continued to try to beat down every product in the tobacco market sector with the same hammer.

And this, he said, was despite the fact that when the FDA granted its premarket tobacco application (PMTA) approval for snus in 2015 it seemed to acknowledge in a press note that health risks were reduced in the case of this product.

Shaw pointed out that the press note said in part: ‘[t]he PMTA decisions for these products reflect evidence showing that these products, marketed as described in the manufacturer’s application, would result in a low likelihood of new initiation, delayed cessation or relapse . . . [and] that these products would likely provide less toxic options if current adult smokeless tobacco users used them exclusively’.

The press note said also that Swedish Match may not claim that the products are ‘FDA approved’, and that the company must receive a separate modified risk tobacco product (MRTP) authorization in order to make any claims of reduced exposure or reduced risk.

Shaw’s piece is at: http://hotair.com/archives/2016/10/15/fda-continues-thwart-less-risky-tobacco-alternatives/