It's time for action

The US Food and Drug Administration has failed to approve a single reduced-harm nicotine product in the past year, despite having unveiled a new ‘roadmap’ in July 2017 that emphasized the role such products can play in reducing tobacco-related illness, according to a piece by Michelle Minton at cei.org.
‘That lapse does a huge disservice to millions of smokers who could benefit from switching from cigarettes to a far less harmful product,’ Minton said.
‘A year ago, the FDA claimed it would balance regulation against encouraging the development of harm-reducing products. But with each passing week it’s become clear that the biggest roadblock on the path to tobacco harm reduction is the agency’s own cumbersome product approval process.’
Minton pointed out that it would be easy for the FDA to encourage the development of less harmful nicotine products for smokers. The market already provided alternatives in the form of e-cigarettes, smokeless tobacco, and heat-not-burn devices, she said. All that was needed to make these products available and viable as smoking cessation tools was for the FDA to establish a regulatory structure that made it easier and cheaper for manufacturers to earn FDA approval to sell the products and advertise them as being of lower risk than combustible cigarettes.
But the FDA seemed to have done nothing to reform its pre-market tobacco approval gauntlet. During the past two years, the agency had received 367 premarket tobacco applications, which are required for the products to be sold legally in the US. None had been approved. The agency had received also 35 Modified Risk Tobacco Product applications (MRTP), which would allow tobacco products to be advertised as lower risk. The agency had not approved any such application, ever.
Minton pointed out that snus had helped Sweden get its smoking rate down to five percent, lower by far than any other EU nation and the US; and, as a result, Sweden had one of the lowest incidences of lung cancer and oral cancers in the EU.
While snus could be sold in the US, it could not be advertised as being of lower risk than cigarettes, even though it was. Consequently, US consumers saw little reason to switch from smoking to smokeless tobacco.
So far, the FDA had considered MRTPs from several snus companies, including Swedish Match, which submitted an application in 2014 and was denied two and half years later. Currently, R.J. Reynolds, which submitted an MRTP in March 2017, was still waiting on a decision from the FDA.
[In December 2016, the FDA announced a partial ruling offering Swedish Match two years to submit an amended application, and TR understands that the company is finalizing its amendment and plans to submit it soon.]