FDA Announces Plan to Reduce Nicotine Levels in Cigarettes

07 August, 2017, 00:48 | Author: Andrea Terry
  • FDA Commissioner Scott Gottlieb MD

Scott Gottlieb, chief of U.S. Food and Drug Administration (FDA), has asked the staff to come up with new rules pertaining to nicotine.

"Reducing nicotine doesn't make a cigarette safe, it just makes it less addictive", Donny said welcoming the recent news from the FDA.

The FDA plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.

The law gives the FDA the authority to regulate levels of tar, nicotine, and any other harmful chemicals of tobacco products. Mr. Donny, the director of Pitt's Center for the Evaluation of Nicotine in Cigarettes, argued that most of the harm linked with smoking isn't caused by nicotine.

The results showed that e-cigarette users were more likely than non-users to make a quit attempt (65 percent versus 40 percent) and more likely to succeed in quitting smoking tobacco for at least three months.

But the FDA is seeking public comment, input from stakeholders and research that outlines the health benefits and any adverse effects of lowering nicotine levels, as well as any evidence supporting or opposing the theory that e-cigarettes and vaping products help smokers quit. With this unexpected announcement, shares of tobacco companies dipped and a praise among some public health advocates started. In fact, based on the FDA's proposed approach to potentially mandate non-addictive levels of nicotine in tobacco cigarettes, 22nd Century Group might be the only company that can deliver such a product.

"These findings need to be weighed carefully in regulatory policy making and in the planning of tobacco control interventions", the researchers, led by Shu-Hong Zhu at the University of California, said in their study.

'It doesn't read like the industry is destined to go up in smoke, ' he said.

According to Commissioner Gottlieb, the approach to nicotine must be accompanied by a strict base of rules and standards for newly-regulated products which should be done in concert and not in isolation, if it is to be successful. Approval of the application is expected late in 2017 and sets the stage for BRAND-A to become the first approved tobacco product on the market that complies with the new guidelines.

In addition, regulations that outline the details on the information the agency expects to be included in the Modified Risk Tobacco Product (MRTP), Premarket Tobacco Applications (PMTAs), and reports to demonstrate Substantial Equivalence (SE) are meant to be released by the agency.


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