July 28, 2017

expert reaction to new FDA tobacco plan, including lowering nicotine in cigarettes to non-addictive levels

The US Food and Drug Administration (FDA) has announced plans to reduce nicotine content in cigarettes.

Prof. Robert West, Professor of Health Psychology, UCL, said:

“The FDA approach is a bold intent – to stop cigarettes being addictive by all but removing the nicotine.  If we could move directly from where we are to a world where no accessible tobacco product contained addictive levels of nicotine that might work.  Unfortunately this will not happen and in the meantime the demonisation of nicotine could undermine the complementary approach of encouraging smokers to switch to less harmful forms of nicotine use such as e- cigarettes.”

Prof. Linda Bauld, Professor of Health Policy, University of Stirling, said:

“These long awaited plans from the US Food and Drug Administration have international significance.  They suggest the US may be the first country in the world to require product standard for cigarettes that include reducing nicotine to non-addictive levels.  They are also providing a reprieve for e-cigarette manufacturers, giving them more time to submit documents to get current and future products approved.  The first of these developments could be problematic, while the second is welcome.

“A number of studies have examined reducing the nicotine in cigarettes, with promising results.  This would make smoking less appealing and addictive.  In carefully controlled trials, there is some evidence it could help smokers cut down or quit.  However, there will be big challenges implementing this in the real world.  Cigarettes are available globally, and selling less addictive products in the USA could result in a black market in imported or counterfeit products.  Reducing the nicotine might also mean smokers take in more toxicants (tar) by puffing harder and for longer on their cigarettes – something the FDA plan to test in a consultation period.  It is important to remember that nicotine is not the harmful constituent in cigarettes, but the many toxicants that are present in the tar.  It remains to be seen how viable this move is.

“On the plus side, the FDA has recognised the huge burden its current approval timelines place on e-cigarette manufacturers, including small companies.  So they have extended their deadline for approval to 2022.  In the meantime existing products can be continue to be sold.  This is good news, particularly given very recent research suggesting that smoking quit rates in the USA have increased since e-cigarettes became available and smoking rates have declined more quickly.  This is a temporary reprieve, however, and the US still needs to find the right system to ensure product standards while still making e-cigarettes available.

“Unfortunately, the announcements don’t include progress on some of the key measures needed in the USA to reduce smoking further, including banning tobacco advertising and making tobacco less available.  These kinds of policies, which are outside the FDA’s remit, would accelerate the current declines in smoking that e-cigarettes and other developments have achieved in the USA in recent years.”

* https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm

Declared interests

Prof. Robert West: “I have not and will not accept any kind of funds, payments or hospitality from companies that make e-cigarettes because of the risk of being perceived as tainted on that count. I undertake research and consultancy for companies that manufacture smoking cessation medications and licensed nicotine replacement products. My salary is funded by Cancer Research UK.”

Prof. Linda Bauld: “None to declare.”