​An evidence-based approach to the tobacco conundrum

​An evidence-based approach to the tobacco conundrum
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The path to successful innovation is never easy, especially in hotly controversial industries. 
 
The Food and Drug Administration (FDA) is now considering whether to approve the first of a new  generation of tobacco products, one designed to heat rather than burn tobacco. This technology produces far less inhalation of harmful chemicals than cigarettes, making it an attractive and safer alternative for current smokers.
 
The purist elites in the tobacco wars of the past 25 years will do anything to prevent advancement and innovation from tobacco companies. Tobacco is harmful, but when blocking the use of less harmful products are the purists tossing the baby out with the bathwater?
 
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The new FDA commission​e​r​,​​ ​Scott Gottlieb​, has been aggressive in his approach to lowering nicotine levels and addictiveness in current cigarettes by “encouraging the innovation of less harmful products while still ensuring that all tobacco products are put through an appropriate series of regulatory gates to maximize any public health benefits and minimize their harms.” He should be applauded for his efforts.
 
 
As a smoker, I appreciate this long overdue effort by tobacco companies (and the new FDA) to modernize their products in acknowledgment of  consumer wishes for less harmful use. As a progressive, I believe government regulators need to embrace healthier, science-based innovations and stop fighting yesterday’s regulatory wars.
 
In a meeting last month, the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) held a public hearing to review an application by Phillip Morris International to sell its heated tobacco product, IQOS, in the United States. TPSAC, with nine voting members drawn from academics and government, is charged with reviewing any application for a “modified risk tobacco product” and making recommendations to the FDA commissioner. 
 
Phillip Morris (PMI) presented evidence that IQOS, already on sale in other countries with rigorous  regulatory systems like Japan, reduces the amount of harmful chemicals found in cigarette smoke by an average of 90-95 percent. The company argued that IQOS could therefore provide a viable path for smokers to reduce serious health risks associated with traditional smoking.
 
The TPSAC experts did not believe PMI presented enough research showing IQOS could be marketed as reducing the risk associated with cigarette smoke. However, they did agree the company had demonstrated that switching completely from cigarettes to IQOS significantly reduces smoker’s exposure to harmful chemicals. Further, the committee unanimously agreed that there is low risk of former smokers relapsing with IQOS and concluded that there is a low risk of non-smokers, particularly youth, adopting IQOS.
 
TPSAC understandably set a high bar for the new product, given tobacco’s notorious history. But the process shouldn’t stop here. PPI believes regulatory decisions should be based on scientific evidence and risk analysis, no matter the product being tested or where the evidence leads us. This means tackling tough consumer protection issues using an open and pragmatic approach to achieve the safest possible outcomes for consumers, while also encouraging further innovation, greater investment, and future job creation.
 
An innovation that dramatically reduces current smokers’ exposure to harmful chemicals is a win, ​something PPI told FDA in public comments submitted for consideration by TPSAC. Conversely, a regulatory decision that bans the safer new product — while leaving conventional cigarettes on the market — would be difficult to explain for the FDA leadership and progressive opponents.
 
The FDA’s review of the Phillip Morris application continues. Ultimately, the agency will weigh the findings from the TPSAC meeting, along with public comments provided to the agency, and its own research when making a final decision. 
 
The agency has the regulatory pathway to let smokers like me use a far safer alternative to cigarettes, and they have a new technology, backed by science, before them. Smart policy and smart technology can enable smarter consumer decisions or the FDA can allow the purists of yesterday to punish the smokers of today.
 
Lindsay Mark Lewis is the executive director of the Progressive Policy Institute, a public policy think tank in Washington D.C.