Philip Morris’ smoking device may be safer than cigarettes, but FDA panel says it’s not safe enough to sell in the U.S.
Tobacco giant Philip Morris had mixed success on Thursday in its bid to sell a federal advisory panel on the wisdom of offering U.S. smokers a potentially safer alternative to cigarettes.
After two days of meetings outside of Washington, D.C., the Food and Drug Administration’s Tobacco Products Scientific Advisory Committee offered a lukewarm endorsement of a product called IQOS, which Philip Morris and its American partner, Altria, hope to introduce to the American market.
In an 8-1 vote, the panel — made up of nine experts on tobacco and its health effects — endorsed the idea that the heated-tobacco device proposed by Philip Morris “significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”
But when asked to judge whether that reduction would translate into better health for smokers who switched to the new product, the panel signaled that it was not convinced by the company’s research.
By a vote of 5 to 4, the members narrowly rejected the claim that “switching completely to IQOS presents less risk of harm than continuing to smoke cigarettes.”
Their skepticism does not seal the fate of the tobacco giant’s plan to market its cigarette alternative to the 42 million Americans who continue to smoke. The final say will be had sometime this spring by FDA Commissioner Scott Gottlieb, who has said the agency aims to “clarify … the role that potentially less harmful tobacco products could play in improving public health.”
FDA commissioners often follow the advice of their expert panels. But they don’t have to, and Gottlieb has several options for how to proceed.
He could block the sale of the IQOS system in the United States altogether. He could also green-light its sale without allowing marketing claims that it is less dangerous than traditional cigarettes.
Or, he could overrule the panel and allow the tobacco giant to sell IQOS and advertise it as a “reduced risk” product.
The IQOS system is already sold in close to 30 countries, including Britain and Japan. While Philip Morris touts it as an innovation that will open a safer new chapter in the history of tobacco use, critics charge that it would weaken smokers’ resolve to make the safest choice — quitting tobacco outright.
Critics argue that by offering past smokers, never-smokers and young people an alternative they perceive as safer, the number of Americans addicted to nicotine could actually rise.
The Campaign for Tobacco-Free Kids is particularly concerned that IQOS will appeal to young people who would otherwise stay away from cigarettes.
Philip Morris “failed to provide FDA any evidence about the impact of the product on non-smoking youth,” the campaign’s president, Matthew L. Myers, said in a statement after Thursday’s vote.
Myers noted that the panel was deeply skeptical that smokers would switch completely to IQOS. By a vote of 8 to 1, the members concluded that many smokers would become long-term dual users of both IQOS and traditional cigarettes. If so, that would negate the idea that IQOS would be a net benefit for public health, he added.
For its part, Philip Morris appeared not to be discouraged by the FDA advisory panel’s lukewarm reception.
“We are encouraged by the recognition of the risk reduction potential of IQOS that clearly emerged from the statements of the committee members,” company spokesman Corey Henry said in a statement. “We are confident in our ability to address the valid questions raised by the committee with the FDA as the review process for our application continues.”
For a product offered as a modern take on tobacco use, the IQOS system certainly looks the part. Available in matte black or modern white, its sleek cylinder encloses a filtered roll of dried tobacco product called a “HeatStick.” With a click, the holder draws a blade heated to 350 degrees through the dried leaf. After 14 puffs or six minutes, a user returns the holder to a case that looks like it could be the latest wireless device. The system is quickly recharged and ready to toast up another heat stick.
For the user, the IQOS system delivers nicotine like an e-cigarette, but with the taste and buzz of tobacco. A cigarette burns at 600 degrees, but at 350 degrees, the HeatStick tobacco never ignites. The user exhales a largely odorless vapor in which some of the most toxic byproducts of combustion — carbon monoxide, nitrogen oxides, formaldehyde, mercury and ammonia — are reduced by 69% to 99.9% compared to the average cigarette on the market.
In two days of hearings, Philip Morris International — the company that supplies Marlboros, Parliaments and Virginia Slims to smokers across the globe — said it is prepared to tell potential customers that IQOS is not danger-free. But it hopes to bolster IQOS’s appeal by positioning the product as a way to improve the health prospects of smokers who cannot or will not quit.
In Britain and Japan, public health officials have been receptive to the idea of “risk reduction” when it comes to smoking. In the interests of offering committed smokers something that may expose them to less harm, they have been willing to entertain the possibility that some new smokers may be created.
“Certainly, these countries have a more caveat emptor approach” in which consumers are encouraged to make choices under circumstances of uncertainty, said Marc Scheineson, a former FDA associate commissioner for legislative affairs who helped draft the 2009 Tobacco Control Act expanding the FDA’s power to regulate tobacco products.
Scheineson, now a partner with the law firm Alston & Bird, said he wasn’t surprised that the scientists and public health experts on the advisory panel were not wholly convinced by Philip Morris’ research findings. Whether the Trump administration’s penchant for reducing regulatory barriers will play out in the FDA’s final decision “will be the interesting thing to watch,” he added.
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