In July of last year, the Food and Drug Administration announced that it wanted to use its regulatory power to lower the amount of nicotine allowed in cigarettes, bringing it down to what the agency calls “non-addictive” levels. This month it’s expected to begin that process, which could remake the tobacco industry and will likely take years, especially if the companies sue. The FDA’s end goal: to produce cigs that are virtually non-addictive. (Though some experts would prefer the term “less addictive.”)
At the same time, the agency is evaluating cigarette alternatives that would deliver nicotine for people who can’t or won’t quit, but without the potentially lethal side effects of lighting up. The FDA strategy, in a nutshell: wean the tobacco industry off traditional cigarettes, without breaking up Big Tobacco. In fact, the industry may emerge even stronger, with a larger market and reduced stigma thanks to its new, “non-addictive” products.
The first product to test this strategy is Philip Morris’s iQOS, pronounced EYE-kose. It’s a sleek, pen-like device (and charger) that heats a Marlboro-branded tobacco stick without burning it. Since burning tobacco is what releases most of its harmful chemicals, the company is claiming the device is less harmful than cigarettes; it claims iQOS eliminates 90 to 95 percent of the chemicals. (The heated tobacco still releases addictive nicotine.) It’s technically different than an e-cigarette, which heats and vaporizes liquid that often contains nicotine, so don’t call it an e-cig; it’s a heated tobacco device. iQOS is already available in about 30 countries, including Canada and Japan, and is used by nearly 4 million people.
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But for Philip Morris to market iQOS in the US as a less-harmful cigarette alternative—what’s known as a “modified risk” tobacco product—it needs FDA clearance. The agency’s initial review of iQOS says it contains lower levels of toxic chemicals than cigarettes, but it can’t say whether that actually means lower risk for tobacco-related diseases like lung cancer, heart disease, and chronic obstructive pulmonary disease (COPD). Since 2009, manufacturers seeking to sell a new tobacco product have to demonstrate that it significantly reduces the risk of disease and doesn’t delay people from quitting cigarettes or encourage more smoking.
A panel of expert advisors will meet Wednesday and Thursday to discuss the findings, then provide their recommendation to the FDA to approve or not approve the device. The agency isn’t obligated to follow the panel’s suggestions, though it usually does.
Experts told Reuters that the FDA’s initial review provides few clues as to how the final decision may shake out. “It’s a complex document with lots of data and findings that could be used by proponents on either side,” Matthew Myers, president of the Campaign for Tobacco Free Kids, told the newswire. We’ll update this post after the panel makes its recommendation.
Myers told the Associated Press that Philip Morris would need to limit iQOS marketing strictly to people who want to quit smoking but have been unwilling or unable to do so; otherwise people who don’t smoke might want the device because it seems harmless enough to try.
If iQOS does eventually win approval, it could go on sale as early as February. That would make Philip Morris—more than a century old, one of the largest and most controversial tobacco companies—the first to bring a less-harmful cigarette to market. The company has spent more than $3 billion on lower-risk products; some argue that if Philip Morris can’t get a modified-risk product approved, no one can. If the FDA’s strategy holds, it would be a major step into the post-cigarette world, with Philip Morris present at the creation.
Update 1/26/18: An advisory committee recommended that the FDA reject Philip Morris' claim that the iQOS device is less harmful than traditional cigarettes; the FDA doesn't have to follow the committee's advice but it usually does. The company is still pursuing FDA approval to sell the device without a so-called "modified risk" claim. That decision is expected within a few months.