The new tobacco product IQOS was recently granted permission to be sold in the U.S., sparking concerns of yet another nicotine delivery device being introduced to the U.S. market amid a youth e-cigarette epidemic.
The Food and Drug Administration determined in April that Philip Morris International can now begin marketing and selling the heat-not-burn device IQOS, the first product of its kind to be sold in the U.S. Heat-not-burn tobacco products, also called heated tobacco products, are electronic devices that heat tobacco leaves to produce an inhalable aerosol, instead of burning tobacco like traditional cigarettes.
While IQOS is an electronic device, the FDA has classified it as a cigarette, which means the product is subject to all the same existing restrictions for traditional cigarettes. Philip Morris claims these products are safer than cigarettes, but much remains unknown about the devices and the impact they will have.
Here are six important things to know about IQOS.
1. IQOS uses different technology than e-cigarettes.
Heat-not-burn products are different from e-cigarettes because they use actual tobacco, not the flavored e-liquid typically found in e-cigarettes. The concept behind heat-not-burn is that it allows users to experience what looks and feels like smoking a regular cigarette without inhaling combusted tobacco.
2. The devices have not been “FDA approved.”
As the FDA stated, while its decision “permits the tobacco products to be sold in the United States, it does not mean these products are safe or 'FDA approved.'”
The company submitted applications to the FDA for two different regulatory approvals: one to market the product as a new tobacco product (called a Pre-Market approval), and the other to market the product as less harmful than other tobacco products (called a Modified Risk Tobacco Product approval). The FDA decision applies to the Pre-Market approval application. The agency has not decided on whether the device can be marketed as less harmful than other tobacco products.
3. Heated tobacco products are not proven to be safer than cigarettes.
Tobacco companies claim that heat-not-burn products are less harmful than cigarettes because when tobacco burns, or combusts, it produces more than 7,000 chemicals that are found in cigarette smoke.
Philip Morris claims that IQOS is less toxic than cigarettes, but multiple papers in an issue of the journal Tobacco Control concluded that the company’s own data does not fully support those claims. Research shows that although IQOS may have lower levels of some toxicants than cigarettes, it can still expose users to higher levels of other toxicants. Likewise, IQOS could expose users to lower risks of some diseases, but higher risks of others.
Philip Morris’ research underscores the fact that fewer toxic chemicals does not mean lower levels of harm when people use the product, and that reduced exposure claims are misunderstood as reduced harm claims.
4. IQOS may appeal to youth.
Truth Initiative® researchers found that IQOS may appeal to youth and young adults because of marketing that depicts the product as “sophisticated, high-tech and aspirational” and “sleek, exclusive items akin to iPhones.”
The marketing of the product is particularly concerning because of the current youth e-cigarette epidemic, driven by JUUL. E-cigarette use has surged, especially among young people — many of whom never smoked cigarettes. In fact, e-cigarette use grew 78% among high schoolers and 48% among middle schoolers in just one year from 2017 to 2018, and JUUL now accounts for three-quarters of the U.S. e-cigarette market.
Another study published in Tobacco Control underscores these concerns: “Just as e-cigarettes, particularly the JUUL-style, promoted with a modern, high-tech image and harm reduction and ‘smokeless’ messages, appeal to adolescents, it is likely that IQOS, marketed in a similar manner, will also appeal to adolescents.”
To prevent youth access to IQOS and exposure to its advertising and promotion, the FDA is placing restrictions on how the products are marketed — especially through websites and social media — and requiring that advertising is targeted to adults.
5. The tobacco cartridges will be available in menthol and could strengthen the Marlboro brand.
Philip Morris plans to offer rolls of tobacco resembling small cigarettes, called HeatSticks, with menthol, a flavor that has been shown to attract young users and make cigarettes easier to smoke and harder to quit. The company did not provide information in its applications to the FDA about how the menthol variant will affect the appeal, toxicology or other health effects of the product.
Additionally, Philip Morris is planning to market HeatSticks under the Marlboro name. Marketing the new device using the Marlboro brand may increase the overall appeal of all Marlboro products, including cigarettes. Research shows that Marlboro tops the list of preferred cigarette brands among teenagers.
6. These products are part of the industry’s efforts to deal with increasing regulation.
Tobacco companies are attempting to undermine government regulation by using harm reduction claims as a strategy for reframing the industry as part of the solution instead of part of the problem, according to commentary in Tobacco Control.
“[Heated tobacco products] are the latest effort by tobacco companies to adapt to a changing regulatory landscape to maintain and expand their customer base amid declining social acceptability of tobacco use and declining cigarette consumption,” the commentary stated. “Where regulations are absent or loopholes exempt [heated tobacco products] from existing regulations, companies market [heated tobacco products] to increase social acceptability for all their tobacco products.”
Source: Truth Initiative