Anti-tobacco groups are warning that introducing yet another inhalation tobacco product to the U.S. market will further fuel an epidemic rise in youth nicotine use, already soaring thanks to the wildly popular Juul e-cigarette brand.
On Tuesday, the that limited sales of the heat-not-burn tobacco device IQOS would be allowed, though with strict marketing restrictions designed to prevent uptake by children and teens.
The products authorized for sale will be sold by Philip Morris International (PMI) through an exclusive license with Altria Group. They include IQOS, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, and Marlboro Fresh Menthol Heatsticks.
Unlike conventional cigarettes, which burn shredded tobacco, the electronic IQOS system heats tobacco-filled sticks to generate a nicotine-containing aerosol. The , and they are already being sold in dozens of countries, including Japan, Canada, Israel, and throughout Europe.
PMI won approval via the FDA's Premarket Tobacco Product Application (PMTA) pathway, but the FDA's announcement noted that "it does not mean the products are safe or 'FDA approved.'"
The agency has yet to rule on a separate application by PMI to allow the devices to be marketed as modified risk tobacco products (MRTP).
So far, no tobacco product has been granted MRTP status by the FDA, although several applications are pending, including IQOS and the "snus" oral tobacco packets marketed by Swedish Match and R.J. Reynolds.
"While the authorization of new tobacco products doesn't mean they are safe, the review process makes certain that the marketing of the products is appropriate for the protection of the public health, taking into account the risks and benefits to the population as a whole," the FDA Center for Tobacco Products director Mitch Zeller, JD, said in the IQOS announcement.
"This includes how the products may impact youth use of nicotine and tobacco, and the potential for the products to completely move adult smokers away from use of combustible cigarettes," he added.
Also, even though the agency emphasized that it hasn't ruled that the PMI Heatsticks are less harmful than conventional cigarettes, it listed reasons to believe they are.
"[T]he agency found that the aerosol produced by the IQOS Tobacco Heating System contains fewer toxic chemicals than cigarette smoke, and many of the toxins identified are present at lower levels than in cigarette smoke," the FDA said. "For example, the carbon monoxide exposure from [the] IQOS aerosol is comparable to environmental exposure, and levels of acrolein and formaldehyde are 89% to 95% and 66% to 91% lower than from combustible cigarettes, respectively."
Skeptical reaction
Officials with anti-tobacco and health groups expressed skepticism that the marketing restrictions will keep the products out of the hands of underage users.
Campaign for Tobacco-Free Kids president Matthew Myers noted in a press statement that the group has repeatedly raised concerns with the FDA about the marketing of IQOS in other countries in ways that appeal to youth users, such as social media and sponsorship of youth-centered events like beach parties and fashion shows.
IQOS products are also sold in dedicated stores that resemble Apple genius bars and kiosks.
"This marketing presents IQOS as a fun lifestyle product, using imagery and themes that will attract kids," Myers said. "If the FDA fails to prevent such tactics in the U.S., there is a serious risk that IQOS will become the next Juul and worsen the current youth epidemic."
E-cigarette usage among youth nearly doubled in 2018, with almost twice as many teen users recorded in national surveys than in 2017. The 1-year increase meant that approximately 1.3 million additional teens were vaping nicotine-containing e-cigarettes.
Altria Group announced on Tuesday that IQOS will be introduced to the U.S. market in Atlanta with a dedicated store in the upscale Lenox Square Mall, and dedicated kiosks and in convenience stores throughout the city.
Myers said this rollout "creates reason for concern."
"Altria stated that IQOS will be launched with a store in Atlanta, presumably like the slick stores in other countries, and that the products will be distributed through 500 retail partners including convenience stores and gas stations where the product will be highly visible to young people," he said.
American Lung Association spokesperson Erika Sward said in addition to the potential for youth uptake, the introduction of IQOS to the U.S. market could negatively impact the intended customer -- adult smokers.
"We are troubled that this product is going into the market with a lot of questions remaining," she told MedPage Today, adding that the FDA's own Scientific Advisory Committee expressed safety concerns about IQOS when considering the product's reduced harm claim.
"The American Lung Association remains concerned about providing yet another mixed message to smokers that instead of quitting and ending their addiction for good, here is another tobacco product for them to try," she said.