April 30 (UPI) — The Food and Drug Administration gave a new electronic tobacco device the green light to enter the U.S. market Tuesday.
The FDA announced that it authorized the marketing of Philip Morris’ new IQOS “Tobacco Heating System,” an electronic device that heats “tobacco-filled sticks wrapped in paper,” producing a nicotine-containing aerosol.
“While today’s action permits the tobacco products to be sold in the United States, it does not mean these products are safe or ‘FDA approved,’ ” the agency said.
The product was given the okay following a “rigorous science-based review” that weighted its risks and benefits to the population as well as tobacco users and non-users, particularly youth, it said.
The FDA said it gave its authorization in part because the product may have health benefits as it contains “fewer toxic chemicals than cigarette smoke, and many of the toxins identified are present at lower levels than in cigarette smoke.”
It also said its decision was made by the likelihood of cigarette smokers wholly transitioning to the product while evidence suggests that non-smokers — including youth — are unlikely to use it.
“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,” FDA’s Center for Tobacco Products Director Mitch Zeller said. “This includes how the products may impact youth use nicotine and tobacco, and the potential for the products to completely move adult smokers away from the use of combustible cigarettes.”
The products are considered cigarettes by the FDA and, therefore, must adhere to existing restrictions and federal laws, such as those that prohibit the product from being advertised on television and radio, the FDA said.
Philip Morris International CEO André Calantzopoulos heralded the decision as a “historic milestone.”
“The FDA’s decision to authorize IQOS in the United States is an important step forward for the approximately 40 million American men and women who smoke,” Calantzopoulos said in a statement. “Some will quit. Most won’t, and for them, IQOS offers a smoke-free alternative to continue smoking.”
However, Campaign for Tobacco-Free Kids is calling for strict advertising enforcement to prevent children from using the products, pointing to international marketing campaigns by Philip Morris portraying it as a fun, lifestyle product while using imagery attractive to youth.
The organization’s president, Matthew L. Myers, said in a statement that without strict oversight from the FDA “there is serious risk that IQOS will become the next Juul and worsen the current youth epidemic.”