The agency showed that it did not consider the unit – Philip Morris International's IQOS "tobacco heating system" – to be safe. And the decision to allow sales is not equal to FDA approval.
The agency said the move followed "a thorough science-based review," after which it decided that the product could have a public health value partly because the unit contained "fewer toxic chemicals than cigarette smoke, and many of the toxins identified are present at lower levels. than in cigarette smoke. "
" Secure new tobacco products undergo a robust preliminary evaluation of the FDA is a critical part of our mission to protect the public, especially youth, and to reduce tobacco-related illness and death, "said Mitch Zeller, director for the FDA's Tobacco Products Center, said in a statement Tuesday.
Moira Gilchrist, Vice President of Strategic and Scientific Communication at Philip Morris International, said the FDA's decision was a "milestone" that would allow the company to bring its product ̵
The company says it expects to distribute and market IQOS in about 90 to 120 days, starting in Atlanta.
But the FDA's decision increased the eyebrows among health guardians. Some are concerned that the product can spread among children, like vaping devices such as Juul.
He said Its organization has repeatedly "raised concerns with the FDA that Philip Morris International has marketed IQOS in other countries in ways that clearly appeal to children, including through social media, sponsorship of events such as beach parties and fashion shows and licking shops and kiosks that look like they sell technical gadgets, not addictive tobacco products. "
Robin Koval, President and CEO of the Truth Initiative, said in an e-mail statement that" the introduction of another nicotine delivery unit to the US market, while in the midst of a youth's e-cigarette epidemic, applies. "
Harold Wimmer, president and chief executive of the American Lung Association, said in a statement that he is" deeply concerned "for the product's potential health impact.
" The Lung Association encourages the FDA to closely monitor how this product is actually being used – and by whom, "Wimmer said." The FDA must take steps to protect youth from starting a tobacco addiction with this product. "
The FDA said it will keep tabs on what happens when the device hits the market, including admissions among If this happens, there may be a reason for the agency to reverse its decision.
"We're keeping an eye on the market, including how the company markets these products," said Zeller, including compliance with regulations to prevent Children are exposed to the product – for example, on websites and social media.
The Agency will also require that packet labels and advertisements warn about the product's addiction. "Don't market the devices" with reduced exposure or reduced risk requirements, "the FDA said. To do so, the company has a separate application in the works.
The company's interest in non-smoking alternatives to cigarettes is part of a sector-wide shift. Last year, the tobacco giant Altria took a 35% stake in Juul in a deal worth $ 12.8 billion.
Altria, spun by Philip Morris International many years ago, will now distribute IQOS in an exclusive deal with the company.
CNN's Danielle Wiener Bronner contributed to this report.