FDA permits sale of Philip Morris IQOS tobacco-heating alternative to cigarettes

(Reuters) – The US Food and Drug Administration announced Tuesday that it would allow Philip Morris to sell a heated tobacco product called IQOS in the US. This is a big win for the international tobacco giant looking to sell more alternatives to traditional cigarettes.

After about two years of review, the FDA found that approval of the device for sale in the US market was “appropriate to protect public health” because the products “produce less or less toxins than flammable cigarettes.”

Unlike flammable cigarettes, the IQOS devices heat tobacco-filled sticks wrapped in paper, creating an aerosol containing nicotine. They are different from e-cigarettes like the popular Juul device, which vaporizes a liquid filled with nicotine.

The FDA’s move is sure to spark a growing debate among public health advocates as to whether such smoking alternatives will shift lifelong smokers to less harmful products or run the risk of addicting a new generation of nicotine. According to the federal government, the consumption of e-cigarettes by middle and upper school students rose sharply in the past year and triggered a crackdown on device manufacturers by the FDA.

Altria Group Inc, which sells Marlboro cigarettes in the United States, will commercialize IQOS devices under a license agreement with Philip Morris International.

Howard Willard, chairman and chief executive of Altria, said the IQOS is being rolled out for the first time in the Atlanta area through an IQOS branded store and other convenience stores like Cirle K. The products are sold in Marlboro and Marlboro menthol flavored varieties.

With this move, Altria has again acquired a stake in a product developed as an alternative to traditional cigarettes after a $ 12.8 billion deal was signed in December to acquire a 35 percent stake in Juul Labs Inc.

FILE PHOTO: A man tries out Philip Morris’s IQOS 3 device after its launch event on October 23, 2018 in Tokyo, Japan. REUTERS / Kim Kyung-Hoon / File Photo

Unlike the Juul, where users insert a pre-filled, flavored nicotine cartridge into a USB-like device, IQOS users insert a miniature cigarette into the end of a device that heats the tobacco for inhalation.

André Calantzopoulos, CEO of Philip Morris International, described the FDA’s announcement as a milestone. “All of us at PMI are determined to replace cigarettes with smoke-free alternatives that combine sophisticated technology and intense scientific validation,” he said.

While Tuesday’s FDA ruling allows Philip Morris to sell IQOS products, they are required to wear warning labels similar to traditional cigarettes and are subject to the same restrictions on television, radio and print advertising.

The FDA has also put restrictions on how the products can be marketed on the internet and on social media.

The FDA is still considering the company’s request to claim the products pose a lower health risk than cigarettes.

IQOS is currently available in Japan, South Korea and much of Europe. The FDA’s announcement Tuesday opens a huge market for the devices and the decision is likely to be cited by health regulators in other countries as Philip Morris expands sales.

Japan was one of the first markets Philip Morris introduced IQOS and it remains one of the most popular markets for devices. Liquid nicotine e-cigarettes are not allowed in Japan, which means that non-combustion devices like IQOS have less competition from vaping devices.

Philip Morris International has made IQOS a core part of its so-called “Smoke-Free Future” initiative, which the company has promoted heavily in full-page newspaper advertisements in the US and around the world.

Company executives have promoted the idea that non-flammable products like IQOS will replace cigarettes and that the company is well positioned to help smokers switch to less harmful products.

Non-smoking and public health advocates have criticized the campaign, asking why the company is not stopping cigarette sales altogether.

Last year, Philip Morris International generated around 14 percent of its annual sales with “reduced risk products” like IQOS.

In reviewing the IQOS product, the FDA found that Philip Morris’s studies “show no reduction in long-term disease risk,” but that smokers who switch to IQOS completely have, and are likely to, lower toxic exposure a lower risk of tobacco-related diseases. “

The FDA review found that current cigarette smokers are the “most likely” group to use IQOS. The agency found that there is limited research on the use of IQOS by adolescents. However, the data in Italy and Japan found that adolescents and current non-smokers have little acceptance.

Reporting by Chris Kirkham in Los Angeles and Tamara Mathias in Bengaluru; Adaptation by Shinjini Ganguli, Bill Trott and Tom Brown

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