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Union says FDA decision to allow Philip Morris to market HTPs will have devastating consequences

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The Union criticised FDA for its decision to allow PMI to market its IQOS heated tobacco product as a 'modified risk product.'

The Union criticised the decision by the U.S. Food and Drug Administration (FDA) to allow Philip Morris International (PMI) to market its IQOS heated tobacco product as a “modified risk tobacco product” (MRTP).

“The FDA´s decision will have absolutely devastating consequences,” said Dr Gan Quan, Director of Tobacco Control at The Union. “It is not a prediction but a blatant given that Philip Morris International will be bolstered by this brazen decision and aggressively market IQOS both in the United States and in lower- and middle-income countries by manipulating  the ‘reduced exposure’ information that this decision provides to entice non-smokers and young adults.”

In May The Union argued in its position paper, Where Bans are Best, that there was insufficient harm reduction evidence that novel products—both e-cigarettes and HTPs— are effective cessation devices for current smokers and that the tobacco industry’s primary motivation is not, as it claims, to help smokers transition from combustibles; instead, it is laser focused on targeting youth via advertisements, social media, event sponsorship, and paid promotions with influencers and celebrities.

Given its willingness to place faith in information provided by Philip Morris, The Union wishes the FDA had remembered with whom it was dealing—and had proceeded with extreme caution. This is a company that, upon receiving April 2019 premarket authorisation, deliberately mispresented its product as receiving FDA endorsement—and a stamp of approval. It is not a matter of if additional duplicitous behavior will ensue but, rather, how quickly.

The FDA’s claims—it states that it will “closely monitor” IQOS to ensure both that it is being used as a transition device among adult smokers and not by youth—would be far more reassuring if the organisation had a better track record on novel tobacco products.

“It took a solid three years for the FDA to ask JUUL for documents on youth sales,” said Gan Quan. “While the agency was asleep at the wheel, the company—which also purported to be interested in helping adult smokers—deliberately appealed to and became the e-cigarette of choice among high school students. JUUL is a kitten compared to Philip Morris International and legitimising its products in any way will prove to be disastrous public health policy.”