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As the FDA stated, while its decision permits the tobacco products to be sold in the United States, it does not mean these products are safe or 'FDA approved.' The company submitted applications to the FDA for two different regulatory approvals: one to market the product as a new tobacco product (called a Pre-Market approval), and the other to market the product as less harmful than other tobacco products (called a Modified Risk Tobacco Product approval)

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Then, last October, PMI paid $2.7 billion to regain the US commercialization rights for IQOS from Altria and announced plans to start manufacturing the product in the country