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Medications, nicotine replacement therapy, and smoking cessation programs can lessen some of these unpleasant symptoms

PMI does not dispute that its IQOS product (including all three components) is a tobacco product under US law7 and subject to most regulations that pertain to tobacco products (eg, premarket review (Section 910)4) and prohibition on distribution of free samples.17 The Deeming Rule, in which FDA took jurisdiction over tobacco products beyond cigarettes and smokeless tobacco, defines component or part to include materials intended or expected to alter or affect the tobacco products performance, composition or characteristics18 and extends FDAs regulatory authority to cover all tobacco products meeting the definition of tobacco product including HTPs and their components and parts.19 Certain provisions of the Deeming Rule (eg, prohibition of sales to customers under age 18 and vending machine sales)20 apply only to covered tobacco products which excludes any component or part that is not made or derived from tobacco.18 20 The loophole FDA created in the Deeming Rule contradicts the clear definition of tobacco product in the TCA4 which includes any component, part, or accessory

Our interview has been edited and condensed for clarity

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