PMI Defends IQOS Before the U.S. FDA
According to CNBC, Philip Morris International met with the U.S. Food and Drug Administration on November 5 to present arguments for why the multinational company and Altria Group should be allowed to import and sell IQOS heated tobacco devices in the Uni
According to CNBC, Philip Morris International (PMI) met with the U.S. Food and Drug Administration (FDA) on November 5 to argue why multinational companies and Altria Group should be allowed to import and sell IQOS heated tobacco devices in the U.S.<\/span><\/div>
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Sources from CNBC reported that PMI told the FDA that the uniqueness of IQOS lies in its ability to help smokers move away from combustible cigarettes, stating that combustible cigarettes pose a greater health risk than heated tobacco devices.<\/span><\/div>
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In late September, the International Trade Commission ruled that IQOS infringed on two patents held by Reynolds. The Biden administration is conducting an administrative review until November 29 to decide whether to ban the sale and import of cigarette alternatives.<\/span><\/div>
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Reportedly, during the FDA meeting, PMI argued that the ITC overstepped its bounds, as the FDA is responsible for regulating tobacco products that can be sold.<\/span><\/div>
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After consulting with several agencies, including the FDA, which regulates tobacco products, the U.S. Trade Representative will make recommendations to President Joe Biden.<\/span><\/div>
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If the government sides with RJ Reynolds in the dispute, IQOS could be pulled from the U.S. market for months while it awaits a decision from Reynolds and the U.S. Patent and Trademark Office on a separate claim.<\/span><\/div>
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PMI has successfully defended similar cases in the UK and elsewhere. British American Tobacco has filed lawsuits against IQOS in Poland, the Czech Republic, Bulgaria, Romania, and Greece, as well as through the European Patent Office.<\/span><\/div>
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For Altria and Philip Morris, the worst-case scenario is that both companies will have to redesign their products, move production to the U.S., or change enough of their designs to avoid patent infringement claims.<\/span><\/div>
