An FDA advisory panel Thursday rejected Philip Morris International's (PMI) claim that its heat-not-burn tobacco product IQOS has been shown to reduce the risk of tobacco-related diseases.
The advisory committee's recommendations will go to the FDA, which is not required to follow them.
"It's a process", said Bonnie Herzog, a tobacco analyst at Wells Fargo. Most of the harmful chemicals in tobacco are released when tobacco is burned, forming the basis of Philip Morris's claim of a less-risky product.
Last July, FDA Commissioner Scott Gottlieb laid out a proposal to begin pushing USA consumers away from traditional cigarettes toward products that deliver nicotine without all the harms of cigarettes.
Food and Drug Administration br / Federal agency of the United States of America.
Last month, a Reuters investigation described irregularities in the clinical trials that supported Philip Morris' iQOS application to the FDA. The company's shares were down 2.8% at $107.50 on Thursday afternoon after falling as much as 6.8%.
Matthew Myers, president of the Campaign for Tobacco Free Kids, said panellists "identified that serious questions remain" about the company's application.
IQOS is said to come somewhere between trendy vaping products and traditional cigarettes on the scale of harm. By using heat instead of flame, Philip Morris claims, IQOS eradicates 90 to 95 percent of toxic compounds in cigarette smoke.
Some panellists were concerned that not all the harmful or potentially harmful chemicals in iQOS were lower than in cigarettes.
In a statement, Philip Morris said it appreciates the "open, positive dialogue and the serious consideration" the committee showed in reviewing the complex science it presented with its modified-risk application.
FDA to have iQOS certified as a modified risk product. The FDA will make a separate decision on whether to allow the product on the market, and - if so - how it could be marketed to consumers. "Ultimately, we think the chances for the FDA to approve PM's MRTP are still good, but timing is tough to predict", Herzog added.
The FDA's final verdict will be closely watched by executives at British American Tobacco, which is conducting clinical trials in preparation for a USA application to sell a rival product, Glo, with health claims. iQOS has already captured 12 percent of Japan's entire tobacco market.
Phillip Morris, up slightly before the late morning announcement, tumbled as low as 103.02 on the news before recovering to trade down 1.3% at 109.11 in early afternoon trade on the stock market today.
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