In a decision expected to test the Trump administration‘s approach to tobacco regulation, U.S. health advisers will vote this week on whether to allow Philip Morris International Inc <PM.N> to claim its novel iQOS tobacco device is less harmful than cigarettes
IQOS is designed to heat tobacco but not burn it, and comes in a sleek package that would not look out of place in an Apple store. 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.
If cleared, iQOS would become the first product to carry a modified-risk claim and could advance the Food and Drug Administration‘s proposed new approach to reduce the dangers of smoking by creating a market for less harmful products than cigarettes.
On Monday, the FDA said its review of iQOS found that the product contains lower levels of toxic chemicals than cigarettes, but could not say whether that translates into lower rates of tobacco-related disease.
Medical and other expert advisors to the FDA will discuss the product on Wednesday and Thursday and recommend whether it should be cleared as a so-called “modified risk” tobacco product. The FDA is not obliged to follow the recommendations of its outside advisers but typically does.
Tobacco experts said the FDA documents do not show a clear point of view by the agency reviewers.
“It’s a complex document with lots of data and findings that could be used by proponents on either side,” said Matthew Myers, president of the Campaign for Tobacco Free Kids.
Philip Morris‘s shares fell 0.1 percent to $108.80 in afternoon trading in New York.
Last month, a Reuters investigation described irregularities in the clinical trials that supported Philip Morris’s iQOS application to the FDA.
For decades, U.S. health agencies have worked to help Americans quit cigarettes to avoid the risks of lung cancer and other disease. National smoking rates have declined to near historic lows of around 15 percent. But in July, newly appointed FDA Commissioner Scott Gottlieb proposed reducing nicotine levels in cigarettes to “non-addictive” levels while increasing development of lower-risk alternatives.
The policy assumes that some percentage of the population will be unable or unwilling to give up nicotine. To make the new strategy succeed, the agency needs a stable of vetted, reduced-risk alternatives to cigarettes. Philip Morris is one of the few companies that can finance such a long development process, spending close to $3 billion on reduced-risk products.
“If this application fails, it will be clear that this is an expensive, wasteful, regulatory dead end,” said Clive Bates, a tobacco expert who runs the consulting firm Counterfactual and advocates for alternative nicotine products.
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