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REUTERS
WASHINGTON
US health advisers on Wednesday began to consider whether Philip Morris International Inc should be allowed to claim its novel electronic tobacco product is less harmful than cigarettes, potentially making it the first such device to carry a reduced risk claim.
The panel of tobacco and public health experts, convened by the Food and Drug Administration, will vote on Thursday on whether data provided by the company supports one of three potential claims that would be used on the product's label and in marketing. The vote is not binding but will influence the FDA's decision.
Its iQOS device heats actual tobacco rather than burns it. Most toxic chemicals in cigarette smoke are produced when tobacco combusts. Other electronic devices usual a nicotine-laced liquid.
A positive vote from the panel could move more US smokers away from cigarettes to electronic alternatives.
The panel discussion comes amid an intense debate over whether electronic cigarettes can help reduce smoking-related disease and death.
FDA staff this week said that iQOS contains fewer harmful chemicals than cigarettes but that it was unclear whether reduced exposure translates into reduced risk of disease.
Results from an 18-month toxicity and carcinogenicity study in mice is expected by the end of June. Some of the data is included in the company's application.
Full results of the study could shed additional light on any potential cancer risk, the FDA said.
The advisory panel will decide whether the company can say iQOS"can reduce the risks of tobacco-related diseases" or it"presents less risk of harm than continuing to smoke cigarettes."
These would be the hardest-to-prove claims.
A third option would state that iQOS"significantly reduces your body's exposure to harmful or potentially harmful chemicals."
