Benzinga | May 14, 2021 08:48AM EDT

FDA Seeks Public Comments On PMI Application To Market IQOS 3 As Modified Risk Tobacco Product

The U.S. Food and Drug Administration (FDA) today opened a public comment period on Philip Morris International's (NYSE:PM) application seeking authorization to market the IQOS 3 electrically heated tobacco system as a Modified Risk Tobacco Product (MRTP).

PMI's application requests the same reduced exposure modification orders granted on July 7, 2020, for the IQOS 2.4 system--the first, and only, electronic nicotine product to be granted marketing orders through the FDA's MRTP process. To authorize MRTP consumer communications, the FDA's Center for Tobacco Products is required by law to conclude that a product is appropriate to promote the public health.

The IQOS 3 device contains a number of technological advancements, compared to the IQOS 2.4 device, including longer battery life and quicker recharge between uses. It was authorized for sale in the U.S. via the FDA's pre-market review process on December 7, 2020, having met the standard that permitting its sale is appropriate to protect public health.