Since the FDA’s deeming regulations went into effect last August, we’ve been waiting to see which company might actually attempt to get marketing approval from the agency, which requires submitting a premarket tobacco application (PMTA).
The process is intimidating and expensive, requiring evidence from studies and trials, and ultimately proof that the product will result in an overall benefit to the public health. Most observers and advocates do not believe a PMTA from an independent vapor company can succeed, and many doubt that even an application by a wealthy tobacco company could either.
Now we may find out. Philip Morris International (PMI) says it submitted a PMTA for its IQOS heat-not-burn (HNB) product last week. While the success or failure of the PMI application may not prove if a vapor product application could pass FDA muster, the result will certainly shine light on questions about the agency’s process, and its commitment to allowing reduced-risk consumer products. PMI has spent many millions of dollars in research on IQOS.
PMI has been selling the device in several countries since 2014, most notably Japan, where PMI claims to have captured two percent of the cigarette market. (Note that vapor products with nicotine are illegal in Japan.) The original Philip Morris company split in 2008 into Altria Group Inc. in the U.S., and PMI in the rest of the world. Altria will sell IQOS in the U.S. if it receives FDA approval. Altria and PMI are best known for selling Marlboro cigarettes.
PMI also submitted a “modified-risk tobacco product” application (MRTP) to the FDA last winter. Modified risk is a designation no tobacco product has yet been granted. Should IQOS be approved as a modified-risk product, it will be allowed to make claims about relative risk that no vapor product can, despite the widely held belief that e-cigarettes pose little or no health risk.
Meanwhile, the clock keeps ticking. We’re now eight months into the 24-month slow-motion demolition of the vapor industry. If we can’t force Congress to change the predicate date in the deeming rule, any company without millions to spend on the FDA’s PMTA lottery is doomed to extinction in 16 months.