FDA, E-Cigarettes, PMTA, And Confusion

The U.S. Food and Drug Administration (FDA) approved the selling of new tobacco products during the marketplace tobacco program (PMTA) pathway. The conclusion, which used to eight fresh Swedish Match snus products, was praised as a milestone in cigarette rules. “Today’s action demonstrates that the premarket tobacco application process is a viable pathway under which products can be marketed if the public health can be protected,” said the director of the FDA’s Center for Tobacco Products, Mitch Zeller.

However, according to Dr. Michael Siegel, a professor of Community Health Sciences at the Boston University School of Public Health "“What the FDA did not readily reveal is that the Swedish Match application was incredibly complex, rigorous, burdensome, comprehensive, and extensive, weighing in at a total of more than 100,000 pages".

Not really 100,000 web pages, the FDAs 67-page verdict overview regarded several places, including behavior pharmacology, chemistry, clinical pharmacology, applied science, environmental technology, epidemiology, medical, microbiology, social research, statistics, and toxicology. “It demonstrates that successfully submitting a PMTA is a resource-intensive, complex, burdensome, and highly expensive project that can only be completed successfully by, if anyone, the absolutely largest e-cigarette companies,” Siegel said. “This is simply not something that a vape shop owner, the owner of a small e-cigarette business, or the owner of a small e-liquid business is going to have the capability or resources to carry out.

”Siegel predicts that the deeming laws will give the FDA the right over e-cigarettes can lead to “a de facto prohibition of all or most electronic cigarettes currently on the market". “This is an insane way to craft a regulatory strategy for the range of nicotine-containing products on the market,” Siegel continued. “The safest products on the market—electronic cigarettes—are being forced to complete complex, burdensome, expensive, and unruly applications for which in most cases it is technically impossible to make the demonstrations that are required by the deeming regulations.”