FDA’s New Product Approval Process: Here’s What’s at Stake

Can any independent electronic cigarette afford the application process?

BOSTON -- Last week, for the first time ever, the U.S. Food and Drug Administration (FDA) authorized the marketing of new tobacco products through the premarket tobacco application (PMTA) pathway. The decision, which applied to eight new Swedish Match snus products, was lauded as a landmark in tobacco regulation. Michael Siegel

“Today’s action demonstrates that the premarket tobacco application process is a viable pathway under which products can be marketed as long as the public health can be protected,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.

However Dr. Michael Siegel, a professor of Community Health Sciences at the Boston University School of Public Health, expressed concerns about what this means for electronic cigarettes.

“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,” Siegel wrote on his Tobacco Analysis blog.

Not quite 100,000 pages, the FDA’s 67-page decision summary considered numerous areas, including behavioral pharmacology, chemistry, clinical pharmacology, engineering, environmental science, epidemiology, medical, microbiology, social science, 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.”

As such, Siegel predicts that the proposed deeming regulations—which will grant the FDA authority to regulate electronic cigarettes—could equate 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.”

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