LAKEVILLE, Minn.— In the past several weeks, leaders in two municipalities in California—San Francisco and Livermore—have proposed banning the sale of any electronic cigarette until these products receive marketing approval by the U.S. Food and Drug Administration (FDA).
Rather than directly ban the products from being sold altogether, the ordinances instead would ban products that have yet to receive an approval order from the FDA regarding a premarket tobacco application (PMTA). This sounds less onerous on its face, but a closer look reveals it would have the same effect of banning every single vapor product being sold in these cities.
The proponents fail to consider the challenges that the FDA has faced in attempting to create a regulatory framework that balances competing policy initiatives—and that manufacturers can successfully and expeditiously navigate—to seek marketing approval for e-cigarettes. Most smaller e-cigarette companies lack the size and financial resources to rush and finalize a PMTA application and each SKU needs a separate PMTA application. The application process from beginning to end can take several years and cost into the millions of dollars.
The FDA is attempting to create a workable regulatory framework that balances both the interest in reducing youth access to products and ensuring that the lifesaving technology is available to help adult smokers quit. Earlier this month in a U.S. District Court, Mitch Zeller, director of the FDA’s Center for Tobacco Products, filed a sworn affidavit with the court arguing against a rush to ban electronic-cigarette products for which manufacturers are unable to complete PMTA applications in an accelerated time frame.
In response to efforts to expedite the process, Zeller declared removing e-cigarettes from the market “would limit the availability of a potentially less harmful alternative [e-cigarette] for adult smokers seeking to transition or stay away from combustible tobacco products. Dramatically and precipitously reducing availability of these [e-cigarette] products could present a serious risk that adults, especially former smokers, who currently use ENDS (electronic nicotine-delivery systems) products and are addicted to nicotine would migrate to combustible tobacco products, even if particular ENDS products ultimately receive marketing authorization and return to the market later.”
“Although there has been great recent progress in declining use of cigarettes for all age groups, I am concerned that these declines could be slowed or reversed in the case of very sudden and very dramatic reductions in availability [of electronic cigarettes],” he said.
In other words, if San Francisco and Livermore adopt their ordinances and remove e-cigarettes from the market, Zeller is warning of a serious risk of adults turning to use combustible tobacco products like cigarettes once again, which would create a greater health risk.
The potential negative health outcome to consumers of eliminating e-cigarettes from store shelves in both San Francisco and Livermore as explained by Zeller should give the city councils of these two municipalities pause and not rush to enact a ban on a product that allows adults to transition to a product that studies have shown to be less harmful than combustible products.