FDA Could Protect Cigarette Companies with its PMTA Decisions

WASHINGTON, D.C. — Over the last month, the Food and Drug Administration has banned the sale of approximately five million nicotine-containing vaping products. Now, with just 24 hours remaining until the agency’s deadline of September 9, 2021, to authorize or deny remaining applications from vaping product manufacturers, the American Vaping Association is calling on the FDA’s Center for Tobacco Products to assure adult consumers that products still pending review will remain on the market.

The FDA formally proposed regulating vaping products as ‘tobacco products’ in April of 2014. Under the later-finalized rule, all vaping product manufacturers were required to submit premarket tobacco applications (PMTAs) so that the FDA could assess whether each of their individual products satisfied the statutory standard of “appropriate for the protection of public health.”

After delays, those applications came due on September 9, 2020. Over six million applications from more than 300 manufacturers were submitted to the Center for Tobacco Products. Under the FDA’s rules, if a product application has not been denied or authorized before the end of day on September 9, 2021, the product can no longer be sold unless the agency grants an extension request to the manufacturer.

“Despite the attention that has understandably been paid to the September 9 deadline, it is doubtful that the FDA will be able to announce the fate of hundreds of manufacturers in a single day. Many of these company’s individual applications are over 100,000 pages in length and are supported by dozens of studies, all of which FDA staff must thoroughly review before making a decision,” said Gregory Conley, president of the American Vaping Association, a pro-vaping advocacy organization.

“Companies that followed the law and submitted as of yet unreviewed applications must be granted the ability to keep their products on the market. Adult consumers, including those who rely on flavored vaping products to stay smoke-free, should not be punished by the FDA’s inability to conduct its reviews in a timely fashion,” he continued.

Conley also offered comment on the application denials, as well as what it will mean for public health if and when the FDA authorizes certain vaping products.

“Several dozen American small manufacturers have had their and their employees’ livelihoods wrecked by the FDA over the last month. These companies produce products that have been used by millions of adult consumers for years without issues, yet the FDA has decided to ban them. Every vaping product ban is a gift from the FDA to traditional cigarette brands like Marlboro and Camel. Yet, if America’s smoking rates go up in 2022 and beyond, no one at the Center for Tobacco Products will be punished or fired.”

“The FDA’s enormously expensive process was established in a way that all but guaranteed failure for small businesses. Quality American businesses being forced to close their doors is a travesty that deserves attention from members of Congress. However, with large portions of Americans inaccurately believing vaping to be just as dangerous as traditional cigarettes, we should not downplay the historic nature of FDA’s eventual decisions.”

Through all the bad news, Conley believes there may be light at the end of the tunnel for adult smokers looking for answers on the health effects of vaping compared to smoking.

“Our nation’s chief health regulatory body declaring some vaping products as ‘appropriate for the protection of public health’ should start a new conversation in the public health community about FDA-regulated harm reduction products. If the FDA admits that adult usage of these products can benefit public health, there is no good reason why state health departments and anti-smoking nonprofits cannot admit the same.”

For additional reading on this subject, we recommend this article by longtime public health advocate Clive Bates: “Will FDA harm health, destroy businesses, and protect the cigarette industry through regulatory overkill? A preview.”