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Congressman Krishnamoorthi Announces Bill To Bring Transparency And Review To E-Cigarette Approval Process

September 10, 2020
Press Release

SCHAUMBURG, IL – Today, following the deadline for e-cigarette manufacturers to submit Premarket Tobacco Product Applications (PMTA) to the FDA in order to legally continue selling their devices in the United States, Congressman Raja Krishnamoorthi announced he will introduce legislation to add transparency and review to the e-cigarette approval process. The Independent Advisory Committee Review of E-Cigarette Applications Act will:

•Require the FDA to publicly list all PMTAs it receives from e-cigarette manufacturers.

•Require the Tobacco Products Scientific Advisory Committee (TPSAC), which was established more than a decade ago to evaluate the health and safety of tobacco products and make recommendations to the FDA Commissioner, to review PMTAs before they are granted.

“Yesterday’s PMTA deadline was an important milestone in the fight against harmful e-cigarettes,” said Congressman Krishnamoorthi, Co-Founder of the Congressional Caucus to End the Youth Vaping Epidemic. “However, without transparency and independent review of PMTAs, too many devices that should no longer be on the market will continue making their way into the hands of kids and teens. My legislation will ensure the PMTA process works as it is intended, and no bad actors slip through the cracks.”

“The Campaign for Tobacco-Free Kids supports the Independent Advisory Committee Review of E-Cigarette Applications Act, and we applaud Congressman Raja Krishnamoorthi for his leadership in introducing this important legislation to ensure that there is transparency and accountability in FDA’s review of tobacco product applications,” said Matthew L. Myers, President of the Campaign for Tobacco-Free Kids. “This important legislation will ensure that the public can assess industry compliance with, and FDA enforcement of, yesterday’s deadline and ensure that there is greater transparency in FDA’s review of tobacco product applications.”

“Once again Congressman Raja Krishnamoorthi is stepping forward as an advocate for the millions of American families whose lives have been upended by the youth vaping epidemic and the predatory behavior of Big Tobacco. This proposed bill forces FDA to make this critical PMTA process transparent, allowing parents and other stakeholders to hold accountable the thousands of bad-actor vape companies who will continue hiding in plain sight, hoping no one notices they are not playing by the long-delayed rules,” said Meredith Berkman and Dorian Fuhrman, Co-Founders of Parents Against Vaping e-cigarettes (PAVe).

Many e-cigarettes currently sitting on the shelves of gas stations, grocery stores, and other retail establishments could now be illegal to sell because the manufacturers of those devices failed to submit PMTAs by yesterday’s deadline. However, consumers and retailers are not able to identify which manufacturers followed the rules and which should have their products removed from the market. Requiring the FDA to publicly list all PMTAs received will allow the products that are no longer legal to be identified and taken off the shelves in compliance with the law.

In general, the devices subject to the PMTA deadline are harmful to children, teens, and young adults. According to the CDC, using e-cigarettes, also known as “vaping,” can harm adolescent brain development; negatively impact attention, learning, mood, and impulse control in youths; and lead to nicotine addiction. A recent study also linked vaping to a significantly increased risk of COVID-19 infection and development of symptoms. It is imperative that the FDA take these serious health impacts into account when considering approval of PMTAs, which is why referring PMTAs to the Tobacco Products Scientific Advisory Committee will put an important check on political decision-making in granting applications.

Read the text of the legislation here.