Senators encourage FDA to reject e-cigarette applications that fail to protect public health

Senators encourage FDA to reject e-cigarette applications that fail to protect public health

Unnerved by a three-month deadline for e-cigarette product review, 17 senators wrote to Food and Drug Administration (FDA) Commissioner Stephen Hahn last week to encourage higher standards of oversight.

Accountability was their main goal, and they criticized the FDA’s current pursuit of it, citing concerns that previous actions by the administration show it may not deny applications for e-cigarette and tobacco products even when they have been shown to be inappropriate to the public health.

As of May 12, all e-cigarette manufacturers will be required to submit product applications to the FDA to be allowed to enter the market. This applies to all flavor products or devices currently on the market, or new items such companies might wish to produce, though they can remain on the market over the year the FDA could take to make such determinations.

Even this restriction was required only by court order, not the FDA.

“When looking at the changing e-cigarette marketplace, including the proliferation of products that use nicotine salts, JUUL-like products, and disposable flavored products, it is virtually certain that many products have entered illegally,” the senators wrote. “FDA will have failed to uphold its responsibility to protect public health if the May 12 deadline is enforced in the same manner as the deeming rule.”

Of particular concern to the senators has been how e-cigarette companies have targeted and affected children. To that end, they requested a science-based review of products that might fuel youth e-cigarette usage. They likewise urged the swift removal of all tobacco products found in violation of either the January 2 or May 12 guidance and deadline, respectively — such as those that do not submit premarket tobacco product applications, flavored cartridge-based products, and products aimed at minors.

“As you know, five million children are now vaping, including one in four high school students—an increase of 135 percent over the past two years alone,” the senators wrote. “To adequately address this youth vaping epidemic, we urge FDA to fully enforce and implement its May 12 deadline with a science-based review that holds industry accountable and prioritizes public health.”