07.06.22

Durbin Statement On FDA's Decision To Stay JUUL Marketing Denial

CHICAGO – U.S. Senate Majority Whip Dick Durbin (D-IL) released the following statement on the Food and Drug Administration’s (FDA) decision to “stay” its marketing denial order of all JUUL Lab Inc.’s products after previously finding these e-cigarettes fail to meet the agency’s public health standard for authorization:

“I was heartened two weeks ago when FDA finally acted to remove JUUL e-cigarettes from the market.  After a lengthy review, FDA scientists determined that JUUL failed to meet the legal requirement to show these e-cigarettes were appropriate for public health, and a marketing denial was issued for all JUUL vaping products. But now—with this unexplained administrative stay of the JUUL denial—we are right back in a legal morass of FDA’s own making.  I am deeply disappointed by FDA’s ongoing failure to competently regulate the e-cigarette market.  And sadly, those most harmed by FDA’s incompetence are our nation’s children.”

Last night, FDA tweeted news about the administrative stay to “temporarily suspend the marketing denial order during the additional review but does not rescind it.”

After years of FDA delay, the U.S. District Court for the District of Maryland ordered the agency to finally begin regulating addictive, kid-friendly vaping products—specifying that FDA had until September 9, 2021, to finalize review of e-cigarette applications. And yet, nearly ten months after the court-ordered deadline, and despite calls from Durbin and other Members of Congress, FDA has still not finished its review of these products—leaving dangerous, kid-friendly e-cigarettes still available on store shelves to hook children.

Last month, Durbin announced findings that more than 750,000 children have started to use e-cigarettes over the last nine months, in the period of time during which the FDA has defied a court order to regulate all e-cigarettes on the market.

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