Durbin Calls FDA and DOJ Officials into Washington Office to Receive Briefing on Lack of Enforcement Against Unauthorized E-Cigarettes

Despite court-ordered deadlines, FDA continues to neglect its responsibility to enforce the removal of e-cigarette products from store shelves that have not proven they are “appropriate for the protection of public health”

WASHINGTON  U.S. Senate Majority Whip Dick Durbin (D-IL), Chair of the Senate Judiciary Committee, called in Food and Drug Administration (FDA) Center forTobacco Products Director, Dr. Brian King, and U.S. Department of Justice (DOJ) Principal Deputy Assistant Attorney General, Brian Boynton, to his Washington office yesterday to brief him on the lack of enforcement against unauthorized e-cigarettes that are addicting millions of children across America.

Durbin convened this meeting after repeatedly calling on FDA to protect children from the dangers of vaping.  Yet, FDA continues to miss and delay critical deadlines forreviewing pre-market tobacco product applications (PMTAs) from e-cigarette manufacturers as the law requires, allowing harmful e-cigarette products to remain on store shelves.  After being sued by public health groups, FDA was ordered by the U.S. District Court in Maryland to complete these reviews by September 9, 2021.  More than two and a half years later, FDA has still not completed its PMTA reviews. In the meantime, thousands of unauthorized e-cigarettes have flooded the market, in violation of the law.

In the meeting, Durbin questioned Dr. King on the FDA’s delay in reviewing PMTAs and reminded him that the agency’s inaction is leading to more children developing an addiction to e-cigarettes.  Durbin pushed for answers on why FDA is neglecting to use its full authority to take enforcement actions against manufacturers or retailers found to be selling unauthorized vaping products. Durbin particularly raised concerns that FDA and DOJ have failed to act against unauthorized e-cigarettes, despite statutory and court-ordered directives to regulate these products.

Last year, Durbin’s office examined FDA’s public data files to identify e-cigarette manufacturers who have received both marketing denial orders and warning letters yet continue to sell unauthorized products, in order to assess FDA’s effectiveness in taking enforcement action against some of the most flagrantly defiant examples.  Durbin’s office found at least 22 vaping products that appeared to be sold online by the manufacturer in violation of the law and in defiance of repeated enforcement actions by FDA.  In addition to those products sold online by the manufacturer, several other such products remain available for purchase from third-party retailers, including one of the most popular e-cigarettes among children, Breeze Smoke.  Durbin’s investigation also found that FDA has only issued “closeout letters” to 10 percent of the 685 tobacco warning letters it has issued since January 1, 2021.  A closeout letter indicates that FDA has verified that corrective action has taken place to address the violations contained in the warning letter.

Durbin asked Mr. Boynton about DOJ’s enforcement strategy regarding manufactures and retailers that have flouted FDA’s enforcement actions.  Durbin probed why more aggressive action has not been taken despite FDA and DOJ’s clear authority under the law.

“The law is clear. E-cigarette manufacturers must prove that a product is ‘appropriate for the protection of public health’ to gain market entry. But thousands of vape products on store shelves today, full of harmful chemicals and nicotine, have not met that requirement, yet are being sold and addicting children nationwide.  For two and a half years, FDA has dragged its feet on completing its review of e-cigarette products, while at the same time has turned a blind eye to dangerous vapes that are illegally being sold.  My patience has worn thin,” said Durbin.  “I called in FDA and DOJ leaders to my office to understand why they are failing to enforce the law in the face of clear harms to children.  I reminded them that they have a job to do and that they have the legal authority to stop unlawful e-cigarette manufacturers from flooding the market.  I hope our conversation spurred them to finally take action to protect the next generation from a lifelong addiction to nicotine.”

Durbin has been a vocal leader in the fight against Big Tobacco, particularly since he lost his father to lung cancer when he was 14.  He went after Big Tobacco when he served in the House of Representatives and led the charge to ban smoking on airplanes, which eventually led to restaurants, office buildings, trains, and much more.  Durbin has also led efforts to grant FDA jurisdiction over tobacco, raise tobacco taxes to prevent youth initiation, and enhance support for tobacco cessation tools.