Durbin Calls Upon GAO To Revive FDA DOJ Interagency Enforcement Activities Against Illegal E Cigarettes

08.29.24

Durbin Calls Upon GAO To Revive FDA-DOJ Interagency Enforcement Activities Against Illegal E-Cigarettes

Years after statutory and court-ordered deadlines, FDA continues to face backlogs in reviewing e-cigarette applications, allowing thousands of dangerous vaping products to flood the market & addict children

CHICAGO - U.S. Senate Majority Whip Dick Durbin (D-IL), Chair of the Senate Judiciary Committee, today sent a letter to the Comptroller General of the United States, Gene Dodaro, urging the Government Accountability Office (GAO) to examine the Food and Drug Administration (FDA) and the Department of Justice's (DOJ) interagency enforcement activities related to the sale of unauthorized e-cigarettes. Durbin has repeatedly criticized FDA and DOJ for the long-overdue review of pre-market tobacco product applications (PMTAs) from e-cigarette manufacturers and inadequate enforcement activities against addictive, kid-friendly e-cigarettes. Today's letter follows a June hearing Durbin held in the Senate Judiciary Committee to address this public health threat.

"Since 2014, e-cigarettes have become the most common form of tobacco product among youth. Today, more than two million children report vaping-approximately 10 percent of middle and high school students," Durbin began his letter. "Despite the known harms of e-cigarettes, more than six thousand distinct types of e-cigarette products are available in retail settings nationwide-nearly all of which are sold in violation of federal law."

Under the 2009, Family Smoking Prevention and Tobacco Control Act (TCA), no tobacco product can enter the market unless its manufacturer first proves to FDA that it is "appropriate for the protection of public health." In 2016, FDA was provided jurisdiction over e-cigarettes through the finalization of the "Deeming Rule," subjecting vaping products to FDA's pre-market authorization requirement. Despite this authority, FDA has repeatedly failed to review and process pre-market tobacco product applications (PMTAs) despite a September 9, 2021, deadline set by the U.S. District Court for the District of Maryland.

"Following that date [September 9, 2021], all unauthorized e-cigarettes on the market should have been subject to enforcement action under the TCA. In fact, FDA stated on December 13, 2023, 'It is illegal to sell, import, distribute, or offer for sale or distribution to U.S. consumers any e-cigarette that has not been authorized by FDA … For unauthorized tobacco products, the pendency of an application does not create any sort of a safe harbor to sell that product,'" Durbin wrote.

However, FDA has authorized only 34 tobacco- or menthol-flavored e-cigarettes for sale in the U.S., meaning that all fruit, candy, or sweet-flavored e-cigarettes are unauthorized and illegal as adulterated and misbranded products under the TCA. Notably, 90 percent of teens who use vaping products consume unauthorized, flavored products. Further, FDA has missed a deadline set in a 2022 law to take enforcement action against unauthorized e-cigarettes that use synthetic nicotine, which include some of the most popular vaping devices among children.

Durbin went on to write about how FDA and DOJ have tools to remove unauthorized vaping products from the market, but that the agencies have repeatedly failed to take substantive action against manufacturers, among others in the supply chain.

"FDA shares responsibility with the Department of Justice (DOJ) for removing unauthorized e-cigarettes from the market. FDA is empowered to pursue certain administrative actions, including issuing warning letters, civil monetary penalty (CMP) complaints, and fines… DOJ, in contrast, has sole authority to institute judicial enforcement actions, such as injunction proceedings, on behalf of FDA in federal court. To date, FDA and DOJ have pursued injunctions against only eight manufacturers," Durbin wrote.

Durbin then highlighted a 2022 Reagan-Udall Foundation report that found poor collaboration between FDA and DOJ on enforcement against unauthorized e-cigarettes. The report detailed several challenges related to FDA-DOJ coordination on enforcement actions, "characterizing the process as 'cumbersome' and subject to competing demands with limited resources." The report concluded that, as a result, DOJ "'may be reluctant to bring cases' that risk adversely affecting FDA's authorities if the actions fail a legal challenge."

Following a meeting Durbin convened with the two agencies regarding their delayed action, DOJ and FDA announced a federal task force to enhance enforcement against dangerous e-cigarette products through collaboration with the Bureau of Alcohol, Tobacco, Firearms and Explosives; U.S. Marshals Service; U.S. Postal Inspection Service; and the Federal Trade Commission. Two days later, Durbin held a Senate Judiciary Committee hearing entitled "Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes" to further pressure FDA and DOJ to act.

Durbin concluded his letter by asking GAO to examine interagency enforcement activities related to cracking down on e-cigarette products.

"To inform the Senate Judiciary Committee's efforts to address the public health harm to children from the widespread market availability of unauthorized e-cigarettes, I request that the Government Accountability Office examine interagency enforcement activities," Durbin wrote before listing eight prompts for GAO to respond to.

Durbin has been a vocal leader in the fight against Big Tobacco, particularly since he lost his father to lung cancer when Durbin was 14 years old. 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.

A copy of the letter is available here and below:

August 29, 2024

Dear Mr. Dodaro:

Since 2014, e-cigarettes have become the most common form of tobacco product among youth. Today, more than two million children report vaping-approximately 10 percent of middle and high school students. The Centers for Disease Control and Prevention and the U.S. Surgeon General have stated that e-cigarettes are not safe, especially for children, teens, and young adults. E-cigarettes contain nicotine, which is highly addictive and can harm adolescent brain development relating to attention, learning, mood, and impulse control. E-cigarettes also can contain cancer-causing chemicals, heavy metals, tiny particles that can be inhaled deep into the lungs, and chemical flavorings linked to lung disease.

Despite the known harms of e-cigarettes, more than six thousand distinct types of e-cigarette products are available in retail settings nationwide-nearly all of which are sold in violation of federal law.

Under the 2009 Family Smoking Prevention andTobacco Control Act (TCA), no tobacco product is permitted to enter the market unless its manufacturer first proves to FDA that it is "appropriate for the protection of public health." In 2016, the Food and Drug Administration (FDA) finalized the "Deeming Rule" to exercise jurisdiction over e-cigarettes as tobacco products, subjecting them to FDA's pre-market authorization requirement. Despite this action, FDA did not enforce the pre-market authorization requirement until the U.S. District Court for the District of Maryland ruled in 2019 that FDA's inaction violated the TCA. The Court ordered e-cigarette manufacturers to submit premarket tobacco product applications (PMTAs) by September 9, 2020, and directed FDA to complete PMTA reviews within one year-i.e., by September 9, 2021.

Following that date, all unauthorized e-cigarettes on the market should have been subject to enforcement action under the TCA. In fact, FDA stated on December 13, 2023, "It is illegal to sell, import, distribute, or offer for sale or distribution to U.S. consumers any e-cigarette that has not been authorized by FDA … For unauthorized tobacco products, the pendency of an application does not create any sort of a safe harbor to sell that product."

To date, FDA has authorized only 34 e-cigarettes for sale in the United States, manufactured by Logic, NJOY, and RJ Reynolds. All other e-cigarettes being sold-including all fruit, candy, or sweet flavored e-cigarettes-are unauthorized and illegal as adulterated and misbranded products under the TCA. Notably, 90 percent of teens who use e-cigarettes consume unauthorized, flavored products.

As part of the district court's 2019 ruling, FDA was ordered to provide quarterly status reports on the agency's progress in adjudicating applications for the class of e-cigarettes with the largest market shares. Currently, FDA has acted on 185 of 186 of those applications. However, the agency still has thousands of pending PMTAs, including for e-cigarettes using synthetic or "non-tobacco" nicotine (nicotine that is not derived from a tobacco leaf, but synthesized chemically), which came under the FDA's jurisdiction in March 2022 and which became subject to enforcement action starting on July 14, 2022, even for timely filed applications. Some of the most popular e-cigarettes used by children today use synthetic nicotine and are on the market illegally.

FDA shares responsibility with the Department of Justice (DOJ) for removing unauthorized e-cigarettes from the market. FDA is empowered to pursue certain administrative actions, including issuing warning letters, civil monetary penalty (CMP) complaints, and fines. The agency has utilized these tools to some degree, including by issuing more than 1,000 warning letters to manufacturers, distributors, and retailers regarding unauthorized tobacco products; 200 CMP complaints (primarily to brick and mortar retailers); and fines for the sale of unauthorized tobacco products in amounts of approximately $20,000 (a fraction of the $1.2 million maximum fine FDA may issue in a single proceeding for multiple violations). DOJ, in contrast, has sole authority to institute judicial enforcement actions, such as injunction proceedings, on behalf of FDA in federal court. To date, FDA and DOJ have pursued injunctions against only eight manufacturers.

In December 2022, the independent Reagan-Udall Foundation issued a report evaluating the regulatory, application review, enforcement, and public communication activities of FDA's Center for Tobacco Products, which oversees implementation of the TCA. In that review, the Reagan-Udall Foundation identified several challenges with respect to FDA-DOJ coordination on enforcement actions, characterizing the process as "cumbersome" and subject to competing demands with limited resources, and finding that DOJ "may be reluctant to bring cases" that risk adversely affecting FDA's authorities if the actions fail a legal challenge.

On June 10, 2024, DOJ and FDA announced the establishment of a federal task force to enhance enforcement against these illegal and dangerous products through collaboration among FDA; DOJ; Bureau of Alcohol, Tobacco, Firearms and Explosives; U.S. Marshals Service; U.S. Postal Inspection Service; and the Federal Trade Commission. Two days later, the Senate Judiciary Committee held a hearing featuring witnesses from DOJ and FDA to examine their roles in taking enforcement action against unauthorized e-cigarettes that pose a threat to children.

To inform the Senate Judiciary Committee's efforts to address the public health harm to children from the widespread market availability of unauthorized e-cigarettes, I request that the Government Accountability Office examine interagency enforcement activities. Specifically:

1. Who FDA uses to conduct inspections of retailers, distributors, and manufacturers to examine potential illegal distribution or sale of unauthorized e-cigarettes, including the number of personnel and resources allocated between FDA employees, third-party contractors, and state partnerships.

1. The process by which FDA issues warning letters and CMPs, including the timeline for re-inspections to verify compliance, the compliance rate of warned firms, and the specific steps undertaken by FDA before issuing a CMP.

1. The resources FDA allocates to process and review submitted PMTAs, including the allocation of resources for products that the agency refuses to file or refuses to accept, or for which FDA issues a marketing denial order.

1. FDA's approach to CMPs, including any obstacles that would explain FDA's failure to thus far assess multiple violations in a single proceeding, despite the ability to bring an action involving multiple violations up to $1.2 million.

1. The evaluation process and prioritization strategy for enforcement against retailers, distributors, and manufacturers of unauthorized e-cigarettes, including for products with pending PMTAs. In particular, a determination of whether FDA or DOJ have taken any enforcement action against a manufacturer for its unauthorized e-cigarette product if the manufacturer filed a PMTA on time or after the relevant deadline (i.e. Sept 9, 2020 for a tobacco-derived nicotine product, and May 14, 2022, for a synthetic nicotine product) and that PMTA was pending at the time of FDA enforcement.

1. DOJ's process upon receiving a referral from FDA regarding an unauthorized e-cigarette, including the number of cases FDA has referred to DOJ, the resources assigned to such cases, and what guidance DOJ may have provided to FDA regarding the types of cases that are appropriate for referral to DOJ.

1. The particular focus of the interagency task force announced on June 10, 2024, its established goals and strategies, and how this interagency task force will augment existing enforcement activities by each member agency.

1. An assessment of what additional resources FDA and DOJ may require to adequately monitor and enforce the law against unauthorized e-cigarettes on the market.

Thank you for your attention to this request.

Sincerely,

-30-

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