The letter comes after the Senate Judiciary Committee held a hearing on the prevalence of youth e-cigarette use and ahead of June 30th deadline for FDA to complete its e-cigarette PMTA reviews
CHICAGO – U.S. Senate Majority Whip Dick Durbin (D-IL), Chair of the Senate Judiciary Committee, along with U.S. Senators Mitt Romney (R-UT), Richard Blumenthal (D-CT), Susan Collins (R-ME), Jeff Merkley (D-OR), Thom Tillis (R-NC), Mazie Hirono (D-HI), and Ron Wyden (D-OR) sent a bipartisan letter to Deputy Assistant Attorney General of the Department of Justice’s (DOJ’s) Consumer Protection Branch, Arun Rao, and the U.S. Food and Drug Administration (FDA) Center for Tobacco Products Director, Dr. Brian King, requesting more information about the recently announced interagency task force to combat the illicit sale and distribution of unauthorized e-cigarettes. In addition to asking several questions about the composition, prioritization, strategy, and resources for the task force, the letter reiterates the primary issue of needing to restore the premarket review process established by federal law.
The letter comes after the Senate Judiciary Committee held a hearing that underscored the alarming level of youth e-cigarette use—including the role of the tobacco industry in flooding the market with kid-friendly, flavored vaping devices—and examined how federal agencies have failed to enforce laws designed to protect children from a lifetime of nicotine addiction. Both Mr. Rao and Dr. King were witnesses at the hearing.
“We appreciate the recent announcement that a federal task force has been established to enhance enforcement against these illegal and dangerous products through collaboration among the Food and Drug Administration (FDA); Department of Justice (DOJ); Bureau of Alcohol, Tobacco, Firearms and Explosives; U.S. Marshals Service; U.S. Postal Inspection Service; and Federal Trade Commission,” the Senators wrote. “We remain deeply concerned about the inconsistency between FDA and DOJ’s public statements that there are only 27 FDA-authorized e-cigarettes and the reality that thousands of unauthorized e-cigarettes in kid friendly flavors, such as Blue Razz Ice, Strawberry Watermelon Bubble Gum, and Red Bull Strawberry, are readily available for purchase.”
The letter also calls for FDA to complete its long-overdue review of pre-market tobacco product applications (PMTAs) from e-cigarette manufacturers. Since FDA missed a court-imposed September 9, 2021, deadline more than 33 months ago, approximately 2.1 million children may have picked up vaping. The new deadline to complete its review is now June 30, 2024—this upcoming Sunday. Under the Tobacco Control Act (TCA), e-cigarette companies are required to obtain authorization from FDA prior to entering the market, which the agency has neglected to properly enforce.
During the hearing, Durbin received confirmation from FDA and DOJ that the burden of proving that an e-cigarette is “appropriate for the protection of public health” is on the manufacturers, and that “there is no safe harbor for e-cigarettes with PMTAs, meaning unauthorized vapes with pending PMTAs are subject to enforcement actions.”
The letter continued, “It is clear that the very first order of business for the task force should be to restore the law’s premarket regime and enforce the removal of all unauthorized e-cigarettes from the market.”
Durbin has repeatedly called on FDA and DOJ to better enforce federal laws against the unlawful sale of unauthorized e-cigarette products. Durbin has slammed FDA for its continued lack of urgency as millions of children have begun using addictive e-cigarettes.
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. 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 smoking bans in 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.
Full text of the letter is available here or below.
Dear Mr. Rao and Dr. King:
Thank you for testifying before the Senate Judiciary Committee on June 12. Your testimony helped Committee members and the public better understand your agencies’ efforts to enforce federal law against the unlawful distribution and sale of unauthorized e-cigarettes, which are currently fueling alarming and unacceptable levels of youth vaping.
We appreciate the recent announcement that a federal task force has been established to enhance enforcement against these illegal and dangerous products through collaboration among the Food and Drug Administration (FDA); Department of Justice (DOJ); Bureau of Alcohol, Tobacco, Firearms and Explosives; U.S. Marshals Service; U.S. Postal Inspection Service; and Federal Trade Commission.
We remain deeply concerned about the inconsistency between FDA and DOJ’s public statements that there are only 27 FDA-authorized e-cigarettes and the reality that thousands of unauthorized e-cigarettes in kid-friendly flavors, such as Blue Razz Ice, Strawberry Watermelon Bubble Gum, and Red Bull Strawberry, are readily available for purchase.
During the June 12 hearing, you each confirmed that, under the Family Smoking Prevention and Tobacco Control Act (TCA), the burden of proof is on manufacturers to demonstrate, prior to market entry, that an e-cigarette is “appropriate for the protection of public health.” You each further confirmed that there is no safe harbor for e-cigarettes with pending premarket tobacco product applications (PMTAs), meaning unauthorized vapes with pending PMTAs are subject to enforcement actions.
In 2019, the U.S. District Court for the District of Maryland found that FDA had violated the TCA and “decided not to enforce the premarket review provisions at all.” The federal court ordered FDA to complete its review of e-cigarette PMTAs by September 9, 2021. While FDA has now missed this deadline by more than 33 months, the agency represented to the court that it would complete its reviews for the products with the largest market share by June 30, 2024. This is the fourth deadline by which FDA has committed to complete this review. FDA and DOJ now have the opportunity to correct course after failures to regulate the e-cigarette market.
It is clear that the very first order of business for the task force should be to restore the law’s premarket regime and enforce the removal of all unauthorized e-cigarettes from the market. To help inform our understanding of the interagency task force, we request responses to the following questions by July 26, 2024:
- How will the task force prioritize enforcement actions between and among manufacturers, distributors, and retailers?
- Will the unlawful sale or distribution of unauthorized e-cigarettes, including those with pending PMTAs, be within the scope of enforcement for the task force?
- How will the task force augment FDA’s issuance of warning letters and civil monetary penalties? Specifically, will the task force provide resources to increase the number of inspections or shorten the timeline for re-inspections to assess compliance?
- There have been a very limited number of injunctions or seizures related to the unlawful distribution and sale of unauthorized e-cigarettes. How will the task force enhance the use of these enforcement actions?
- What new civil and criminal authorities, aside from violations of Sections 902 and 903 of the Federal Food, Drug, and Cosmetic Act, does the task force anticipate using? Do you plan to request additional authorities from Congress for this purpose?
Thank you for your attention to this pressing public health matter. We look forward to your response.
Sincerely,
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