Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes (U.S. Senate Committee on the Judiciary)

Hearing	Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes
Committee	U.S. Senate Committee on the Judiciary
Date	June 12, 2024

 

Hearing Takeaways:

• The Vaping Policy Landscape: Committee Members and the hearing’s witnesses expressed concerns over the widespread prevalence of youth vaping and the U.S.’s response to this issue. They noted how vaping can expose teenagers to harmful chemicals and can cause teenagers to develop harmful nicotine addictions. The hearing particularly focused on how the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) is regulating and overseeing the electronic cigarette (e-cigarette) market and how the U.S. Department of Justice (DoJ) is enforcing the illegal manufacturing, distribution, and selling of e-cigarettes.
  • Prevalence of Illegal E-Cigarette Products at Retail Stores: Committee Members, Dr. Walley, and Ms. Shapiro raised concerns over how illegal e-cigarettes are widely available at retail stores and how these products remain very accessible to children. Several Committee Members displayed illegal products that they were able to purchase at nearby stores. Deputy Assistant Attorney General Rao alleged that some overseas e-cigarette manufacturers will routinely misdeclare shipments at port of entry to evade import alerts. He further alleged that retailers are continuing to manufacture their own products in individual stores. Mr. Spross testified that his organization, the National Association of Tobacco Outlets (NATO) has a zero-tolerance policy in terms of ensuring that its retailer members are trained to prevent e-cigarette sales to youth. He also testified that NATO has regularly informed its members of the FDA’s targeted e-cigarette brands to ensure that its members know which products the FDA is taking action against. 
  • Vaping Industry Marketing Tactics: Sen. Richard Blumenthal (D-CT) and Deputy Assistant Attorney General Rao expressed concerns that the vaping industry is marketing their products toward children in order to make them lifetime customers. Sen. Blumenthal asserted that many tobacco companies are purchasing vaping manufacturers are applying their marketing tactics to these manufacturers. Mr. Abboud expressed the interest of his trade association, the Vaping Technology Association (VTA) in working with the Committee to develop marketing restrictions for vaping products.
• Current Federal Enforcement of E-Cigarettes: Committee Members, Ms. Richardson, Mr. Spross, Mr. Abboud, Dr. Walley, and Ms. Shapiro criticized the FDA and the DoJ for failing to adequately oversee the U.S. vaping market. They cited the widespread availability of illegal and unapproved e-cigarettes within the U.S. market as evidence for these enforcement failures. CTP Director King stated however that the FDA is engaging in coordinated enforcement efforts against illegal e-cigarettes with the DoJ, U.S. Customs and Border Patrol (CBP), the U.S. Federal Trade Commission (FTC), and the U.S. Postal Inspection Service (USPIS). He testified that the FDA has conducted nearly 1.5 million underage tobacco sale inspections resulting in 138,000 warning letters, 33,000 civil money penalties, and 200 no-tobacco-sale orders (NTSOs) for a variety of products. 
  • Federal Multi-Agency Task Force to Combat the Illegal Sale and Distribution of Illegal E-Cigarettes: Director King and Deputy Assistant Attorney General Rao highlighted how the FDA and the DoJ had very recently announced the creation of a federal multi-agency task force to combat the illegal sale and distribution of illegal e-cigarettes. They noted how this multi-agency task force includes several federal law enforcement partners, including the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), the U.S. Marshals Service, USPIS, and the FTC. While Ms. Richardson, Mr. Spross, and Dr. Walley applauded the creation of this task force, Full Committee Chairman Richard Durbin (D-IL) and Sen. Thom Tillis (R-NC) expressed frustration that this task force had taken too long to be formed. Sen. Tillis further criticized the exclusion of the CBP from this task force.
  • Federal Coordination with State and Local Law Enforcement Agencies to Combat Illegal E-Cigarettes: Sen. Jon Ossoff (D-GA) and Ms. Richardson expressed interest in facilitating coordination between the DoJ, state law enforcement agencies, and local law enforcement agencies on efforts to combat illegal e-cigarettes. Deputy Assistant Attorney General Rao remarked that the DoJ’s Consumer Protection Branch’s federal law enforcement partners “constantly” work with local law enforcement in all of their matters and would welcome further engagement with state and local law enforcement agencies to address this problem.
  • The FDA’s Premarket Tobacco Product Application (PMTA) Process: The Family Smoking Prevention and Tobacco Control Act requires e-cigarette companies to obtain FDA authorization before bringing products to market. This authorization under the law can only be granted if the companies making the products first prove that their products are “appropriate for the protection of public health.” Mr. Spross noted however that the FDA is currently not prioritizing enforcement against vaping products that have fully complied with its 2016 deeming rule and that have filed PMTA applications that remain pending before the Agency. He highlighted how the FDA has repeatedly acknowledged that the removal of vaping products pending PMTA review would stimulate illicit market activity and take potentially reduced harm products away from smokers. Committee Members, Ms. Richardson, Mr. Spross, Mr. Abboud, and Dr. Walley raised concerns over the FDA’s failure to properly review e-cigarettes under the established PMTA process and that illegal products have been allowed to flood the U.S. market. They also expressed frustration that the FDA maintains a significant backlog of e-cigarette applications currently under review, despite a federal court order for the FDA to complete its review by September 2021. Mr. Abboud further called on the FDA to provide greater guidance to e-cigarette manufacturers so that they can better navigate the PTMA process. Director King testified that the FDA has received nearly 27 million pre-market applications for e-cigarettes and indicated that the FDA is legally required to review all of these applications. He called on Congress to provide the FDA with more funding and resources so that it can properly review all of these applications. He also stated that Congress should extend the agile hiring authorities of the 21st Century Cures Act to the CTP to improve the CTP’s ability to recruit, hire, and retain personnel.
  • Concerns Regarding the FDA’s Allocation of Enforcement Resources: Sen. Tillis raised concerns that the FDA has not provided greater scrutiny toward applications from less-established e-cigarette companies. He suggested that these companies are more likely to offer dangerous e-cigarette products and therefore warrant more scrutiny than currently regulated and established tobacco companies. Mr. Abboud also criticized the FDA for allocating a large portion of their resources toward retail inspections. He noted that the FDA’s data indicates that vaping retailers have the best compliance rates in terms of not selling vaping products to underaged individuals. Director King remarked however that he could not make broad generalizations about the potential safety of proposed e-cigarette products. He asserted that making such generalizations would not be consistent with the available scientific evidence.
  • Recent Recission of the FDA’s Marketing Denial Order Against Juul Labs: A key area of controversy involved the FDA’s recent decision to rescind a marketing denial order against U.S. vaping manufacturer Juul Labs. Sen. John Cornyn (R-TX) stated that this recission moves the status of Juul Labs’s products before the FDA to pending status, which means that Juul Labs is no longer allowed to sell its products within the U.S. However, Sen. Richard Blumenthal (D-CT) stated that this recission does allow for Juul Labs’s products to remain on the market. Both Senators expressed interest in resolving the confusion surrounding Juul Labs’s current application with the FDA. Of note, Director King indicated that while he could not comment on the specific details of a pending application, he stated that the FDA is working “as tirelessly as possible” to complete its review of Juul Labs’s products.
  • The FDA’s Fines and Warning Letters for Illegal E-Cigarettes: Committee Republicans argued that the FDA’s current use of fines and warning letters for the illegal manufacturing and sale of e-cigarette constitutes an insufficient substitute for regulation. Director King stated however that most FDA warning letter recipients engage in corrective actions in response to the letters. He also stated that the FDA has taken escalated actions in response to non-responsive warning letter recipients.
  • The U.S.’s Combatting of Illegal Foreign E-Cigarettes Products: Committee Members, Ms. Richardson, and Mr. Spross raised concerns over the prevalence of illegal foreign-manufactured e-cigarettes within the U.S. They noted how many of these illegal e-cigarettes come from China and contain illegal and harmful substances. Director King stated that while more actions could be taken to address the foreign sources of illegal e-cigarette products, he noted how the FDA’s current authorities are confined to products that reach the U.S. He mentioned how the FDA is engaged in rulemaking on registration and listing, which would enable the FDA to engage further with international e-cigarette manufacturers. He stated however that resource constraints limit the FDA’s ability to address illegal e-cigarette products that have entered the U.S. market. Deputy Assistant Attorney General Rao also mentioned how the DoJ has brought criminal actions against individuals involved in the importation of counterfeit vaping-related items. Deputy Assistant Attorney General Rao remarked that the DoJ is very concerned regarding the widespread prevalence of illegal Chinese e-cigarette imports.
  • The DoJ’s Enforcement of Illegal Vaping Products: Deputy Assistant Attorney General Rao remarked that the DoJ’s Consumer Protection Branch will use every tool available to halt the illegal sale of unauthorized e-cigarettes. He indicated that these tools include the seizure of unlawful products and the pursuit of criminal investigations and prosecutions under the Prevent All Cigarette Trafficking (PACT) Act. He also testified that the DoJ’s Civil Division has defended the FDA in over 80 legal challenges filed by e-cigarette manufacturers. He indicated that while many of these legal challenges have not yet been decided, he testified that the DoJ has prevailed in more than a dozen of these cases (including in unanimous decisions in seven courts of appeal). 
  • Federal Treatment and Enforcement of Flavored E-Cigarettes: Committee Members, Director King, Deputy Assistant Rao, Ms. Richardson, Dr. Walley, and Ms. Shapiro raised concerns over the widespread availability of flavored e-cigarettes and how these products are often used to appeal to children. They noted how the FDA has not approved any e-cigarette products and that the Family Smoking Prevention and Tobacco Control Act prohibits the sale of flavored vaping and e-cigarette products within the U.S. Mr. Abboud noted however that the U.S. Centers for Disease Control and Prevention’s (CDC) National Youth Tobacco Survey (NYTS) had found that flavored offerings are not the reason that youth first try e-cigarettes or the reason that youth currently use e-cigarettes. Sen. Tillis and Mr. Abboud also raised concerns that the FDA’s banning of flavored e-cigarettes had fostered an illicit market for these products. 
  • Regulation of Social Media Advertisements of Vaping Products: Sen. Marsha Blackburn (R-TN) raised concerns over how social media platforms (such as TikTok and Instagram) are being used to market illegal fruit and dessert-flavored e-cigarette to children. She called on the FDA and the DoJ to look into this issue through their newly formed multi-agency task force. Director King noted that the FDA has authority over the manufacturing, marketing, and sale of e-cigarette products and does not have the authority to take action against individuals. He stated however that the FDA can take action in instances where a social media influencer is connected to an e-cigarette manufacturer. He mentioned how the FDA has previously issued warning letters on this topic. He also highlighted how the FTC will be involved in the multi-agency task force and stated that the FTC has “key authorities” to address harmful advertising practices.
  • Impact of E-Cigarette Use on Tetrahydrocannabinol (THC) Consumption: Sen. Tillis, Sen. Mike Lee (R-UT), and Dr. Walley raised concerns that e-cigarettes can drive THC consumption and that this consumption may harm young people. Sen. Tillis also raised concerns over the growing popularity of THC vaping products and stated that many of these products are illicit Chinese imports that contain dangerous additives. 
  • E-Cigarettes as Smoking Cessation Tools: Sen. Tillis, Sen. Cornyn, and Mr. Abboud argued that e-cigarettes can serve as an effective smoking cessation tool and cautioned against the pursuit of outright bans of these products. Mr. Abboud added that flavored e-cigarettes can support smoking cessation efforts. 

Hearing Witnesses:

Panel I:

1. Dr. Brian King, PhD, MPH, Director, Center for Tobacco Products, U.S. Food and Drug Administration
2. Mr. Arun Rao, Deputy Assistant Attorney General, Consumer Protection Branch, Civil Division, U.S. Department of Justice

Panel II:

1. Mr. Tony Abboud, Executive Director, Vapor Technology Association
2. Ms. Yolonda Richardson, President and CEO, Campaign for Tobacco-Free Kids
3. Ms. Josie Shapiro, High School Student, Lincoln High School
4. Mr. David Spross, Executive Director, National Association of Tobacco Outlets
5. Dr. Susan Walley, MD, MHCM, NCNTT, FAAP, Immediate Past Chair, Section on Nicotine and Tobacco Prevention and Treatment, American Academy of Pediatrics

Member Opening Statements:

Full Committee Chairman Richard Durbin (D-IL):

• He remarked that the hearing would consider the U.S.’s “alarming” level of youth e-cigarette use and examine how federal agencies have failed to enforce laws that protect children from developing nicotine addictions.
  • He showed a video highlighting how addictive and dangerous e-cigarettes are for children.
• He discussed how cigarettes are responsible for over 480,000 deaths each year and stated that the hearing is part of his continued effort to stop these “needless” deaths.
• He noted how the percentage of high school students smoking cigarettes has fallen from 28 percent in 2000 to 2 percent today.
  • He attributed this decline to the efforts of Congress and public health advocates.
• He stated however that large tobacco companies have responded to declining youth smoking rates through rebranding and introducing new e-cigarette products.
  • He asserted that the tobacco industry is now targeting children in their promotion of e-cigarette products.
• He stated that the tobacco companies target children because the addictive nature of nicotine makes children more prone to become lifetime customers of their products.
• He recounted how Altria had first introduced e-cigarettes with their Juul product and noted how Juul Labs had introduced “flashy” devices, “kid-friendly” flavors, and advertisements that included young and attractive people.
  • He commented that Juul Labs had caused a wave of nicotine addiction and mentioned how then-FDA Commissioner Scott Gottlieb had described this addiction as an epidemic.
• He remarked that the FDA and the DoJ possess the necessary tools to prevent the youth vaping epidemic and asserted that the FDA and the DoJ have failed to make use of these tools.
• He discussed how the Family Smoking Prevention and Tobacco Control Act requires e-cigarette companies to obtain FDA authorization before bringing products to market.
  • He indicated that authorization under the law can only be granted if the companies making the products first prove that their products are “appropriate for the protection of public health.”
• He stated however that the FDA had long ignored its responsibility under this law until public health groups had successfully sued the FDA to fulfill its responsibilities.
• He noted how the U.S. District Court for the District of Maryland had found the FDA was violating the Family Smoking Prevention and Tobacco Control Act and had ordered the FDA to complete its review of e-cigarette applications by September 9, 2021.
  • He indicated however that the FDA has not yet completed this review, despite the passage of the deadline.
• He stated that the FDA could and should have ordered every single unauthorized e-cigarette off the market following the passage of the court-ordered September 9, 2021 deadline.
• He expressed frustration with how the FDA’s inaction had enabled thousands of unauthorized e-cigarettes to flood the market.
  • He commented that many of these unauthorized e-cigarettes have flavors that are designed to appeal to children and addict children to nicotine.
• He stated that there is no evidence that e-cigarettes and their fruity flavors are targeted at adults (despite the claims of the tobacco industry).
  • He noted how the rate of e-cigarette use is nearly twice as high for middle school students as it is for adults.
• He mentioned he is releasing findings from a U.S. National Institutes of Health (NIH) funded Monitoring the Future study and indicated the study estimates that 2.1 million children have begun vaping since September 9, 2021.
• He then discussed how the FDA relies upon the DoJ to bring enforcement actions for violations of the law and criticized the DoJ for failing to address illegal e-cigarettes.
  • He noted that while only 23 e-cigarette brands have been authorized for sale in the U.S. to date, he highlighted how there are more than 6,000 e-cigarette brands available for sale in the U.S.
• He expressed frustration with the FDA and the DoJ for permitting thousands of vaping products to remain available for sale in the U.S. when the manufacturers of these products have not received authorization for the products.
  • He added that the manufacturers of these products have often not filed applications to sell the products.
• He stated that e-cigarette companies have addicted a new generation of children to nicotine while the FDA and the DoJ have failed to address e-cigarettes.
  • He commented that this growth in the popularity of e-cigarettes undermines the U.S.’s successful efforts to dissuade children from smoking traditional cigarettes.

Sen. Thom Tillis (R-NC):

• He stated that the FDA’s banning of legitimate flavored vaping products has caused cheap Chinese knockoff vaping products to flood the U.S. market.
  • He noted that while these imported vaping products are mostly illegal, he commented that the U.S. has not taken significant enforcement actions against these products.
• He highlighted how there has been a 1,500 percent increase in “kid-friendly” vaping flavors sold between 2020 and 2023.
  • He noted how more than 25 percent of the youth e-cigarette users report using these products daily and how over one-third of these youth report using these products more than 20 days per month.
• He discussed how tobacco is his state of North Carolina’s oldest industry and mentioned how North Carolina leads the U.S. in tobacco farming and manufacturing.
  • He indicated that tobacco supports over 27,000 jobs within North Carolina.
• He remarked that no one wants children using e-cigarettes (especially illegal and counterfeit products that are being dumped within the U.S. by China’s state-controlled tobacco monopoly).
  • He mentioned how he had voted in favor of raising the legal age for purchasing tobacco products to 21.
• He noted that while youth e-cigarette use has decreased by 60 percent since 2019, he asserted that the FDA’s lack of guidance, transparency, and enforcement has enabled the Chinese Communist Party (CCP) and organized crime to flood the U.S. with dangerous illicit vaping products.
  • He commented that the FDA’s refusal to follow Congressional intent and implement the Family Smoking Prevention and Tobacco Control Act has led to “disastrous” consequences for public health and U.S. jobs.
• He stated the FDA had “conveniently” just announced an inter-agency task force to address these longstanding problems with vaping products.
  • He described this announcement as a “thinly veiled political stunt” and noted how the announcement comes two and a half years after a Reagan-Udall Foundation report had recommended the creation of such a task force.
  • He further criticized the FDA’s exclusion of CBP from the inter-agency task force.
• He remarked that the FDA could not create a functioning market for regulated tobacco products through solely relying upon fines and warning letters.
• He asserted that the FDA must create a consistent, transparent, and science-based process for reviewing applications for new tobacco products.
  • He called the FDA’s current process for reviewing these applications “broken.”
• He noted how the FDA currently has 560,000 pending tobacco product applications and indicated that this figure includes more 557,000 applications for e-cigarettes.
• He highlighted how the FDA has only approved one-thousandth of one percent of all of its received e-cigarette applications to date.
  • He indicated that it has been more than two years since the FDA has authorized a new e-cigarette product.
  • He further indicated that the FDA’s CTP had not authorized a new e-cigarette product under Director Brian King’s leadership.
• He remarked that the FDA’s “de facto ban” on regulated reduced risk alternatives for adult smokers has resulted in a youth vaping epidemic and a lack of enforcement against illegal cigarettes.
• He also stated that the U.S. is experiencing a “plague” of illicit counterfeit THC vaping products entering the U.S.
  • He commented that much of these illicit counterfeit THC vaping products are related to Chinese imports.
• He asserted that many of the health problems associated with vaping actually stem from fake dirty THC vaping products that contain dangerous additives.
• He mentioned how the Eastern Band of Cherokee Indians tribe (which is in western North Carolina) has started to sell THC-based products within their sovereign territory and raised concerns that these products could pose harms to consumers.
  • He highlighted how behavioral health professionals have found that THC-based products are among the leading causes of psychotic events.
• He expressed interest in combating the problem of youth vaping and called youth vaping a major public health threat that is being perpetrated by China.

Panel I Opening Statements:

Dr. Brian King, PhD, MPH (Center for Tobacco Products, U.S. Food and Drug Administration):

• He noted that while e-cigarettes have been the most used tobacco product among U.S. youth since 2014, he stated that there has occurred a greater than 60 percent decline in the number of middle and high school students using e-cigarettes over the previous five years.
  • He highlighted how youth e-cigarette usage had declined by 580,000 high school students in 2023 alone.
• He remarked however that more work is required to address youth vaping and testified that the FDA is employing a “comprehensive enforcement approach” and pursuing other activities to address this problem.
• He also stated that the FDA is pursuing an “all-government” approach across the vaping supply chain to address youth vaping and highlighted how the FDA is working with various federal partners on this effort.
  • He indicated that these partners include the DoJ, CBP, the FTC, and USPIS.
• He testified that the FDA has conducted thousands of inspections of e-cigarette manufacturers and distributors and indicated that these inspections had resulted in almost 900 warning letters.
  • He also mentioned how the FDA has issued over 550 warning letters to retailers regarding unauthorized e-cigarettes.
• He stated that the FDA can escalate its actions if warning letter recipients fail to take corrective actions and discussed how the FDA has taken several “first of their kind” actions over the previous two years.
  • He first mentioned how the FDA has built cases to support the first injunctions against e-cigarette manufacturers and distributors in coordination with the DoJ (which now total eight complaints filed).
  • He secondly mentioned how the FDA had conducted the first seizure of an e-cigarette distributor in coordination with the DoJ and the U.S. Marshals Service.
  • He thirdly mentioned how the FDA had issued the first civil money penalties against e-cigarette manufacturers (which now total nearly 60 penalties).
  • He fourthly mentioned how the FDA had issued the first civil money penalties against e-cigarette retailers for the sale of illegal e-cigarettes (which now total nearly 100 penalties).
  • He lastly mentioned how the FDA had participated in a “landmark” joint operation with CBP resulting in the seizure of more than $18 million worth of unauthorized e-cigarettes.
• He stated that the aforementioned work is in addition to the FDA’s “robust” program to prevent underage tobacco sales.
  • He testified that the FDA has conducted nearly 1.5 million underage tobacco sale inspections resulting in 138,000 warning letters, 33,000 civil money penalties, and 200 NTSOs for a variety of products.
• He expressed the FDA’s commitment to taking more escalated enforcement actions in conjunction with its federal partners.
  • He commented however that several factors complicate the pursuit of these escalated enforcement actions.
• He testified that the FDA has received nearly 27 million pre-market applications for e-cigarettes and indicated that the FDA is legally required to review all of these applications.
  • He asserted that the requirement to review all of these applications combined with the “rapidly evolving” tobacco product landscape presents an “unprecedented” time and resource challenge for the FDA.
• He also noted how the CTP is fully funded via user fees and stated that these user fees have not been updated to reflect the current tobacco product marketplace.
  • He called for Congressional support to address these funding challenges and mentioned how the FDA’s fiscal year (FY) 2025 budget proposal includes user fee updates.
• He remarked that Congress should provide the FDA with authorization to collect user fees from e-cigarette manufacturers (who are all currently not paying any fees).
  • He specifically called for increasing these user fee collections by $114 million to account for the increased workload and for indexing all future user fee collections for inflation.
• He also stated that Congress should extend the agile hiring authorities of the 21st Century Cures Act to the CTP to improve the CTP’s ability to recruit, hire, and retain personnel.
  • He highlighted how the CTP is the only FDA center without such hiring authority.
• He concluded that the FDA has taken “important strides” to address unauthorized e-cigarettes and acknowledged that the FDA can take additional actions to address this issue.
  • He expressed confidence that the FDA’s five-year strategic plan coupled with Congressional support would enable the Agency to remove unauthorized e-cigarettes from the marketplace and prevent children from accessing these vaping products.

Mr. Arun Rao (Consumer Protection Branch, Civil Division, U.S. Department of Justice):

• He remarked that there exists an “urgent need” to combat the illegal distribution and sale of unauthorized e-cigarettes.
• He stated that illegal e-cigarettes pose a significant public health risk to Americans and noted how these products contribute to addiction and health issues.
  • He warned that e-cigarettes pose a “dire threat” to youth who are often the primary targets of aggressive marketing campaigns.
• He noted how illegal e-cigarettes have “flooded” the U.S. and highlighted how many of these illegal products originate from abroad (particularly China).
• He discussed how tens of millions of e-cigarette applications have been filed with the FDA for authorization and asserted that many e-cigarette manufacturers have exploited the FDA’s PMTA process.
  • He alleged that some e-cigarette manufacturers have sought to evade FDA denial orders through making minimal alterations to previously denied products and then filing additional applications with the FDA.
  • He also alleged that some overseas e-cigarette manufacturers will routinely misdeclare shipments at port of entry to evade import alerts.
  • He further alleged that retailers are continuing to manufacture their own products in individual stores.
• He remarked that the cumulative impact of the aforementioned factors has made illegal e-cigarettes very accessible, which have enabled young people to obtain illegal e-cigarettes at brick and mortar retailers and online stores.
• He stated that the DoJ’s Consumer Protection Branch plays an important role in supporting the FDA’s efforts to ensure that illegal e-cigarettes stay off market and explained that the DoJ’s Civil Division defends FDA marketing denial orders in court from e-cigarette manufacturer challenges.
  • He testified that the DoJ’s Civil Division has defended the FDA in over 80 legal challenges filed by e-cigarette manufacturers.
  • He indicated that while many of these legal challenges have not yet been decided, he testified that the DoJ has prevailed in more than a dozen of these cases (including in unanimous decisions in seven courts of appeal).
  • He further mentioned how the DoJ had received a significant adverse decision in one such case in the U.S. Court of Appeals for the Fifth Circuit and indicated that the DoJ is seeking review from the U.S. Supreme Court in this case.
• He also discussed how the DoJ’s Consumer Protection Branch plays an important role in enforcing the Family Smoking Prevention and Tobacco Control Act.
• He highlighted how the FDA has pursued monetary penalties under the Family Smoking Prevention and Tobacco Control Act against over 55 manufacturers and 100 retailers and has sent warning letters to even more manufacturers and retailers.
  • He acknowledged that while the DoJ cannot impose penalties itself under this law, he stated that the DoJ is prepared to assist the FDA in collection actions to ensure compliance with the law.
• He testified that the DoJ’s Consumer Protection Branch has partnered with the FDA on significant enforcement actions, including the first domestic seizure of unauthorized e-cigarettes.
• He mentioned how the DoJ’s Consumer Protection Branch also has the authority to bring civil injunction actions in matters referred to the DoJ by the FDA.
  • He acknowledged that while these actions do not allow for the DoJ to recover monetary penalties (which limits their deterrent effect in some circumstances), he called these actions an “appropriate tool” in some cases.
• He testified that the DoJ’s Consumer Protection Branch has secured injunctions against six entities, is continuing litigation against another entity, and had recently filed a proposed consent decree.
  • He indicated that the DoJ remains ready to take action on additional referrals in consultation with the FDA.
• He further discussed how the DoJ’s Consumer Protection Branch and the FDA had recently announced the creation of a multi-agency task force solely focused on addressing the threats posed by illegal e-cigarette sales.
  • He commented that this task force combines the expertise of multiple law enforcement partners, including the ATF, USPIS, the U.S. Marshals Service, CBP, and FTC.
• He remarked that the DoJ’s Consumer Protection Branch will use every tool available to bolster its efforts to halt the illegal sale of unauthorized e-cigarettes.
  • He indicated that these tools include the seizure of unlawful products and the pursuit of criminal investigations and prosecutions under the PACT Act.
• He also expressed the DoJ’s Consumer Protection Branch’s willingness to work with Congress on its legislative efforts to address illegal e-cigarettes.
  • He commented that Congress must ensure that the DoJ and the FDA are able to effectively pursue critical enforcement actions.

Congressional Question Period:

Full Committee Chairman Richard Durbin (D-IL):

• Chairman Durbin stated that an e-cigarette manufacturer has the burden of proving to the FDA that their product is “appropriate for the protection of the public health” before the product can enter the market under the Family Smoking Prevention and Tobacco Control Act. He asked Director King and Deputy Assistant Attorney General Rao to confirm this statement.
  • Director King confirmed Chairman Durbin’s statement.
  • Deputy Assistant Attorney General Rao confirmed Chairman Durbin’s statement.
• Chairman Durbin mentioned how the FDA has authorized 23 e-cigarette brands to date and how the FDA has not authorized any flavored e-cigarettes. He displayed a photograph of a vape shop located less than one mile from the FDA’s headquarters. He highlighted how the photograph shows a variety of flavored e-cigarettes for sale. He further held up a flavored e-cigarette that had been purchased from this vape shop. He emphasized that the FDA has not authorized any of the flavored e-cigarettes being sold at this vape shop and asserted that these illegal flavored vaping products are meant to target children. He asked Director King to explain how these illegal sales are allowed to occur.
  • Director King remarked that the FDA has a pre-market paradigm for reviewing tobacco product applications. He stated that the sheer volume of these applications and the volume of the market requires the FDA to prioritize its enforcement efforts.
• Chairman Durbin emphasized that many vaping products remain available for sale within the U.S. despite the product manufacturers not having received FDA approval for the products. He asserted that the FDA has failed to carry out its responsibilities in these instances. He asked Director King to explain this situation.
  • Director King remarked that the sheer volume of the vaping product landscape requires that the FDA have time to conduct scientifically and legally defensible reviews for the 27 million applications submitted to the FDA.
• Chairman Durbin interjected to state that e-cigarettes manufacturers (rather than the FDA) have the burden of proving that their products are appropriate for the protection of public health. He emphasized that the FDA does not need to disprove these assertions from e-cigarette manufacturers.
  • Director King reiterated that the FDA has received a substantial number of applications for e-cigarette products and testified that the FDA has “hundreds” of scientists that are working on a daily basis to review these applications. He stated that the FDA has made “good progress” on reviewing these applications.
• Chairman Durbin asked Director King to indicate whether an e-cigarette manufacturer could sell their products without FDA approval through simply filing complex applications.
  • Director King answered no. He stated that the FDA seeks to ensure that it reviews the science that is submitted as part of e-cigarette applications. He discussed how the FDA’s review process for e-cigarette applications involves three phases and indicated that the FDA can remove applications from its review process if the applications lack necessary information. He stated however that if an e-cigarette manufacturer provides enough scientific information in their application, then the FDA must complete a scientific review of the application. He commented that this scientific review process is time consuming.
• Chairman Durbin asked Deputy Assistant Attorney General Rao to indicate whether tobacco company lawyers are outmaneuvering the U.S. government and causing the U.S. to not enforce current federal laws.
  • Deputy Assistant Attorney General Rao described the current e-cigarette landscape as a very litigious environment. He stated that the DoJ’s Consumer Protection Branch has been actively defending the FDA in federal courts.
• Chairman Durbin interjected to note that it has been 33 months since the U.S. District Court for the District of Maryland had imposed its deadline on the FDA to complete its review of e-cigarette applications. He commented that this review remains incomplete, despite Deputy Assistant Attorney General Rao’s contention that there exists an “urgent need” to address illegal e-cigarettes. He asked Deputy Assistant Attorney General Rao to explain why the FDA has not completed its review of e-cigarette applications 33 months after its court-imposed deadline.
  • Deputy Assistant Attorney General Rao stated that he shares Chairman Durbin’s concerns regarding the widespread prevalence of illegal e-cigarettes. He also stated that the DoJ’s Consumer Protection Branch is serious about its obligations to enforce federal tobacco laws aggressively with regard to illegal e-cigarettes.
• Chairman Durbin interjected to ask Deputy Assistant Attorney General Rao to provide a definition for the phrase “burden of proof.”
  • Deputy Assistant Attorney General Rao defined “burden of proof” as the evidence that needs to be established in a court of law.
• Chairman Durbin asked Deputy Assistant Attorney General Rao to indicate who has the responsibility of proving the safety of e-cigarette products under current federal law.
  • Deputy Assistant Attorney General Rao indicated that e-cigarette manufacturers have the responsibility of proving the safety of e-cigarette products under current federal law.
• Chairman Durbin asked Deputy Assistant Attorney General Rao to indicate whether e-cigarette manufacturers have proven safety of the e-cigarette products that he had highlighted are being sold near the FDA’s headquarters.
  • Deputy Assistant Attorney General Rao answered no.
• Chairman Durbin asked Deputy Assistant Attorney General Rao to address how the U.S. should stop e-cigarette manufacturers from openly defying federal law and from selling their vaping products to children.
  • Deputy Assistant Attorney General Rao remarked that the U.S. should signal its aggressive enforcement within the e-cigarette space as a priority across the Executive Branch.
• Chairman Durbin interjected to comment that signals are insufficient and asserted that the U.S. must take action to address the illegal e-cigarette sales. He expressed frustration that the FDA and the DoJ’s Consumer Protection Branch had just recently announced a multi-agency task force to address illegal e-cigarette sales.
  • Deputy Assistant Attorney General Rao remarked that the DoJ’s Consumer Protection Branch has taken several actions to address illegal e-cigarette sales. He stated that the DoJ’s Consumer Protection Branch stands ready to assist in the collection of civil money penalties issued against e-cigarette manufacturers. He also stated that the DoJ’s Consumer Protection Branch has been working with the FDA and the U.S. Marshals Service on illegal e-cigarette seizures.
• Chairman Durbin interjected to assert that the DoJ’s Consumer Protection Branch and the FDA are failing to address illegal e-cigarette sales. He stated that the failure of the DoJ’s Consumer Protection Branch and the FDA to address these illegal sales is causing children to become addicted to e-cigarettes.
  • Deputy Assistant Attorney General Rao remarked that a multi-pronged approach will be required to address the sale of illegal e-cigarettes. He noted how the DoJ’s Consumer Protection Branch is working with multiple federal partners (including the FDA, ATF, and USPIS) on criminal and civil enforcement actions to address illegal e-cigarette sales. He expressed optimism that the DoJ’s Consumer Protection Branch could make progress in addressing this problem through working with its federal partners.
• Chairman Durbin reiterated that e-cigarette manufacturers have the burden to prove that their products are appropriate for the protection of public health. He stated that these e-cigarette manufacturers have failed to meet their burden of proof and are continuing to sell their products without federal approval. He expressed frustration that the DoJ’s Consumer Protection Branch and the FDA are allowing this sale of illegal e-cigarettes. He asked Deputy Assistant Attorney General Rao to indicate whether e-cigarette manufacturers are violating the law when the manufacturers sell their products without federal approval.
  • Deputy Assistant Attorney General Rao answered affirmatively.

Sen. Thom Tillis (R-NC):

• Sen. Tillis asked Deputy Assistant Attorney General Rao to confirm that the major tobacco companies are not manufacturing many of the illegal e-cigarette products currently for sale.
  • Deputy Assistant Attorney General Rao stated that there exist many companies within the U.S. vaping market beyond the major tobacco companies.
• Sen. Tillis interjected to ask Deputy Assistant Attorney General Rao to indicate whether focusing on the large tobacco companies or focusing on the sale of illegal e-cigarettes would be a more effective strategy for protecting the youth.
  • Deputy Assistant Attorney General Rao stated that the complexity of the U.S. tobacco and vaping market necessitates a multi-pronged approach.
• Sen. Tillis interjected to note that the FDA faces resource constraints and stated that the FDA’s fee structure should be modernized. He commented however that this modernization would not occur instantaneously. He asked Deputy Assistant Attorney General Rao to indicate whether the U.S. should prioritize addressing the large tobacco companies or combatting the sale of illegal e-cigarettes.
  • Deputy Assistant Attorney General Rao stated that the DoJ’s Consumer Protection Branch would work with the FDA to determine the most effective use of their current resources.
• Sen. Tillis interjected to ask Director King to indicate whether the FDA’s received e-cigarette applications are mainly coming from established tobacco companies or from non-traditional companies.
  • Director King stated that both established tobacco companies and non-traditional companies are submitting e-cigarette applications to the FDA.
• Sen. Tillis interjected to ask Director King to estimate the breakdown of the companies submitting e-cigarette applications to the FDA.
  • Director King testified that the FDA receives e-cigarette applications from both major tobacco companies and smaller manufacturers.
• Sen. Tillis interjected to ask Director King to address whether established tobacco companies or non-traditional companies would be more likely to submit dangerous e-cigarette products to the FDA.
  • Director King remarked the safety of e-cigarette products is dependent upon the scientific information submitted to the FDA. He asserted that he could not make a sweeping generalization as to whether established tobacco companies or non-traditional companies have safer e-cigarette products.
• Sen. Tillis interjected to ask Director King to clarify whether he is asserting that e-cigarette products coming out of heavily regulated tobacco companies are likely to be as dangerous as Chinese-manufactured e-cigarette products.
  • Director King remarked that he could not make broad generalizations about the potential safety of proposed e-cigarette products. He stated however that there exists a diverse landscape of e-cigarette products that involve different device types. He asserted that making generalizations regarding the safety of these products would not be consistent with the available scientific evidence.
• Sen. Tillis expressed interest in how the U.S. has not assessed which parties are most responsible for unsafe e-cigarette products. He stated that it would be useful for the U.S. to identify where the most dangerous e-cigarette products are and to determine how these products are allowed to systematically come to market. He then asked Director King to explain why the FDA had announced its inter-agency task force to address illegal e-cigarette sales two years after the release of the Reagan-Udall Foundation’s 2022 report.
  • Director King testified that the FDA has been working “systematically” to address all 15 recommendations from the Reagan-Udall Foundation’s 2022 report. He stated that the FDA has made progress on implementing these recommendations and has made quarterly reports on this progress. He noted how the report’s task force recommendation involves multiple agencies and commented that time was required to set up this task force.
• Sen. Tillis then noted how Director King’s previous answers have indicated that the FDA must review every single new e-cigarette product application. He asked Director King to indicate whether the FDA provides new e-cigarette products the benefit of the doubt pending review.
  • Director King answered no. He stated that e-cigarette manufacturers do not receive safe harbor protection for submitting an application to the FDA.
• Sen. Tillis interjected to ask Director King to confirm that e-cigarette manufacturers cannot begin selling their products once these manufacturers apply for FDA approval for their products.
  • Director King reiterated that e-cigarette manufacturers do not receive safe harbor protection for submitting an application to the FDA. He stated that any e-cigarettes that do not have authorization through the FDA’s PMTA pathway or other pathways are on the market illegally (and at risk of enforcement).
• Sen. Tillis interjected to ask Director King to indicate whether all of the e-cigarette products currently available for sale in the U.S. are legal and subject to FDA review and approval.
  • Director King stated that he could not speak to the legality of every single e-cigarette product currently available for sale.
• Sen. Tillis interjected to note that U.S. retailers are selling potentially dangerous e-cigarette products. He expressed frustration and confusion over how these products can remain on the market. He then recounted how he had previously used dipping tobacco and had then transitioned to a nicotine pouch substance. He indicated that he had subsequently quit using nicotine all together. He stated that tobacco-free nicotine products help people to quit using tobacco and may enable people to ultimately quit consuming nicotine. He warned that removing e-cigarettes from the U.S. market will cause many people to continue using harmful tobacco products.

Full Committee Chairman Richard Durbin (D-IL):

• Chairman Durbin stated that flavored e-cigarette products are often meant to appeal to children.

Sen. Thom Tillis (R-NC):

• Sen. Tillis interjected to ask the witnesses to indicate whether any major tobacco companies are selling flavored products that are meant to appeal to children.
  • Director King answered affirmatively. He stated that there are several large tobacco companies manufacturing flavored e-cigarette products that have been documented to appeal to children.

Sen. Cory Booker (D-NJ):

• Sen. Booker discussed how fentanyl analogs coming from China are inflicting significant harm on Americans and mentioned how Congress has sought to address this problem in a bipartisan manner. He raised concerns that many e-cigarette products are coming from foreign countries that do not provide sufficient scrutiny and safety precautions. He asked the witnesses to discuss the foreign-manufactured e-cigarette products that are currently being sold in U.S. stores. He also asked the witnesses to address how these products pose risks to U.S. citizens.
  • Director King noted that while e-cigarettes as a general product class have lower product risks than conventional cigarettes, he stated that e-cigarettes are not safe. He indicated that while the levels of toxicants in e-cigarettes are “markedly lower” than the levels of toxicants in traditional cigarettes, he highlighted how e-cigarettes have aerosols that can contain potentially harmful constituents. He stated that the e-cigarette marketplace is “vast” and that there exists variability across product types and brands.
• Sen. Booker asked Director King to indicate whether e-cigarette products coming from foreign countries (such as China) could pose threats to the U.S.
  • Director King remarked that any e-cigarette products could pose a threat to the U.S., regardless of their country of origin. He stated that the FDA maintains a pre-market paradigm to review the scientific evidence underlying e-cigarette products and to determine whether these products adhere to statutory requirements.
• Sen. Booker asked Director King to indicate whether foreign knockoff vaping products are subverting the U.S.’s existing safeguards and regulations.
  • Director King answered affirmatively and added that many dangerous e-cigarette products are being manufactured domestically as well. He remarked that the sheer volume of the e-cigarette marketplace makes it challenging to police this space. He called for an “all-government” approach to address illegal e-cigarettes. He stated that the U.S. is making progress in terms of reviewing applications for new e-cigarette products and ramping up enforcement of illegal e-cigarette products. He asserted however that more resources and more personnel are required to oversee the e-cigarette market.
• Sen. Booker emphasized that dangerous e-cigarette products may be flowing into the U.S. market that originate from foreign countries. He asked Director King to clarify whether he is asserting that limited resources are impeding the efforts of U.S. law enforcement agencies to combat these dangerous e-cigarette products.
  • Director King stated that limited personnel and resources are limiting the U.S.’s ability to combat dangerous e-cigarette products.
• Sen. Booker asked Director King to indicate whether the U.S. could take additional actions to address the foreign sources of illegal e-cigarette products.
  • Director King stated that while more actions could be taken to address the foreign sources of illegal e-cigarette products, he noted how the FDA’s current authorities are confined to products that reach the U.S. He mentioned how the FDA is engaged in rulemaking on registration and listing, which would enable the FDA to engage further with international e-cigarette manufacturers. He remarked that this rulemaking would enable the FDA to engage more with Chinese e-cigarette manufacturers that are responsible for the “bulk” of illegal e-cigarette products. He stated however that resource constraints limit the FDA’s ability to address illegal e-cigarette products that have entered the U.S. market.

Sen. John Cornyn (R-TX):

• Sen. Cornyn noted how 18.4 million vaping products had been sold in September 2023 and highlighted how there has been a 1,500 percent increase in “kid-friendly” flavored vaping products between 2020 and 2023. He displayed several examples of these “kid-friendly” flavored vaping products that his staff had recently purchased from a gasoline station, including a watermelon bubblegum flavored vaping product and an apple mellonberry flavored vaping product. He asked Director King to indicate whether these vaping products are designed to appeal to children.
  • Director King stated that he could not speak to the intent of the manufacturers behind Sen. Cornyn’s displayed vaping products. He stated however that flavored vaping products do appeal to children. He noted how 90 percent of youth e-cigarette users use flavored e-cigarette varieties.
• Sen. Cornyn noted how the warnings on vaping products indicate that the products can expose users to nicotine. He asked Director King to confirm that nicotine is an addictive substance.
  • Director King described nicotine as a “highly addictive drug.”
• Sen. Cornyn also noted how the warnings on vaping products indicate that the products can cause birth defects, reproductive harm, and cancer. He asked Director King to indicate whether vaping products are safe to consume.
  • Director King stated that there do not exist any e-cigarettes that are safe. He commented however that e-cigarettes have lower risks than traditional cigarettes.
• Sen. Cornyn interjected to emphasize that e-cigarettes are not safe. He noted however that e-cigarettes can support many adults in their efforts to quit using tobacco. He mentioned how both of his displayed vaping products indicate that the products are for sale in the U.S. only, designed in the U.S., and manufactured in China. He asked Director King to indicate whether these displayed vaping products are available for sale in China.
  • Director King stated that while he could not speak to whether the manufacturers of Sen. Cornyn’s displayed vaping products are evading Chinese law, he indicated that Chinese law currently prohibits the sale of flavored e-cigarettes.
• Sen. Cornyn emphasized that these displayed vaping products cannot be sold in China and can be sold in the U.S. He stated that these vaping products are meant to victimize and addict children to nicotine delivery devices. He asked Director King to confirm that his displayed vaping products are nicotine delivery devices.
  • Director King confirmed that Sen. Cornyn’s displayed vaping products are nicotine delivery devices.
• Sen. Cornyn then recounted how the FDA had previously issued a marketing denial order against U.S. vaping product manufacturer Juul Labs, which would have prevented the company from selling its vaping products. He noted however that Juul Labs had challenged the marketing denial order in court and had obtained a stay, which enabled Juul Labs to continue to legally sell its vaping products. He mentioned how the FDA had recently rescinded this marketing denial order. He stated that this rescission moves the status of Juul Labs’s products before the FDA to pending status, which means that Juul Labs is no longer allowed to sell its products within the U.S. He described this situation as “Kafkaesque” given how Juul Labs can no longer sell its vaping products after the FDA has rescinded its marketing denial order for the company’s products. He stated however that illegal Chinese vaping products make $3 billion annually advertising directly to U.S. citizens. He asked Director King to confirm the veracity of his previous statements.
  • Director King commented that Sen. Cornyn’s previous statements are accurate “in general.”
• Sen. Cornyn expressed interest in developing legislation to address the current confusion within the e-cigarette marketplace.

Sen. Jon Ossoff (D-GA):

• Sen. Ossoff asked the witnesses to confirm that there do not exist any FDA-approved flavored vaping or e-cigarette products.
  • Director King clarified that tobacco is a flavor. He stated however that the FDA has not authorized any non-tobacco flavored e-cigarettes.
• Sen. Ossoff asked Deputy Assistant Attorney General Rao to confirm that the Family Smoking Prevention and Tobacco Control Act prohibits the sale of flavored vaping and e-cigarette products within the U.S.
  • Deputy Assistant Attorney General Rao confirmed that the Family Smoking Prevention and Tobacco Control Act prohibits the sale of flavored vaping and e-cigarette products within the U.S.
• Sen. Ossoff asked Deputy Assistant Attorney General Rao to explain why flavored vaping and e-cigarette products remain widely sold within the U.S. if such sales are illegal.
  • Deputy Assistant Attorney General Rao remarked that the Executive Branch is taking enforcement actions across various vectors to address the illegal sale of flavored vaping and e-cigarette products. He noted how the DoJ’s Consumer Protection Branch has been engaged in defense of the FDA’s marketing denial orders in federal courts across the U.S. He indicated that there have been more than 80 cases to date related to these marketing denial orders and testified that the DoJ’s Consumer Protection Branch has prevailed in a dozen of these cases. He also mentioned how the DoJ’s Consumer Protection Branch is working with the FDA and the U.S. Marshals Service on domestic seizures of illegal e-cigarettes. He highlighted how there had been a seizure earlier in 2024 in southern California that had resulted in the confiscation of 45,000 illegal cigarettes. He stated however that the DoJ’s Consumer Protection Branch can do more to address this problem and mentioned how the DoJ has brought many civil injunctive actions against e-cigarette manufacturers. He noted how the DoJ Consumer Protection Branch is involved in the recently announced multi-agency task force. He expressed the DoJ’s Consumer Protection Branch’s interest in working with Executive Branch law enforcement partners to address illegal e-cigarette sales.
• Sen. Ossoff interjected to emphasize that no non-tobacco-flavored e-cigarettes are FDA-approved and legal for sale within the U.S. He noted however that flavored e-cigarettes remain widely available within the U.S. He mentioned how a 2019 study had found that 20 percent of his state of Georgia’s high school students had used vaping products. He indicated that flavored products and bright packaging had caused many of these students to start using these products. He stated that the unregulated and illegal nature of these vaping products can lead these products to sometimes be laced with other drugs or contaminants. He asked Deputy Assistant Attorney General Rao to address how the DoJ’s Consumer Protection Branch will prioritize enforcement efforts aimed at vaping products that are contaminated or that contain other deadly and illegal drugs.
  • Deputy Assistant Attorney General Rao remarked that the DoJ’s Consumer Protection Branch’s highest priority is enforcement against vaping products that are contaminated or that contain other deadly and illegal drugs. He noted how these dangerous vaping products often originate from China. He mentioned how the DoJ has brought criminal actions against individuals involved in the importation of counterfeit vaping-related items. He expressed the DoJ’s Consumer Protection Branch’s interest in working with the multi-agency task force to bring additional e-cigarette-related enforcement actions.
• Sen. Ossoff asked Deputy Assistant Attorney General Rao to indicate what he would say to Georgia families who fear that their teenage children may unintentionally and inadvertently consume an illegal and dangerous substance through a vaping product.
  • Deputy Assistant Attorney General Rao remarked that the Executive Branch is taking a “very aggressive” approach to address illegal and dangerous vaping products. He elaborated that the Executive Branch is using all available tools and working closely with law enforcement partners to consider all potential avenues for enforcement against this threat.
• Sen. Ossoff asked Deputy Assistant Attorney General Rao to address how the DoJ’s Consumer Protection Branch could work with local law enforcement agencies to ensure that there is no fentanyl in the e-cigarettes and vaping products being marketed toward children.
  • Deputy Assistant Attorney General Rao remarked that the DoJ’s Consumer Protection Branch and other federal law enforcement partners would appreciate the opportunity to engage with local law enforcement agencies on addressing dangerous e-cigarette and vaping products.
• Sen. Ossoff interjected to ask Deputy Assistant Attorney General Rao to indicate whether the DoJ’s Consumer Protection Branch is currently engaging with local law enforcement agencies to ensure that there is no fentanyl in the e-cigarettes and vaping products being marketed toward children.
  • Deputy Assistant Attorney General Rao stated that the DoJ’s Consumer Protection Branch’s law enforcement partners are constantly considering cooperating with local law enforcement agencies as a strategy for addressing dangerous e-cigarette and vaping products. 
• Sen. Ossoff interjected to ask Deputy Assistant Attorney General Rao to indicate whether the DoJ’s Consumer Protection Branch is working directly with local law enforcement agencies to identify fentanyl-laced vaping pens. He also asked Deputy Assistant Attorney General Rao to indicate whether his office could help facilitate partnerships between the DoJ’s Consumer Protection Branch and local Georgia law enforcement agencies to address this problem.
  • Deputy Assistant Attorney General Rao indicated that the DoJ’s Consumer Protection Branch would welcome Sen. Ossoff’s assistance in facilitating partnerships between itself and local Georgia law enforcement agencies to address illegal e-cigarette and vaping product sales. He remarked that the DoJ’s Consumer Protection Branch’s federal law enforcement partners “constantly” work with local law enforcement in all of their matters and would welcome engagement with Georgia law enforcement agencies to address this problem.

Sen. Marsha Blackburn (R-TN):

• Sen. Blackburn stated that Director King had evaded Sen. Booker’s question regarding the lack of verification surrounding Chinese-produced e-cigarettes that are entering the U.S. market. She asked Director King to explain the FDA’s pre-market paradigm and third-party verification process for ensuring that tainted and illegal e-cigarette products are not entering the U.S. market. She also asked Director King to indicate whether e-cigarette manufacturers are currently receiving safe harbor protection after submitting their products to the FDA for review. She requested that Director King provide his responses to these questions in writing for the hearing’s record. She then discussed how social media platforms (such as TikTok and Instagram) are being used to market illegal fruit and dessert-flavored e-cigarettes to children. She stated that the new multi-agency task force should consider the use of social media in promoting illegal e-cigarette products to children. She asked Director King to indicate whether the FDA is considering the role that social media plays in promoting illegal e-cigarette products to children.
  • Director King noted that the FDA has authority over the manufacturing, marketing, and sale of e-cigarette products and does not have the authority to take action against individuals. He stated however that the FDA can take action in instances where a social media influencer is connected to an e-cigarette manufacturer. He mentioned how the FDA has previously issued warning letters on this topic. He also highlighted how the FTC will be involved in the multi-agency task force and stated that the FTC has “key authorities” to address harmful advertising practices. He commented that the FTC’s authorities will be useful as part of a coordinated approach to address illegal e-cigarette sales and marketing.
• Sen. Blackburn asked Director King to indicate whether the FDA is referring entities to the DoJ and the FTC for enforcement actions following its issuance of warning letters.
  • Director King testified that the FDA has regularly engaged with the DoJ and the FTC, even prior to the recent establishment of their multi-agency task force. He stated that the FDA will make referrals to the DoJ and the FTC for enforcement actions depending on the merits of the case.
• Sen. Blackburn interjected to ask Director King to indicate the number of social media influencers promoting illegal e-cigarette products that the FDA has referred to the DoJ and the FTC for enforcement actions. She also asked Director King to indicate the number of social media influencers have been penalized for their promotion of illegal e-cigarette products.
  • Director King stated that the FTC would be better suited to answer Sen. Blackburn’s question.
• Sen. Blackburn interjected to criticize Director King for not providing direct responses to her questions. She stated that FDA warning letters are meaningless if the DoJ and the FTC are not going to follow up with enforcement actions based on these warning letters.
  • Director King indicated that most FDA warning letter recipients take corrective actions in response to the letters. He also stated that the FDA has taken escalated actions regarding non-responsive warning letter recipients. He mentioned how the U.S. has issued injunctions against e-cigarette manufacturers, civil money penalties against e-cigarette manufacturers, and civil money penalties against e-cigarette retailers. He acknowledged the need for the U.S. to take additional actions to address illegal e-cigarette sales and expressed hope that the new multi-agency task force will be impactful.
• Sen. Blackburn asked Deputy Assistant Attorney General Rao to indicate whether the DoJ’s Consumer Protection Branch is planning to use civil and criminal penalties to address illegal e-cigarette sales.
  • Deputy Assistant Attorney General Rao remarked that the DoJ’s Consumer Protection Branch is exploring all tools to address illegal e-cigarette sales, including civil and criminal penalties.
• Sen. Blackburn interjected to assert that the Executive Branch has been slow to respond to illegal e-cigarette sales. She criticized the witnesses for only discussing their future aspirations and stated that the Executive Branch has failed to establish a plan for addressing illegal e-cigarette sales.

Sen. Mike Lee (R-UT):

• Sen. Lee remarked that the U.S. must address the problem of teenagers using vaping products and criticized entities for seeking to addict teenagers to nicotine. He mentioned how studies have shown that e-cigarette use can serve as a gateway to marijuana and other drug use (especially among younger users). He discussed how the U.S. government has issued numerous regulations for tobacco products and has failed to make determinations on applications for legal tobacco products from U.S. companies. He stated however that the U.S. government has concurrently failed to take enforcement actions against illegal Chinese e-cigarette imports. He commented that small businesses receive limited or no guidance as to which e-cigarette products are legal. He asserted that the current regulatory and enforcement environment for e-cigarettes has resulted in more vaping activity among teenagers. He noted how the FDA has publicly committed to clearing the backlog of pending vaping product applications by June 30, 2024. He highlighted however that many of these vaping product applications have been pending for several years. He questioned the FDA’s ability to meet their June 30th deadline and why the FDA has taken so long to review vaping product applications. He remarked that if the U.S. is to establish a complex regulatory regime for vaping products, then the U.S. should ensure that this regulatory regime works. He expressed frustration that the U.S.’s current regulatory regime for vaping products creates unnecessary challenges for U.S. manufacturers while failing to address illegal Chinese vaping products. He reiterated his concerns regarding the FDA’s current backlog of vaping product applications. He then mentioned how there had occurred a 1,000 percent increase in the use of disposable e-cigarettes by high school students between 2019 and 2020 (which he described as a “very significant jump”). He noted how most of these e-cigarettes are illegal, flavored, Chinese-produced, and aimed at children. He stated that China’s sales of e-cigarettes into the U.S. market generate an estimated $3.5 billion annually. He lamented however that the DoJ’s Consumer Protection Branch has taken “little-to-no” civil enforcement actions against illegal Chinese e-cigarette importers. He asked Deputy Assistant Attorney General Rao to explain why the DoJ’s Consumer Protection Branch has not taken significant actions against illegal Chinese e-cigarette importers.
  • Deputy Assistant Attorney General Rao remarked that the DoJ is very concerned about the widespread prevalence of illegal Chinese e-cigarette imports. He testified that the DoJ’s Consumer Protection Branch has been working with its law enforcement partners (including the U.S. Marshals Service) on seizing illegal e-cigarettes.
• Sen. Lee interjected to ask Deputy Assistant Attorney General Rao to indicate how many enforcement actions the DoJ’s Consumer Protection Branch has brought against illegal Chinese e-cigarette importers.
  • Deputy Assistant Attorney General Rao testified that the DoJ’s Consumer Protection Branch had brought multiple enforcement actions against e-cigarette manufacturers. He stated that the DoJ is considering whether to pursue criminal charges against certain e-cigarette manufacturers and whether to exercise its authorities under the PACT Act.
• Sen. Lee noted how the U.S. government possesses both civil and criminal authorities to address the illegal sale of e-cigarettes. He asked Deputy Assistant Attorney General Rao to address why ATF is not bringing more criminal enforcement actions against large Chinese illegal e-cigarette importers.
  • Deputy Assistant Attorney General Rao testified that the DoJ’s Consumer Protection Branch is working closely with the ATF on the use of the PACT Act. He expressed the DoJ’s Consumer Protection Branch’s commitment to working with the ATF to make “additional headway” in addressing Chinese illegal e-cigarette importers.
• Sen. Lee reiterated his concerns over how the U.S. has subjected U.S. tobacco companies to a lengthy licensing process while illegal Chinese e-cigarette products are being allowed to flood the U.S. market. He asked Deputy Assistant Attorney General Rao to indicate whether this situation is problematic.
  • Deputy Assistant Attorney General Rao described the e-cigarette marketplace as an “extremely complex” and “rapidly evolving” area. He expressed the DoJ’s Consumer Protection Branch’s eagerness to work with law enforcement partners to address illegal e-cigarette sales.
• Sen. Lee expressed hope that the U.S. can bring enforcement actions against illegal e-cigarette manufacturers and that the FDA can clear its backlog of pending vaping product applications.

Sen. Richard Blumenthal (D-CT):

• Sen. Blumenthal recounted how he had helped lead the successful lawsuit during the 1990s from state attorneys general against the large tobacco companies. He expressed hope that the hearing would help support efforts to reduce the use of vaping products (particularly flavored e-cigarette products) and bolster federal enforcement actions against illegal e-cigarette product manufacturers. He lamented that the U.S.’s enforcement actions against these manufacturers has been “lagging and lacking.” He mentioned how the FDA had recently rescinded its marketing denial order issued to Juul Labs and indicated that this rescission will cause Juul Labs’s products to remain on the market while the FDA continues its review of these products. He expressed concerns that the FDA’s rescission will cause a surge in illegal e-cigarettes being sold to and used by vulnerable populations, which will fuel the youth vaping epidemic. He asserted that leaving Juul Labs’s products on the market when the products have not met statutory health standards is “unacceptable and dangerous.” He mentioned how he had released a February 2024 report as Chairman of the U.S. Senate Committee on Homeland Security and Governmental Affairs’s Permanent Subcommittee on Investigations finding that the regulatory efforts of the FDA (including extensions of compliance deadlines and the prioritization of the enforcement of certain e-cigarette products) have failed to curtail unauthorized e-cigarette products and to prevent youth e-cigarette usage. He asked Director King to address the evidence that the FDA possesses to allow for e-cigarette products to remain available on the market. He also asked Director King to indicate whether the FDA’s recent rescission of its marketing denial order issued to Juul Labs would increase the use of Juul Labs’s products. He also asked Director King to explain how the FDA could permit Juul Labs’s products to remain on the market when the FDA has not yet completed its review of the products.
  • Director King expressed his commitment to following the science when reviewing Juul Labs’s application with the FDA. He stated that the FDA is conducting a full substantive review of Juul Labs’s entire application. He noted that a product that lacks full FDA authorization is not on the market legally and that any product lacking such authorization is at risk of enforcement. He indicated that while he could not comment on the specific details of any individual product, he stated that the FDA has an important paradigm in place and that the FDA must prioritize its resources accordingly. He testified that the FDA is monitoring the use of e-cigarette products (including products that appeal to children).
• Sen. Blumenthal asked Director King to discuss the actions that the FDA is taking to mitigate the harms caused by Juul Labs as the FDA completes its review of Juul Labs’s products.
  • Director King remarked that the FDA is engaging in a robust scientific review of the evidence underlying Juul Labs’s products, which includes a review of the toxicologic and other potential risks of these products. He also mentioned how the FDA is working on enforcement actions related to these products.
• Sen. Blumenthal interjected to ask Director King to indicate when the FDA’s review of Juul Labs’s products will be completed.
  • Director King indicated that while he could not comment on the specific details of a pending application, he stated that the FDA is working “as tirelessly as possible” to complete its review of Juul Labs’s products.
• Sen. Blumenthal expressed frustration with the FDA’s continued failure to provide sufficient and timely enforcement against illegal e-cigarette products. He then asked Deputy Assistant Attorney General Rao to discuss how the DoJ’s Consumer Protection Branch plans to approach its enforcement activities regarding illegal e-cigarettes.
  • Deputy Assistant Attorney General Rao testified that the DoJ’s Consumer Protection Branch plans to work with its federal law enforcement partners identify potential e-cigarette enforcement gaps and areas where additional support may be useful. He also indicated that the DoJ’s Consumer Protection Branch is working to identify ways that other agencies (including state attorneys general and state law enforcement agencies) could support efforts to address illegal e-cigarette sales. He commented that this effort will require an “all of government” approach and expressed the DoJ’s interest in engaging with state and local law enforcement partners on this effort.
• Sen. Blumenthal indicated that his question period time had expired. He remarked that Congress should provide additional impetus and momentum for the U.S.’s efforts to address illegal e-cigarette sales.

Full Committee Chairman Richard Durbin (D-IL):

• Chairman Durbin noted how Deputy Assistant Attorney General Rao had stated that the DoJ’s Consumer Protection Branch’s highest priority is enforcement against illegal vaping products and that this enforcement is an urgent issue. He also noted how Deputy Assistant Attorney General Rao had called for the U.S. to adopt a “very aggressive approach” and to use all available tools to address this issue. He indicated that he would provide the address of the store selling illegal e-cigarette products located within one mile of the FDA’s headquarters to Deputy Assistant Attorney General Rao. He called on the DoJ to pursue the sale of these illegal e-cigarette products at this store to demonstrate its seriousness about addressing illegal e-cigarette sales.
  • Deputy Assistant Attorney General Rao expressed the DoJ’s commitment to addressing illegal e-cigarette sales and to pursuing enforcement actions without “fear or favor” based on facts and the law.
• Chairman Durbin indicated that his staff would provide Deputy Assistant Attorney General Rao with the specific address of the store that he had highlighted. He expressed the Committee’s intention to follow-up to see whether the store continues to sell illegal e-cigarette products within two weeks.

Sen. Thom Tillis (R-NC):

• Sen. Tillis stated that the sale of illegal e-cigarette products is not confined to the store that Full Committee Chairman Richard Durbin (D-IL) had mentioned. He commented that the sale of these illegal products is widespread throughout the U.S. He then highlighted how the e-cigarette manufacturer EBDesign Disposable Vape is headquartered in California and manufactures its products in China. He asked Director King to address why the U.S. is not engaging in enforcement actions against EBDesign Disposable Vape and other similar U.S.-based companies if the companies are contracting to make illegal e-cigarette products for sale within the U.S.
  • Director King testified that the FDA has engaged in enforcement actions against EBDesign Disposable Vape and indicated that EBDesign Disposable Vape is a progeny from the Elf Bar product. He stated that the FDA has engaged in a series of blitzes on a monthly basis against this company. He indicated that these blitzes have involved warning letters to retailers and civil money penalties. He remarked that Elf Bar and its progeny products are the most used e-cigarette products among children and testified that the FDA is prioritizing its resources to address these products. He also noted that while the top two e-cigarette products being used by children come from Chinese manufacturers, he indicated that the third and fourth most used e-cigarette products being used by children come from domestic manufacturers. He called it important for science to inform the FDA’s enforcement approach regarding illegal e-cigarette products and stated that the FDA plans to maintain a nimble enforcement approach.
• Sen. Tillis interjected to ask Director King to elaborate on the market shares of the four e-cigarette product manufacturers that he had referenced.
  • Director King indicated that the two U.S.-based e-cigarette manufacturers that he had referenced have greater market share while the two Chinese-based e-cigarette manufacturers that he had referenced have greater prominence amongst youth.

Full Committee Chairman Richard Durbin (D-IL):

• Chairman Durbin asked Director King to confirm that the FDA has historically levied fines against illegal e-cigarette retailers and has not historically levied fines against illegal e-cigarette manufacturers.
  • Director King testified that the FDA has initiated its first civil money penalties against illegal e-cigarette manufacturers within the previous year. He expressed hope that the FDA would continue levying these penalties in the future.
• Chairman Durbin remarked that the U.S. should issue fines against both illegal e-cigarette retailers and illegal e-cigarette manufacturers.
  • Director King expressed agreement with Chairman Durbin’s remark and commented that a comprehensive approach is key to addressing illegal e-cigarette sales.
• Chairman Durbin indicated that the Committee would follow up with Director King and Deputy Assistant Attorney General Rao to ensure that the FDA and the DoJ’s Consumer Protection Branch are using all available tools to address illegal e-cigarette sales.

Panel II Opening Statements:

Note: Full Committee Chairman Richard Durbin (D-IL) mentioned how the Committee had invited e-cigarette manufacturers Altria, R. J. Reynolds Tobacco Company, Japan Tobacco International, and Shenzhen Miracle Technology to send representatives to testify at the hearing. He indicated however that none of these companies had agreed to send representatives to testify at the hearing.

Ms. Yolonda Richardson (Campaign for Tobacco-Free Kids):

• She stated that her organization, the Campaign for Tobacco-Free Kids, is the leading advocacy organization working to reduce tobacco use.
• She highlighted the Campaign for Tobacco-Free Kids’s support for the Family Smoking Prevention and Tobacco Control Act and indicated that this law had provided the FDA with the authority to regulate tobacco products.
  • She commented that one of the most important tools that Congress gave the FDA as part of this law was the authority to conduct pre-market reviews of new tobacco products before the products can be legally sold.
• She mentioned how the Family Smoking Prevention and Tobacco Control Act prevents tobacco manufacturers from using economic considerations to decide which new tobacco products will enter the market.
  • She indicated that the law instead empowers the FDA to decide when new tobacco products will enter the market based on the need to protect public health after a “careful review” of the scientific evidence.
• She lamented however that the FDA has not effectively applied pre-market review to e-cigarette products and stated that the FDA had failed to assert its authority over e-cigarettes until a substantial e-cigarette market had already formed.
  • She noted how e-cigarettes have now become the most popular tobacco product among American youth.
• She also indicated that the FDA had further delayed implementation of pre-market review requirements for e-cigarette products, which has caused these products to remain on the market for years.
  • She noted how the FDA had initiated its premarket review process for e-cigarette products in 2020 only after the Campaign for Tobacco-Free Kids and other public health groups had successfully challenged the delay.
• She stated that the Campaign for Tobacco-Free Kids is “encouraged” that the FDA has appropriately applied the public health standard to its reviews of e-cigarettes as intended by the Family Smoking Prevention and Tobacco Control Act.
  • She expressed her organization’s agreement with the FDA’s determination that flavored tobacco products should not be permitted because these products increase the appeal and use of e-cigarettes by youth.
• She lamented however that the FDA’s implementation of pre-market review requirements for e-cigarette products has been slow and noted how several e-cigarette companies have flooded the FDA with pre-market applications for millions of products.
  • She commented that this sheer volume of applications has further delayed the pre-market review process.
• She discussed how thousands of e-cigarette products remain under FDA review and asserted that the FDA appears to maintain an unstated policy of not taking enforcement actions against e-cigarette products with pending applications (including flavored e-cigarettes).
• She remarked that the large number of unauthorized e-cigarettes on the market continues to present risks to public health.
  • She warned that these unauthorized e-cigarettes are highly addictive, can expose users to harmful substances, and have consistently been shown to appeal to youth.
  • She noted how the FDA has rejected applications for millions of flavored e-cigarettes for the aforementioned reasons.
• She stated that while the FDA has taken some important enforcement actions against e-cigarettes over the previous year, she asserted that more and stronger enforcement action against e-cigarettes is needed.
• She mentioned how the Campaign for Tobacco-Free Kids and 77 other organizations had recently sent a letter to the FDA, the DoJ, and CBP urging the adoption of several changes.
  • She first called on the FDA to seek greater monetary penalties and asserted that the FDA’s current monetary penalties remain too low to serve as a deterrent.
  • She secondly called on the DoJ to prioritize tobacco product enforcement and act more quickly and aggressively when violations are found.
  • She thirdly called on CBP and the FDA to prioritize efforts to stop the illegal importation of authorized e-cigarette products.
  • She fourthly called on the U.S. to bring enforcement actions against all parties within the e-cigarette supply chain, including manufacturers, wholesalers, distributors, and retailers.
  • She fifthly called on the FDA to end the broad exercise of enforcement discretion for e-cigarette products with a pending application.
  • She lastly called on the FDA to complete its review of e-cigarette products and asserted that the FDA must review these products in the pre-market stage (rather than in the post-market stage).
• She applauded the recent announcement regarding the creation of the multi-agency task force to address illegal e-cigarette sales.
• She stated however that this multi-agency task force must be immediately followed with “concrete and comprehensive” enforcement actions.
  • She also asserted that federal agencies should coordinate closely with states and localities on enforcement activities where appropriate.
• She remarked that pre-market review has “great potential” to reduce youth e-cigarette use and warned that a lack of enforcement would cause companies to continue to flout FDA requirements (which would imperil the youth).

Mr. David Spross (National Association of Tobacco Outlets):

• He discussed how his trade association, NATO, represents more than 66,000 retail stores throughout the U.S.
• He expressed support for a well-functioning regulatory system where FDA oversight leads to accelerated reductions in underage tobacco product use and tobacco-related harms.
  • He commented that illicit markets threaten this goal and the “responsible retail community” that seeks to operate within the legal system.
• He remarked that NATO’s members take compliance seriously and noted how NATO’s members include licensed retailers that verify the age of their customers to prevent sales to minors.
  • He also testified that NATO has regularly informed its members of the FDA’s targeted e-cigarette brands to ensure that its members know which products the FDA is taking action against.
• He stated that illicit and unregulated e-cigarette products have overrun the e-cigarette marketplace and indicated that most of these products are Chinese-manufactured flavored products.
  • He expressed frustration that the FDA has engaged in “piecemeal” enforcement of illegal e-cigarette products and commented that this enforcement often ignores the most egregious actors within the space.
• He described the recently announced multi-agency task force to address illegal e-cigarette sales as a “good start” and asserted that the task force must use its full range of enforcement tools to be successful.
  • He commented that the task force should specifically focus on the largest illicit e-cigarette manufacturers and distributors.
• He contended that more aggressive enforcement action against illegal e-cigarette sales could enable the restoration of order to the e-cigarette marketplace.
• He also remarked that an effective regulatory system for e-cigarettes requires a more coherent compliance framework that clearly communicates the FDA’s enforcement priorities.
  • He elaborated that the FDA should indicate the e-cigarette products that it wants immediately removed and the e-cigarette products that can remain on the market.
• He noted that while the FDA has indicated that only 23 authorized vaping products are legal, he stated that the FDA is currently not prioritizing enforcement against vaping products that have fully complied with its 2016 deeming rule and that have filed PMTA applications that remain pending before the Agency.
  • He noted that the FDA has repeatedly acknowledged that the removal of vaping products pending PMTA review would stimulate illicit market activity and take potentially reduced harm products away from smokers.
• He asserted that NATO’s members that are seeking to abide by the law require greater clarity from the FDA.
• He also remarked that the FDA must reform its PMTA process and contended that this process has “fallen short” of its intended purpose.
  • He commented that the failure of the PMTA process has resulted in a “flourishing” illicit e-cigarette market.
• He noted how the FDA has only authorized a limited number of smoke-free products to date, despite the fact that millions of adult consumers are seeking better alternatives to smoking.
  • He commented that smoke-free products are much less harmful than cigarettes for smokers that want to quit smoking cigarettes.
• He stated that the limited number of available FDA-authorized smoke-free products has resulted in consumer demand for these products being met by unregulated Chinese companies.
  • He asserted that having the FDA authorize more smoke-free products will help build a more regulated market.
• He expressed NATO’s support for policy solutions that will reduce underage tobacco use and support tobacco harm reduction.
  • He expressed NATO’s interest in working with the FDA, the multi-agency task force, and the Committee to address these issues.

Mr. Tony Abboud (Vapor Technology Association):

• He first discussed how his trade association, VTA, seeks to protect and promote the U.S. vaping industry.
  • He indicated that the trade association has members from all levels of the vaping distribution chain, including manufacturers, distributors, suppliers, and small retailers.
• He then noted how youth vaping in the U.S. has “dramatically resolved” from its 2019 peak and indicated that youth vaping has since declined by 61 percent.
  • He largely attributed this decline in youth vaping to the adoption of federal legislation raising the legal age to purchase tobacco products to 21 and mentioned how his trade association had supported this policy change.
• He highlighted how the CDC’s NYTS has found that the youth vaping rate is now at its lowest level in more than a decade.
  • He indicated that only 4.4 percent of youth use e-cigarettes regularly and that an even small percentage of youth use e-cigarettes daily.
• He noted that youth have consistently reported in the NYTS that flavored offerings are not the reason that they first try e-cigarettes or the reason that they currently use e-cigarettes.
  • He also highlighted how the “dramatic” rise in flavored disposable vaping products in the U.S. since 2019 has corresponded with a “dramatic” decline in youth vaping rates.
• He stated that VTA continues to advocate for federal marketing and access restrictions to further protect youth from e-cigarettes.
• He recounted how Dr. Nancy Rigotti of Harvard Medical School had recently advocated in the New England Journal of Medicine that the medical community use e-cigarettes as a means of supporting smoking cessation efforts.
  • He also mentioned how the Medical University of South Carolina had published the largest clinical trial in the U.S. in the fall of 2023 finding that e-cigarettes help people quit smoking better than the FDA-approved medicines on the market, even if the individuals had no intention of quitting smoking.
  • He further mentioned how Abigail Friedman of the Yale School of Public Health had found that flavored e-cigarette restrictions result in a direct increase in cigarette sales in the jurisdictions with the restrictions.
• He criticized the FDA’s current regulation of tobacco and stated that the FDA was supposed to implement the Family Smoking Prevention and Tobacco Control Act to provide Americans with access to less harmful cigarettes.
  • He asserted that the FDA has instead misused its power to impose a de facto ban on flavored vaping products without reviewing the science.
• He noted how the FDA has authorized 16,000 combustible tobacco products and only a “handful” of vaping products since the enactment of the Family Smoking Prevention and Tobacco Control Act.
  • He highlighted how the FDA has not authorized a single vaping product or nicotine pouch product within the previous two years.
  • He commented however that the FDA has “rushed” 2,000 new combustible tobacco products (including 821 new cigarette products) to the market within the previous two years.
• He asserted that the FDA has failed to fulfill its regulatory responsibilities and expressed frustration that the FDA is requesting additional funding to pursue actions that federal courts have declared to be illegal.
• He noted how the FDA has repeatedly stated that every single vaping product on the market is illegal, regardless of whether the product’s manufacturer has a pending application.
  • He argued that the FDA is effectively enforcing prohibition against e-cigarette products and called the FDA’s efforts futile.
• He remarked that the FDA should instead focus on prioritizing harm reduction in its regulation of e-cigarettes and authorize more e-cigarette products (which he described as less harmful than traditional cigarettes).
• He contended that expanding the availability of flavored e-cigarette products is the only way to curb the illicit demand for e-cigarettes and will support Americans to quit smoking.

Dr. Susan Walley, MD, MHCM, NCNTT, FAAP (American Academy of Pediatrics):

• She remarked that e-cigarettes are addictive and dangerous for children and contended that the U.S. is not doing enough to protect the youth from the tobacco industry.
  • She accused the tobacco industry of seeking to profit from youth e-cigarette use.
• She noted how over 2 million children and adolescents currently use e-cigarettes and commented that the U.S.’s “tobacco epidemic” is not over.
  • She acknowledged that while youth tobacco use has fallen from its peak, she asserted that youth tobacco use remains at a “shockingly and unacceptably high number.”
  • She further noted how over a quarter of youth e-cigarette users use e-cigarette products every day.
• She stated that one of the main reasons that children are attracted to e-cigarettes is the sweet fruit, candy, and mint flavored products being marketed and indicated that these flavors can mask the harshness of tobacco.
  • She added that flavored e-cigarette products are often marketed with packaging that resembles candy and snack food.
• She discussed how she has observed first-hand as a practicing pediatrician how teenage e-cigarette users develop nicotine addictions and noted how the adolescent brain is more susceptible to nicotine addiction.
  • She commented that this susceptibility to nicotine addiction can cause symptoms of dependence to appear within days or weeks of first experimentation with e-cigarette use.
• She highlighted how teenagers with nicotine addiction that do not fulfill their nicotine cravings can experience unpleasant withdrawal symptoms (such as irritability and anxiety), which can lead to continued e-cigarette use.
  • She commented that many young people are not using e-cigarettes sporadically and are instead engaged in consistent, frequent, and dependent e-cigarette use.
• She lamented that trusted adults (such as parents, teachers, and pediatricians) have limited options to assist children in quitting e-cigarette products.
• She discussed how pediatricians have experienced significant challenges in terms of helping children to quit e-cigarette products due to the high level of nicotine contained in the products, targeted marketing of the products, and easy access to the products.
  • She commented that pediatricians have limited access to effective tools for addressing youth nicotine addiction because youth tobacco cessation treatment (particularly for e-cigarettes) has had limited research funding.
• She remarked that the best strategy for avoiding youth nicotine addiction is preventing the use of any tobacco products in the first place.
  • She asserted that the most effective way to stop youth e-cigarette use is to remove all flavored tobacco products from the market.
• She discussed how the FDA has already reviewed millions of e-cigarette products applications and stated that the FDA has “appropriately” rejected most of these applications.
  • She highlighted how the FDA has determined that no e-cigarette products that are flavored are appropriate for the protection of public health.
• She noted how the FDA has authorized only 23 e-cigarette products and indicated that these 23 products are sold under three brands.
  • She added that none of these products are available in flavors beyond tobacco.
• She stated however that thousands of flavored e-cigarettes remain accessible to children.
  • She displayed an illegal flavored e-cigarette product that she had purchased at a store that is walking distance from a school.
• She noted how 90 percent of youth e-cigarette users report using a flavored e-cigarette product, even though the FDA has not authorized any flavored products.
• She remarked that e-cigarette manufacturers, distributors, and retailers should stop producing, distributing, and selling unauthorized e-cigarette products.
  • She commented that the tobacco industry and its partners are unlikely to take these actions on their own.
• She called on the federal government to address the sale of illegal cigarettes and applauded the FDA’s recent creation of a multi-agency task force to address the issue.
  • She also stated that Congress can support these Executive Branch enforcement efforts through ensuring that these efforts receive sufficient funding.
• She remarked that the U.S. can solve the problem of youth e-cigarette use so long as it makes a deliberate effort to do so.

Ms. Josie Shapiro (High School Student):

• She indicated that she is a high school senior and testified that she is addicted to nicotine as a result of e-cigarette use.
• She mentioned how her friends had begun to use vaping products during the 7th grade and noted how her friends had viewed vaping products as harmless.
  • She commented that the flavors and coloring packaging of vaping products had caused this false perception that vaping products are harmless.
  • She also commented that her peers had used vaping products to emulate certain social media influencers.
• She recounted how her friends would leave class early to engage in vaping and commented that the ease of concealing vaping products makes it easy for teenagers to hide their vaping activities from parents and teachers.
  • She mentioned how she had begun using vaping products during the 9th grade as part of her socialization with peers.
• She stated that while she had initially believed that she was simply enjoying the flavors of vaping products, she indicated that she soon began to crave the nicotine that vaping products provide.
• She discussed the ease of obtaining vaping products as a teenager and noted how teenagers can obtain vaping products through asking an older person to purchase the products, purchasing vaping products from friends, or purchasing the products from stores that do not check customer identifications (IDs).
  • She testified that she soon purchased her own vaping product and would leave class early to engage in vaping and stated that her entire social experience had been centered around vaping.
• She remarked that her nicotine addiction made her feel out of control, helpless, and alone.
  • She testified that vaping had impacted her mood, her breathing ability, and her skin.
• She discussed how vaping and nicotine addiction ruins relationships between friends and families and recounted how vaping addiction had caused one of her friends to grow isolated.
  • She testified that she eventually moved from vaping to cigarette smoking and indicated that she later experimented with other drugs.
• She remarked that she continues to struggle with nicotine addiction and attributed this addiction to her initial use of a flavored vaping product.
• She testified that she had tried multiple times to quit vaping and commented that quitting vaping is very difficult.
  • She elaborated that various routine activities (such as socializing with friends, driving her car, going into bathrooms, and going into convenience stores) can trigger her to engage in vaping.
  • She indicated that she has not been able to stop vaping for more than two months at a time.
• She stated that her nicotine addiction impacts her physical and mental health and asserted that the vaping industry has harmed her for profit.
• She expressed hope that her sharing of her story would prevent young people from ever beginning to use vaping or tobacco products.
  • She noted how there are over 2 million children in the U.S. that use vaping products and warned that federal inaction would cause more children to suffer the same problems as she has suffered.
• She called on the U.S. to ban all flavored e-cigarettes and warned that the U.S.’s failure to ban these products will lead children to continue becoming addicted to e-cigarettes.

Congressional Question Period:

Full Committee Chairman Richard Durbin (D-IL):

• Chairman Durbin first thanked Ms. Shapiro for sharing her vaping addiction experience and provided Ms. Shapiro with encouragement regarding her efforts to overcome her vaping addiction. He then asked Dr. Walley to respond to the argument that vaping could be an effective tool for combating tobacco use.
  • Dr. Walley remarked that she understands the impact of long-term tobacco use based on her training as a nicotine and tobacco specialist and as a former medical director of a tobacco consultation service. She indicated that she would welcome additional FDA-proven safe and effective smoking cessation therapies. She noted how the FDA has already approved safe and effective smoking cessation therapies. She called it “crucial” that the medical community and society provide access to these safe and effective FDA-approved smoking cessation therapies.
• Chairman Durbin then asked Mr. Abboud to respond to Ms. Shapiro’s experience with vaping and nicotine addiction.
  • Mr. Abboud stated that he views Ms. Shapiro’s experience with vaping and nicotine addiction from the perspective of being a parent of three children (who are teenagers and young adults). He stated that concerns regarding teenage vaping are not new for his family or other families.
• Chairman Durbin interjected to ask Mr. Abboud to indicate whether his children engage in vaping.
  • Mr. Abboud indicated that some of his children do engage in vaping. He stated that his family has discussed this issue.
• Chairman Durbin asked Mr. Abboud to indicate whether he has encouraged his teenagers to quit vaping.
  • Mr. Abboud answered affirmatively.
• Chairman Durbin interjected to emphasize that Mr. Abboud does not want his own children to engage in vaping. He asked Mr. Abboud to address why children should be allowed to continue vaping.
  • Mr. Abboud remarked that he does not want any children to engage in vaping. He highlighted how the U.S. had raised the age to purchase tobacco products to 21 to prevent this activity and mentioned how VTA had advocated for this policy. He also expressed support for regulations that would prevent children from accessing vaping products.
• Chairman Durbin interjected to ask Mr. Spross to address how NATO’s retailers view vaping products. He asked Mr. Spross to indicate whether NATO’s retailers believe that they have no moral obligation to children purchasing vaping products.
  • Mr. Spross testified that NATO takes a zero-tolerance policy in terms of ensuring that its retailer members are trained to prevent e-cigarette sales to youth.
• Chairman Durbin interjected to ask Mr. Spross to indicate whether NATO’s retailers sell flavored vaping products.
  • Mr. Spross answered affirmatively. He testified that NATO has communicated the 23 vaping products that have received FDA authorization to its retailer members. He also noted that there exist vaping products that have filed PMTAs in a timely manner according to the statutory deadlines and indicated that these products are not currently receiving FDA enforcement.
• Chairman Durbin remarked that a PMTA application submission is not the same as FDA approval. He noted that vaping product manufacturers have the burden of proving that their products are safe and commented that many vaping products currently available for sale have not met this burden of proof. He asked Mr. Spross to indicate whether he understands this distinction.
  • Mr. Spross stated that he understands the distinction between a PMTA application submission and FDA approval. He also remarked that the inability to sell vaping products through licensed and regulated retailers that engage in age verification practices will result in these products being sold in the illicit market. He noted how there are currently 250,000 applications before the FDA and mentioned how some of these applications have been awaiting FDA decisions for over four years.
• Chairman Durbin asked Mr. Spross to indicate whether he understands that these vaping product applications must remain under FDA review under federal law until the vaping product manufacturer proves the safety of their proposed products.
  • Mr. Spross answered affirmatively.
• Chairman Durbin stated that retailers cannot continue to sell vaping products while the manufacturers of the products are working to prove that the products are safe. He asked Mr. Spross to indicate whether he understands this dynamic.
  • Mr. Spross indicated that he understands this dynamic.
• Chairman Durbin asked Mr. Abboud to indicate whether it is reasonable to demand that vaping manufacturers prove that their products are safe for public health before the products can be sold within the U.S.
  • Mr. Abboud stated that the FDA had created regulations for vaping products, set deadlines for complying with these regulations, requested and received money from Congress to enforce these regulations, and changed the rules and requirements of these regulations after applications had already been submitted. He added that these changes were made in a manner that did not involve any public policy oversight. He stated that the net result of the FDA’s actions was the mass removal of products from the marketplace, which spawned an illicit marketplace.
• Chairman Durbin interjected to note that the Family Smoking Prevention and Tobacco Control Act requires the vaping product manufacturer to prove that their products are safe for public health. He asked Mr. Abboud to indicate whether he understands this responsibility.
  • Mr. Abboud answered affirmatively. He remarked that vaping product manufacturers require guidance from the FDA as to how to prove that their products are safe for public health. He noted that the Reagan-Udall Foundation had stated that the FDA had not provided this guidance for what is required to prove that products are appropriate for the protection of public health or how they are interpreting the Family Smoking Prevention and Tobacco Control Act. He criticized the FDA for not implementing the Reagan-Udall Foundation’s findings. He reiterated that the FDA is not providing guidance to vaping product manufacturers regarding how to comply with the Family Smoking Prevention and Tobacco Control Act and added that the FDA is not telling retailers which vaping products are under Agency review.
• Chairman Durbin interjected to emphasize that 23 vaping product manufacturers have received FDA authorization for their vaping products. He commented that these authorizations indicate that manufacturers know how to comply with the FDA’s requirements.
  • Mr. Abboud remarked that Chairman Durbin’s description of these FDA authorizations of vaping products constitutes an overstatement. He noted how these 23 vaping product authorizations apply to just eight vaping products and indicated that only five of these eight vaping products are currently available on the market. He asserted that there currently do not exist a sufficient number of vaping product options available for U.S. smokers.
• Chairman Durbin concluded that the U.S. must understand the dangers associated with vaping products if it seeks to discourage children from vaping activities.

Sen. Thom Tillis (R-NC):

• Sen. Tillis expressed opposition to policies that would remove safer alternatives to smoking. He stated that many currently available nicotine products (such as nicotine lozenges and nicotine pouches) help people to quit using tobacco and mentioned how he had personally used these products to quit tobacco. He emphasized that these alternative nicotine products are meant for adult use and stated that the Committee is working to ensure that children cannot access these products. He then emphasized that retailers are currently selling illegal vaping products. He asked Mr. Spross to submit communications that NATO makes to its member retailers discouraging the sale of illegal vaping products for the hearing’s record.
  • Mr. Spross testified that NATO communicates to its members any time there occurs an enforcement action against products that the FDA deems illegal.
• Sen. Tillis then remarked that the vaping industry’s future depends on the U.S.’s ability to stop teenage vaping activity. He commented that the vaping industry likely does not want their revenues to come from children. He asked Mr. Abboud to indicate whether there the U.S. has a youth vaping problem that requires fixing. 
  • Mr. Abboud remarked that the U.S. has a youth vaping problem.
• Sen. Tillis asked Mr. Abboud to identify his ideal policy solutions for addressing youth vaping.
  • Mr. Abboud first called on the U.S. to adopt strong marketing and access restrictions for vaping products. He criticized Congress for its narrow focus on banning flavored vaping products and commented that there are other marketing issues that Congress should address. He stated that the U.S. could successfully address youth vaping without removing all flavored vaping products from the market. He then criticized the FDA’s current regulation of vaping products and called the FDA’s PMTA process broken. He criticized the FDA for rejecting all flavored vaping applications en masse and commented that this mass rejection has opened the Agency to litigation risk. He remarked that the FDA should implement a tobacco product standard that would provide clarity around allowable product ingredients and manufacturing standards. He commented that the implementation of such a standard would foster a regulated market for vaping products. He contended that the FDA should prioritize harm reduction in its review of vaping products. He warned that the FDA’s failure to provide clear regulatory standards for vaping products would cause vaping products to be sold in the illicit market and these products to be unlicensed and untaxed.

Sen. Richard Blumenthal (D-CT):

• Sen. Blumenthal asked Mr. Abboud to confirm that he is opposed to having his children engage in vaping because of the associated health risks.
  • Mr. Abboud remarked that he wants his children to be healthy.
• Sen. Blumenthal stated that vaping poses health risks, including nicotine addiction and exposure to unknown substances. He elaborated that the substances within vaping cartridges originating from China are unknown and could be as harmful as the carcinogens in tobacco. He also expressed respect for Mr. Abboud’s criticisms of federal vaping regulations. He mentioned how he had released a February 2024 report as Chairman of the U.S. Senate Committee on Homeland Security and Governmental Affairs’s Permanent Subcommittee on Investigations documenting the regulatory failures that have created the U.S.’s current vaping policy problems. He noted how this report had documented the failures of federal agencies to address vaping addiction, the “shameless” marketing tactics of e-cigarette companies, and the need for enhanced federal enforcement of illegal vaping products. He asked Mr. Abboud to indicate whether he would support providing federal agencies with additional resources and adopting stronger regulations to address the U.S.’s current vaping challenges.
  • Mr. Abboud referred to Sen. Blumenthal’s previous question and commented that he also does not want his children to drink alcohol or to use cannabis. He stated that he does not seek to have popularity inform his policy views.
• Sen. Blumenthal interjected to ask Mr. Abboud to indicate whether he would support providing the FDA and other enforcement agencies with additional resources to better enforce restrictions on vaping product sales.
  • Mr. Abboud contended that a lack of resources in not preventing the enforcement of restrictions on vaping product sales. He remarked that the FDA has not used its existing resources in an efficient and effective manner. He noted how the FDA has allocated a large portion of their resources toward retail inspections. He stated that the FDA’s data indicates that vaping retailers have the best compliance rates in terms of not selling vaping products to underaged individuals.
• Sen. Blumenthal interjected to ask Mr. Abboud to indicate whether vaping product manufacturers and retailers have marketed vaping products to children.
  • Mr. Abboud remarked that there exists “some poor marketing” involving vaping products. He indicated that VTA has advocated for the U.S. to adopt marketing restrictions for these products.
• Sen. Blumenthal interjected to state that vaping product manufacturers and retailers have adopted the same marketing practices as the tobacco industry.
  • Mr. Abboud interjected to assert that providing federal agencies with additional resources for enforcement activities would not sufficiently address youth vaping. He contended that Congress should instead pass new laws to address youth vaping. He stated that enforcing a prohibition on vaping products would cause these products to move to the illicit market and argued that this approach would be ineffective.
• Sen. Blumenthal interjected to comment that Mr. Abboud’s arguments resemble those used by the tobacco industry. He highlighted how many tobacco companies are purchasing vaping manufacturers and stated that the tobacco companies are applying their marketing tactics to these manufacturers. He asserted that vaping companies are using the tobacco industry’s marketing tactics to target children.
  • Mr. Abboud expressed VTA’s interest in working with the Committee to develop marketing restrictions for vaping products and indicated that VTA has long been interested in these policies. He stated however that providing the FDA with more resources would not be effective given how the Agency currently functions.
• Sen. Blumenthal indicated that his question period time had expired. He asserted that resources are key for supporting enforcement activities.

Sen. Thom Tillis (R-NC):

• Sen. Tillis discussed how vaping has become the delivery mechanism of choice for THC consumption. He mentioned how behavioral health experts have reported an increase in psychotic responses to legal drugs. He noted how the Eastern Band of Cherokee Indians tribe is starting to sell THC products in his state of North Carolina and highlighted how this tribe is marketing these products in its native language. He remarked that the Committee should consider how vaping is being used for THC consumption.
  • Dr. Walley noted how there exists significant co-use of tobacco and THC and stated the American Academy of Pediatrics is concerned about this issue.