VTA’s Executive Director Tony Abboud sat down with Regulator Watch to unpack the results of the 2023 National Youth Tobacco Survey and what it means for the FDA. Watch the full video below.
Also Read Unraveling FDA Decisions: A Threat to Public Health or Playing Favorites?
In this latest video, the Vapor Technology Association investigates the FDA Center for Tobacco Products’ decisions impacting millions seeking to quit smoking.
Despite evidence supporting flavored e-cigarettes for cessation, the FDA’s crackdown raises concerns. The video exposes regulatory inconsistencies, emphasizing the need for science-based decisions promoting public health.
Key Points:
Let’s come together and shape a future where science guides regulations for effective harm-reduction tools. Advocate with us for a balanced regulatory environment that safeguards youth and supports adults, particlarly those most in need, in their efforts to quit smoking.
WASHINGTON – November 2, 2023 – The Vapor Technology Association (VTA) today called on the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) to immediately start communicating with adult smokers about the scientifically proven harm reduction and smoking cessation benefits of e-cigarettes and start approving a wide variety of e-cigarettes, including flavored products. Study after study has shown that flavored e-cigarettes are proven to be the most effective products available on the market to help adults reduce their use of combustible tobacco or quit altogether.
The call from VTA comes after newly released 2023 National Youth Tobacco Survey (NYTS) data from the U.S. Centers for Disease Control and Prevention (CDC) revealed that the U.S. youth vaping rate dropped another 4 percentage points from 2022 and now sits at 10% – the lowest level in more than a decade even amid broad availability of flavored vapes in the market.
According to CDC data from 2019 and 2023, the youth vaping rate in the U.S. plunged a massive 61% since it peaked in 2019.
“While last year’s dramatically reduced youth vaping figure justified the CTP’s decision to stop referring to youth vaping as an ‘epidemic,’ this latest 2023 NYTS data validates CTP’s decision,” said Tony Abboud, executive director of the Vapor Technology Association (VTA). “It is now clear that any claim about a persistent youth vaping epidemic in the U.S. can only be considered anti-scientific.”
The youth vaping rate has fallen to a 10-year low despite the continued availability of flavored nicotine vaping products. This fact fundamentally rejects the misinformation refrain spread by regulators and activists that flavors drive youth vaping.
Year after year, the CDC NYTS survey has revealed that flavors are not even one of the top six reasons youth vape, with a mere 6.4% of youth citing flavors as the reason they vape in the CDC NYTS 2022 survey. However, the CDC did not disclose the answer to this question in this year’s survey and instead chose to fill its report with a variety of details related to youth use that have nothing to do with why they vape – a critical part of past surveys.
“Because youth vaping continues to plummet despite the wide availability of flavored products, and because flavored e-cigarettes have been proven to help adult smokers quit, it’s time for the FDA to acknowledge and promote their benefits for adult smokers,” continued Abboud. “This year’s NYTS data is a clear sign that FDA actions, which have been myopically focused on denigrating flavored e-cigarettes to ‘protect youth’ are dangerous and misinformed.”
“In light of these latest findings, VTA renews the call it made at last week’s Food and Drug Law Institute Tobacco & Nicotine Policy conference for CTP to acknowledge the dramatically reduced youth vaping rate – now even lower – and immediately start educating adult smokers about the fact that vaping is dramatically safer than smoking and encourage smokers to use or even try e-cigarettes if they can’t quit if they can’t quit another way,” said Abboud.
VTA also encourages regulators to work with it and finally adopt the series of marketing reforms and youth access restrictions that will further drive down youth vaping while ensuring that a wide variety of flavored vaping products remain available and accessible to adult smokers through adult-only stores.
FDA’s policies are leaving behind American smokers. Smokers are increasingly over-represented in marginalized black, low-income, low-education, and LGBTQ+ communities and continue to die at unacceptable rates. These communities deserve to hear the truth about how to lower their risk and improve their chances of quitting smoking. According to a recent report from the Center for Black Equity, the “broad approval of flavored vaping products will save Black and LGBTQ+ lives, reduce smoking, and drive meaningful progress in lowering preventable cancer rates.”
“Americans need real solutions and information, not bureaucratic posturing around big data,” concluded Abboud. “Every year the FDA remains wedded to its prohibition mentality and keeps the public in the dark about the benefits of flavored e-cigarettes, millions of Americans will continue to smoke, suffer, and die.”
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The Vapor Technology Association is the U.S. industry trade association whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.
Also Read FDA’s Center for Tobacco Products Must Reverse Course to Quickly Reduce Smoking Harms
Federal Agency has Lost its Way on Tobacco Harm Reduction
At the Food and Drug Law Institute’s Tobacco & Nicotine Policy Conference in Washington, D.C. this week, Vapor Technology Association (VTA) Executive Director, Tony Abboud presented his reactions to a keynote speech delivered by Center for Tobacco Product’s (CTP) Director Brian King and particpated on a panel examining CTP’s current trajectory on tobacco and nicotine regulation.
Abboud warned that CTP is implementing a de facto ban on vaping and explained how CTP is actively undermining its mission to end smoking in three critical ways:
Despite the robust body of evidence with high scientific certainty that e-cigarettes are more effective at smoking cessation than CTP’s preferred traditional nicotine replacement therapies, CTP has been reluctant, if not downright refused, to embrace the science about vaping and tobacco harm reduction. As CTP prepares to release their strategic plan, Abboud demanded that the agency make harm reduction the “foundation of its strategic plan” and that it speak “immediately, loudly, and repeatedly,” as follows:
Abboud also shared the statistics regarding CTP authorization of 900 new cigarettes while authorizing only 8 vaping devices. Without a clear and unambiguous debunking of misinformation and an acknowledgment of the true state of the science, and without the rapid authorization of less harmful vaping products, CTP will be fully implementing it already de facto ban on vaping in the U.S. we are headed toward mass-market exit of vaping products. You can watch VTA’s Executive Director’s presentation and download the slides below.
Also Read Unraveling FDA Decisions: A Threat to Public Health or Playing Favorites?
A new Global Vape Alliance representing the future of vaping has been announced, with a Declaration aiming to foster collaboration, promote responsible vaping practices, and champion the cause of harm reduction in the e-cigarette industry.
The Global Vape Alliance brings together major international vaping bodies including the Electronic Cigarette Industry Committee of the China Electronics Chamber of Commerce (ECCC), the US Vapor Technology Association (VTA), the “UK Vaping Industry Association (UKVIA)” and the Independent European Vape Alliance (IEVA).
The historic Declaration underscores the power of unity within the global vaping industry, with a commitment to public health, environmental sustainability, and the wellbeing of smokers seeking alternatives like e-cigarettes to traditional tobacco products.
Key highlights of the Global Vape Alliance Declaration include:
Vapor Technology Association firmly believes that unity and cooperation within the vaping industry can lead to a world without smoking.
Tony Abboud, Executive Director of the Vapor Technology Association, said: “Despite the enormous body of science that has declared vaping nicotine dramatically safer than smoking, the vapor industry’s detractors around the globe push a dramatically misinformed narrative. Declaring a shared commitment to furthering sound science, truthful information about vaping safety, and a commitment to meaningful regulations, industry leaders around the world can better serve companies and, more importantly, millions of consumers using vaping products to reduce and/or quit smoking cigarettes.“
For more information about the Global Vape Alliance Declaration, please visit the Global Vape Alliance Website. https://globalvapealliance.com
Presented by Tony Abboud, Executive Director
Food and Drug Administration – Center for Tobacco Products
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Docket No. FDA–2023–N–2873
Good morning. Thank you for the opportunity to provide input on the Strategic Plan.
I will address three c\ore priorities in CTP’s creation and implementation of a Strategic Plan.
The Agency needs to immediately loudly and repeatedly announce its commitment to the principles of harm reduction and, in so doing, loudly and repeatedly communicate the public health goal of reducing risk through the use of vaping and modern oral nicotine products. If this is not the centerpiece of CTP’s messaging and Strategic Plan and announced as such, then the cacophony of misinformation regarding less harmful nicotine alternatives, about which Director King has lamented himself, will simply undermine whatever Strategic Plan CTP eventually puts in place.
The Strategic Plan must fix what can only be considered a broken PMTA process. A couple of points here:
The Reagan-Udall Foundation critiqued CTP for having undefined application requirements. They said, “Applicants, … will struggle to address the issues necessary to meet the APPH standard unless FDA clearly articulates its expectations. CTP has a responsibility to clearly identify application requirements, if for no other reason than to reduce the burden on the Agency itself and improve efficiency.”
But there is another more important reason. A scientific regulatory scheme which purports to determine what is appropriate for the protection of public health but which does not specify the science that is necessary for making that assessment is ultimately ineffective and subjective. CTP’s Strategic Plan MUST include the specific and finite list of studies and data which is required to support an APPH determination and which, if provided within certain parameters, will be sufficient for CTP’s evaluation and issuance of a marketing order.
The Reagan-Udall Foundation’s critique was clear. They said: “The plan must …explain how FDA is interpreting the APPH standard.”
The key question they said is, “how to weigh the public health benefits of the percentage of adults who use ENDS that will completely quit smoking combustible tobacco products against the potential public health harms that youth who use ENDS will acquire a lifelong addiction to nicotine or proceed to use combustible tobacco products.” To that end, CTP must clearly end its current subjective application of APPH in which it has proclaimed that ALL flavored ENDS products are attractive to youth regardless of the specific product at issue and regardless of that product’s experience, if any, with youth. This presumption was made without any reference to the product at issue in the application and, thus, is entirely unscientific and evidence of a double standard. Very simply, the presumption imposed in CTP’s July 2021 fatal flaw memo is no longer defensible in light of the Reagan-Udall Foundation’s findings. CTP can and should establish an objective assessment mechanism for evaluating each of the scientific studies presented on each of the prongs of the APPH test that ultimately results in a score for each product’s application based on an objective, not subjective, assessment of the science presented.
Meaningful change will not come unless CTP implements safeguards to ensure that the review process is insulated from external pressures and that CTP scientists are allowed to unapologetically follow the science. The revelations of FDA’s own scientific staff about political interference in a scientific review process must be dramatically addressed. In other words, CTP scientists must be allowed to complete their reviews of applications without interference or changes in review protocols/standards which were not in place prior to applications being filed.
CTP cannot afford a repeat occurrence of an Acting Commissioner, for example, belatedly interjecting herself into the scientific process to alter decisions that otherwise would have been endorsed by the Office of Science. Unless this occurs, CTP will be unable to execute its mission and public confidence in FDA decisions will be further eroded.
VTA’s Executive Director Tony Abboud sat down with Regulator Watch to do a quick review of the Orchestrated campaign tying Fentanyl to nicotine vapes. Watch the full video below.
VTA Insider keeps you informed of critical issues impacting the nicotine products industry both in Washington, DC and in the states. We will cover regulatory developments, legislation, news of note and other industry insights. VTA will also share our analysis of what we as an industry need to do to grow and prosper.
Let’s Dive In.
What’s New: Recently, VTA’s Executive Director Tony Abboud presented a stark warning to the industry at the Next Generation Nicotine Delivery Conference in Miami, Florida. The newest and greatest threat to the availability of less harmful nicotine vaping products in the U.S. is an ongoing orchestrated public affairs campaign to the unsubstantiated claims that illicit Chinese supplied vaping products are being laced with products such as fentanyl.
Why it matters: This will have ramifications for the entire industry and the millions of consumers because it jeopardizes all vaping products.
The facts: If, as asserted, millions of “illegal flavored disposables” are being imported into the U.S. with fentanyl, where’s the outbreak? The made up fentanyl narrative has all the markings of EVALI:
What it means: The fentanyl narrative threatens all nicotine vaping because nearly every vaping product is manufactured in China. If we allow this fiction to take root – it will scare consumers away from vaping and back to smoking and create an opening for FDA to deny all PMTAs.
The damage will NOT be limited to disposables. The campaign is as anti-flavor as it is anti-disposable.The geopolitical narrative is so hyped it will taint all vape devices since they ALL are made in China.
Bottom line: the vaping industry will not get three strikes. The industry must coalesce around a response on the level of the actions we took to stop the ill-conceived flavor ban response to the EVALI crisis. A copy of VTA’s presentation is available here.
The big picture: At the end of June, the FDA staged yet another “retail blitz” to manufacture a vaping crisis that does not exist. If this sounds vaguely familiar it’s because it’s the same playbook that FDA has used time and again.
The bottom line: 34 million adults are addicted to cigarettes – the only product which when used as intended will kill you. By selectively targeting vaping under the false pretense of a youth cris, FDA is working overtime to eliminate effective harm reduction options for adults and ensuring the only option for many will be to continue smoking.
The big picture: On June 14, 2023, the Vapor Technology Association (VTA) filed an amicus curiae brief with the Supreme Court of the United States in the case Avail Vapor, LLC, et al. v. US Food & Drug Administration. VTA’s petition seeks Supreme Court review of the Marketing Denial Orders issued to petitioners in connection with their open-system flavored vaping products.
Go deeper: World’s leading tobacco and nicotine researchers have undermined the scientific underpinnings of the FDA’s decision-making rationale. Review by the Court is important not to re-examine the science (which courts will not do), but to evaluate the propriety of the highly questionable process.
By the numbers: The independent vapor industry comprises more than 10,000 companies across the U.S. The industry is responsible for generating more than 130,000 jobs. FDA’s removal of all flavored vaping products from the market would lead to the shutdown of close to 10,000 businesses, causing the loss of 99,158 full-time equivalent jobs.
Why it matters: One week after the Fourth Circuit’s decision upholding the MDOs, an Independent Tobacco Expert Panel released its report on FDA’s Center for Tobacco Products which revealed serious regulatory failings of the agency, including those specifically raised by Petitioners in the Supreme Court Petition.
Stay tuned in with us for lots of new developments and make sure your friends and colleagues are signed up to receive our news and information.
Got questions? If you have any questions about the issues we have covered, have suggestions for content, or how you can support our efforts, please feel free to contact us at press@vaportechnology.org.
Evidence clearly demonstrates that vaping helps adult smokers quit, yet many communities are being misinformed about the relative risks of e-cigarettes.
A policy of “harm reduction equity” that prioritizes eliminating cancer and other diseases caused by cigarette use should be the highest public health priority of the FDA. Yet FDA’s words and actions have led many to believe erroneously that vaping is as harmful as, or more harmful than smoking. FDA’s backward approach to harm reduction means that it is currently easier to get a new cigarette product approved than an e-cigarette alternative.
Smoking remains the number one health risk to adults in the United States. Approximately 34 million adults are still addicted to cigarettes – the only product which when used as intended will kill you. Nearly 1300 Americans die from a smoking related illness every day – almost 475,000 people annually. That is COVID scale event – every two years!
In the LBGTQ communities – the problem is worse. LGBTQ people out-smoke the general population by 68%. This high rate of LGBTQ smoking is a current and ongoing health crisis.
LGBTQ smokers need to receive accurate information from FDA about the relative risks of vaping and smoking – it is a matter of life and death.
LGBTQ communities experience health disparities because social stigma and discriminatory treatment often cause stress and anxiety. Common coping mechanisms include smoking tobacco, drugs and alcohol. Because of higher smoking rates, LGBTQ communities carry the burden of a much higher risk of cancer and other diseases:
The FDA and the Center for Tobacco Policy (CTP) is charged, ultimately, with protecting all Americans from tobacco-related disease and death. This means the FDA must do everything to help people move off combustible tobacco and toward lower risk alternatives. FDA’s backward approach to harm reduction means that it is currently easier to get a new cigarette product approved than an e-cigarette alternative. And the fact that the FDA is on pace to eliminate more than 99% of vaping products from the market means that the only choice left remaining will be deadly cigarettes.
According to the American Cancer Society, cigarette smoking is the leading cause of cancer mortality in the United States – responsible for as much as 98% of all tobacco-related deaths. This is a generational health crisis that is preventable. Unfortunately it is also a problem that disparately impacts historically marginalized communities.
In a recent landmark essay in the American Journal of Public Health, 15 past presidents of the staunchly anti-tobacco Society for Research on Nicotine and Tobacco articulated the state of the science which demands an honest discussion about our public policy toward tobacco e-cigarettes. U.S.
policymakers are ignoring these scientific leaders’ warnings and missing the opportunity to reshape U.S. e-cigarette policy before more lives are lost.
According to these scientists, the need to pay attention to adult smokers is particularly important from a harm reduction equity perspective.
“African Americans suffer disproportionately from smoking-related deaths, a disparity that, a new clinical trial shows, vaping could reduce. Today’s smokers come disproportionately from lower education and income groups, the LGBTQ (lesbian, gay, bisexual, transgender, and queer or questioning) community, and populations suffering from mental health conditions
and from other drug addictions.”
While vaping is not risk free, we know that it is the most effective of all the nicotine alternatives. Since 2010, when e-cigarettes became widely available in the US, we have seen adults who smoke drop by a remarkable 62 percent. Other countries are far ahead of the U.S. in this regard.
Since 2015, the United Kingdom’s Health Agency Public Health England and the Royal College of Physicians each conducted a full review of all e-cigarette research and concluded that vapor products are at least 95% safer than combustible cigarettes. Now, Britain’s National Health Service promotes e-cigarettes as a means to quit smoking and even permits the sale of flavored vapor products inside hospitals.
And in April of 2023, the UK government announced its landmark program in which “One million smokers will be encouraged to swap cigarettes for vapes under a pioneering new ‘swap to stop’ scheme designed to improve the health of the nation and cut smoking rates.” The UK government is handing out free vaping starter kits to smokers to achieve its smoke free by 2030 goal..
Even in the U.S., the National Academies of Sciences Engineering and Medicine conducted its
own review of all the research and concluded in 2018:
So, while the FDA repeatedly talks about health equity, FDA’s refusal to acknowledge and apply the obvious principles of harm reduction to vaping dramatically highlights the inequity of its approach to harm reduction. Ultimately, the FDA will fail in its mission to end smoking and will particularly fail those in the LGBTQ communities who are disproportionately affected by smoking death and disease.
Less than 4% of underage youth indicate that they use vaping products “frequently.” FDA’s singular focus on decreasing this number by removing vaping products from the market is leaving millions of adult smokers with no alternatives to cigarettes. Vaping can be a benefit to public health and there is ample evidence supporting the potential of vaping to reduce smoking’s toll – particularly among the communities that remain addicted to cigarettes at higher rates. Making it harder for adults to access vapor products makes it harder for them quit and ensures that they engage in the riskiest behavior, (smoking) longer.
Given the unequal burden the LGBTQ community bears for cancer and other health risks directly associated with smoking, limiting adult choice for a lower risk product only serves to expand the harm reduction equity gap. Quitting smoking is hard. Only 10% of adults who try to quit will ultimately succeed. FDA needs to expand the understanding of less risky alternatives to smoking for the communities most at risk.
The FDA has spent the “vast majority” of its resources denigrating e-cigarettes and denying 99% of all applications from hundreds of companies seeking to market the very products, which Center for Tobacco Products Director King admitted have “markedly less risk than a combustible cigarette product.” This begs the question of what FDA has been doing with its remaining resources to address combustible tobacco products which FDA Commissioner Califf has said are the “most dangerous”?
To find out, the Vapor Technology Association conducted an analysis of FDA data and the answer is, frankly, disturbing. Based on a review of all marketing authorizations for cigarettes and vaping products made by the FDA over the last five years, we have learned that FDA has authorized combustible tobacco products at a dangerously high rate.
In the last five years, while the FDA has approved only a handful of e-cigarettes in tobacco flavor only, it has at the same time accelerated the introduction of 1,213 new combustible tobacco products into the U.S. market. Of these 1,213 new combustible tobacco products, the FDA has approved for sale 892 new cigarette products amounting to a whopping 74% of all the new combustible tobacco products FDA has allowed to be marketed.
FDA Approvals of Combustible Tobacco Products: January 2018 – December 2022
To make matters worse, the FDA allowed every one of these combustible products to be expedited to the market with only 90-days’ notice and without any demonstration that these new combustible tobacco products are appropriate for the protection of public health – because, of course, such products could never meet that same standard applied only to the new and innovative less harmful products. Moreover, all of the new combustible products approved were not subject to any robust scientific review and more than half of the new cigarettes authorized by the FDA were exempted from providing any scientific evidence at all.
The FDA Commissioner said this month that getting rid of combustible tobacco products “is written into the mission of the FDA.” That’s an odd statement given the FDA is approving combustible tobacco products over less harmful vaping products at a rate of 45:1. Not sure how that advances the FDA’s mission. Perhaps the FDA can explain it, because we cannot.
Also Read: How FDA’s Anti-Vaping Policies Affect Minorities in America
