Sign Out Sign Out

Vapor Technology Association

Join Today Dashboard

VTA Critiques FDA’s Denial of SMOK Device PMTAs

by

STATEMENT FROM THE VAPOR TECHNOLOGY ASSOCIATION IN RESPONSE TO CTP’S DECISION TO DENY MARKETING OF SMOK E-CIGARETTE PRODUCTS 

WASHINGTON, D.C. – January 16, 2024 – The following statement is attributable to Tony Abboud, executive director of the Vapor Technology Association (VTA):

“Today’s decision by the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) to issue 22 marketing denial orders (MDOs) for SMOK e-cigarette premarket tobacco applications further reinforces FDA’s steadfast commitment to its de-facto ban on e-cigarettes in the U.S.”

“For the first time, CTP has denied marketing authorization for purely technological devices that, per CTP’s own announcement, contain no tobacco, no nicotine, no e-liquid, and no flavorings. Still, CTP concluded that the American people couldn’t be trusted with these products because they “have the potential to be used with any e-liquid on the market and available to the consumer, which could include tobacco-flavored and non-tobacco flavored e-liquids.” In other words, CTP will deny Americans any device which allows them to consume nicotine in a manner that is scientifically proven to be dramatically less harmful than combustible cigarettes.”

“Today’s announcement reveals a rapid acceleration of CTP’s efforts remove any and all vaping devices from the market. Predictably claiming its decision was based on science, in actuality it had little to do with the data. CTP blithely asserted that SMOK products are popular with youth e-cigarette users. However, the 2023 National Youth Tobacco Survey (NYTS) data relied on by CTP, revealed the opposite. Not only did the data show another massive decline in youth use of any e-cigarettes (down 60% since 2019 and at a decade low), the data cited actually showed that less than one-tenth of one percent (230,000) of American youth even tried one of the SMOK products CTP just banned. Based on this objectively minute risk, CTP is barring millions of responsible adults from using these popular and technologically innovative products.”

“Like virtually all e-cigarettes, SMOK devices are a critical tool for American smokers looking for a less harmful alternative to smoking deadly cigarettes. CTP’s decision today is a rejection of technological innovation and is the most serious indication yet that it will not stop until all vaping products are eliminated in the U.S.”

“With CTP’s announcement, the VTA is once again renewing its call for CTP to reverse course, actually follow the science, and restore scientific primacy and integrity to its regulatory process.” 

# # #

About VTA: The Vapor Technology Association is the leading industry trade association in the United States 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.

VTA Announces New Leadership Team

by Leave a Comment

VTA’s new leadership is dedicated to advancing the independent vapor industry’s efforts to promote sound science-based regulation that will ensure the future of tobacco harm reduction

WASHINGTON, D.C. – January 11, 2024– The Vapor Technology Association (VTA) today announced the election of new members to its leadership team. The VTA Board of Directors elected Dr. David Johnson, Ph.D, as its new Board President, and elected Charles “Chuck” Melander as its new Treasurer.

“We are proud to welcome both David and Chuck to VTA’s Board and leadership team,” said Tony Abboud, VTA’s Executive Director. “Collectively, David and Chuck bring decades of valuable scientific and regulatory expertise, and bold, visionary leadership to the Vapor Technology Association as we chart the future of tobacco harm reduction and smoking cessation alternatives to cigarettes at the federal and state levels.  I am excited to work with them as we drive our Association’s goals and our core mission of advocating for e-cigarettes as  less harmful alternatives to combustible cigarettes.

Dr. David Johnson

Dr. Johnson is president of VTA member e-LiquidTech, Inc., an industry leading e-liquid and flavor manufacturer and major supplier to the tobacco and vaping industries. Dr. Johnson, a Ph.D in chemistry and analytical chemistry, brings to VTA over 30 years of scientific, regulatory, and management experience, including over 20 years in the tobacco and vape industries at Swedish Match – North America and at Turning Points Brands. Dr. Johnson also serves on the U.S. Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) as a small tobacco industry representative. Dr. Johnson’s extensive range of professional experiences and knowledge will support the scientific and regulatory focus and strategy of the Association. 

“It’s an honor and privilege to be recognized among my peers at VTA’s member companies, and I look forward to serving in my new role leading the Association and serving on VTA’s Executive Committee,” said Dr. Johnson. “We know that we have a lot of work to do, and I’m proud to be a part of this great team that has been leading and will continue to lead the charge to provide equitable access to vaping products as an important harm reduction and health equity tool.”

Chuck Melander

Mr. Melander, the Chief Strategy Officer of VTA member Streamline Vape Co., an industry leading e-liquid company, brings an entrepreneurial mindset, with a long record of brand building, driving radical growth, strategic and long-term planning efforts, and regulatory strategy. With a well-tenured career at Swedish Match and Turning Point Brands, where he served on the Executive Teams that drove rapid growth within the companies, Mr. Melander developed strong expertise in less harmful nicotine alternatives to cigarettes. Mr. Melander, a biochemist by training, has also served as an alternate member of TPSAC. Mr. Melander has an acute understanding of the legal and regulatory framework at both the federal and state levels.

“I am excited to take on this new challenge at VTA and move into a role which allows me to bring my experience in the vaping and tobacco industries to advance commonsense policies which support the broad access for responsible adult use of vaping products,” said Mr. Melander. “I thank the VTA Board for this nomination, and I look forward to working with the rest of the Executive Committee and the Board to advance VTA’s critically important mission.”

“On behalf of the VTA Board, I would also like to thank George Cassels-Smith, CEO of Tobacco Technology Inc and e-LiquidTech, Inc., for the steady and thoughtful leadership he has provided to VTA over the past three years and for the sound guidance he has provided me,” said Tony Abboud.  Under Mr. Cassels-Smith’s leadership, VTA was able to weather the organizational challenges presented by the pandemic, restore VTA’s footing as a leading voice for rational science-based regulation of less harmful nicotine products, and establish a strong direction for the future.  “The vaping industry owes Mr. Cassels-Smith a debt of gratitude for his past and continuing commitment to VTA and our common mission.”

Dr. Johnson and Mr. Melander assumed their new roles in December and, together with Jon Glauser, who also was re-elected by the Board as VTA’s Secretary, will serve on VTA’s Executive Committee.

David Johnson
Chuck Melander

# # #

About VTA: The Vapor Technology Association is the leading industry trade association in the United States 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.

VTA Response to the 5th Circuit En Banc Opinion Rebukes the FDA’s “De Facto Ban on Flavored E-Cigarettes”

by

STATEMENT FROM THE VAPOR TECHNOLOGY ASSOCIATION IN RESPONSE TO THE FIFTH CIRCUIT COURT OF APPEALS OPINION IN WAGES AND WHITE LION INVESTMENTS, LLC (DBA TRITON DISTRIBUTION) V. U.S. FOOD & DRUG ADMINISTRATION:

The following statement is attributable to Tony Abboud, executive director of the Vapor Technology Association:

“The en banc opinion of the United States Court of Appeals for the Fifth Circuit that was released last Wednesday is nothing less than a blistering indictment of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) for its intentional misleading of the U.S. e-cigarette industry and unlawful manipulation of its own pre-market tobacco application (PMTA) regulatory process. To use the language of the court, “Over several years, the Food and Drug Administration (“FDA”) sent manufacturers of flavored e-cigarette products on a wild goose chase,” in search of an approval that the FDA admitted in court it was never, ever, going to grant.

“The court was so stupefied by the FDA’s bad-faith efforts to reject all flavored e-cigarette products it cited Shakespeare to illustrate the full extent of the FDA’s disingenuity, particularly after the court explained that the plaintiffs in that case provided scientific evidence that e-cigarettes “save lives”. The court also emphasized the dramatic and abrupt “FDA flip-flop” which led to the implementation of what the court called a “de facto ban” on flavored e-cigarette products in the U.S. This was in addition to the voluminous jurisprudence cited by the court laying bare just how egregious the behavior of the FDA administrative state has been towards e-cigarette products and the consumers that use them. As the court stated, “No principle is more important when considering how the unelected administrators of the Fourth Branch of Government treat the American people.”

“The ruling by the Fifth Circuit’s en banc panel makes the recent release of the CTP five-year strategic plan – a case study in bureaucratic posturing – essentially null and void.  Nothing in the strategic plan demonstrates that the FDA acknowledges its past and recurring failings or, to the extent that it does, has any commitment to using its enormous regulatory power to authorize less harmful flavored e-cigarette products to save lives.  Worse, the strategic plan completely failed to address the central criticism of the Reagan-Udall Foundation that the FDA has failed to explain what evidence it demands to authorize e-cigarettes as “appropriate for the protection of public health” or otherwise explain how the agency is even interpreting or applying that legal standard.  And worst of all, the strategic plan reveals that FDA has no plan or intent to speak factually to the American public about the benefits of switching from smoking to vaping at any time in the near future.

“Compared to the diametrically opposite approach taken in England – where the government has authorized more than a million flavored e-cigarette products, is telling smokers to use e-cigarettes to quit smoking, and is giving away e-cigarette starter kits to one million of its smokers as part of its ‘Swap to Stop’ program designed to end smoking by 2030 – the U.S. FDA is locked in an anti-scientific ideologically prohibitionist mentality which will ensure that millions of Americans will continue to suffer from smoking related diseases and die from cigarette smoking every year.

“The Vapor Technology Association renews its call for FDA and specifically CTP to reverse course, follow the law, and restore scientific primacy and integrity to its regulatory process by rapidly reviewing and approving the pending flavored e-cigarette PMTAs in accordance with this latest demand by the Fifth Circuit.”

Media Contact
press@vaportechnology.org

About VTA

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

VTA Response to CTP 5 Year Strategic Plan

by Leave a Comment

The Vapor Technology Association has reviewed the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) five-year strategic plan. In short, VTA is deeply disappointed with the plan’s lack of substance and absence of specifics to move American smokers off of combustible products towards effective harm-reduction nicotine options.

In October, at the Food & Drug Law Insitute’s Tobacco and Nicotine Policy Conference in Washington, D.C., VTA called on FDA to make harm reduction the “north star” of the strategic plan. The plan that has now been released lacks any commitment, much less a clear roadmap, to aggressively move people who smoke towards non-combustible forms of nicotine. It speaks vaguely about the importance of health equity and insists that a primary focus of CTP remains on reducing tobacco-related death and disease – but provides no insight, details, or specific methods by which CTP will achieve this. Nor does it acknowledge the latest science in support of e-cigarettes as the most effective non-combustible option for smoking cessation.

Most concerning is that CTP’s strategic plan fails to even attempt to address the Reagan Udall Foundation’s (RUF) central and most damning criticisms that go to the core of CTP’s job:

  1. that CTP has not clearly met the most basic elements of its tobacco and nicotine regulatory program by defining what is required of applicants under the “Appropriate for the Protection of the Public Health” (APPH) standard in the Tobacco Control Act, and
  2. that CTP has not clearly explained how it is assessing the science to determine what is APPH.

The silence of CTP’s strategic plan on these issues is defeaning. By failing to address these core criticisms, CTP’s five-year strategic plan will continue to generate misinformation, inefficiency, litigation, and suspicions of political interference.

VTA has repeatedly called on CTP to speak immediately, loudly, and repeatedly to adults about tobacco harm reduction in order to start saving lives now. Instead, CTP mentions the notion of conducting “foundational” and “formative” research on whether it might speak to adults – at some unknown time in the future – about harm reduction and less harmful vaping and other nicotine alternatives. Meanwhile, 480,000 people die prematurely every year from cigarette smoking.

The release of CTP’s five-year strategic plan, which took a full year to construct, was an opportunity to demonstrate bold, not bureaucratic, leadership on tobacco harm reduction that could close the deadly chapter of cigarettes in America. Instead, what the American public was given is document that reflected little more than a commitment to bureaucracy without any real direction or goals, much less a strategy to achieve those goals. Only 15 of the 27 pages of government pabulum (littered with pictures, graphics, and process tables) could actually be considered a recitation of the “plan” but, in total, it revealed nothing more than a “check the box” exercise (which failed to even check the most important boxes).

The strategic plan was a huge missed opportunity for the bureacracts to stand up for science and tobacco harm reduction, and stand up for the millions of smokers in vulnerable Black, LGBTQ+, and low income popluations who would benefit the most from a plan that actually kickstarted the important work of improving and saving lives and reducing or eliminating smoking related diseases. Instead, CTP demonstrated that its hands are firmly gripped upon a wheel that it is refusing to turn as it careens off a public health cliff with the lives of American smokers in tow.

Unraveling FDA Decisions: A Threat to Public Health or Playing Favorites?

by Leave a Comment

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:

  • Flavored e-cigarettes, vital for smoking reduction, face unwarranted bans.
  • The FDA’s perplexing approval of only eight vaping products in four years prompts questions about regulatory consistency.
  • Despite youth use decline, arbitrary FDA regulations affect millions of adult smokers relying on vaping.
  • FDA’s misinformation and actions amount to regulatory negligence which disproportionately impacts marginalized communities.

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.

Also Read NYTS 2023 – VTA Calls on FDA to Approve Flavored E-Cigarettes for Adult Tobacco Harm Reduction After Another Massive Drop in 2023 Youth Vaping Rate

NYTS 2023 – VTA Calls on FDA to Approve Flavored E-Cigarettes for Adult Tobacco Harm Reduction After Another Massive Drop in 2023 Youth Vaping Rate

by Leave a Comment

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.”

Media Contact
press@vaportechnology.org

About VTA

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

FDA’s Center for Tobacco Products Must Reverse Course to Quickly Reduce Smoking Harms

by

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:

  1. CTP remains focused on youth vaping while marginalizing adult smokers looking for alternatives to quit cigarettes;
  2. CTP has no plans to educate consumers on the risks and benefits of smoking vs. vaping;
  3. CTP is on a path to eliminate consumer access to vapes as a tobacco harm reduction or smoking cessation option.

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:

  • State unequivocally that tobacco harm reduction is its north star.
  • Fully acknowledge that vaping is dramatically safer than smoking. 
  • State that vaping and MON products are critical tools for THR & cessation.
  • Encourage smokers to use/try smoke-free tobacco if they can’t quit.
  • Authorize a wide-variety of smoke-free products, including flavored ENDS products which have been proven to help adults transition off cigarettes.

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.

Download Full Presentation

Also Read Unraveling FDA Decisions: A Threat to Public Health or Playing Favorites?

Vapor Technology Association Joins Founding of New Global Vape Alliance to Combat Misinformation

by Leave a Comment

Launch marked with a historic Declaration to effect responsible and positive change on a global scale

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:

  • Regulatory Compliance: Facilitate the sharing of best practices to ensure member companies adhere to existing vaping laws, regulations, and industry standards, with a strong focus on responsible marketing and protecting youth.
  • Industry Promotion: Elevate the e-cigarette industry’s professionalism, importance, and sustainability by fostering communication among industry stakeholders and encouraging technological innovation in vaping devices.
  • Public Health: Emphasising harm reduction by promoting the adoption of vaping products among conventional smokers to reduce harm, while openly providing information about the health effects of vaping and its impact on physical health.
  • Environment Protection: the Alliance will advocate for eco-friendly strategies in vaping, promote recycling, low-carbon design, and urge compliance with environmental laws related to vaping products.

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

VTA Calls Attention to FDA Misinformation at Stakeholder Meeting

by Leave a Comment

Comments of the Vapor Technology Association

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.

First

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.

Second

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.

Third

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.

Read VTA’s Full Comments (PDF)

Follow Us

Copyright © 2024 Vapor Technology Association.
All Rights Reserved.

Privacy Policy |
 Terms Of Use

Created by Black

Let’s Connect

Subscribe to VTA

Myth vs Fact

Continue to VTA