News | Page 3 | Vapor Technology Association

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

November 14, 2023 by Ethan D'Souza 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

November 2, 2023 by Ethan D'Souza 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

October 27, 2023 by Ethan D'Souza

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:

CTP remains focused on youth vaping while marginalizing adult smokers looking for alternatives to quit cigarettes;
CTP has no plans to educate consumers on the risks and benefits of smoking vs. vaping;
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

October 8, 2023 by Ethan D'Souza 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

September 7, 2023 by Ethan D'Souza 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)

VTA’s Executive Director Addresses the Fentanyl Threat

July 14, 2023 by Ethan D'Souza

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 June 2023: Fentanyl Threat & FDA Over Regulations

July 12, 2023 by Ethan D'Souza Leave a Comment

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.

Beware of the Fentanyl False Flag

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:

Hospitalizations and illnesses involving young people using THC vapes.
Products clearly adulterated by unscrupulous drug dealers.
Headlines are hyped and conflate all vaping products.
Direct calls for eliminating flavored nicotine vaping.
Regulators and legislators are feeding the misleading narrative.

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.

FDA’s Poisonous Pantomime

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.

What’s different this time: FDA paired their blitz announcement with two CDC reports that traffic in dangerous misinformation and blatantly misrepresent the real trends in youth vaping.
The first study FDA presents includes aggregated retail data (not youth usage) that show vapes sales are up and by implication – youth usage. This is not the case. CDC’s own National Youth Tobacco Survey has shown the dramatic reduction in youth e-cigarette use. As smokers use ENDS products to quit cigarettes – we should expect to see replacement trends at the retail level.
The second study FDA presents attempts to portray an increase in calls to poison control centers related to vaping as sign that a crisis as at our doorstep. To do that, FDA presents this data out of context.
Go deeper: If we told you that there were 6,074 cases for children under the age of five related to vaping you might be concerned. But what if you also knew that:
- There were 96,000 cases involving cosmetics
- There were 94,000 cases involving household cleaners
- There were 72,000 cases involving prescription drugs
- There were 6,180 cases involving THC (cannabis)

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.

VTA Files SCOTUS Brief Supporting Avail Vapor’s 4th Circuit Appeal

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.

Worth your time

A recent study in the American Journal of Medicine finds that among individuals attempting to quit smoking, nicotine e-cigarettes are more efficacious than conventional nicotine replacement or behavioral smoking cessation therapies, and may prove beneficial in reducing smoking-related health risks.
Reason Magazine recently published a piece highlighting that since the Food and Drug Administration began regulating ENDS as “tobacco products,” public understanding of the relative risks of various tobacco products has declined.

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.

Warning: The Greatest Threat to Vaping – Disinformation

June 28, 2023 by VTA Editors

During this week’s Next Generation Nicotine Delivery USA 2023 conference, VTA’s Executive Director presented a stark warning to industry leaders about a new orchestrated anti-vaping campaign.

The Next Generation Nicotine Delivery USA 2023 brought together 150+ executives from the industry for two days of insight, discussion and debate in Miami, Florida. VTA’s participation at the event included a keynote presentation and panel discussions led by VTA Executive Director Tony Abboud.

Abboud’s presentation highlighted the misinformation surrounding EVALI that was used to malign nicotine vaping in the past and then revealed a highly-funded ongoing disinformation campaign that is being orchestrated to create a false narrative linking “Chinese-manufactured” flavored disposable nicotine vaping products with fentanyl without substantiation. The presentation also revealed how FDA officials, unlike in 2019, appear to be feeding the false narrative with their public statements.

The presentation drew stark parallels between how certain players used the illicit THC cartridge EVALI crisis of 2019 to attack flavored nicotine vaping, and how the scant cases of illicit THC cartridges being found to contain fentanyl are now being wrongfully amplified and tied to flavored nicotine disposable vaping products. VTA Executive Director Tony Abboud starkly warned that the industry is facing a manufactured crisis – EVALI II – the repurcussions of which will be worse than EVALI. He also warned that the misleading campaign alleging the mass importation of fentanyl-tainted Chinese disposable vapes will threaten the entire nicotine vaping industry, will taint all device types as they are all made in China, will force fear-driven regulatory overreactions that will have nothing to do with the real issue, and will confuse and frighten consumers back to smoking cigarettes.

VTA called on all companies to coalesce, as it did in 2019, around a VTA strategy to answer this false narrative, reminding the audience of the success it had in responding to the ill-considered 2019 flavor ban response to EVALI.

Greatest Threat to Vaping Presentation Deck (PDF)

VTA Files SCOTUS Brief Supporting Avail Vapor’s 4th Circuit Appeal

June 17, 2023 by Tony

WASHINGTON, June 18, 2023 – 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. The brief was filed in support of Petitioners’ – Avail Vapor and Blackbriar Regulatory Consulting – Petition for Writ of Certiorari seeking Supreme Court review of the Marketing Denial Orders issued to Petitioners in connection with their open-system flavored vaping products. VTA’s amicus brief encouraged the Supreme Court to take up the case because it will have “major public health and economic impacts that will dramatically affect millions of Americans.”

First, VTA explained that only 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. The report which roundly crticized the FDA’s handling of pre-market tobacco applications, like those at issue in the Petition, had been called for by FDA Commissioner Robert Califf himself.

Second, VTA explained that the world’s leading tobacco and nicotine researchers have undermined the scientific underpinnings of the FDA’s decision-making rationale, and called into question the public health objectives of removing flavored ENDS products from the market, making review by the Court important not to simply re-examine the science (which courts generally will not do), but to evaluate the propriety of the highly questionable process used by FDA to implement the requirements of the Tobacco Control Act.

Third, VTA explained that the independent vapor industry comprises more than 10,000 companies across the United States and is responsible for generating more than 130,000 jobs and more than $22 billion in economic activity for the U.S. economy – an industry that would be devastated by FDA’s continued march to ban flavored ENDS. VTA also explained the results of its expert economists’ analysis that 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, the loss of $5,258,906,715 in wages and benefits, and the loss of $16,449,776,269 to the U.S. economy, all of which makes the issue before the Court important for consideration.

The goal of the brief is to encourage the Supreme Court to take up the case petitioning for review. Our hope is that our amicus brief offers the Supreme Court additional context and rationale for why reviewing FDA’s actions is exceptionally important. Read the brief or download here:

22 1112 Amicus Brief Of Vapor Technology Association

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.

VTA Insider May 2023: LBGTQ & Nicotine Products

May 30, 2023 by Black Development Leave a Comment

Let’s Dive In.

A heavy lift in DC

The big picture: The E-Cig Summit and the Food and Drug Law Institute convened in Washington, D.C. There is too much to detail in this newsletter but a few key big-picture takeaways:

Science is clear: Scientists from around the world convened to discuss the continuing growing body of the science behind the importance of vaping and nicotine alternatives to smoking cigarettes. In study after study presented, the scientists presented unflinching perspectives on everything from data to policy.

The Consensus: FDA is broken and is failing in delivering an effective harm reduction message. Vaping can be a huge benefit to public health and there is ample evidence supporting the potential of vaping to reduce smoking’s toll. 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.

Why it matters: Litigation is now effectively driving health policy. FDA had a plan to review the large number of PMTAs received and to streamline its reviews in a scientifically defensible matter for flavored ENDS. FDA had announced its plans, priorities and processes in June 2021.

Then, all that changed with the direct interference from a former Acting Commissioner who forced the creation of the “fatal flaw” memorandum which was used to en masse deny all flavored vaping products.
This and other interference with scientific decisions was called out by scientists inside & outside FDA’s Center for Tobacco Products.
Given FDA’s actions, companies had no option but to litigate.

FDA enforcement needs to be focused on the bad actors, i.e., those companies which have completely ignored FDA’s regulations. While Director Brian King proudly spoke about the pace of PMTA denials (99% of all vaping products) he acknowledged the difficulty with enforcement. No surprise here since bans cannot be enforced. But, as was highlighted in the Reagan-Udall report, FDA has taken little action against companies that chose never to even apply through the PMTA process.

Misinformation for the masses

Data courtesy of Clive Bates from Counterfactual

At the E-Cig summit last week, our friend Clive Bates of Counterfactual gave an excellent presentation focused on how the U.S. should be rethinking tobacco and nicotine regulation. The entire presentation is worth a read but the chart above is a perfect encapsulation of the problem.

The public is being fed misinformation concerning the relative health risks of smoking vs. vaping and the problem is getting worse. People are now more likely to believe that vaping is as dangerous as smoking than they were ten years ago.

FDA officials acknowledged the problem of misinformation during the Q&A segment at the E-Cig Summit and committed to developing a public affairs campaign targeted at adults. These type of campaigns take months to develop so don’t expect anything dramatic anytime soon.

Doubling Down on Youth. In the same talk, however, CTP Director Brian King, who again acknowledged the dramatic decline in youth vaping, doubled down on youth experiementation. He said there is no acceptable level of youth vaping usage, foretelling what will continue to dictate FDA’s continued vaping product denials.

The bottom line: Quitting smoking is hard. Only 10% of adults who try to quit will ultimately succeed. FDA needs to expand the understanding of the dramatically less risky alternatives to smoking for tens of millions of adults who are addicted. Of course vaping is not free from risk and there are trade-offs but those tradeoffs should be made explicit so that we can reduce death and disease by giving people the information to de-risk their behavior.

But, Director King went on to say that there was a difference between enforcement discretion and enforcement prioritization.
King promised promised a formal letter soon from CTP in response to VTA’s questions to clarify CTP’s position.

Advancing harm reduction equity

fda vapor regulations — FDA Must First Practice Harm Reduction Equity to Achieve Health Equity

The big picture: CTP Director Brian King has made the concept of “health equity” as it relates to tobacco product regulation a centerpiece of his plan. King characterized FDA’s focus on health equity in the following way:

“We have a tremendous opportunity to prioritize health equity and create meaningful change for populations that have been disproportionately affected by tobacco use.”
Director King also created the first “health equity” leadership position inside CTP.

By the numbers: 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. 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. In fact, according to the NIH, smoking related deaths are on track to surpass HIV/AIDS as a cause of death among gay men.

Why it matters: CTP is promoting health inequity and would be better served to focus on vaping as a tool to promote “harm reduction equity” which would have more immediate benefits and potentially immeasurable benefits for historically marginalized communities.

The bottom line: The FDA and its Center for Tobacco Products (CTP) is charged 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 easier to get a new deadly cigarette product approved than an e-cigarette alternative.
And the fact that the FDA has declared more than 99% of vaping products “illegal” means that the only choice left remaining will be deadly cigarettes.

Harm Reduction Equity: Conversely, a focus on harm reduction equity means telling the communities that are disproportionately impacted by smoking related death and disease the truth – that vaping while not risk free is less risky than smoking. Given the unequal burden the LGBTQ community and other populations disproportionately affected by smoking (such as the African-American community, those of lower incomes, those afflicted with mental health issues) bear for cancer and other health risks associated with smoking, limiting adult choices and access to lower risk products will only serve to expand health inequities in our society.

The real story on combustibles

FDA has a responsibility to create a marketplace that allows the most innovative and safe products to emerge so that adults have access to them. With all the news about the product denials for flavored vaping products, you might be surprised to learn that the FDA has approved for sale more than 1,200 combustible products including nearly 900 new cigarettes!

FDA Approvals of Combustible Tobacco Products 2018 –2022

FDA Commissioner Robert Califf recently said in a March 6, 2023 Wall Street Journal interview, “There aren’t many people who argue in favor of combustible tobacco … Well, I mean, we always start from the presumption that combustible tobacco is the most dangerous part of this. And we need to get rid of that as much as we possibly can. It’s written into the mission of the FDA.”

There aren’t many people who would argue with that. So why is the FDA under his leadership approving so many of combustible products? You can check out the full VTA analysis of FDA product approval data here.

FDA’s continued refusal to accept known scientific truths about vaping and modern oral nicotine will only ensure that cigarettes remain dominant in the U.S.

Worth your time

Leading Tobacco-Control Experts call on FDA to change – and fast.

some of the world’s leading tobacco-control scientists and public health experts wrote to FDA Commissioner Califf calling on him and the FDA to rethink its current posture.
The group focused on the hyper-critical findings of the Reagan-Udall Foundation’s review of CTP and made specific recommendations for changing the way CTP handles tobacco and vaping regulations.

Juul Whitepaper: Juul Labs Inc. has published “The Real-World Impact of ENDS for Adult Smokers: Tobacco Harm Reduction Through Real-World Data and Evidence.” We encourage you to read it here.

Two main requirements of effective harm reduction: (1) that the products are much less harmful than cigarettes, and (2) that these products displace smoking at the population level.

No doubt the whitepaper it will be panned because of the source but “risk-proportionate regulation” is related to FDA’s “continuum of risk” concept. We have to keep pushing to embed this harm reduction priority as our public health strategy.