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VTA Statement: Response to Gov. Youngkin’s Amendments to SB550/HB1609

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WASHINGTON – April 10, 2024 – The following statement is attributable to Tony Abboud, executive director of the Vapor Technology Association (VTA):

“While VTA is deeply disappointed that the Virginia State Legislature did not consider the science, overwhelming adverse impact on Virginia’s economy, and harm reduction benefits of e-cigarettes when passing SB550/HB1609 , we would like to express our gratitude to Governor Glenn Youngkin’s office for the time and attention they paid to the real danger to Virginia consumers and small businesses of banning all vapor products, an alternative that is currently helping Virginians quit smoking cigarettes.”

“The Governor’s amendment delaying the effective date is wise as it will ensure that Virginia does not precipitously shut down an important industry by rubber stamping a federal regulatory decision-making process which the 5th Circuit Court of Appeals has declared unlawful, the final legality of which the U.S. Supreme Court will be reviewing this year and next. VTA intends to use this time to allow our store owners the opportunity to share with their elected officials just how detrimental this legislation will be to their livelihoods as well as their customers’ health.”

“We applaud Governor Youngkin for issuing these amendments and standing up to Big Tobacco’s continued attempts to boost lagging cigarette sales by immediately shutting down Virginia’s small businesses selling less harmful alternatives to cigarettes.” 

“In light of these developments in Virginia, VTA continues its call for state and federal officials to restore scientific primacy and integrity to the regulations which govern the safe and reliable sales of e-cigarettes to adult consumers.  And VTA applauds the state legislature for passing SB 582/HB 790 – a comprehensive set of reforms that implement the strongest, proven policies that will reduce the appeal of, access to, and use of vapor products by youth – which VTA has been advocating for many years.” 

“VTA looks forward to working with Gov. Youngkin, the General Assembly, and smoking reduction advocates in Virginia to demonstrate why drastic changes in approach are required in the 2025 legislative session.”

Cancer Moonshot & Vaping Ad

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This ad explains that President Biden has one of the best tools available to achieve his Cancer Moonshot – universal access to flavored e-cigarettes. Smoking is the #1 cause of death and disease in the U.S., but the FDA’s Center for Tobacco Products refuses to authorize less harmful e-cigarettes choosing instead to authorize 900 new cigarettes.

NEW POLL: American Public Grossly Misinformed About Benefits of E-Cigarette Use to Smokers & Low Risk of Vaping

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New polling conducted by KAConsulting, LLC, led by U.S. presidential advisor and market analytics expert Kellyanne Conway, reveals misinformation from public health institutions around e-cigarettes creates significant confusion for American public.

WASHINGTON – November 30, 2023 – The Vapor Technology Association (VTA) today
released new polling from pollster Kellyanne Conway, which reveals a significant information
gap in public perception versus reality regarding e-cigarettes being an effective tool for adults in
need of smoking cessation and harm reduction alternatives.

The poll is a national online survey of 1,000 registered U.S. voters, including 35% Republicans;
35% Democrats; 16% independents; and 14% unaffiliated. VTA’s polling sought to better
understand the current state of Americans’ knowledge, perceptions, and opinions on e-cigarette
use, including perceptions of where vaping lies among other risky behaviors, like smoking
cigarettes, drinking alcohol, and smoking marijuana.

The poll confirms what many scientists and academics have lamented for years: The American
people are overwhelmingly misinformed by public health institutions, such as the U.S. Food and
Drug Administration’s Center for Tobacco Products (CTP), on the dramatically lower risks and
significant benefit tradeoffs of vaping nicotine versus smoking cigarettes, which kill nearly half a
million Americans every year.

When provided factual information about e-cigarettes, public perception of vaping skewed from
largely negative towards a demonstrable openness around the potential benefits of e-cigarettes,
particularly for current smokers. Additionally, the poll demonstrates that Americans, despite their
overwhelmingly negative views on e-cigarettes, ranked numerous other behaviors and lifestyle
choices, like drinking alcohol or smoking marijuana, as much riskier.

“The poll that VTA conducted with Kellyanne and her team underscores what we have argued for years: that public health officials and lawmakers must follow the science when it comes to vaping and stop misinforming the public about the benefits and relative risks of e-cigarettes and other non-combustible nicotine products, especially as an effective harm reduction tool for those who currently smoke cigarettes,” said Tony Abboud, executive director of VTA. “This watershed polling demonstrates the clear and present danger of this public health misinformation gap that needs to be addressed.”

“This poll demonstrates the effect of information underload combined with unaddressed confusion about an issue – the result is chaos,” said Kellyanne Conway. “Yet, when Americans are provided accurate information about e-cigarette use, their opinion shifts dramatically. This shows the power of politicized science versus actual science.”

Key findings included in the polling’s results:

  • An overwhelming majority of Americans (84%) have a negative view of vaping nicotine and 78% wrongly believe that vaping nicotine is as or more dangerous than smoking cigarettes.
  • When informed that vaping is more effective than nicotine replacement therapies such a nicotine gums and patches in helping adult smokers quit, 37% of respondents say they are less likely to support a ban.
  • When informed of the United Kingdom’s “Swap to Stop” program of handing out free vaping starter kits to help people stop smoking, 40% of Americans say they would be more likely to support such a program in the U.S.
  • More than half of Americans (53%) say FDA’s rejection of 99% of e-cigarette applications while approving cigarettes over vaping products at a rate of 45 to 1 is unreasonable policy.
  • A majority of Americans (79%) state that banning e-cigarettes would just result in a black market for people to continue buying and selling nicotine vaping products.
  • Half of Americans (49%) say it is unreasonable policy for FDA to use youth vaping as a reason to ban flavored e-cigarettes when FDA also says youth vaping is not an epidemic.
  • More than half (56%) of Americans believe that FDA is making unfair decisions or playing politics about tobacco and vaping and should return to focusing on protecting public health.
  • Only 35% of Americans say FDA should continue on its current path with respect to tobacco and vaping.
  • Vaping nicotine is considered the least dangerous activity (7%) to a person’s life when compared to other activities, like using illegal drugs, not wearing a seatbelt in a car, poor nutrition, and drinking alcohol.

The FDA’s CTP sets tobacco and e-cigarette policy in the U.S. The use of selective science to
justify agenda-driven decisions regarding e-cigarettes or any other less harmful non-
combustible product is ultimately dangerous to public health and confusing for millions of
Americans looking to quit smoking. This new data reveals the extent of this confusion and the
fact the majority of Americans think that FDA is heading in the wrong direction with its e-
cigarette and tobacco policy.

“This polling clearly demonstrates that the FDA’s Center for Tobacco Products has been successful in creating confusion around vaping in the U.S., and when provided the facts, the majority of Americans believe that FDA’s current trajectory of banning virtually all e-cigarettes is the wrong policy which is driven by political and not scientific rationale,” concluded Mr. Abboud.

“VTA looks forward to working with all regulators to correct the record, get the right information about vaping benefits to American consumers, and help reset the FDA’s skewed agenda on less harmful nicotine products based on science and common-sense solutions.”

For more information and a complete copy of the poll, follow the link below.

View Complete Poll Results (PDF)

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 VTA’s Executive Director Addresses the 2023 National Youth Tobacco Survey

Warning: The Greatest Threat to Vaping – Disinformation

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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 Issues Statement Criticizing FDA Inspection Blitz Announcement

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Vapor Trade Group Warns Against What it Says Is FDA Misinformation That Jeopardizes Harm Reduction Mission

WASHINGTON, June 23, 2023 (Newswire) – Following the FDA’s announcement of what it called a “nationwide retailer inspection blitz” which targeted 189 small business retailers, Vapor Technology Association Executive Director Tony Abboud released the following statement:

“The actions this week by the FDA demonstrate once again that it has no control over the market it is charged with regulating. FDA’s announcement unfairly targets small business owners while offering its tacit support of the biggest companies. FDA currently operates with a de facto policy to remove all non-tobacco flavored vaping products from the market, while it continues to approve combustible tobacco products at an alarming rate. FDA has a responsibility to create a marketplace that allows the most innovative products that adults actually want to use, not arbitrarily pick winners and losers due to pressure from political officials.”

FDA synchronized its “blitz” announcement with not one, but two CDC reports, which misrepresent the real trends in youth vaping. One study cited by FDA was conducted with an agenda driven special interest group and funded by a prominent billionaire. The CDC’s own National Youth Tobacco Survey has shown the dramatic reduction in youth e-cigarette use. Since its peak in 2019, vaping is down 50% amongst high schoolers and 70% amongst middle schoolers, and now sits at 2014 levels.

In fact, Brian King, the Director of the Center for Tobacco Policy (CTP), has stated publicly that CTP no longer considers youth vaping an epidemic. This is welcome news. And given these facts, the reported “rise” in flavored vape sales must necessarily be amongst adults who either desire or need less harmful alternatives to cigarettes.

“FDA has also misused scant data from a second CDC study to sensationalize the risk to small children by claiming a supposed increase in poison control calls – the overwhelming majority of which – 99.8% – had no major effect. This sleight of hand is being used to justify its actions against just one product while at the same time ignoring the data showing two other vaping products owned by cigarette companies were also specifically identified in the study.”

Given the known dangers of smoking, FDA must take a stronger stance on cigarettes than it does on vaping. Instead, the FDA has authorized the sale of 900 new cigarette products, two-thirds of which are owned by the biggest tobacco companies. The FDA can no longer, in good conscience, continue down this path.

34 million adults are addicted to cigarettes – the only product which when used as intended will kill you. By selectively targeting vaping, FDA is working overtime to eliminate effective harm reduction options for adults and ensuring the only option for many will be to continue smoking.”

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’s Recommendations to the Reagan-Udall Foundation

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VTA PMTA Recommendations

  1. FDA must implement safeguards at the Center for Tobacco Products (CTP) to ensure that the scientific review process is insulated from external pressures and that CTP scientists are allowed to unapologetically follow the science.
  2. Immediately rescind the July 9, 2021 and August 17, 2021 process memos which resulted in the en masse denial of flavored ENDS products, restore the holistic review process and the primacy of the appropriateness for the protection of public health balancing test.
  3. Build the off-ramp from smoking by accelerating the authorization of ENDS products and using the full scope of CTP’s post-marketing order authority to monitor and control for youth concerns.
  4. Clearly articulate CTP’s use of enforcement discretion to work companies through the PMTA process, particularly for non-tobacco nicotine (i.e., synthetic nicotine) applications.
  5. Communicate with companies to seek additional information or corrections and avoid rejections based on administrative or technical failings and the needless litigation that follows.
  6. Establish defined testing methods for END products which create transparency and certainty.
  7. Eliminate redundant and unnecessary testing to streamline the PMTA process.
  8. Develop and publish a PMTA proposed regulation with a finite checklist of required information that is required for PMTA review.
  9. Equally fund research for identifying how ENDS products can be solutions for smoking, rather than simply identifying problems with ENDS products and youth.

VTA Regulations and Guidance Recommendations

  1. CTP should implement a Comprehensive Plan on tobacco and nicotine that includes a clear acknowledgment of the FDA’s commitment to:
    1. the continuum of risk related to tobacco products and a recognition that ENDS and modern oral nicotine products sit at the lower end of the risk continuum,
    2. promoting innovation of those products at the lower end of the risk continuum, particularly ENDS and modern oral nicotine products,
    3. promoting innovation in nicotine, particularly synthetic nicotine,
    4. a pure scientific review process,
    5. funding science to evaluate the benefits of ENDS and modern oral nicotine products,
    6. working with companies to facilitate the application review process,
    7. aggressively educating adult smokers on the benefits of trying ENDS products if they are otherwise unwilling or unable to quit smoking using other methods,
    8. using its enforcement discretion to allow products under review to remain on the market pending authorization reviews, and
    9. a streamlined process which will ensure prompt review of product applications.
  2. CTP should engage industry and other stakeholders in the guidance and regulation processes by:
    1. Converting its listening sessions to engagement sessions so that CTP personnel are encouraged to communicate, ask questions and engage with stakeholders during meetings;
    2. Reinstituting its public stakeholder workshops which bring together all stakeholders to provide input on key regulatory policies and strategies; and
    3. Establishing an additional technical advisory committee dedicated to newly deemed alternative nicotine products to have a more focused strategy for less harmful nicotine products
  3. CTP should issue proposed regulation or guidance on product standards that:
    1. Explicitly allows widely accepted statistical design methods of research, aggregate testing, and extrapolation for ENDS product stability testing, and
    2. Permits manufacturers to market safety and/or quality enhancements with 60-Day notice to FDA.  

VTA Enforcement Recommendations

  1. CTP must use its full authority to ramp up interdiction of illicit products at the ports.
  2. CTP needs to streamline and reprioritize its enforcement efforts, rather than focusing so much on generally ineffective retail level enforcement.
  3. CTP should publish list of NTN products currently under PMTA review to facilitate industry and FDA enforcement efforts.
  4. CTP should restructure its enforcement efforts, through a guidance document, to achieve the following altered enforcement priorities:
    1. Stopping the flow all disposables into the U.S. market for which no PMTA has been filed by interdicting products at the ports;
    2. Enforcing against other ENDS products for which no PMTA has been filed, first prioritizing tobacco-derived products which make up the bulk of the market and then NTN products (since the latter are only a fraction of the market);
    3. Enforcing against counterfeit and illicit products which grossly violate marketing standards, trademark laws, or otherwise have marketing campaigns directed at youth; and
    4. Enforcing against products for which CTP has issued marketing denial orders (MDOs) after a full scientific review consistent with requirements of the Tobacco Control Act, except of course, those subject to an FDA administrative stay or a court-ordered stay of enforcement.

VTA Public Education & Communication Recommendations

  1. CTP must loudly and repeatedly correct the public record that nicotine does not cause cancer and that ENDS products, in the words of CTP Director King “have markedly less risk than a combustible cigarette”;
  2. CTP must commit equal resources to conducting an aggressive public education campaign, targeted to the adult consuming public, on the dangers of smoking and the lower risks of ENDS and modern oral nicotine products, explaining the continuum of risk, and encouraging adult smokers who have been unable or unwilling to quit to try e-cigarettes; and
  3. CTP must end the misleading youth education campaigns that are designed to scare youth (and adults) with false statements regarding the risks of e-cigarettes.
Read VTA’s Full Comments (PDF)

The VTA Submits Supreme Court Amicus Brief on Vaping Flavor Ban

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WASHINGTON, November 15, 2022 (Newswire.com) – On Nov. 8, 2022, voters in California passed a ballot initiative (Proposition 31) upholding a 2020 law banning the sale of most flavored tobacco products. On Nov. 9, 2022, R.J. Reynolds (RJR), filed a federal lawsuit challenging California’s ban as being unlawfully preempted by the Family Smoking Prevention and Tobacco Control Act of 2009, (TCA). Yesterday, the Vapor Technology Association (VTA) filed an amicus brief with the Supreme Court of the United States in support of a Petition for Writ of Certiorari in another RJR case asserting similar arguments against the earlier L.A. County ordinance banning all flavored tobacco products. Supreme Court review is critical for two reasons.

First, the “substantial effect on the Nation’s economy” created by the sale of tobacco products is of great significance. The passage of the TCA in 2009 led to the creation of a new, independent distribution chain of companies, including manufacturers, distributors, suppliers, and retailers, that has steadily grown outside of the traditional tobacco products industry, offering their customers non-combustible nicotine vapor products as alternatives to smoking cigarettes. According to a new economic impact report (prepared by John Dunham & Associates), 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.

This industry would be devastated by unrestricted flavor bans, given its unique and substantial reliance on the sale of flavored vapor products to adult consumers. Importantly, the potential shutdown of close to 10,000 businesses, causing the loss of 99,158 full-time equivalent (FTE) 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 makes the issue before the Court incredibly important. In the state of California, where the majority of e-liquid manufacturers of the independent vapor products industry are based, losses would total approximately 6,925 FTE jobs, paying $445,565,776 in wages and benefits, and the economic output of the California economy would be diminished by $1,497,332,882 if flavored vapor products could not be sold. 

Second, since the passage of the L.A. County Ordinance – leading tobacco-control scientists have challenged the notion of banning flavored e-cigarette flavors and have warned that decreasing availability of flavored vaping products harms the ability of adult smokers to quit smoking cigarettes. Instead of blanket bans, these tobacco-control scientists endorse alternative time, place and manner restrictions for the sale of flavored vaping products.

Permitting local and state governments to implement unscientific bans that directly interfere with the fundamental purpose of the TCA and would overrule the FDA’s decision-making for products deemed appropriate for the protection of public health, is not only unlawful, but is dangerous from a public health perspective, in VTA’s view.

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.

Here’s Why the FDA’s Vaping Policy Should Change

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Comments of the Vapor Technology Association

Presented by Tony Abboud, Executive Director

INTRODUCTION

Good morning.  The Reagan-Udall Foundation’s mission[1] of “modernization,… accelerating innovation and enhancing product safety” could not be better applied to any other product category within the FDA’s ambit of authority than less harmful nicotine products.

This review couldn’t have come at a more important time and Commissioner Califf should be applauded for calling for it and Director King should be applauded for embracing it. FDA’s new leaders have an historic opportunity to dramatically change public health in the U.S. by boldly correcting errors of the past, eliminating political interference in the scientific process, providing a clear roadmap for the approval of less harmful nicotine products, and accelerating innovation away from the deadliest product on the market – the combustible cigarette.

But, this will not happen, if at all, at a fast enough pace to save the lives of millions of Americans who still smoke cigarettes unless serious process changes are made.

What has the Agency done well?  

You have asked us to address three components and I will start with what the FDA has done well.

  1. In 2017, Commissioner Gottlieb announced a Comprehensive Plan for addressing tobacco and nicotine issues.  Foreseeing the challenges of PMTA compliance, Gottlieb extended the deadline for filing from 2018 to 2022 since the agency still needed to “issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers.” The comprehensive plan also expressly acknowledged the continuum frisk and that ENDS products fall at the lower end of the risk continuum when compared to cigarettes.
  2. CTP issued an ANPRM on the important issue of flavors to examine their impact on initiation and on smoking cessation.
  3. CTP has effectively administered its Substantial Equivalence application process for reviewing new tobacco products.  

What has the Agency not done well?

Unfortunately, these positive steps have not led to the successful execution of CTP’s mission.

Since January 2020, CTP’s efficient management of the SE process has bizarrely resulted in the authorization of 600 new combustible tobacco products, 250 of which are new cigarettes. In contrast, FDA’s management of the PMTA process has authorized only 6 less harmful ENDS devices, some of which are antiquated technologies and/or have virtually no market presence.  How did this happen?

First, the FDA abandoned its Comprehensive Plan and did everything but create the “efficient, predictable, and transparent” process Gottlieb said was necessary. 

CTP never finalized the “foundational rule” for PMTAs before applications were filed and it acquiesced to a 2-year acceleration of the filing deadline notwithstanding the unavailability of that final rule. This forced companies to rely on non-binding guidance, rush scientific research and data collection, submit redundant applications, and conduct unnecessary testing. 

Second, CTP failed to apply the continuum of risk in its comparative assessment of ENDS to cigarettes and also failed to distinguish between open and closed ENDS products.

Third, CTP abandoned its ANPRM on flavors in 2018, ignoring the enormous body of science presented by all stakeholders, including VTA’s substantive review of all flavor studies.

Fourth, CTP altered its review process and standards AFTER applications had been accepted for substantive review, using those changes to deny countless PMTAs all without conducting that substantive review, and failed to balance all the prongs of the APPH test, choosing instead to use single alleged deficiencies to deny applications.

These actions plunged the entire category into chaos and CTP’s decisions into protracted litigation.

This was all driven by an exclusive focus on youth and flavors which has been directly criticized by the 15 past presidents of SRNT, the most esteemed group of tobacco-control scientists, as threatening the chances of adult smokers to quit. I’ll briefly explain one example of how the Agency’s prior interim leadership allowed outside influences to subvert the PMTA scientific process on this issue alone.  

Flavor Example

In August 2020, CTP’s Office of Science documented its process for reviewing applications for flavored ENDS products and explained that it anticipated approving such products as APPH.  At a June 11, 2021 public meeting, the Office of Science transparently explained the process and priorities it was using to review PMTAs.

Two weeks later, when FDA’s Acting Commissioner Woodcock testified before a Congressional committee on June 23, committee members demanded that Woodcock deny JUUL’s PMTAs and deny any flavored e-liquid PMTAs claiming thatwas her responsibility regardless of the science.

Immediately after the hearing, I learned from those inside the FDA that Woodcock injected herself on the  flavor issue. Two weeks thereafter, CTP documented Woodcock’s interjection in a now infamous July 9 “fatal flaw” memorandum, explaining that the Office of Science was “tasked” by the Acting Commissioner to implement a “new plan” to “take final action” on as many flavored ENDS applications as possible – a complete reversal of both the process and priorities they announced less than one month earlier.

The memorandum articulated a review process which imposed a new testing prerequisite, 11 months after the applications were filed. CTP created a new “presumption” that all flavored products are attractive to youth to justify the new requirement for long-term product specific studies on cessation and a heightened standard for flavored ENDS.  CTP’s scientists were forced to alter their process to ensure the blanket rejection of virtually all flavored applications and did so without even reviewing the applications and science submitted.  The process change effectuated a de facto policy change and as it was unfolding in September 2021, I heard from people inside FDA who were stunned that the Agency had changed its position “without any scientific support.”

This leads me to recommendations.

RECOMMENDATIONS

  1. CTP must implement safeguards to ensure that the review process is free of external pressures. I have only highlighted one of many examples. Unless the process is insulated, CTP will never be allowed to execute its mission.
  2. Unapologetically follow the science and announce approvals.  The Office of Science must be allowed to complete its reviews and when it authorizes applications, those decisions should immediately and loudly be announced to the marketplace. 
  3. Immediately reverse the fatal flaw memo and actually review the science presented.  This means not imposing a non-product-specific presumption regarding initiation (i.e. that ALL flavored products are attractive to youth) while demanding “product specific” data regarding cessation.
  4. Restore the primacy of APPH balancing test. This means treating the cessation and population benefits prong equally to the initiation prong.  This means conducting a holistic review and not singling out one set of data on which it justifies denials.
  5. Use CTP’s enforcement discretion to work companies through the PMTA process.  Virtually all PMTAs have been submitted on grossly accelerated timeframe. Working with companies that can comply with the requirements and providing them the time necessary to complete the required science ensures a stronger process. This particularly applies to FDA’s recently acquired non-tobacco nicotine authority. This also applies to smaller manufacturers who don’t have large scientific staff or resources.
  6. Avoid rejections based on administrative or technical failings.  CTP has refused to accept certain otherwise robust applications because of technicalities. In these cases, reviewers should be authorized to pick up the phone and get those technicalities cured, rather than plunge the agency into protracted and wasteful litigation
  7. Establish defined testing methods.  This should be done for HPHC testing and while ensuring those methods are consistent with normal human use.
  8. Eliminate redundant and unnecessary testing.  For example, biomarker studies and inhalation studies are irrelevant when companies have presented data showing a dramatic reduction (or absence) of toxins.
  9. Use the full scope of its post-marketing order authority. In balancing the APPH, CTP should rely on post-market surveillance and post-market consumer studies to monitor its authorizations and suspend or withdraw a marketing order if it finds new evidence would so justify it.
  10. Equally fund research proposals.  FDA funded research is critical to the review process. To date, the agency has only funded research purporting to identify problems, i.e., youth initiation. CTP should equally fund research on smoking cessation.

CONCLUSION

In conclusion, today, CTP is stuck, trapped if you will, managing a monstrous rule of its own creation.  It needs direction from this Foundation to impose a transparent set of requirements and to ensure strict and fair adherence to science-based decisions.  As a final note, CTP needs to appreciate that the entire application approval process is being made virtually irrelevant due to the Agency’s inability to stop the flow of products into this country from companies ignoring the regulatory process. It is our hope that the Reagan-Udall Foundation’s review will ultimately create an “efficient, predictable, and transparent” process and, in so doing, make real the promise of less harmful nicotine products.

[1] Mission of R/U and mission of the FDA: “The Reagan-Udall Foundation for the Food and Drug Administration is an independent 501(c)(3) organization created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”

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