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.

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[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.”