Tag: Chris Howard

An Optimistic Look Back

Credit: Sunshower Shots
The vapor industry may finally be able to be optimistic about the future after 2023’s roller coaster ride.
By Chris Howard
In February of this year, Vapor Voice published my reflections on my past 11 years affiliated with the vapor industry. And while many would say that the vapor industry has been a roller coaster, I remain firm in my belief that a place for vapor products exists in a United States harm reduction strategy. That said, the way things are going at present, it could be years before we see this materialize.
At the end of yet another tumultuous year for the vapor industry and the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), now seems like a good time to review my perceptions from February. What have we seen in 2023? On the one hand, the CTP is clearly reacting to the Reagan-Udall Foundation (RUF) process.
The center is prioritizing stakeholder engagement with, for example, in-person visits between Director Brian King and companies throughout the industry and a recent public meeting on the premarket tobacco product application (PMTA) process. Cynics, on the other hand, would be quick to criticize the center, as flavored disposable vapor products appear virtually unrestricted in retail stores across the nation and the PMTA process remains stagnant. Moreover, the progression to more vapor marketing denial orders (menthol) and the promotion of more bans and prohibitions (flavors, cigars, menthol) are also troublesome.
With the above in mind, let’s reflect on what I wrote earlier this year (see “Head in the Clouds,” Vapor Voice, Issue 2, 2023) and discuss what lies ahead in 2024 and beyond.
Make a Long Story Short
In February, I wrote about suggestions from the RUF for the CTP to provide “more detailed summaries of applications that have made it through the process—so that industry can place emphasis on areas that the agency deems to be a higher priority and eliminate superfluous activities that ultimately add little value. Doing this and taking steps to simplify the requirements would ultimately enable both the industry and the CTP to employ a more focused approach, resulting in greater efficiency for all involved.”
The good news is that FDA leadership continues to signal this is a priority for the agency. Moreover, the FDA recently held a public meeting in which they provided additional insight regarding the PMTA process that many in the industry have been seeking. Unfortunately, thousands of PMTAs remain pending, and it is unclear how the FDA will handle this existing burden. Expectations remain high for 2024, and I am optimistic we will see progress soon.
You Get Out What You Put In
Reflecting on the difficulty of the PMTA process, I pointed out the exceptionally high standard the FDA has set for premarket review and that companies cannot take shortcuts and expect good results. We all recognize the standards set for tobacco-derived nicotine products are very high, and many applications fell short of even the minimum requirements.
Looking forward, we should expect this high standard to also be applied to PMTAs filed for nontobacco nicotine (NTN) products. The CTP will apply the same rigor when reviewing NTN products—likely with similar results. Industry cannot expect to file short shrift applications and receive market orders. Time, rigor and resources are required to be successful.
Don’t Hold Your Breath
Credit: Ezume Images
Recall that I suggested it would take the FDA considerable time to increase the efficiency of the PMTA approval process. This continues to be true. And now even more stakeholders are voicing this same concern. Most recently, the Health and Human Services Office of the Inspector General (OIG) published a report titled “The Food and Drug Administration Needs to Improve the Premarket Tobacco Application Review Process for Electronic Nicotine-Delivery Systems to Protect Public Health.”
The OIG audit, in part, focused on the CTP’s inability to review PMTAs within the statutory timeframes and contained a key recommendation “that CTP work with the Office of Personnel Management to obtain direct-hire authority to assist CTP in reaching its full-time equivalent personnel goal and assess the PMTA review process and develop an action plan to resolve the backlog of PMTA applications and achieve compliance with the 180-day statutory timeline.” Ultimately, the report offers yet another series of solutions to what appears to be insurmountable obstacles faced by the FDA.
On the flipside, as the CTP learns more and, hopefully, becomes more efficient in application review, we will most certainly begin to see a more consistent and reliable process. While nothing on the horizon suggests the evidence required to satisfy the “appropriate for the protection of public health” (APPH) standard will lessen, my hope is that we are approaching some level of predictability that will enable companies to refocus on innovation and invest in reduced-harm products.
Two Wrongs Don’t Make a Right
Credit: Jon Anders Wiken
In February, I suggested two wrongs were prevalent in the vapor space. One was the uptick of youth use of vapor products. The other was the sensationalized public health response prioritizing prohibition and often disregarding the opportunity lost by adult smokers seeking alternatives to cigarettes. While we certainly haven’t seen much movement from many in public health, we have seen progress when it comes to youth choices.
In 2019, the National Youth Tobacco Survey (NYTS) reported a shocking 20 percent past 30-day (high school and middle school combined) e-cigarette use. The 2019 report also indicated 27.5 percent of high school students and 10.5 percent of middle school students used e-cigarettes in the past 30 days. Fast-forward four short years and those numbers have decreased dramatically. In 2023, the NYTS reported significant reductions with 7.7 percent overall, 10 percent high school and 4.6 percent middle school past 30-day e-cigarette use. These results clearly indicate that tools like Tobacco 21, public education campaigns and parental engagement work to change youth behaviors.
And it’s worth noting that this reduction occurred despite the proliferation of the noncompliant flavored disposable e-cigarettes available throughout the nation. Unfortunately, instead of lauding success and working to make electronic nicotine-delivery systems more available to adult cigarette smokers, prohibition remains a priority for many, so we still have work to do to prioritize the benefits of reduced harm products for smokers.
When Life Gives You Lemons, Make Lemonade
Credit: Pontus
In February, I indicated, “smokers deserve our efforts to offer satisfying, reduced harm products ….” I still believe that a place for innovation exists in the vapor space. As technology develops and youth vaping numbers continue to decline, new opportunities are inevitable. Of course, the pitfalls associated with long lead time (and expensive) PMTA data development and even longer agency review processes still impede modernization of the category.
That said, the hope is that a better, more predictable, timely and stable review process will take hold. To effect this change, vapor advocates must continue to hold the CTP accountable for implementing reforms in line with RUF recommendations. To be clear, this is a total industry effort. By weeding out bad actors, promoting compliance and continuing to advocate for the lives of smokers, we can succeed in this effort.
I closed my article in February with the hope that I would look back at the end of 2023 to see that the CTP has evolved and used the RUF report to prioritize the continuum of risk and move harm reduction forward. Are we there yet? Unfortunately, no. But that said, I am optimistic that the worst is behind us. Vapor advocates are not giving up, and they don’t seem like they will throw in the towel anytime soon.
More and more smokers are quitting cigarettes with vapor products. And the FDA is gradually making changes to increase efficiency and effectiveness. Hopefully by this time next year, we will be in an even better place with the increased certainty we are seeking.
Chris Howard is executive vice president of new product compliance and external affairs for Swisher and former senior vice president, general counsel and chief compliance officer for E-Alternative Solutions.
December 31, 2023
Head in the Clouds

Credit: James Thew
A vaping industry veteran uses some time-tested adages to reflect on his 11 years in the space.
By Chris Howard
In the new year, as I reflect on my past 11 years of experiences in the vapor space, I think it is better late than never to share some thoughts on where we have been and where we should be headed. Because we are never too old to learn, I thought I would strike while the iron is hot (hopefully you can see the theme here).
From 2018 to 2021, the industry suffered incalculable upheaval and uncertainty as we went through a shortened premarket tobacco product application (PMTA) period and a seemingly never-ending series of marketing denial orders (MDOs). While 2022 wasn’t necessarily any better for industry, it sure got a lot worse for the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP).
To recap, we saw multiple challenges to MDOs that shed some inconvenient light on the CTP review processes. We also witnessed significant delays in the CTP’s ability to meet the Maryland Court-imposed deadlines. Congress regularly attacked the CTP (and the greater FDA) for perceived shortcomings. And, finally, we saw the results of the Reagan-Udall Foundation review that, even with the soft touch given to the CTP, did not paint a flattering picture of the workings of our regulator. In all, it was a rough year for a new center director and the staff.
With the above in mind, a few time-tested adages can aptly describe my reflection on the vapor industry—which I offer here for your consideration:
Make a Long Story Short. After nearly seven years since the finalization of the Deeming Rule, the CTP and industry have collectively learned that some of the standards/requirements making up the PMTA process could be streamlined to say the least. By way of example, does the CTP really need for each company to spend thousands of dollars on the same literature review? Are behavioral surveys to show youth aren’t attracted to tobacco-flavored products necessary at this point?
Are there other commonalities across numerous applications that could now be updated or otherwise removed from consideration given consistent findings? As suggested by the Reagan-Udall Foundation, the CTP should consider providing more detailed summaries of applications that have made it through the process—so that industry can place emphasis on areas that the agency deems to be a higher priority and eliminate superfluous activities that ultimately add little value. Doing this and taking steps to simplify the requirements would ultimately enable both the industry and the CTP to employ a more focused approach, resulting in greater efficiency for all involved.
You Get Out What You Put In. Applicants who skimped and filed weak applications without regard to the requirements set forth by the CTP have nearly universally learned a valuable lesson. The PMTA process is expensive, and extremely rigorous science is required to show that your products are appropriate for the protection of public health (APPH). While many sought shortcuts and/or complain that the CTP’s guidance is unclear and/or vague, several companies have demonstrated that vapor products can indeed meet the FDA’s high standards.
Which companies are these? These are the companies who expended significant time and resources to develop robust applications covering each scientific discipline and other requirements set forth in the June 2019 “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems, Guidance for Industry” and in the November 2021 Final Rule regarding “Premarket Tobacco Applications and Recordkeeping Requirements.”
Don’t Hold Your Breath. It’s hard to believe it now, but there was a time when both applicants and the CTP shared an optimism that reviews of applications could be accomplished in accordance with the prescribed timeline. This “certainty” provided an objective framework enabling industry to develop various business plans for all deemed products in the pipeline.
Unfortunately, the ultimate glut of applications proved to be an insurmountable burden for the FDA—resulting in nearly all timelines falling by the wayside. For anyone with pending PMTAs and for those manufacturers contemplating filing new PMTAs, don’t expect to obtain results quickly. Hopefully, the CTP will adopt some of the recommendations contained in the Reagan-Udall Foundation report to increase its overall efficiency and enable the industry to plan more effectively.
When Life Gives You Lemons, Make Lemonade. For innovators in the vapor space, initially life was very good. They had a great product that was considered profitable and a key to moving harm reduction forward. Unfortunately, things didn’t go exactly as expected, and life gave everyone in the vapor space lemons—and a huge basket of lemons at that. We had youth vaping; e-cigarette or vaping product use-associated lung injury (EVALI); near constant, questionable scientific studies demonizing electronic nicotine-delivery systems (ENDS); state and federal legislation to tax, limit and ban; a regulatory agency that swept the market nearly clean of flavored products—the list goes on.
It’s quite easy to despair, but now is the time to make lemonade. As an industry, we need to innovate within the narrow confines provided. We need to continue to ensure that the FDA makes its decisions based on science while we develop improved nonflavored options and better marketing schemes to prevent youth exposure. Smokers deserve our efforts to offer satisfying, reduced-harm products—I’m confident this innovative and adaptable industry can do just that.
It’s Not Over Until It’s Over. Over the past 11 years, I have seen so many industry advocates walk away from the vapor category due to a variety of circumstances. Unfortunately, with each powerful voice that leaves, the ultimate goal of ensuring that vapor products are an important part of an FDA-sponsored harm reduction platform becomes even more difficult to reach. In my opinion, the story isn’t over. Several vapor products have received market granted orders, and I expect that we will see more in the near future.
Moreover, additional studies continue to show the obvious health benefits of vapor products as compared to combustible cigarettes and that they are a valuable tool for adult smokers seeking to quit. Maybe owning a vape store and selling thousands of flavors isn’t on the horizon, but helping smokers seeking alternatives can still be a meaningful priority. I encourage past and current members of the vapor community to revisit their priorities with a new focus on educating the public—even if the journey hasn’t been as fulfilling as you hoped it might be.
Two Wrongs Don’t Make a Right. In case anyone missed it, several young people decided to experiment with vapor products a few years ago. Fortunately, that trend is unquestionably subsiding thanks to the introduction of T21 and the gradual decrease in the “fad” of vaping. It certainly isn’t right to (and no responsible manufacturer should) sell ENDS products to or in a manner attractive to kids. Unfortunately, the handling of the regulation of ENDS and, more particularly, flavored ENDS by both public health commentators and regulators is also wrong.
In 2016–2017, ENDS were the next best thing. They held the promise and potential to restructure the tobacco use market in the United States from combustible cigarette death and disease to an inhalable nicotine product that reduces risk and disease burden. The “second wrong” in response to Juul, EVALI, the abandonment of harm reduction and an avalanche of inaccurate reporting, propaganda and sensationalism resulted in the gutting of the flavored ENDS space (most of which did not have a youth vaping issue) in the form of refuse-to-file letters and MDOs based on a seemingly arbitrary solution.
These two wrongs, when coupled, don’t make a right—what these two wrongs make is a missed public health opportunity. Unlike the United Kingdom, which has embraced ENDS and driven down smoking rates, the U.S. has moved in the opposite direction—vilifying, banning and restricting. In this case, the two wrongs will result in increased smoking and increased disease.
The Perfect is the Enemy of the Good. As the PMTA review picture gains incremental clarity, we often see policy of pursuit of perfection (e.g., ill-defined demands for long-term cessation trials for flavored products). Whether this pursuit is expedient to remove disfavored products or flavors from the market or we are seeing the level of evidence required to gain a market order rise to a standard only found in the drug center is for you to consider.
However, the net effect is an increasingly complex (and expensive) set of criteria to satisfy the APPH standard. The public health standard, however, should not be a pursuit of perfection—it should be a pursuit of decreasing cigarette smoking mortality and morbidity. While there may be risks associated with some of the reduced-harm products, those risks are dramatically fewer than those posed by cigarettes. Accepting reasonable evidence to support reduction of harm to enact lifesaving and life-extending regulatory policy just makes good sense.
Don’t Miss the Forest for the Trees. Throughout the public health community, harm reduction principles are embraced and promoted to reduce the harms related with drugs, sex and other potentially harmful activities. For some reason, though, with rare exception, nicotine and combustible cigarette smokers don’t seem to merit a harm reduction strategy.
In the face of 460,000 smoker deaths each year, prudent regulatory policy would embrace products down the spectrum of risks—not ban them. European regulators have seen the forest—they promote reduced-harm products while discouraging combustible cigarette smoking. In the U.S., unfortunately, we ran into the first sapling off the trail and haven’t really progressed from there.
While the past 11 years have provided many ups and downs in the vapor space (a lot of downs), I’m hopeful that we can turn a corner in 2023 and beyond. In the past, it seemed like it was the vapor industry versus the world. Today, however, it is possible that we are at the dawn of a new era of tobacco regulation.
My hope is that when I look back on the next 11 years, the CTP has learned from the missteps of the past. I hope the center uses the valuable insights it has been provided, like the findings in the Reagan-Udall Foundation report, to reorient the center on not just prohibiting products but rather crafting policy and standards that assist combustible cigarette smokers in moving away from those harmful products. I hope to look back on tobacco control policy that doesn’t just involve saying “no” to every option but rather embraces harm reduction and doesn’t leave smokers behind. Maybe we can have our cake and eat it too.
Chris Howard is executive vice president of new product compliance and external affairs for Swisher and former senior vice president, general counsel and chief compliance officer for E-Alternative Solutions.

February 28, 2023
EAS Offers an Inside Perspective to CTP Review
By Chris Howard and Rich Hill
Recently, U.S. Food and Drug Administration Commissioner Robert Califf announced an external evaluation of both the Human Foods Program and the Center for Tobacco Products (CTP). The FDA press release observed that “… even greater challenges lie ahead as we determine how the agency will navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant consequences for public health. To that end, the review will push toward ‘organizational excellence.’”
Califf is right—the CTP clearly requires assistance. The purpose of this article is to review how the CTP arrived in this untenable situation and to suggest areas of focus for the review of the CTP processes.
How Did We Get Here?
There is little doubt that the CTP is in an unenviable position. No matter which way the agency turns, it is impossible to please everyone. The anti-tobacco/vaping groups will never be satisfied until all tobacco products are gone—so realistic harm reduction propositions from the center will always be met with opposition. And when the CTP tries to develop policies with a focus on efficiency, many in the industry claim that they are “prohibitionist” and that they have no regard for harm reduction and/or the human and economic consequences of their decision-making.
Recently, several court opinions and CTP actions have significantly contributed to the challenging environment for the CTP:

West Virginia v. EPA. While not directly related to the CTP, the West Virginia v. EPA Supreme Court decision has reopened the question as to whether discretion of regulatory agencies may become more limited in the future. The court seems poised to chip away at longstanding doctrines (or apply them more forcefully) to limit agency power and place policymaking back with the legislature.

Cigar Association of American v. FDA. More recently, in the Cigar Association of America v. FDA case, Judge Amit Mehta of the U.S. District Court for the District of Columbia examined whether the FDA’s decision not to exempt premium cigars from the Deeming Rule was arbitrary and capricious. The court ultimately found that the FDA ignored evidence in the rulemaking record—and ruled against the agency.

Juul v. FDA. Days later, the CTP found toxicological issues with Juul’s popular vapor products and issued marketing denial orders (MDOs) for those products. Not surprisingly, Juul immediately requested and received an emergency stay of the MDOs from the D.C. Circuit. Without missing a beat, the CTP promptly “… administratively stayed the marketing denial order. The agency [determined] that there are scientific issues unique to the Juul application that warrant additional review.” Several commentators questioned the CTP’s rationale for its decision to re-review Juul’s applications, and some have gone so far as to suggest that this quick reversal indicates a less than appropriate review of Juul’s data or worse—a lack of confidence in the CTP’s decision-making. Either way, the entire chain of events draws into question the CTP’s review process.

Finally, the CTP is still under pressure to complete decisions on premarket tobacco product applications (PMTAs) for those companies addressed in the Maryland court decision which, according to the CTP, will not be completed until next summer. Further compounding the CTP’s problems, the center continues “processing” approximately 1,000,000 synthetic nicotine PMTAs past the congressional deadline for marketing decisions on July 13, 2022. How the center will respond to this pressure is anyone’s guess. So far, it seems like the CTP continues to move at its own pace, following the Maryland court’s order to the best of its abilities.
These external and internal factors point to one conclusion that cannot be ignored—the CTP appears to be struggling and needs something to change. With the above in mind, the following are a few areas ripe for external (and internal) review at the CTP.
Credit: Fizkes
Operational Changes
Operationally, the CTP seems to have the resources (personnel and budget) to successfully regulate tobacco products. That said, certain policy choices and administrative actions (both self-inflicted and externally inflicted) appear to hamper the center’s ability to effectively manage the space. Importantly, effective regulation is hamstrung by the complexity of the U.S. tobacco regulatory scheme, a lack of clear standards for product testing and approval and a too opaque product application process.
The most challenging operational issues come from the existing regulatory scheme, which is too complex for tobacco products. The Tobacco Control Act dictates the parameters/guardrails, but the CTP has latitude in how the process is implemented. The comprehensive PMTA guidance and robust final rule demand a scientific depth that goes too far. The question is: Is all of the delineated scientific data really necessary to determine that a product is appropriate for the protection of public health (APPH)?
If comparing to combustible cigarettes, it would seem that most electronic nicotine-delivery product APPH determinations could be made based on chemistry alone. Piling on bench toxicology, human factors, pharmacokinetic and behavioral studies, it’s no wonder the review process takes so long.
Standards are not clear. Without clear standards, the CTP and industry both are left constantly employing guesswork and conjecture to facilitate decision-making. While understandably there is no simple formula for APPH, clear expectations would be beneficial and efficient. By way of example, which device characteristics really need testing? What is the depth of stability testing necessary? What constitutes a sufficient PK [pharmacokinetic] study? While the initial meeting with the Office of Science is often useful to help answer questions like these, better defining product-specific standards and setting minimums would go a long way to streamlining the approval process.
Transparency is lacking. While one can review the Technical Project Lead Reviews and some of the review standards memos that the CTP places on its website, few PMTA applicants have any idea what’s going on with their applications at any given time. Other than the initial pre-PMTA meeting and the sole deficiency letter, there is little that applicants know about the status (both administratively and substantively) of their applications. While more transparency about the status of applications would be welcome, more back and forth on issues in applications would benefit everyone—particularly the CTP. In the case of Juul, reports indicate that Juul provided thousands of pages of data related to the toxicological issue that the CTP raised in the MDOs. If the now outdated additional information requests were utilized by the CTP, Juul would have pointed out this data, and at least one issue could have been resolved well short of a trip to the courthouse.
Credit: Oleg
Policy Changes
It goes without saying that U.S. government policy can be fickle to say the least. Setting and maintaining long-term policy is difficult—especially in light of changing administrations every few years. Despite this, overriding policy tenants as they relate to harm reduction can, and should, form the cornerstone of tobacco regulatory policy. If harm reduction is the priority, then regulators need to prioritize pathways for reduced-harm products to enter the market, incentivize innovation and focus on providing offramps to combustible cigarette smokers seeking to quit smoking.
Harm reduction policy. During the tenure of former Commissioner Gottlieb at the FDA, many in the industry thought harm reduction would prevail and that all would recognize vapor products’ place at the opposite end of the continuum of risk from combustible cigarettes. Unfortunately, the significant uptick in youth experimentation with a few types of vapor products prodded the CTP into a tough position. Public health groups, dissatisfied with the CTP’s pace, forced the center into a corner via litigation.
Assuming the goal of the Tobacco Control Act remains to reduce smoking-related morbidity and mortality, harm reduction strategies are central to achieving that goal. Importantly, harm reduction strategies should be palatable to all stakeholders. While the CTP has several initiatives moving forward, is there a plan for initiatives dedicated to moving smokers to safer alternatives? Efforts to move smokers to less risky alternatives do nothing when those less risky alternatives cannot succeed via the PMTA pathway. Current tobacco policy is remarkably dissimilar from the variety of strategies employed for other unsafe behaviors where harm reduction is embraced as the primary alternative. In areas such as drug use and sexually transmitted diseases, our society generally accepts reduced-harm efforts, but for tobacco, collectively we are still searching for that sweet spot.
Given all the challenges that the CTP faces, working on harm reduction policies hand-in-glove with nongovernmental groups and industry probably does not seem like the best use of time. When the center was first formed, frequent scientific meetings were held on various issues (such as harmful and potentially harmful constituents). These have fallen off in recent years, likely in part due to Covid and also due to the onerous demands on the center. Prioritizing genuine and open conversations between the CTP, industry and tobacco control groups is critical to developing strong harm reduction policies. Holding scientific meetings (either through the CTP or the Tobacco Products Scientific Advisory Committee) on harm reduction plans and policies would add transparency and bring all ideas to the table.
The FDA should not let the perfect be the enemy of the good when considering reduced-harm products. At present, PMTA reviews appear to be searching for the perfect. Reviews seem to focus on the smallest details that might pose a risk while ignoring a more generalized comparison to combustible products with 70 known carcinogens (and a track record of 480,000 deaths per year). APPH does not mean no risk—it means less risk than the deadliest consumer product ever invented, the combustible cigarette. Reconsidering how APPH is adjudged would be an excellent first step in combatting morbidity and mortality attributable to smoking.
Investing in harm reduction must be incentivized. If one wants to develop a new product, the timeline is a hard stop. A year of product development, up to three years of PMTA testing (including two years of stability and time to plan, conduct and write up the studies) plus one year to three years of the CTP review before the possibility of a marketing order sounds like a pretty poor investment. The PMTA process must change to bring less risky products more rapidly to market.
Society must not forget about smokers. Youth tobacco issues are important, but the 1,300 smokers dying each day are important too. A balanced harm reduction policy—controlling youth access and exposure while moving combustible cigarette smokers to quitting tobacco altogether or moving to a less risky product is necessary.
Moving Forward
Hopefully the external review will be a fruitful exercise—one that provides robust alternatives for the CTP to consider. The review, if rightly focused, will address foundational issues that will, in the end, lead tobacco regulation to a reasonable, reduced-harm world where smokers are given hope for a future.

Chris Howard is vice president, general counsel and chief compliance officer at E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands.
Rich Hill is the compliance director and associate general counsel of E-Alternative Solutions.
August 22, 2022
What’s Next for Vapor?

The long roller coaster ride for the vapor industry will likely continue for the foreseeable future.
By Chris Howard and Rich Hill
It’s been a long and arduous journey since the finalization of the Deeming Rule in 2016. As most of you will recall, this was the moment when we transitioned from operating in an unregulated market to plowing forward under a complicated and onerous regulatory scheme in the blink of an eye. Shortly thereafter, the U.S. Food and Drug Administration announced a renewed prioritization of harm reduction and proclaimed that vapor could play a leading role in that effort.
Chris Howard
Rich Hill
Then, as quickly as a bright future for harm reduction blossomed, the lights dimmed, and vapor became the villain in the harm reduction story overnight. In addition to paralyzing propaganda and misplaced demonization by activist groups throughout the U.S., the industry also faced an onslaught of crippling requirements associated with a 10-month window to submit premarket tobacco product applications (PMTAs). Costing millions of dollars, 99 percent of the PMTAs ultimately submitted to the FDA’s Center for Tobacco Products (CTP) were summarily rejected based upon a standard, akin to a clinical cessation trial, that none in the industry expected.
As of the date of this writing, some of the largest players in the e-liquid space have closed their doors or have moved into yet another risky proposition—synthetic nicotine. Despite the setbacks over the past several years, many still believe reports of vapor’s death as a harm reduction tool are greatly exaggerated. Notwithstanding this cautious optimism, it is clear that 2022 is going to be yet another difficult year for the vapor category.
Current state as we enter 2022
As we enter 2022, much of the flavored e-liquid market is gone and may never return. While we have seen marketing orders for first-generation e-cigarettes and tobacco disks that are no longer marketed, we have not seen marketing orders for any modern electronic nicotine-delivery system (ENDS) or oral nicotine products. We have seen a marketing order for a combustible low-nicotine cigarette, along with a reduced exposure order for the same. While litigation continues around the rejected PMTAs, the FDA still lacks a commissioner, and we have no knowledge of who will replace retiring CTP Director Mitch Zeller. Most importantly, other than removing flavors from the market, we have no clear understanding of the FDA’s harm reduction strategy.
Predicting the future in 2022
PMTAs. Few question the fact that the CTP was given a Herculean task by the Maryland federal court. Processing, let alone reviewing, 6.5 million PMTAs in a year was unquestionably an impossible requirement. Candidly, the fact that the CTP was able to get the majority through acceptance and filing was a significant achievement. Of course, for most reading this, the outcome was obviously disappointing as nearly all requests for marketing orders for flavored ENDS products were rejected in late 2021. As the various challenges to the marketing denial orders play out over the next year, many hold out hope that the CTP will be found to have violated the Administrative Procedures Act and/or acted arbitrarily or capriciously in its decision-making process.
Credit: JHVEPhoto
With respect to those applications that remain pending with the CTP (primarily tobacco and menthol flavors, pod systems and disposable devices), we believe the FDA will issue marketing orders for several tobacco-flavored pods and disposable e-cigarettes in 2022. Assuming the remaining applications otherwise meet the statutory standards, there is little reason for the CTP to deny applications for tobacco-flavored pods, e-liquids and disposables given the evidence that such products are not particularly attractive to youth. That said, we question whether any action will occur before the new FDA commissioner and CTP director are in place and have an opportunity to address policy concerns.
As for menthol offerings, we anticipate that the FDA will not act until the proposed product standard banning menthol is released. It was interesting to note that a menthol-flavored combustible cigarette with lower nicotine levels was granted an exposure modification order. The CTP’s action may indicate a desire to provide “off-ramps” for combustible menthol cigarette smokers in a world where menthol cigarettes are potentially banned. Ideally, the CTP will grant marketing orders for menthol-flavored ENDS to provide an alternative product for current menthol cigarette smokers. This would provide a potential cessation or maintenance product to the millions of menthol smokers in the U.S.—thus reducing the risk of the formation of black and gray market activities.
Credit: SYCprod
Finally, marketing orders for flavored ENDS products seem unlikely in 2022. If the clinical cessation trial/longitudinal cohort study requirement proves to be administratively appropriate, it would seem difficult, if not impossible, that any flavored product will even make it to the review phase with such data for six months to 12 months at a minimum. Even then, it is an open question as to how much and what kind of data will be deemed to be sufficient by the CTP. We see a world where flavored ENDS are once again marketed, but it seems unlikely to occur in the near future.
Product standards. We have all heard that the CTP intends to issue draft product standards banning both menthol in cigarettes and flavored cigars by April of this year. These purported product standards, along with the recent marketing orders granted for lower nicotine combustible cigarettes, are telling with where the focus of the FDA’s policy stands. The standards appear to demonstrate an agency bent on removing any flavors from combustible tobacco products unless those products cannot create or sustain addiction. We can be assured that the product standards will face a blizzard of regulatory and legal challenges and will likely take many years to implement.
Synthetic nicotine. A few months ago, synthetic nicotine seemed like the last bastion of flavored ENDS products in the marketplace. While these products currently do not have a regulatory home, we fully expect that the existing legislative efforts will ultimately provide the CTP the authority to regulate synthetic nicotine. Once granted, all regulatory requirements for deemed tobacco products will apply, such as PMTAs. In the unlikely event Congress does not successfully provide such authority, we expect state legislatures to address the issue with prohibitive laws banning synthetic nicotine.
FDA administration. One wildcard in the mix is the turnover in key personnel at the FDA. In his largely collegial confirmation hearing, the commissioner nominee, Robert Califf, stated that his top two priorities upon confirmation were not tobacco related. Rather, he intends to focus on (a) emergency preparedness and response and (b) patient and consumer protection through “systematic evidence generation” related to medical and food products. While he faced few questions on tobacco-related issues, many skeptics believe his views toward tobacco products are similar to the current administration. Whether he will take a proactive stance toward prioritizing harm reduction is unknown.
Credit: Neil Lockhart
Unfortunately, Zeller’s retirement removes a harm reduction proponent. What can we expect in a replacement? In short, the most likely replacement will be a candidate who has solid tobacco control chops and is aligned with the current policy flow against flavored products. We don’t expect to see any novel tobacco control or harm reduction policies (akin to former FDA commissioner Scott Gottlieb’s approach in 2018).
The roller coaster ride continues
Unfortunately, it appears that the long roller coaster ride for the vapor industry will continue for the foreseeable future. The good news, if you can call it that, is that the Biden administration has a variety of nontobacco-related issues to address—particularly up to the mid-term elections—which could lessen the likelihood of additional draconian polices imposed on the industry. At this point, it appears that 2022 will be about waiting—waiting for court decisions, waiting for policymakers and waiting for policy decisions.
We won’t be so naive as to say that things can’t get worse in 2022. That said, if you have made it this far, now certainly doesn’t seem like the time to give up.
Chris Howard is vice president, general counsel and chief compliance officer, and Rich Hill is compliance director and associate general counsel of E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands.

February 21, 2022
Howard: Will Harm Reduction Prevail?

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It could be some time before the U.S. Food and Drug Administration issues marketing orders for flavored vapor products.
By Chris Howard
For the past 10 years, we have ridden a rollercoaster together. We have experienced the same highs and lows and shared the hope that harm reduction will prevail in the end. Then, over the course of the past several weeks, the journey ended abruptly with marketing denial orders (MDOs) for so many. Not surprisingly, several question whether the vapor industry can ever recover.
The FDA’s Recent Actions
For what it’s worth, the recent actions of the U.S. Food and Drug Administration should not have been a surprise to anyone in the vapor industry. We have known for several years that being part of a highly regulated segment would not be easy. In fact, the FDA made its expectations clear in its 2016 Draft Guidance entitled Premarket Tobacco Product Applications for Electronic Nicotine-Delivery Systems (ENDS). In sum, this document revealed that obtaining a marketing order for vapor products would require scientific expertise, extensive data development and very deep pockets.
That said, the FDA’s rationale for such broad-based denials has raised questions among many. More specifically, the FDA provided the following rationale in its Aug. 26, 2021, news release:
In light of the public health threat posed by the well-documented, alarming levels of youth use of flavored ENDS, the agency has reviewed the applications subject to this action to determine whether there is sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth. Based on existing scientific evidence and the agency’s experience conducting premarket reviews, the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study, although the agency does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable.
Chris Howard
The primary question we are left to ponder is whether this balancing of interests exceeds the FDA’s standard for assessing whether a product is appropriate for the protection of public health. Based on Section 910 of the Tobacco Control Act, which describes the appropriate standard of review, it appears that this balancing is one of many facets of an application that the FDA is required to consider.
Appropriate for the Protection of Public Health
Section 910 of the Tobacco Control Act provides the FDA’s standard of review for new tobacco products:
…whether the marketing of a tobacco product for which an application has been submitted is appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account—
(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and
(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.
So clearly, the risk of initiation of flavored ENDS products by youth is relevant as is the likelihood of ceasing use by smokers generally. Without a doubt, the FDA has determined that evidence related to part (A)—cessation—must outweigh part (B), initiation. This risk balancing, in the FDA’s own words, is reflected in data from clinical studies or longitudinal studies demonstrating that adult use of flavored ENDS leads to cessation (or switching) outcomes that exceed the risk of youth initiation of tobacco product use. And yet, despite this seeming clarity, many questions surround this analysis. For example, by how much must adult cessation exceed youth initiation? What if both tobacco varieties and flavored varieties show the same or similar cessation rates? Has the FDA considered the reduction in use by youth resulting from the recent change in the age to purchase tobacco products to 21 when examining the balancing of risks versus benefits?
These questions are likely to remain unanswered for quite some time. Many committed companies are already beginning efforts to satisfy the FDA’s outstanding requests for clinical studies and/or longitudinal data, but the development of data will take several months. Obviously, this is likely to do significant damage to an already fractured market—and even more potential damage to smokers seeking an alternative to combustible cigarettes.
Flavors Are Critical for Harm Reduction
Despite these tumultuous past few weeks, the FDA is arguably the biggest advocate for harm reduction. Given the agency’s desire to provide options to adult smokers to move away from traditional combustible cigarettes, it seems clear that a pathway for flavors to return does indeed exist.
Along with the rest of the industry and many public health researchers, I believe that the removal of all flavored products would negatively impact harm reduction efforts in the United States. Some vapers will undoubtedly return to smoking combustible cigarettes. And smokers who might have transitioned to ENDS products may now elect not to do so. In the studies conducted at my company, E-Alternative Solutions, we demonstrated that adults prefer flavors and that flavors assist adults in transitioning from combustible cigarettes to potentially less harmful alternatives. Existing literature documenting the research conducted by others also supports this proposition. Moreover, anecdotal reports are easy to find on Twitter and multiple other social media forums.
While it may not be apparent from the FDA’s recent actions, I do not believe that flavored ENDS are finished in the United States. While the bar appears high, I hope and expect, for the sake of adult smokers in this country, that we will see flavored ENDS on the U.S. market again. That said, it could take time until the agency issues market orders for flavored vapor products.
What’s Next?
The FDA’s recent decisions will likely prompt many to appeal and some to resort to litigation [at least two suits are known to have been filed already]. The FDA appears prepared to address these initiatives and is prioritizing enforcement of those failing to comply with MDOs and/or who are selling vapor products that have not undergone premarket review. While these activities are ongoing, many will begin longitudinal studies and the hard work to identify alternative methods to show the FDA that flavors are determinative in adult smokers’ efforts to switch from combustible cigarettes.
Ultimately, we will have to wait while the remainder of the story unfolds. Hopefully, the FDA will be prepared to work directly with sophisticated manufacturers to ensure that flavored ENDS can continue to play a role for adult smokers seeking alternatives.
Chris Howard is the vice president, general counsel and chief compliance officer of E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands.

October 14, 2021
Industry Experts Look Back on the PMTA Process

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As the FDA’s deadline to approve marketing applications nears, industry experts look back on the submission process.
By Chris Howard and Rich Hill
It’s been nearly a year since many of us filed premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration for new tobacco products, so now seems like a perfect time to reflect on what we took away from the experience. Below you will find a Top-10 list of learnings from the front line.
1. Everyone (and no one) is an expert.
From day one, we worked with dozens of consultants, researchers, similarly situated companies, regulators, outside counsel and other stakeholders. Which groups provided the most insight?
Answer: It certainly wasn’t the ones who claimed to definitively know everything about a particular facet of the PMTA. Rather, we felt most confident when working with those who acknowledged the inherent uncertainty in the process. The ability to speak candidly with these individuals enabled us to collaborate to best achieve our goals of meeting FDA expectations. We learned the least from those who “guaranteed” us security or made promises about what the FDA needs/wants.
2. The FDA is not the enemy.
Believe it or not, the agency isn’t out to get you. The Center for Tobacco Products (CTP) is not maliciously trying to ensure that all applications for new tobacco products are denied. Despite what you read from frustrated vapers on Twitter, the team at the CTP is doing what they are required to do—assessing whether new tobacco products are appropriate for the protection of public health.
Yes, it is expensive and requires a lot of work to meet this standard, but collaborating with the FDA is a much better approach to achieving this goal compared to taking an adversarial posture. If a combustible cigarette can receive a market order, then there is clearly a path for modern oral products and electronic cigarettes to do the same.
3. Money talks.
Unfortunately, not too many shortcuts are acceptable when it comes to a PMTA, so as a result, the entire process is expensive. While you can reduce your spend by seeking discounts, collaborating with others, etc., the fact remains that you will need to make a substantial investment in this work.
Throughout the process, we sought the best deals without sacrificing quality and looked for ways to reduce costs wherever we could, but we still spent a significant sum for our product applications. The greatest potential PMTA cost savings really begins with what products you intend to put through the process. Doing a full, scientifically sound PMTA for 1,000 stockkeeping units (SKUs) is not realistic. Make hard choices about your products in the beginning and pare your list down—this will generate your greatest cost savings.
4. Not all labs are created equal.
This may seem obvious, but just because a lab is certified, has a slick website and talks a good game doesn’t mean they have the scientific rigor or physical capacity to complete your project. Many labs jumped into the “PMTA testing game”—but the solid labs delivered on time and provided scientifically sound methods and results. How do you choose a solid partner?
Answer: Seek out laboratories that have a reputation working with your products. They don’t have to be the biggest, but they need to be experienced with the testing you are seeking. Audit them with external consultants. Do they have sufficient equipment and personnel to handle the throughput you need to finish on time (especially with competing client demands)? Ultimately, you get what you pay for. You can go to the cheapest labs, but there is no guarantee that you will get results on time or on target.
5. No kids allowed.
This goes without saying, but vapor products are obviously for adults only. We are all aware of the concerns regarding youth usage of vapor products, and you can be sure that the FDA places a priority on this topic. Take the time to describe the practices you employ to deter youth usage of your products.
Don’t try to guess the minimum you need to do to achieve the goal. Rather, show the FDA that you are willing to spare no expense when it comes to this issue. We drafted company marketing standards and have shared them industrywide to encourage others to adopt the same.
6. The perfect is the enemy of the good.
A premarket tobacco application for a handful of SKUs can consist of tens of thousands of pages. Given this, we can confidently say that forgetting to indent a paragraph is not going to be determinative in whether the FDA ultimately decides to grant you a market order.
Details obviously matter, but prioritize conveying your message(s) clearly by prioritizing substance over form. A misplaced semicolon isn’t going; to make the difference.
7. Tell your story.
Which story matters the most? Is it what you read this morning online about Juul and kids?
Answer: No, the FDA isn’t evaluating your application based on what others in the industry are doing. Your application is the opportunity to tell the story of why your products are appropriate for the protection of public health. Don’t be consumed by details about what is going on with other products.
8. From here to there
Finding a publishing partner that can handle your application is critical. Not all electronic publishers do large-scale projects. Many publishers want more time for loading and checking your application than you realistically can afford. Some publishers work with 20–30K pages exclusively (which doesn’t work as most PMTAs far exceed that page count).
Clearly communicate your timelines and ensure that your publisher’s project management teams can meet expectations. Because it’s the final step in the submission process, publication is naturally a bit of a scramble—which makes it prone to errors. Develop a dedicated quality control process so that you can confirm that your publisher submitted your complete application.
9. It’s not over until it’s over.
You will undoubtedly feel a sense of relief following the submission of your application, but we caution you to keep your eye on the prize. The FDA will inevitably have questions about your products in the form of a deficiency letter, so you need to stay focused on responding with the detail required.
These questions will come with deadlines, so do not wait until the last minute to prepare your response. Nothing would be worse than fumbling the ball at the goal line.
10. Uncertainty is the only certainty.
Anyone working in the vapor industry during the past five years knows exactly what I am talking about. The PMTA process is effectively in its infancy and, as such, several variables are subject to change. Is this a reason to give up on harm reduction and your individual goal of securing a market order?
Answer: No. Embrace the changes as they arrive and do your part to help the FDA develop a clear path forward for your future applications. This evolving regulatory environment provides an opportunity for you to help shape changes. Those who back away won’t have this luxury.
Chris Howard is the vice president, general counsel and chief compliance officer of E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands. Rich Hill serves as regulatory compliance director for E-Alternative Solutions.
August 23, 2021
Howard: CBD Market to See Regulatory Uptick in 2021

The Covid-19 pandemic slowed the regulatory process in 2020, creating an expected uptick in 2021.
By Chris Howard, special to VV
After CBD’s explosive growth in 2019 following the passage of the 2018 Farm Bill that legalized hemp, 2020 began navigation of a regulatory environment in flux. Burgeoning federal and state regulation, as well as increased research into consumer trends and tastes, begins outlining the future of CBD.
The Covid-19 pandemic slowed progress in the U.S. Food and Drug Administration’s (FDA) decision making around CBD, setting up 2021 as a crucial year for the industry, although it is unlikely that any FDA regulations will be finalized this year. Vapor industry veterans, who witnessed the regulatory battles with the FDA, are rightfully wary of the government’s efforts to oversee CBD, but the initial steps seem promising. It is still early days for the CBD industry, and the FDA appears willing to collaborate with the industry on many issues that are important to manufacturers and retailers alike.
As we look ahead, I offer some thoughts on the current CBD market, where regulatory efforts are and finally, what to expect as the CBD space matures.
State of the market
After CBD’s rise to prominence in 2019, last year represented more incremental growth. According to the Brightfield Group, a leading cannabis and CBD market research provider, the United States CBD market grew from $627 million in 2018 to over $4 billion in 2019, an increase of over 650 percent. In 2020, market growth slowed to 14 percent as CBD could be found in more stores and additional uncertainty caused retailers to tread carefully. Despite this recent modest growth, the Brightfield Group projects the CBD market will continue to grow from $4.7 billion in 2020 to nearly $15 billion by 2024.
Driving this growth is a mixture of increased consumer awareness and interest as well as improved access. Sales continue to increase in key market areas, especially e-commerce, creating more competition for CBD specialty stores and vape shops selling these products. C-stores were previously well positioned to capitalize on the market, but research from Technomic, a management consulting company, shows that consumers are being selective where they shop to better hand-pick CBD products.
Chris Howard
Consumer form factor preference (the types of products available containing CBD) has been another important area of analysis. Tinctures remain popular, especially with new CBD users. Lotions have become a huge source of interest for consumers with many over-the-counter topical, beauty and skin care companies investing heavily in these products. Refining offerings will be a key part of crafting common sense regulation and helping CBD companies make more confident investments in their product lines.
Regulations in 2021
It is no surprise that the FDA took significant interest in CBD as it quickly grew from an industry valued in the hundreds of millions to one worth billions. Yet, the agency has been slow to definitively rule on any regulations apart from taking a firm stance against companies making therapeutic or health claims, especially during the pandemic.
Where does that leave us now? The FDA’s studies into CBD are ongoing, both analyzing the effects of the compound as well as auditing the contents of current products, although progress has slowed due to Covid-19. Meanwhile, there remains some pressure from congress to create policy around CBD to act as a stopgap while the FDA creates long-term guidance.
I remain optimistic that the FDA will introduce a framework for the specific purpose of regulating products containing CBD that permits the marketing and sale of all form factors in the U.S. This includes food and dietary supplements, a source of much back and forth between CBD advocates and regulators. That said, it is unlikely that a rule will be finalized in 2021. I expect this to be subject to a lot of discussion this year. We will find out more based on how the Biden administration addresses CBD in the year ahead.
In the meantime, CBD companies are forced to navigate a labyrinth of state-by-state regulations. CSP and Grocery Business research indicates 46 states have created CBD laws. State laws can run directly counter to existing federal guidelines, such as those concerning food and beverage products—which are prohibited federally but which are permissible for sale within some states. The patchwork created by these various regulations continues to make national distribution of CBD products a challenge and in some cases even threatens the supply chain of hemp growers and manufacturers.
Looking ahead
While we await final FDA guidance on CBD, I see companies in this industry dealing with many of the same issues we’ve seen over the years in the vapor industry.
The cost of entry for many in the space will become increasingly burdensome once the FDA begins setting regulations, forcing many smaller CBD companies to exit the market. This is similar to what we have seen with PMTAs in vapor, where the larger companies have been far more well equipped to maintain a compliant product selection.
Although it has not been a concern yet, CBD companies should remain mindful and vigilant to ensure that they are taking the necessary steps to prevent youth use of CBD products. Taking a proactive stance now and preventing youth use will help avoid many of the issues faced by the vapor category over the past two years.
Although there are many complex considerations with CBD, it is hard not to get excited about this industry’s future. With continued strong market growth and an apparent pathway to sensible regulation from the FDA for sellers and consumers alike, the future remains bright. In 2021, I hope to see more progress from regulators as we continue to create a strong framework that will work to the benefit this industry and consumers for years to come.
Chris Howard is vice president, general counsel and chief compliance officer for E-Alternative Solutions.
March 5, 2021