Fixing U.S. vape regulation – twelve proposals

In practice, FDA's regulation of the US vape market amounts to not regulating at all. I offer a diagnosis and twelve remedies.

The 23 vape products authorised by the FDA for legal sale in the United States account for around one per cent of the total market in the financial year 2023, depending on estimates of the size of the untracked market and other forms of illicit trade.

In this post, I will provide a diagnosis of the problems with the FDA’s handling of its responsibilities for the regulation of safer nicotine products, notably vaping products. I finish with a set of twelve proposals to address these problems.

FDA has lost control of the U.S. vape market

In the tobacco and nicotine market, is the US FDA a tough public health regulator or an expensive and ineffective anti-American bystander? FDA poses as the former, but its performance suggests the latter.

In December, Reuters mentioned an estimate of the market share of the 23 vape products authorised by FDA:

Yet those 23 products combined represented less than 3% of e-cigarette sales in the United States from July through September, according to the Circana data. In all, the data show more than 3,000 new vaping products have been introduced to the United States market over the past year.

Reuters, China e-cigarette titan behind ‘Elf Bar’ floods the US with illegal vapes, 6 December 2023.

This is an upper estimate for the share of the “tracked market,” generally relying on scanner data from retailer chains. However, proprietary estimates of the size of the total market, including untracked and illicit sales, suggest the share of the 23 authorised products is in the range of 1.3% to 0.7%. I have approximated to 1%. It might be more, it might be less, but either way it is very little.

Is it tough? When a regulator blocks 99.9999% of the vape (ENDS) products submitted for authorisation, approving only 23 distinct products that amount to six similar systems in a single flavour, tobacco, then I guess that sounds like pretty tough regulating. What a fearless guardian of public morals and America’s young!

The vast majority of applications are dismissed without review, but thousands are held up pending review or subject to denial. Of >26 million initial applications for vapes, only 23 have been authorised through this process.

But what if we leave behind the abstract statistical world of what the FDA has authorised and denied? What if we visit the real world of consumers, shops, the internet, social media, WhatsApp groups and Telegram channels, cryptocurrencies, containerised trade, and the giant and highly innovative Shenzen vape manufacturing supercluster—essentially the world’s leading supplier? Then how does FDA’s performance look?

In the real world, we do not find a tough regulator. We find no regulator for the 99% of the market accessed by consumers—the products could be anything, made anywhere, and under any conditions. Many will be absolutely fine, high-quality products, and the result of continuing innovation in China. But some may not be. The point is the regulator is missing in action; it has lost regulatory quality control over the products people are actually using. By abdicating responsibility in this way, it is not serving the American public or public health; it is hiding from a problem of its own making while pretending the issue is resources for enforcement.

Is the answer better enforcement?

No. It is common to frame this failure as an enforcement problem. However, the enforcement challenge is a consequence of the extreme constriction placed on market entry. The “war on drugs” was seen as a problem of enforcement and taken to extremes. But I think the main lesson from the war on drugs is that the drugs won.

In this case, we not only have a robust demand for the underlying product, nicotine, but also an extreme squeeze on the safer ways to take it, and that demand will not go away because FDA doesn’t authorise the products. It is not even clear what is legal and not legal, with the FDA operating a system in which it decides using “enforcement discretion” what has de facto lawful status, even if technically illegal.

But the law is the law, right? Just suppose enforcement was the answer, and the calls to “clear the market” of unauthorised products were heeded, and the enforcement was successful. Then what?

Campaign for Tobacco-Free Kids, Press Release

What would be the effect of clearing the market on almost 18 million adult vapers over 21+? And the younger ones (2.1 million school-age adolescents use e-cigarettes (2023, NYTS)? Over 20 million Americans would be affected.

Source: Altria, Q1 2024 Quarterly metrics

What would these people do if the market was cleared? We certainly won’t learn anything about that from the Campaign for Tobacco-Free Kids or the 78 organisations that apparently think this is a good idea. They haven’t given this the slightest thought and probably do not think it is important. Yet, it could have a profoundly negative effect on public health.

Maybe some would start to smoke. The FDA regulates around 3,000 authorised, fully lawful cigarette products. For others, there will be the 23 authorised e-cigarettes, but few are likely to find these almost obsolete tobacco-flavoured products all that enticing. Then there are the younger vapers – around half in the 18-24 age group have never smoked. They went straight to vapes (but they may have been smokers in a counterfactual world without vapes). Maybe the federal government is telling them, “Now is the time to give smoking a try”. Perhaps a deeper, darker illicit market will form. Perhaps more people will start to mix their own liquids, or buy internationally.

One response that we can rule out is that 20+ million people using vapes will suddenly become abstinent. How could these groups pretend to be interested in public health if their preferred policy is a massive contraction of the vape market with no apparent interest in what behaviour change this will trigger.

Nevertheless, the federal government needs to look busy, so on June 10, we have an announcement: Justice Department and FDA Announce Federal Multi-Agency Task Force to Curb the Distribution and Sale of Illegal E-Cigarettes. It won’t work, but here’s the terrible thing: if it did work, it create a public health crisis.

FDA is effectively operating a failed vape prohibition

The FDA is operating a regulatory regime that is now indistinguishable from a prohibition. Despite thousands of perfectly good products for which credible applications have been made, the FDA Center for Tobacco Products has authorised no new vapes since 10 June 2022—that’s two years of obstruction and inaction, which it habitually blames on hapless applicants but arises from its own impenetrable process. And it is not like there are no cigarettes on the market… there are probably around 3,000 distinct cigarette products, and the FDA is authorising product “improvements” for smoking products all the time: between 2020 and March 2024, FDA accepted over 5,000 “Substantial Equivalence” upgrades to combustible tobacco products. So, for the smoking tobacco trade, it’s working very nicely.

FDA’s pedantic or obstructive interpretation of its duties under Section 910 of the Tobacco Control Act – whether by casual accident or malicious design – creates almost insurmountable regulatory hurdles and barriers to entry for vapes. Many companies and products simply do not have the cash flow and fat profits from cigarettes to cross-subsidise an effort to meet the FDA’s almost impossible-to-meet evidential hurdles. We must be clear: The FDA is not regulating whether a product is “appropriate for the protection of public health”. It is applying a brutal market filter to select only those companies or product lines that have the giant revenues, scientific resources, and simple mass-market products to meet the FDA’s evidential requirements, which are themselves opaque, arbitrary and shifting. This is prohibition dressed in the semi-respectable garb of regulation. It has nothing to do with ensuring the public is provided with lawful, well-regulated options to meet legitimate demand.

Note that in the European Union there are over 300,000 vape products eligible for lawful sale [see COM(2021) 249 final, footnote 23]. So far, there has been no catastrophe in the European Union that I am aware of that would justify the U.S. restricting the lawful products to 23. Even if 300,000 feels like too many, surely there is a middle ground between 300,000 and 23. I don’t know, say 10,000 products? What would it take to get 10,000 products lawfully onto the U.S. market? Certainly not the current system.

Implications of FDA’s failure to regulate 99% of the market

If only about 1% of the market is sales of products covered by FDA-authorised vape products, that creates at least five strategic issues.

  1. First, a chokehold on legitimate supply does not cause legitimate demand to somehow disappear. Whether FDA officials approve or not, there are American citizens who wish to use nicotine because it makes them feel good or function better. Not unreasonably, they would like to do this without dying in agony or living in misery, and so seek out non-combustible options. So, yes, there will be robust demand. It does not matter whether moralising onlookers deem this demand right or wrong; it is a phenomenon in the real world. That means supply will mobilise to meet demand by whatever means necessary and viable, including extensive illicit trade, as we are seeing now. This is much harder to control following the rise of the Shenzhen-based Chinese manufacturing industry and the internationalisation of the trade in vaping products and supporting communications and commercial infrastructure. Sorry about that, but that is the reality.
  2. Second, with its boot on the windpipe of American-based vape businesses, the FDA is handing a giant advantage to the Chinese competition. The technical, scientific, creative, and legal resources of American vape businesses are mired in endless, exhausting efforts to prove the acceptability of products that are already 8-10 years old to the satisfaction of the unyielding, never-satisfied FDA. In contrast, the Shenzhen innovation system is tirelessly focused on the consumer – what the consumer wants today and what they need to get around pointless regulation (e.g. in Europe). So, who will be making the products that people want to use in 2024 and 2030? Will it be the consumer-focused innovators in China or the backwards-looking compliance slaves in the United States? FDA is nurturing demand for illicitly supplied Chinese products.
  3. Third, any idea that the FDA is somehow protecting American youth is laughable. If its bizarre constraints on law-abiding manufacturers mean that 99% of the market is unregulated for adults, that means pretty well any product is available to youth through social sources, informal markets and non-compliant retailers. On a flawed rationale based on youth protection, FDA officials now insist that American manufacturers meet a “comparative efficacy standard” for justifying flavoured vaping products. Since this opaque standard was first revealed, no one has met it. Does that mean youth are denied access to flavoured products? No, obviously not. FDA’s standard just means demand is met from outside the tiny slice of the market where the FDA is notionally in control.
  4. Fourth, it is wrong to see this as an enforcement problem. The problem is the creation of an inevitable giant illicit market to meet consumer demand. 99% of the sales are going to products that have various forms of illegal status: never applied, never assessed, not yet assessed, assessed and denied, denied and subject to litigation, in litigation with a stay, and, above all, don’t give a ****. This is not a problem that can be solved by “enforcement” – it can only be solved by creating a legitimate market for the products people want. As discussed above, it would be grossly irresponsible and certainly not appropriate for the protection of public health to shut this illicit trade down. Do we now have to be thankful for illegal activity preventing a public health crisis? The scale of the enforcement problem is not a measure of risk to the public. On the contrary, enforcement in the current environment harms the public by denying pro-health choices and imposing various forms of heavy-handed policing. The enforcement challenge should be understood as a consequence of FDA’s epic failure to manage its regulatory mandate.
  5. Fifth, this cannot be fixed with more money, only reform. The last thing anyone in Congress should do is pour money into this bottomless well of failure. FDA is seeking an additional $114 million to add to the annual $712 million it already receives from user fees (see Budget request, FY2025, p9). The demand for more money should be rejected with a counter-proposal for reform. A good reform package would radically improve the efficiency of the FDA’s authorisation process, lowering costs, improving morale among FDA’s staff, and reducing the scale of the enforcement effort because more of the market is lawful—the purpose of the reforms.

A total rethink is required to restore a lawful, regulated, and compliant market that meets consumers’ legitimate demand for safer alternatives to cigarettes and imposes controls to protect youth. If that cannot be done from within the FDA and driven by its leadership, it needs to be imposed by Congress, the Administration, or even the courts.

Let us list the type of reforms needed:

Develop a credible strategy to update the comprehensive plan

On the Alice in Wonderland principle:

If you don’t know where you are going, then any road will take you there.

Lewis Carroll [attributed]

FDA must develop and communicate a principled, transparent, proportionate, and legally defensible regulatory strategy that governs its intent and interpretation of its duties under the Tobacco Control Act.

If applicants are clear on what is expected and how their applications will be evaluated, there will likely be fewer applicants and better-quality applications. A robust regulatory strategy is the structural solution to the backlogs, litigation, enforcement burdens, and overwhelming demands on FDA staff and applicants. Although the Center for Tobacco Products published the Center for Tobacco Products Strategic Plan in December 2023, this does not meet this requirement and is largely concerned with packaging what the FDA already does into a new format based on five “goals”.

Cross-Cutting Themes: Science, Health Equity, Stakeholder Engagement, Transparency
GOAL 1: Develop, Advance, and Communicate Comprehensive and Impactful Tobacco Regulations and Guidance 
GOAL 2: Ensure Timely, Clear, and Consistent Product Application Review
GOAL 3: Strengthen Compliance of Regulated Industry Utilizing All Available Tools, Including Robust Enforcement Actions
GOAL 4: Enhance Knowledge and Understanding of the Risks Associated With Tobacco Product Use
GOAL 5: Advance Operational Excellence

Mission: To protect the public health of the U.S. population from tobacco-related death and disease by comprehensively regulating the manufacture, distribution, and marketing of tobacco products; educating the public, especially youth, about the dangers of using tobacco products; and promoting and supporting strategies that ensure an equitable chance at living a healthier life for everyone.

Center for Tobacco Products, Five-year Strategic Plan

This strategy is essentially a continuation of business-as-usual. It doesn’t change anything that matters and will not achieve the imperative of restoring a lawful market. The mission is an unambiguous failure. The combustible market is largely untroubled by the FDA’s regulation, and the far safer non-combustible market is 99% outside the FDA’s control, bar a few enforcement activities that make little difference.

What the FDA needs is an update to the 2017 “Comprehensive Plan” that takes account of developments since 2017. In 2023, experts on science, regulation and policy suggested the following framework, elaborated with further detail in their letter to FDA Commissioner Califf :

  1. To degrade the attractiveness and addictiveness of cigarettes and other combustible tobacco products. FDA should use its powers to control ingredients, addictive agents, emissions, exposures, packaging, warnings, marketing, and retailer behaviors.
  2. To promote transition pathways to smoke-free status. FDA should authorize a wide range of low-risk nicotine products that will allow smokers low-risk alternatives and an off-ramp from smoking. Using its wider regulatory powers, FDA should promote smoking cessation with better evidence-based treatments.
  3. To control risks arising from the ongoing use of smoke-free nicotine products. The FDA should use its powers to ensure that non-combustible tobacco products, while not risk-free, are safe enough and have an acceptable risk threshold. It should create a system of standards and soft standards (“comply or justify”) that would expedite the pre-market application process.
  4. To protect young people from tobacco-related health and welfare risks. FDA should take a holistic view of the interests of young people, especially those at the highest risk from tobacco or substance use, and recognize young people benefit in multiple ways when the adults in their lives quit smoking.
23 authors: Reagan-Udall Foundation evaluation of FDA’s tobacco program – a response, via University of Michigan [PDF]

In my view, this (or something like it) is far superior as it gives a sense of how FDA will use the powers it has under the TCA and articulates what it is trying to achieve. It would clarify regulatory intent.

Clarity and transparency of “appropriate for the protection of public health”

The Reagan-Udall evaluation highlighted a range of unavoidable trade-offs in making determinations under the “Appropriate for the Protection of Public Health” (APPH) standard.

This lack of clarity, transparency, and communication extends to questions about: how the Agency intends to balance individual risk/benefit against population risk/benefit while carrying out its public health mission; how the Agency will weigh concerns about youth uptake of nicotine products against the harm-reduction potential of non-combustible tobacco products, how the Agency views the science that must inform these decisions

Reagan Udall Foundation, Operational Evaluation of Certain Aspects of FDA’s Tobacco Program, December 2022 [PDF]

So far, there has been no clear articulation of the FDA’s response to this challenge, yet this concept is at the heart of the FDA’s tobacco and nicotine mission. The legislation provides only the most cursory direction on the meaning of ‘appropriate for the protection of public health’ (APPH). This is the relevant text from the legislation:

Tobacco Control Act, Section 910(c)(4)

It is simply stated, but it gives no insight into how these behaviour change effects should be assessed or compared with each other. Although there is guidance on making a Pre-Market Tobacco Application (PMTA), this guidance says little about what this language actually means and how the test will be evaluated. Here is an example:

FDA recommends that you provide a detailed explanation of how the data and information provided in your PMTA (including the information required by section 910(b)(1) of the FD&C Act) constitute valid scientific information that would support a finding by FDA that marketing your new tobacco product is APPH.

See Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems: Guidance for Industry Section D (p.12)

Major issues with APPH that the FDA has yet to address

Trade-offs. In practice, the FDA takes a simplistic view of the public health test without ever making its assumptions explicit and open to examination. Applicants are essentially flying blind in how they interpret the APPH test described above. Judging by its actions and statements, the FDA apparently places a high (but unstated) implicit value on preventing the uptake of any vaping product by any youth. It places a relatively low value on adult smoking cessation, even though this has larger and far more rapid health effects than preventing youth vaping uptake. It does not even distinguish between youth who would never have smoked and the beneficial effects of vaping on youth who would otherwise have smoked. It provides no guidance on how it would compare the magnitude of benefits to adults and detriments to youth. It appears to weigh the diversion of youth from smoking by vaping as a negative, as if somehow, in a counterfactual world with no vapes, no young people would smoke. It appears to believe that new nicotine products are only for existing smokers and not for people who want to use nicotine because they like it.

Ignoring vaping benefits to youth. FDA denies any value at all in the diversion of young people from smoking to vaping, yet this is a large-scale, real-world phenomenon and highly valuable in public health terms. It explains why youth smoking has declined so rapidly (over-performing Healthy People targets by some distance in 2020 and already passing the target for 2030). Vaping is why quite a high proportion of young people have never smoked before vaping (in the counterfactual world, they would have been smokers). There is no legal basis for ignoring vaping harm reduction benefits to youth. Not only does the Act give no basis to exclude this, it is easy to show that the Act explicitly requires that it is considered; vaping causes a decreased likelihood of cigarette smoking among those who do not currently smoke, and there is nothing in the Act that says this must be ignored (or can be ignored) simply because the benefit arises in the population aged under 18. The problem for CTP is that recognising youth diversion from smoking and acknowledging the large long-term public health benefits it creates would utterly destroy the reasoning that underpins its current regime.

A common currency for health impacts? To resolve trade-offs, a common currency of harm is unavoidably necessary to weigh the various effects of a range of changes in tobacco use status. There is, however, a well-established currency that can be used: discounted quality-adjusted life-years (QALYs). This is a standard metric in health policy assessment that incorporates monetised estimates of mortality and morbidity impacts based on how society values life. The use of QALYs is recommended in the Health and Human Services Guidelines on Regulatory Impact Analysis, where you can also find a good explanation. QALYs were also used in the 2016 Deeming Rule Regulatory Impact Analysis (e.g. see use in a breakeven analysis in Final Impact Analysis, Table 3, Page 17). Even if precise estimates were difficult, the use of QALYs would provide conceptual clarity for a health-based interpretation of the APPH test. If this metric was used, it would undoubtedly give great weight to adult smoking cessation. Why? Because the effects of switching and smoking cessation on health are large and rapid. The health effects of youth vaping would take decades to emerge and would be far less than smoking – and would be heavily outweighed by the effects of youth vaping as an alternative to smoking.

Limitations of individual product assessment. FDA assesses each product or product group in isolation – the PMTA and its assessment are for a product, not a category. But for the vast majority of products, the effect of a marketing denial would be for potential consumers to use the next available similar product. This would have no effect on population health. Let me give an example: there is talk of manufacturers offering “age-gating” using Bluetooth and a smartphone app to verify the age of the user and to lock the device if necessary. Would this prevent youth use? No. Canny youngsters would access the products that do not have this feature. Unless every product has it, the age-gating is pointless for public health – just virtue signalling. Needless to say, cigarette packs will never have age-gating, so there will always be that option for adolescents denied access to a vape product. So, to assess population effects, it would be necessary to look at the aggregate effect of all determinations. However, this is not possible in advance or from within each product assessment. The individual assessment only makes any sense when it is concerned with individual risks of using that specific product. The right way to address individual risk is to use the normal consumer protection concept of setting standards that control the main chemical, thermal, electrical and mechanical risks to users.

Aggregation of all assessments. What happens if the totality of millions of individual PMTA determinations adds up to create some bad harmful effects? For example, no single denial order will have much material impact on, say, vape shops. But if all or almost all flavoured products are denied because of the chosen methodology for evaluation, then vape shops would become unviable – possibly losing a large number of effective private sector community-based “quit-smoking” services. How are non-marginal effects like this considered by the FDA? The answer is that they are not considered. Each individual decision is taken independently of the others. This is a serious problem because the FDA does not hold itself, its own policies and practices, to an APPH standard. Suppose the FDA operates a system that shuts down vape shops, drives vapes underground, and protects the cigarette trade by erecting high barriers to entry to low-risk alternatives. Well, sorry about that… that is what is happening, but the FDA says it cannot do anything about that.

De facto tobacco product standards. A version of the argument above is to question whether the FDA is operating an informal system of tobacco product standards. But note this is just a special case of the general problem of accountability for aggregate effects. In this argument, the FDA is using a restrictive methodology to create a de facto tobacco product standard simply by making it impossible for certain products ever to access the market. It is the use of process and evidential barriers to have the same effect as a product standard. This might apply, for example, to non-tobacco flavoured liquids or refillable devices. The catch here is that for legitimate tobacco product standards, there is a process under Section 907 of the Tobacco Contol Act, and this places the burden on the FDA to show its standard is APPH, see §907(a)(3). In the case of banning flavours or refillable devices, that would be a very high bar and I sincerely doubt FDA would ever be able to meet it. So why should it bother? It can achieve almost the same effect through a restrictive assessment process.

Whether or not the FDA is operating a system of illegal tobacco product standards (of course, it denies this) or that’s just what it looks like when it applies its duties in law is essentially a theological argument that, absent a smoking gun document, will not be proven either way. But how much does that matter? Whether or not there is the intent, the process the FDA is using creates the aggregate effects that are not accounted for (in the way they would have to be if these were standards, rather than process outcomes that look like standards). Surely, a public health regulator should verify that it is not doing more harm than good, whether or not the law explicitly requires it?

Addressing the challenges of “appropriate for the protection of public health”

These are my proposals for how to make this work better.

  1. The pre-market phase should concentrate on individual risk characteristics of the product and its packaging and marketing. The pre-market tobacco application for a product should focus on those aspects under the control of the applicant – primarily the risks attributable to the product itself (chemical, thermal, physical, electrical) and the proposals for packaging and marketing. The impacts on the population and on the market as a whole depend on a wide range of factors outside the control of the applicant. These are inherently beyond the scope of an individual application or assessment and unknowable in advance. Such factors include competitor products, the illicit market, aggregate effects of all other FDA determinations, pricing, media coverage, state laws and taxes, fads and fashion, and enforcement against illegal rival products.
  2. Pre-market assessment of APPH should draw on soft standards set out in guidance. The aim should be to establish pre-market thresholds of product safety and responsible marketing. These should be widely and easily understood and attainable by companies operating with sound product stewardship in clean facilities. These thresholds could be implemented through “soft standards” set out in guidance. For example, a soft standard that creates a presumption against using cartoons or childish branding would signal manufacturers not to include such imagery in pre-market applications (or be prepared to justify it) and to expect priority enforcement action in the absence of a PMTA.  I refer to these as soft standards because they would be used as heuristics in the premarket assessment of APPH. De facto standards are necessary to ensure FDA is acting consistently across products and between assessors. Such standards would be subject to a “comply or justify” regime – the applicant does not have to meet them but would need to justify an exception.
  3. Pre-market authorisation would be conditional and subject to post-market assessment and verification. The products would be, as now, authorised conditionally with the right to withdraw the marketing order in the light of post-market assessment. Post-market assessment would test for adverse population effects or adverse public health developments not foreseen during pre-market assessment.
  4. FDA scientists should focus on category-wide insights and novel products and risks. The FDA would not spend its scientific resources and staff expertise on thousands of repetitive assessments of broadly similar individual products that are standard in the industry worldwide. Those products should be addressed with soft standards coded in guidance. Scientific resources would be better spent on understanding risks at the category or sub-category level – for example, the effects of synthetic nicotine, products that use acids to modify pH, particular flavour ingredients, battery safety, and drawing lines between responsible and irresponsible marketing. It is not appropriate to reinvent those insights in the assessment of every product. In-depth assessment and scientific expertise should also be used to address novel products and potentially novel risks.
  5. Population health impacts should be assessed post-market. These behaviour-change effects only become evident once the product is on the market. Attempting to assess this pre-market is not much better than guesswork. If the 2015 Juul product had been assessed for population effects before it was launched, who would have predicted Juul’s rise from 2017 to 2020? No one predicted what happened, and if they had, the prediction would not have been taken seriously. By assessing population effects post-market, FDA would be in a position to take corrective action at the category or sub-category level, not just every individual product assessed in isolation. It would be a more powerful and effective way of controlling for adverse population effects.
  6. Much better market surveillance is needed. Post-market assessment requires a much better understanding of the complete marketplace, not just the tiny market in authorised products, but the whole market, including unauthorised products and the various forms of illicit, and close to real-time. This means a greater investment in market surveillance, not just imposing surveillance conditions on the small number of products that are authorised. FDA should launch a comprehensive surveillance system publishing as much as possible.
  7. Use a unified measure of health and welfare impact to assess trade-offs. The assessment of population effects requires the assessment of a wide range of behaviour changes and trade-offs. These should incorporate realistic assumptions about the underlying demand for nicotine and the displacement of smoking among youth. It should resolve trade-offs as far as possible using a unifying objective measure like discounted QALYs. This would place a high premium on developments that increased smoking through reduced cessation, increased relapse or the loss of a diversion effect. But it would also penalise acute harmful effects on young people and could incorporate dependence as a dimension of degraded quality of life in the estimate of QALYs. Note that precise estimates are likely to be impossible, but sensitivity or breakeven analysis should be sufficient in most non-marginal cases. And most cases will be non-marginal.
  8. FDA should sensitize itself to unintended harmful consequences of its own actions. It could do this by undertaking regulatory impact analysis on a continuing basis, with a report to the public and to Congress every two years. The assumptions made in the 2016 Final Regulatory Impact  Analysis have turned out to be embarrassingly incorrect. Oversight functions in Congress or the Administration (OMB/OIRA) should insist that the FDA updates its RIA and assess whether the case it made for deeming still holds water and, if not. what would need to change to ensure there was a net benefit to the American people and to reassess value for money and efficiency in the light of experience and outturns.
  9. Make it easier to innovate. Introduce a simplified system for evaluating incremental improvements to authorized products so American consumers can benefit sooner from product innovations. This should apply to both the PMTA process for authorizations and the MRTP pathway for modified risk claims. FDA’s processes should encourage pro-health innovation, not obstruct innovation or deny Americans access to the best technologies available worldwide.
  10. Bring a public service ethos to the regulator’s role. FDA should provide applicants with meaningful information on the progress of their applications with estimated decision dates. For many businesses, the FDA’s decisions are mission-critical and may be the difference between business viability and failure. They are entitled to timely assessments and realistic expectations about decision-making. FDA should engage with applicants to address reasonable application deficiencies so that these can be remedied with a view to FDA granting marketing orders rather than as a reason for abrupt denial. FDA should be aiming for a regulated competitive market with a diverse range of compliant products.
  11. Audit and model best practices in efficient regulation. The federal government has a sound framework for good regulatory practice set out in relevant Executive Orders (see White House Regulatory Matters).   Relevant Executive Orders on good regulatory practice include EO 12866 (Regulatory planning and review), 13563 (Improving Regulation and Regulatory Review ), 13579 (Regulation and Independent Regulatory Agencies ), 13610 (​​Identifying and Reducing Regulatory Burdens). FDA should commission an independent forensic audit of its practices against the principles set out in these Executive Orders and address deficits. FDA should not be granted further financial resources. It should focus on reform to reduce the exceedingly high cost of its regulatory activities, both to itself and to applicants.
  12. Implement a prioritised system of enforcement. The key challenge for enforcement is to reduce the burden of enforcement by establishing a proportionally regulated, lawful market in nicotine products that people legitimately wish to use. FDA should resist irresponsible calls to “clear the market” or take draconian enforcement action in a market that is mostly dysfunctional. However, until it can provide a structural solution to problems of its own making, it should focus enforcement activity on the involvement of criminal networks and products that for which no pre-market application has ever been made.

FDA officials will claim that these measures are impossible under a strict reading of the Tobacco Control Act. I don’t believe that. The duty to assess APPH is vaguely stated, but the intent is clear. The intention of Congress was clear at the time the Act was settled: to encourage the uptake of reduced-risk products for harm reduction but the prevent false harm reduction options like “light & mild” cigarettes. This was driven by the findings of ground breaking 2001 Institute of Medicine report, Clearing the Smoke: assessing the science base for tobacco harm reduction. There is nothing in the Act that requires the FDA to take an impossible or ineffective approach to regulating the market or determining APPH. My main point is that the FDA’s current process does not and cannot establish APPH. There is nothing to stop the FDA from doing something that works and would be appropriate for the protection of public health.

They just have to want to do it.

And that may be the real problem.

Your views on the above are welcome in the comments or to me directly.

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2 thoughts on “Fixing U.S. vape regulation – twelve proposals”

  1. Ergo, the FDA do not want to do it (for whatever reasons). They do not want to realistically endorse, encourage, or even really allow vapes in a viable form that consumers will actually use (or enjoy), unless it is the very few that have been authorised (all closed systems, in tobacco flavour only, and all owned by Big Tobacco).

    I can’t help but smell a rat. Coupled with the WHO’s continued attacks (and lies) on tobacco harm reduction, the restrictions/bans on vapes are now becoming endemic globally (or have been for a while). Anti-vape propaganda is rife.

    So this obviously begs the question why, and how much, is corruption the root cause, rather than just twisted ideology…

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