The WHO and FDA Say They Want a Smoke-Free World – So Why Are They Regulating Like It’s 2005?

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Key Points:

• Global Context: Delegates from 183 countries are meeting in Geneva for the 11th Conference of the Parties (COP11) to the WHO Framework Convention on Tobacco Control (FCTC) – marking 20 years of the treaty. What began as a fight against combustible tobacco has shifted into a dogmatic rejection of harm reduction, ignoring both science and consumer demand.

• Regulatory Parallels: The WHO and U.S. FDA share similar flaws: both regulate tobacco and nicotine through frameworks written for a cigarette era (2005–2009), not today’s diverse marketplace of smoke-free alternatives. Their systems now protect the cigarette market by overregulating safer options.

• Scientific Consensus Ignored: Research has long shown it is combustion – not nicotine – that kills. Cigarettes emit 7,000+ chemicals, including 69 carcinogens. As Michael Russell observed in 1976: “People smoke for the nicotine, but die from the tar.” Yet both WHO and FDA continue to demonize nicotine rather than focus on smoke reduction.

• Continuum of Risk: Nicotine products exist on a clear spectrum of harm — with combustible cigarettes as most harmful, heated and vapor products reducing exposure, and oral nicotine and NRTs presenting the lowest risk. Real-world evidence shows that harm reduction products accelerate smoking declines far more effectively than WHO-endorsed bans and tax hikes.

• WHO’s Anti-Harm Reduction Stance:

  • WHO officials have called e-cigarettes “a treacherous camouflage of a health disaster.”

  • The FCTC continues to treat all nicotine products like cigarettes, disregarding its own definition of tobacco control, which includes harm reduction.

  • COP11 is expected to push for new restrictions on noncombustible alternatives, contradicting harm-reduction principles.

• FDA’s Parallel Failure: The 2009 Tobacco Control Act set an arbitrary 2007 “grandfather date”, forcing modern harm reduction products into the unworkable PMTA process.

  • The result: only 39 e-cigarette products authorized for 20 million U.S. adults who vape. Most small-business PMTAs were denied, favoring large tobacco companies.

• Youth Use Myths vs. Reality: Despite policy panic, youth vaping is down 70 percent since 2019 – to 5.9 percent in 2024. Surveys show most youth vape out of curiosity or stress, not flavors or nicotine dependence. Meanwhile, youth smoking has nearly vanished, showing that harm reduction works better than prohibition.

• Global Comparisons: Countries embracing harm reduction see the fastest declines in smoking:

  • U.S. (ages 18–24): 81.8 percent decline since 2007.

  • Canada: Smoking among 20–24-year-olds dropped from 18.5 percent to 8 percent (2015–2020).

  • New Zealand: Down from 24.6 percent (2011/12) to 4.2 percent (2023/24).

  • UK: Down from 25.7 percent (2011) to 8.1 percent (2024).

  • These countries embraced vaping and heated tobacco, while the WHO continues to fight them.

• Policy Contradictions:

  • The FDA, Health Canada, UK, and New Zealand have acknowledged that vaping is far less harmful than smoking.

  • The UK “Swap to Stop” program distributes 1 million vape kits to help smokers quit – the opposite of the WHO’s prohibitionist approach.

• The Core Problem: Both WHO and FDA claim to want a smoke-free world, yet regulate as if it’s still 2005, ignoring the tools that could get us there. By clinging to outdated policies, they protect cigarettes, block innovation, and deny adults access to safer products.

• Policy Takeaway: As COP11 debates the future of tobacco control, delegates and regulators must embrace harm reduction, not prohibition. Progress toward a smoke-free world depends on acknowledging science, supporting adult choice, and focusing on the real enemy – combustion, not nicotine.

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Currently, delegates from 183 countries are meeting in Geneva, Switzerland for the 11th Conference of the Parties (COP11) to the Framework Convention on Tobacco Control (FCTC) of the World Health Organization. This first-of-its-kind global health treaty recently marked twenty years in effect. Yet what was once intended to confront the harms of combustible tobacco has evolved into a framework that refuses to acknowledge science, adult consumer demand, or the undeniable continuum of risk that exists among tobacco and nicotine products.

This refusal mirrors how the U.S. Food and Drug Administration regulates tobacco and nicotine under the 2009 Family Smoking Prevention and Tobacco Control Act. Although created in different political systems, both the WHO and FDA have arrived at regulatory structures that effectively protect the cigarette market and delay global progress toward a smoke-free world. As delegates debate new regulatory approaches, it is crucial that they remain focused on the true public-health goal: protecting the world from the harms of combustible tobacco smoke while respecting national sovereignty and adult consumer choice.

The FCTC and TCA were adopted in 2005 and 2009, respectively, before the rise of modern alternatives to cigarettes such as e-cigarettes, heated tobacco products, and oral nicotine. These frameworks were built for a cigarette era, not today’s diverse nicotine marketplace. The WHO now places disproportionate emphasis on demonizing nicotine, exaggerating its addictive potential while ignoring that combustion – not nicotine – is responsible for nearly all smoking-related disease. Meanwhile, the FDA recognized the continuum of risk in 2017 and pledged to communicate this reality through both education and product access, but in practice it has been slow and inconsistent in authorizing less harmful products.

Scientific understanding has long established that it is the smoke that kills. Combustible cigarettes contain hundreds of ingredients, and when burned they generate more than 7,000 chemicals, including 69 known carcinogens. As researcher Michael Russell famously observed in 1976, people smoke for the nicotine but die from the tar. For decades, researchers, manufacturers, and adult consumers have sought ways to obtain nicotine without the harms of combustion, leading to the development of a range of significantly lower-risk products.

Tobacco and nicotine products clearly exist along a continuum of risk, with cigarette smoking being the most harmful, followed by products that reduce but do not eliminate smoke. Products that remove combustion entirely, including oral nicotine and nicotine replacement therapies, present the least harm, while vapor products fall between these categories but still dramatically reduce risk compared to combustible cigarettes.

Nearly two decades of real-world human evidence show that the rise of tobacco harm reduction products coincides with sharper declines in smoking rates than the declines associated with restrictive WHO-endorsed approaches such as high taxation, marketing bans, and outright prohibitions. Yet both the WHO and FDA continue to focus narrowly on youth and industry narratives while ignoring the 1.2 billion adults who still smoke worldwide, including more than 30 million in the United States. Policymakers are often presented with misleading arguments meant to blur distinctions between products and minimize the role of consumer demand, resulting in regulatory barriers that keep adults from switching away from cigarettes.

The WHO’s shift away from evidence-based harm reduction has become increasingly explicit. In 2019, former FCTC head Dr. Vera Luiza da Costa e Silva urged policymakers to “be vigilant,” describing e-cigarettes as “a treacherous and flavored camouflage of a health disaster.” Another FCTC official dismissed harm reduction outright as a trap designed by industry to sustain nicotine use. At COP8 in 2018, delegates declared heated tobacco products to be tobacco products under the treaty and recommended that they be regulated exactly like cigarettes, despite a significantly reduced toxicant profile. In 2021, the WHO included e-cigarettes in its report on the global tobacco epidemic for the first time, framing them as a threat to tobacco control and claiming, without causal evidence, that youth who even try e-cigarettes are twice as likely to smoke cigarettes later.

As the FCTC treats all nicotine-containing products as falling under the treaty, it is widely expected that COP11 will pursue additional restrictions on adult access to noncombustible alternatives, disregarding the FCTC treaty’s own definition of tobacco control, which includes harm reduction strategies aimed at reducing exposure to tobacco smoke.

The FDA’s regulatory structure reflects many of the same flaws. Congress created the agency’s tobacco authority in 2009, establishing an arbitrary February 2007 grandfather date to determine which products could apply through a simplified pathway. Because nearly all modern harm reduction products were developed after that date, they must undergo the far more burdensome Premarket Tobacco Product Application process, which has now proven unworkable for both regulators and manufacturers.

E-cigarettes entered the U.S. market in 2006–2007 driven by consumer interest, not large tobacco companies. It was not until 2012 that Lorillard acquired Blu, and Altria and Reynolds did not launch their own vaping products until 2014. In 2020, millions of PMTAs were submitted, largely by small businesses, only for FDA to issue sweeping denials that prioritized concerns about youth use even as youth vaping rates were already declining. To date, only 39 e-cigarette products have been authorized for the more than 20 million adults who were vaping in 2023.

Both the WHO and FDA continue to fixate on youth use, ignoring both the reasons youth vape and the dramatic declines in youth vaping itself. In 2024, only 5.9 percent of U.S. middle and high school students reported current e-cigarette use, down from 20 percent in 2019. National data consistently show that youth vaping peaked in 2019 and is driven more by curiosity and stress coping than by flavors or nicotine dependence. In 2021, only 13.7 percent of youth cited flavors as a reason for vaping, while 43.4 percent reported vaping to manage anxiety, depression, or stress.

Even more striking is the sharp decline in youth and young adult smoking – declines that align with increased availability of safer alternatives rather than with restrictive regulatory models. In 2023, just 5.9 percent of U.S. adults aged 18 to 24 were smoking, an 81.8 percent decline since 2007. Canada saw smoking rates among 20- to 24-year-olds fall from 18.5 percent in 2015 to 8 percent in 2020. New Zealand saw even steeper declines, with smoking among 18- to 24-year-olds dropping to 4.2 percent in 2023/24, down from 24.6 percent in 2011/12. In the United Kingdom, only 8.1 percent of adults aged 18 to 24 were smoking in 2024, compared to 25.7 percent in 2011.

These countries have embraced harm reduction rather than suppressing it. The FDA has authorized several e-cigarette products as “appropriate for the protection of public health.” Health Canada affirms that switching completely from smoking to vaping reduces harm. New Zealand’s Ministry of Health has stated that vaping is much less harmful than smoking. In 2023, the UK government launched its “swap to stop” initiative to distribute one million vape kits to help smokers quit.

As COP11 delegates consider new measures to reduce the global burden of smoking, they should take note of the unintended consequences of restrictive regulatory approaches in the United States and elsewhere. Policies that limit access to noncombustible alternatives risk undermining the central purpose of tobacco control: reducing the harm caused by smoking. Harm reduction products that eliminate or reduce combustion align with the principles that underpin both the FCTC and the U.S. TCA. It is time for policymakers to acknowledge this reality and support strategies that actually reduce smoking-related disease and death.

Nothing in this analysis is intended to influence the passage of legislation, and it does not necessarily represent the views of Tobacco Harm Reduction 101.