WHO Criticized for Questioning FDA’s Harm Reduction Assessment, Accused of Defying Scientific Consensus

Aug.20.2025
WHO Criticized for Questioning FDA’s Harm Reduction Assessment, Accused of Defying Scientific Consensus
A World Health Organization (WHO) official, Dr. Roa, recently questioned the U.S. Food and Drug Administration’s (FDA) scientific assessment of e-cigarettes and nicotine pouches, claiming there was no independent consensus and suggesting its conclusions may have been influenced by the industry. Her remarks contradict the consensus of leading international scientific bodies and are seen as a direct challenge to FDA’s credibility and to the integrity of public health science.

Key Points:

  • Origin of the Dispute: Dr. Roa, a Panamanian official set to chair COP11, publicly challenged FDA’s scientific review of e-cigarettes and nicotine pouches, saying no independent consensus supports the claim these products are significantly less harmful.
  • Scientific Evidence: Numerous international authorities, including the Royal College of Physicians, Public Health England, and the U.S. National Academies of Sciences, Engineering, and Medicine, have confirmed that non-combustible nicotine products are substantially less harmful than cigarettes.
  • Impact of Remarks: Roa’s comments were seen as an attack on FDA’s independence and credibility, potentially undermining WHO’s authority in global public health governance.
  • Background Factors: Analysts suggest WHO’s recent shift on harm reduction may be linked to U.S. funding cuts rather than new scientific evidence.
  • Policy Risk: If this position is maintained at COP11, it could affect future global tobacco control policies, especially by hindering harm reduction strategies in low- and middle-income countries.
  • Call to Action: Scholars and regulators urge WHO to base its policies on evidence and recognize the potential role of harm reduction products in reducing smoking-related disease and death.

 


 

As global tobacco control policy approaches a critical juncture, a senior World Health Organization (WHO) official’s public statement has sparked widespread concern among academics and industry alike. Dr. Reya Roa, a Panamanian health ministry official and the designated chair of the 11th Conference of the Parties (COP11) to the Framework Convention on Tobacco Control (FCTC) this November, recently issued a statement questioning the FDA’s scientific assessment of non-combustible nicotine products such as e-cigarettes and nicotine pouches.

 

In her statement, Roa asserted that there is currently “no independent, industry-free scientific consensus” supporting claims that these products are significantly less harmful than cigarettes. She further implied that FDA’s evaluations might lack independence. Her comments have been widely interpreted as a direct challenge to the authority of the U.S. regulator and its science-based decision-making.

 

However, many international and national scientific authorities have reached a strong consensus on the reduced risks of harm reduction products. For example:

 

  • Royal College of Physicians (2016): Concluded that the long-term health risks of inhaled e-cigarette vapor are “unlikely to exceed 5% of those associated with smoking.”
  • Public Health England (now the Office for Health Improvement and Disparities): Reported that e-cigarettes are at least 95% less harmful than smoking.
  • U.S. National Academies of Sciences, Engineering, and Medicine (2018): Found that e-cigarettes emit substantially fewer toxic substances compared to combustible cigarettes.

 

Experts argue that Roa’s claims not only contradict established scientific evidence but also risk undermining WHO’s credibility in global public health governance. Some commentators note that WHO’s shift away from supporting harm reduction may be tied to reduced U.S. funding in recent years, rather than the emergence of new evidence. In fact, WHO’s 2015 report explicitly recommended that national authorities could use FDA’s regulatory framework as a model for best practices.

 

Industry analysts warn that if this stance persists at COP11, it could have serious implications for the future of global tobacco control policy. As the highest decision-making body under the FCTC, COP11 is expected to provide evidence-based guidelines for participating countries. If its chair denies existing scientific consensus, policy discussions risk drifting away from science, potentially delaying the adoption of harm reduction strategies in low- and middle-income countries.

We welcome news tips, article submissions, interview requests, or comments on this piece.

Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn


Notice

1.  This article is intended solely for professional research purposes related to industry, technology, and policy. Any references to brands or products are made purely for objective description and do not constitute any form of endorsement, recommendation, or promotion by 2Firsts.

2.  The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.

3.  This article is not intended to serve as the basis for any investment decisions or financial advice. 2Firsts assumes no direct or indirect liability for any inaccuracies or errors in the content.

4.  Access to this article is strictly prohibited for individuals below the legal age in their jurisdiction.

 

Copyright

 

This article is either an original work created by 2Firsts or a reproduction from third-party sources with proper attribution. All copyrights and usage rights belong to 2Firsts or the original content provider. Unauthorized reproduction, distribution, or any other form of unauthorized use by any individual or organization is strictly prohibited. Violators will be held legally accountable.

For copyright-related inquiries, please contact: info@2firsts.com

 

AI Assistance Disclaimer

 

This article may have been enhanced using AI tools to improve translation and editorial efficiency. However, due to technical limitations, inaccuracies may occur. Readers are encouraged to refer to the cited sources for the most accurate information.

We welcome any corrections or feedback. Please contact us at: info@2firsts.com

U.S. Judge Stays Helix, NJOY Challenge to FDA PMTA Rule Pending New Rulemaking Court Stays Altria's Helix, NJOY Challenge to PMTA Rule as FDA Prepares New Rulemaking
U.S. Judge Stays Helix, NJOY Challenge to FDA PMTA Rule Pending New Rulemaking Court Stays Altria's Helix, NJOY Challenge to PMTA Rule as FDA Prepares New Rulemaking
A federal judge in Texas on Oct. 8 granted a joint request by the FDA and plaintiffs including Altria subsidiaries Helix Innovations and NJOY to stay litigation challenging the agency's 2021 PMTA rule. The court cited FDA's anticipated rulemaking concerning the regulation at issue. FDA announced on Sept. 28 that it intends to reassess the PMTA framework and could initiate new rulemaking to replace it. The parties must file a joint status report within 45 days and every 45 days thereafter. A motion by three Reynolds American companies to intervene remains pending.
Regulations
Oct.10
JTI Proposes 25-Cent Irish Cigarette Tax Increase, Says It Could Raise €45 Million
JTI Proposes 25-Cent Irish Cigarette Tax Increase, Says It Could Raise €45 Million
Japan Tobacco International's Irish business has proposed a €0.25 tax increase on a pack of 20 cigarettes in its pre-Budget 2027 submission, below the €0.50-or-more increases typically imposed in recent Irish budgets. JTI says the proposal could generate around €45 million in additional Exchequer revenue while limiting further movement toward illicit and non-Irish-tax-paid tobacco. Revenue's existing estimate for a comparable €0.25 increase, including pro-rata rises on other tobacco products, is about €18 million for a full year.
JTI
Sep.18 by 2Firsts Perspectives
Ireland Raises Nicotine Product Taxes Again as Cigarettes Gain €1 and Vape Duty Is Set to Jump 40%
Ireland Raises Nicotine Product Taxes Again as Cigarettes Gain €1 and Vape Duty Is Set to Jump 40%
Ireland has increased tobacco excise under Budget 2027 and announced a further rise in its E-liquid Products Tax. From Oct. 7, the tax burden on a pack of 20 cigarettes in the most popular price category increased by €1, with pro-rata increases on other tobacco products. The government plans to raise EPT from €0.50 to €0.70 per millilitre from Jan. 1, 2027, a 40% increase applying to both nicotine-containing and nicotine-free e-liquids. The tobacco duty increase is expected to raise about €63.1 million in a full year.
Regulations
Oct.09
STIIIZY Redesign Fails to Escape PAX Labs Patent Import Ban as Section 337 Case Also Involves China ALD
STIIIZY Redesign Fails to Escape PAX Labs Patent Import Ban as Section 337 Case Also Involves China ALD
U.S. Customs and Border Protection ruled that STIIIZY had not shown that the redesigned cannabis-vape products covered by its latest request fall outside an ITC limited exclusion order tied to PAX Labs patents. CBP accepted some of STIIIZY’s claim-construction and non-infringement arguments, but the company did not address two additional claims in the same patent. Earlier STIIIZY redesigned cartridges and certain associated components imported with them had received separate CBP clearance.
Sep.16
UK Vape Duty Starts in October as Hayati, DOJO and Others Launch Lower-Capacity Products With Lower Per-Unit Tax
UK Vape Duty Starts in October as Hayati, DOJO and Others Launch Lower-Capacity Products With Lower Per-Unit Tax
The UK's Vaping Products Duty will take effect on October 1, 2026, at a flat rate of £2.20 per 10ml of vaping liquid. Ahead of implementation, DOJO, PIXL and Hayati have introduced or been reported to be adding lower-capacity tiers alongside larger products. DOJO has added a 6ml BLAST7K Fresh below its 10ml BLAST10K Fresh, PIXL offers both a 12ml 8000 and a 6ml 5K, while retailer Ninja Vapes says Hayati is preparing a 7ml 4K alongside its existing 12ml 6K. The pattern points to a growing lower-capacity tier in the UK market, although the brands have not all explicitly linked the changes to the new duty.
Sep.23
Product | JT Launches Three Autumn-Limited Ploom Tobacco Sticks in Japan Across EVO, MEVIUS and CAMEL Brands
Product | JT Launches Three Autumn-Limited Ploom Tobacco Sticks in Japan Across EVO, MEVIUS and CAMEL Brands
Japan Tobacco Inc. (JT) launched three limited-edition autumn tobacco sticks for its Ploom heated tobacco devices in Japan on October 16, 2026, under the EVO, MEVIUS and CAMEL brands. All three are regular tobacco variants with seasonal packaging. Each pack contains 20 sticks, priced at ¥620, ¥590 and ¥570, respectively, including tax. The products are compatible with all Ploom devices and are sold in limited quantities exclusively through the CLUB JT online store while supplies last.
product
Oct.20