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FDA Approves JUUL Menthol E-Cigarettes and Releases Key Scientific Evaluation Criteria

Preface

On July 17, 2025, the U.S. Food and Drug Administration (FDA) granted JUUL marketing authorization, approving its e-cigarette device and 3%/5% menthol pods for legal sale in the United States. This makes JUUL, following brands like NJOY and Vuse, another mainstream closed-system e-cigarette brand to receive approval for menthol-flavored products, drawing widespread industry attention. The following content summarizes key points from the FDA’s Technical Project Lead (TPL) Review, Environmental Assessment (EA), and Finding of No Significant Impact (FONSI).

I. FDA Approval Summary

High-risk flavored products are unlikely to meet the public health standard required by the Tobacco Control Act unless they demonstrate sufficient benefits for adult smokers in terms of switching or harm reduction. To keep such products on the market, companies must provide robust data showing full substitution among adults or significant reductions in cigarette use; otherwise, marketing authorization can be revoked at any time.

According to the TPL Review, the FDA’s decision in this round was based on substantial hard data. In terms of behavioral evidence, JUUL submitted a randomized controlled trial (RCT) involving 675 participants and a two-year longitudinal cohort study of approximately 2,000 individuals. These studies showed that menthol-flavored e-cigarettes enabled 51% of adult cigarette users to achieve complete seven-day substitution, significantly outperforming JUUL’s tobacco-flavored products.

Nicotine pharmacokinetics data revealed that JUUL menthol pods deliver approximately 79% of the plasma nicotine exposure (AUC) of cigarettes but significantly alleviate withdrawal symptoms. From a physico-chemical and toxicological standpoint, all 20 harmful and potentially harmful constituents (HPHCs) in whole-pod aerosols were below 15% of those found in 3R4F reference cigarettes. The carcinogenic risk of menthol pods was estimated by modeling to be within 5% of 3R4F levels. Ames, micronucleus, and cytotoxicity tests all returned negative results. On the biomarker level, six weeks after switching, participants exhibited reductions of 85% in NNAL and 62% in COHb. Together, these findings support the conclusion that the menthol version offers a net benefit in terms of adult substitution or harm reduction.

In addition, the FDA for the first time simultaneously released the Environmental Assessment and FONSI. The EA, compiled by the FDA’s Center for Tobacco Products (CTP), analyzed the manufacturing, use, and disposal lifecycle of JUUL’s pre-filled disposable pods (menthol and Virginia tobacco, 3%/5%) and hardware. The report compared two scenarios—“approval” (granting marketing authorization) and “no action” (maintaining the status quo, denying approval)—evaluating potential impacts on air, water resources, soil and biodiversity, solid and hazardous waste, and regulatory compliance. Particular attention was given to JUUL’s production facilities in New Richmond and Hudson, Wisconsin, secondhand and thirdhand vapor emissions in U.S. markets during use, and the disposal pathways for lithium batteries and nicotine residues. The results indicated that the expected production volume would not significantly increase emissions or solid waste, nor affect protected habitats, concluding no significant adverse impacts on human or environmental health.

Based on the EA, the FDA’s Office of Science signed the FONSI on July 10, 2025, confirming that granting marketing orders for JUUL’s five products would not have significant environmental impacts. The finding was based on the absence of additional emissions during manufacturing, manageable use-phase risks, and waste management practices comparable to existing electronic nicotine delivery systems (ENDS), thus obviating the need for a full environmental impact statement.

II. Specific Protection Requirements for Minors

Youth protection measures were highlighted in the TPL Review as a core condition for risk mitigation. The FDA divided these measures into two levels:

Online sales must implement robust age and identity verification systems to restrict purchases by minors. This requirement has been written into the marketing authorization conditions and must be continuously enforced.

At the device level, access restrictions such as fingerprint or other biometric unlocking mechanisms should be incorporated to ensure minors cannot activate the devices.

The FDA made it clear that only “device access restrictions” hold promise for meaningfully reducing youth risk from flavored ENDS. However, JUUL’s current application did not include such features. Consequently, regulators explicitly warned in the authorization: if future monitoring shows rising use among minors or the company fails to add device access restrictions, the authorization may be reassessed.

It is noteworthy that throughout the TPL Review, youth risk was nearly decisive for the approval trajectory of JUUL menthol pods. Considering that nearly 90% of adult smokers established nicotine dependence before age 18, and early initiation increases the likelihood of persistent addiction, “blocking youth initiation” is viewed as the top priority for public health protection. The FDA cited data from the 2024 National Youth Tobacco Survey (NYTS), which found nearly 88% of youth e-cigarette users preferred non-tobacco flavors, with menthol/mint accounting for 15.1%. Additionally, 12.6% of youth had used JUUL products in the past 30 days, and 3.2% considered JUUL their “usual brand.” Based on these findings, regulators concluded that the appeal of flavored ENDS to youth is well-documented and significant. Only when a company provides a comprehensive set of hard data—RCTs, longitudinal cohorts, HPHC comparisons, pharmacokinetics, and biomarkers—demonstrating that adult substitution benefits far outweigh youth risks will the FDA deem a product “appropriate for the protection of public health” and approve it.

III. Implications of This Approval for the E-Cigarette Industry

JUUL’s approval signals that the FDA has set more specific and quantifiable compliance thresholds for flavored ENDS. Behavioral, toxicological, and clinical data must align with uniform reference values. Moreover, youth protection measures are trending from “online age gates” to a composite system of “online verification + device-level access control.” The simultaneous release of the EA and FONSI also indicates that environmental assessments are becoming part of the routine review checklist, with manufacturing emissions, lithium battery disposal, and nicotine residue management now under regulatory scrutiny.

More importantly, this case has provided the FDA review team with comprehensive practical experience—deepening their expertise in data evaluation and procedural control, while also making publicly available many reusable operational details. As regulatory transparency increases, any flavored ENDS seeking approval must meet equally or even more stringent evidentiary requirements on public health, youth protection, and environmental impact. Otherwise, even products that have entered the review process could be denied or revoked due to imbalanced risk-benefit assessments.

References:

1. U.S. Food and Drug Administration, Center for Tobacco Products. Technical Project Lead (TPL) Review—JUUL Device and JUUL pods Menthol 3 % / 5 % & Virginia Tobacco 3 % / 5 % [R]. Silver Spring, MD: FDA; July 2025.

2. U.S. Food and Drug Administration, Center for Tobacco Products. Environmental Assessment for Marketing Orders for New Electronic Nicotine Delivery System Products Marketed by JUUL Labs [R]. Silver Spring, MD: FDA; July 2025.

3. U.S. Food and Drug Administration, Center for Tobacco Products, Office of Science. Finding of No Significant Impact (FONSI)—JUUL Device and JUUL pods [R]. Silver Spring, MD: FDA; 10 July 2025.

4. Centers for Disease Control and Prevention; U.S. Food and Drug Administration. National Youth Tobacco Survey 2024: Results and Detailed Tables [EB/OL]. Atlanta; Silver Spring: CDC/FDA, 2024

5. United States Congress. Family Smoking Prevention and Tobacco Control Act [S]. Public Law 111-31, 22 June 2009.

Authors:

1.Zheng Mingwei – Master of International Law, Shenzhen University; Chair of Corporate Practice Committee & Equity Partner, Beijing Zhongyin (Shenzhen) Law Firm; External Mentor, University of International Business and Economics; Legal Expert for Legal Daily. Phone/WeChat: 13927417509.

2.Chen Xuefei – Juris Doctor (JD), City University of Hong Kong; Legal Assistant, Beijing Zhongyin (Shenzhen) Law Firm.