Introduction

The global vape and E-cigarette market has grown rapidly in recent years. As demand for vape, vapor, and fruit-flavored E-cigarettes increases, new types of nicotine products are emerging. These include oral tobacco (snus-like pouches), nicotine gum, nicotine sprays, and synthetic nicotine-based vapes. However, the regulatory landscape for these novel nicotine products is still evolving, and in many countries, it remains inconsistent and fragmented.

This article explores the legal definitions, regulatory gaps, and policy trends in China and leading global markets, aiming to offer a comprehensive guide for stakeholders in the vape and E-cigarette industry.

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1. Classification of New Nicotine Products

1.1 Legal Definitions

In China, oral tobacco is defined as a smokeless oral product placed between the lips and gums. It dissolves in saliva and releases nicotine without combustion. The U.S. FDA defines oral tobacco similarly but emphasizes that it is packed in small pouches.

On the other hand, nicotine gum and lozenges are typically not defined as tobacco products. They are considered alternatives for nicotine delivery via the oral mucosa, without tobacco leaf or combustion. Nicotine sprays and transdermal patches also fall under the category of nicotine replacement therapies, which are generally regulated as medicinal products in Western countries.

1.2 Conflicts Between Law and Innovation

As synthetic nicotine becomes more widespread, many legal frameworks—designed for traditional tobacco—are increasingly outdated. This creates gray zones, especially where the product’s formulation doesn’t match current legal definitions.

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2. Regulation of Nicotine: Domestic and International Perspectives

2.1 Use of Nicotine

Beyond vapes and fruit-flavored E-cigarettes, nicotine has applications in medicine, pesticide production, and neuroscience research. However, its primary commercial use remains in smoking-related products.

2.2 China’s Regulatory Framework

China’s standards only allow tobacco-extracted nicotine in E-cigarette products, prohibiting synthetic nicotine. Nicotine is also classified as a toxic chemical, requiring:

• Production licenses
• Sales permits
• Hazardous chemical management
• Police approval for purchasing toxic substances

E-cigarette and aerosol manufacturers must operate via a regulated trading platform. Companies producing oral nicotine products may be required to register as tobacco or medicinal entities, depending on the product’s ingredients.

2.3 Global Regulation

United States

• Synthetic and tobacco-derived nicotine are both classified as tobacco products.
• Any fruit-flavored vape must go through PMTA (Premarket Tobacco Product Application).
• All vape manufacturers, wholesalers, and retailers must be licensed.
• Warning labels such as “Nicotine is an addictive chemical” are mandatory.

United Kingdom

• Tobacco-extracted oral tobacco is banned.
• Synthetic nicotine gum and lozenges are allowed but should be registered as medicines if intended for smoking cessation.
• Vapes must meet product notification, labeling, and safety requirements under TRPR.

European Union

• The Tobacco Products Directive (TPD) bans oral tobacco containing tobacco extract.
• Products using synthetic nicotine may bypass TPD regulation unless registered as medicinal items.
• Each member state applies its own judgment.

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3. Regulation of Oral Tobacco

3.1 China

There is no uniform law governing oral tobacco. In April 2024, the State Tobacco Monopoly Bureau clarified:

• Products with extracted nicotine are treated as tobacco products.
• Products with synthetic nicotine are treated under vape aerosol laws.
• Products registered as medicine are governed under drug administration.

This suggests a move toward ingredient-based regulation, differentiating between synthetic and extracted nicotine.

3.2 United States

The U.S. applies the same rules to oral tobacco as it does to E-cigarettes and fruit-flavored vapes. All products need PMTA approval and must comply with nicotine warning labels. In 2025, the FDA approved 20 oral tobacco products under PMTA—a significant regulatory milestone.

3.3 United Kingdom and European Union

In the U.K. and EU:

• Extracted nicotine oral tobacco is prohibited.
• Synthetic nicotine versions are not yet clearly regulated, making them technically legal.
• Enforcement is inconsistent across member countries.

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4. Regulation of Nicotine Gum

4.1 China

Nicotine gum is not clearly regulated. It might fall under “chewing tobacco” if made from tobacco-extracted nicotine, but synthetic versions do not fall into any legal category, leaving them unregulated.

4.2 United States

• Considered a tobacco product if it contains nicotine.
• However, the FDA also classifies nicotine gum as one of seven approved smoking cessation aids.
• Dual identity as both tobacco and medicine complicates approval.

4.3 U.K. and E.U.

• Encouraged to register as medicinal nicotine replacement therapy.
• Not mandatory, allowing products to be sold as general consumer goods if they don’t make medical claims.

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5. Challenges of Outdated Laws

5.1 Lag Between Law and Market Innovation

The rapid emergence of synthetic nicotine, vape aerosols, and fruit-flavored E-cigarettes is outpacing traditional tobacco law. Most regulations were written with cigarettes or early-generation vapes in mind.

5.2 Differentiating Synthetic and Extracted Nicotine

There’s no international consensus. Some nations regulate them equally; others don’t. This inconsistency creates:

• Legal loopholes
• Consumer confusion
• Taxation and classification issues

Some jurisdictions (e.g., U.S.) classify all nicotine products together, regardless of source, which simplifies enforcement and enhances compliance clarity.

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6. Implications for the Vape Industry

6.1 Industry Growth

• The global synthetic nicotine market reached $7.8 billion in 2023.
• Projected annual growth rate exceeds 34%.
• Fruit-flavored vape products continue to dominate E-cigarette shelves, despite growing scrutiny.

6.2 Flavor Restrictions

• Several countries have imposed flavor bans to deter youth vaping.
• This includes restrictions on fruit, dessert, and menthol flavors.
• Many companies are now shifting to tobacco-only flavor profiles to remain compliant.

6.3 Public Health and Safety

• Synthetic nicotine is not necessarily safer than tobacco-derived nicotine.
• Many assumptions around purity or reduced harm are not scientifically proven.
• Regulation must prioritize product testing, labeling, and youth protection.

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7. Strategic Recommendations

1. Unify the definition of nicotine products to include all delivery formats and sources.
2. Close regulatory gaps, especially regarding synthetic nicotine and oral products.
3. Mandate transparency in labeling for nicotine content, type, and risks.
4. Limit child-appealing flavors, especially in fruit-flavored vapes and gum-based formats.
5. Establish universal standards for quality control and PMTA-like evaluations.
6. Encourage international cooperation for shared databases, testing protocols, and market monitoring.

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Conclusion

The future of vape, E-cigarette, and fruit-flavored nicotine products hinges not only on innovation but on legal clarity. As synthetic nicotine continues to disrupt traditional tobacco markets, countries must adapt regulatory frameworks that balance innovation with public health concerns. For vape industry stakeholders, especially wholesalers and independent sellers, staying informed and compliant is essential to long-term success.