FDA Vape Regulations: Key Changes, Enforcement Trends, and What Chinese Brands Need to Know

2025-01-15

The United States is the world's largest market for vapes, and for Chinese vape companies, understanding U.S. vape regulatory policies is critical as they impact export and business strategies. This article will summarize the FDA's vape regulations for 2024, focusing on legislative changes, enforcement trends, and PMTA approval progress.

I. Legislative Developments

On August 15, 2024, the FDA and the Treasury Department issued a new proposed regulation requiring vape product importers to submit an STN (Submission Tracking Number) to Customs. The STN is a unique identifier assigned to products that have submitted a Pre-Market Tobacco Application (PMTA) to the FDA. According to the new rule, vape products that do not submit an STN to Customs will be prohibited from entering the U.S. market. This move aims to improve import review efficiency, enabling the FDA to identify vape products that may pose greater public health risks more quickly. The introduction of this regulation presents new challenges for vape trade and compliance between China and the U.S., urging companies to accelerate compliance with FDA requirements.

On August 29, 2024, the FDA also issued a new legal update concerning the age restrictions for tobacco product sales. The new regulation raised the minimum purchasing age for tobacco products from under 27 to under 30 and increased the minimum age to access vending machines containing tobacco products from 18 to 21. Brian King, director of the FDA’s Center for Tobacco Products, stated that this measure aims to further protect young people from the health risks of tobacco products and enhance protections for teenagers. Have questions about vapes? snoopy smoke vape answers all your questions!

These two legal changes demonstrate the FDA's increasing efforts to reduce youth tobacco use, especially in regulating vape products. For Chinese vape brands, this means they must scrutinize their products’ compliance more strictly, particularly in terms of protective designs aimed at preventing youth usage.

II. Enforcement Trends

In 2024, the FDA intensified its enforcement against illegal vape products. On June 10, the U.S. Department of Justice and the FDA jointly formed a federal multi-agency task force to combat the distribution and sale of illegal vapes. The task force includes several government enforcement agencies, such as the FDA, the Department of Justice, the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), the U.S. Marshals Service (USMS), the U.S. Postal Inspection Service (USPIS), and the Federal Trade Commission (FTC). The task force focuses on cracking down on the illegal sale of vape products, especially to prevent minors from accessing nicotine-containing vape products.

The FDA's enforcement actions include warning letters, civil fines, seizures/confiscations, import alerts, and bans.

1.    Warning Letters: In 2024, the FDA issued multiple warning letters to retailers for selling unapproved vape products, especially from Chinese brands (e.g., E brand, LM brand, G brand). For example, on February 1, 2024, the FDA sent warning letters to 14 online retailers for selling unapproved vape products. Similar warnings were issued throughout February, March, May, and July 2024 to various retailers.

2.    Civil Fines: In addition to warning letters, the FDA imposed fines on some retailers. On January 30, 2024, the FDA fined 21 retailers selling Chinese Es brand vapes for continuing to sell unapproved products despite FDA warnings. On February 26, 2024, 20 more retailers selling Chinese E brand vapes were fined. These penalties serve not only to punish non-compliant retailers but also to warn the industry that compliance in the vape market is becoming increasingly important.

3.    Seizures/Confiscations: In 2024, the FDA, in collaboration with Customs, seized large quantities of unauthorized vape products. On April 30, 2024, the FDA and the Department of Justice seized over $700,000 worth of vape products from Chinese brands, including P brand, E brand, and Es brand, at a warehouse in California. Later seizures occurred in Chicago and Los Angeles in June and October.

4.    Import Alerts: As of December 2024, 34 Chinese vape companies have been added to the import alert list, an increase of 19 companies from the previous year. Products from companies on this list are prioritized for detention by the FDA, which prevents them from entering the U.S. market without further inspection. This increases the regulatory burden on these companies’ exports.

5.    Bans: The FDA has also implemented stronger ban measures, prohibiting certain companies from continuing to manufacture and sell unapproved vape products. For example, on June 11, 2024, the U.S. District Court in Colorado issued a permanent injunction against Boosted LLC, barring them from selling unapproved vape products. Similar bans were imposed on companies like Soul Vapor LLC, showing that the FDA's crackdown on illegal behavior has become more aggressive.

III. PMTA Applications and Approvals

The FDA regulates vape market entry primarily through the PMTA process. Under the regulation, all vape products must submit a PMTA application and receive FDA approval before entering the U.S. market. In 2024, the FDA approved several vape products, mainly focusing on tobacco and menthol flavors. On June 21, 2024, the FDA approved four menthol-flavored vape products from NJOY, marking the first non-tobacco flavored vapes to receive approval. On July 18, 2024, Reynolds also successfully received approval for seven tobacco-flavored vapes.

However, as of December 2024, the FDA had only approved 34 PMTA applications, most of which were tobacco and menthol flavors. Flavored vapes have not yet been approved. The FDA is cautious regarding flavored vapes, considering their potential appeal to young people, which could increase health risks. The approval standards emphasize that vape companies must prove their products benefit adults and effectively prevent youth use.

For flavored vapes, the FDA has stated that although youth use remains a concern, flavored vapes may still be approved if companies provide substantial evidence proving the product benefits adults more than it risks attracting minors. Therefore, vape companies must take stricter measures to prevent underage use when applying for PMTA approval.

IV. Corporate Strategies and Future Outlook

In light of the FDA's increasingly stringent regulations, Chinese vape companies must enhance their compliance awareness. First, companies should ensure their products meet FDA requirements according to U.S. laws and regulations. This includes submitting PMTA applications and adopting technical designs to prevent youth access to vapes. Companies like British American Tobacco have already begun developing technologies to prevent youth access to vapes, while domestic Chinese companies have relatively weaker development in this area.

Second, companies should invest more resources in compliance. While PMTA application fees and timelines are long, obtaining sales approval through legal channels will provide companies with stable market share and long-term brand effects. Therefore, Chinese companies should actively submit PMTAs and provide sufficient evidence proving their products’ benefits for adults. Additionally, companies should focus on product appearance and functional design to avoid attracting minors.

Moreover, companies should pay attention to the FDA’s core requirements for protecting minors and actively participate in relevant technological innovations. The Chinese vape industry should avoid relying solely on existing design and functional innovations and instead focus on fundamentally solving the issue of youth usage. This approach will not only enhance a company's competitiveness but also ensure its products meet FDA compliance requirements, preventing harsher regulatory measures.

V. Conclusion

In summary, the FDA’s vape regulations are becoming stricter in 2024, particularly in terms of cracking down on illegal distribution and sales and limiting youth access. Chinese vape companies must recognize the importance of compliance and strengthen management at every stage of production and sales. Going forward, companies need to better respond to the FDA’s legislative and enforcement requirements, adjust their business strategies in a timely manner, and ensure sustainable development in the complex international market. Only by strengthening compliance investment, focusing on youth protection, and solving core regulatory issues can Chinese vape companies establish a strong presence in the global market and avoid further sanctions and crackdowns.

VI. The Impact on Chinese Vape Brands

As the FDA tightens its regulations, the challenges for Chinese vape companies are becoming more significant. While the regulatory landscape is undoubtedly challenging, it also presents opportunities for companies that are proactive in compliance and innovation. By adhering to the new PMTA requirements and implementing effective age-restriction technologies, companies can not only avoid penalties but also build a reputation for trustworthiness in the global market. Can't find the right vape? Snoopy Smoke Extra Tank helps you customize the perfect experience!

Furthermore, staying ahead of trends in flavors and formulations can offer a competitive edge. For instance, while flavored vapes are still under scrutiny, companies that can demonstrate the adult appeal of their flavored products while ensuring they do not attract minors will likely find success. Investment in R&D focused on safer, more appealing vape technologies, such as nicotine-free options or flavors designed for specific adult preferences, can also set brands apart.

Ultimately, Chinese vape companies must remain agile and adaptable. Understanding the FDA's shifting stance and aligning product offerings with U.S. regulations will be crucial in maintaining a strong market presence. Firms that can navigate these regulatory hurdles while innovating responsibly are better positioned to thrive in both the U.S. and international markets.