Home
Company
Product
Regulation
China
Data
Exhibition
Interview
中文版
Home
Company
Product
Regulation
China
Data
Exhibition
Interview
中文版
Search

Philippine FDA Requires Licenses for Vape Products with Medical Claims

Dec.22.2025
Philippine FDA Requires Licenses for Vape Products with Medical Claims
The Philippine Food and Drug Administration has announced that establishments selling vaporized nicotine and non-nicotine products and novel tobacco products with medicinal or therapeutic claims must secure Licenses to Operate. Such products are also required to be registered as pharmaceutical products through the Center for Drug Regulation and Research. The FDA urged stakeholders to comply with the new requirements to ensure product safety, efficacy and quality.

Key Points

 

  • The Philippine FDA issued Advisory No. 2025-1487;
  • Vape products with medicinal claims must secure Licenses to Operate;
  • All manufacturers, importers, distributors and retailers are covered;
  • Products must be registered as pharmaceutical products;
  • Compliance is required to ensure safety and quality standards.

 

 

2Firsts, December 2025,22 – According to SunStar Philippines, the Philippine Food and Drug Administration (FDA) now requires all establishments selling Vaporized Nicotine and Non-Nicotine Products (VNNPs) and Novel Tobacco Products (NTPs) with medicinal or therapeutic claims to secure Licenses to Operate.

 

Based on Advisory No. 2025-1487, the FDA said that manufacturers, traders, importers, exporters, wholesalers and retailers offering such products must apply for licenses as pharmaceutical establishments under the Department of Health.

 

The FDA added that all VNNPs and NTPs with medicinal or therapeutic claims must be registered prior to manufacture, distribution and sale.

 

The agency said these products must be registered as pharmaceutical products through the Center for Drug Regulation and Research (CDRR).

 

The FDA urged all stakeholders to fully comply with the new requirements, stating that adherence to regulatory standards is necessary to ensure the safety, efficacy and quality of VNNPs and NTPs with medicinal or therapeutic claims in the market.

 

Image Source: SunStar Philippines

 

References:
[1] FDA requires licenses for stores selling vapes with health claims
Also Read:
[1] Philippine BIR Will Destroys Nearly 450,000 Illicit Vape Products Over Unpaid Taxes
[2] Philippines’ DTI Proposes Mandatory Advertising Permits for Vape Products
[3] Philippines Probe Agency Seizes 800 Smuggled Vape Products in Manila, Stores Face Multiple Charges

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

China Tobacco Regulation Shift：Policy Updates and Market Impact
China Tobacco Regulation Shift：Policy Updates and Market Impact
U.S. Military Could Test Nicotine Pouches and Vapes for Smoking Cessation as Washington Examiner Cites ZYN and Potential $4 Billion Reduction in Related Defense Costs
U.S. Military Could Test Nicotine Pouches and Vapes for Smoking Cessation as Washington Examiner Cites ZYN and Potential $4 Billion Reduction in Related Defense Costs
The House-passed FY2027 National Defense Authorization Act includes a provision authorizing the defense secretary to conduct a one-year smoking-cessation pilot for active-duty service members. Section 707 lists counseling, nicotine gum and patches alongside what the bill calls "electric nicotine delivery systems," nicotine pouches and heat-not-burn products. A recent Washington Examiner op-ed cited ZYN as an example in arguing for the provision, but the legislation does not name any commercial brand or supplier. ZYN is made by PMI-owned Swedish Match USA, with specified products holding FDA marketing authorizations and modified risk orders.
Sep.20
BAT CFO Dragos Constantinescu Takes Office, Returning After Seven Years and Former Asahi Europe Leadership Role
BAT CFO Dragos Constantinescu Takes Office, Returning After Seven Years and Former Asahi Europe Leadership Role
Dragos Constantinescu has officially taken up his role as Chief Financial Officer and Executive Director at British American Tobacco (BAT). He previously spent 16 years at BAT across finance and general management roles in Europe before joining Asahi in 2019 and becoming CEO of Asahi Europe & International in 2025. His return comes as BAT continues to advance its “A Better Tomorrow” transformation.
BAT
Sep.01
UK Directors Banned After 352,688 Vapes Imported From China Were Misdeclared as Medical Nebulizers in £15 Million Tax Case
UK Directors Banned After 352,688 Vapes Imported From China Were Misdeclared as Medical Nebulizers in £15 Million Tax Case
The UK Insolvency Service said YSK Enterprises imported large quantities of vapes from China in 2023, with a shipment addressed to the company declared as medical nebulizers before Border Force found 352,688 vaping products. HMRC calculated nearly £15 million ($20.3 million) in unpaid VAT and customs duty, alongside about £437,000 in corporation tax. Two directors were disqualified for nine years. The case predates the UK's Vaping Products Duty, which will introduce vape-specific excise and duty-stamp requirements from October 2026.
Regulations
Sep.11
On-Site Report | After FDA Announces Review of PMTA Framework, CTP Director Details Reform Priorities
On-Site Report | After FDA Announces Review of PMTA Framework, CTP Director Details Reform Priorities
FDA CTP Director Bret Koplow used his FDLI keynote in Washington to outline how the agency is rethinking the PMTA framework. He discussed category-specific review, nicotine pouch and sPMTA pilots, AI-assisted review, a 70% reduction in pending applications, and a major staffing constraint: CTP currently has only nine scientific review teams. He also reaffirmed tobacco harm reduction while stressing youth protection, flavored products, risk communication, and the challenge of unauthorized e-cigarettes.
Regulations
Oct.06
Canada Considers Easing Pharmacy-Only Nicotine Pouch Sales Rules, Potentially Reopening Convenience Store Channel
Canada Considers Easing Pharmacy-Only Nicotine Pouch Sales Rules, Potentially Reopening Convenience Store Channel
Canada's federal government is considering changes to current restrictions on where nicotine pouches can be sold, potentially allowing authorized products to return to convenience stores and other general retail channels, although no decision has been made. Since 2024, emerging nicotine replacement therapy products such as nicotine pouches have been largely restricted to behind-the-counter pharmacy sales. Health Canada, meanwhile, continues to recall unauthorized and higher-strength nicotine pouches, indicating that the current discussion concerns retail access for authorized products rather than a broad relaxation of nicotine pouch regulation.
Sep.14
PMI Showcases ZYN, IQOS and U.S. Investments at NACS Show 2026
PMI Showcases ZYN, IQOS and U.S. Investments at NACS Show 2026
At the 2026 NACS Show in Las Vegas, Philip Morris International (PMI) showcased its ZYN nicotine pouches, IQOS heated tobacco products and U.S. investments. A 2Firsts review of FDA records found that several ZYN products displayed at the booth were not on the agency's marketing authorization list, including certain nicotine strengths and flavors. A PMI booth representative also confirmed that IQOS is currently sold in three U.S. states, while the newer IQOS ILUMA system remains under FDA review.
EXPO
Oct.10
Related Topics
News Regulation
Related Read
U.S. Military Could Test Nicotine Pouches and Vapes for Smoking Cessation as Washington Examiner Cites ZYN and Potential $4 Billion Reduction in Related Defense Costs
U.S. Military Could Test Nicotine Pouches and Vapes for Smoking Cessation as Washington Examiner Cites ZYN and Potential $4 Billion Reduction in Related Defense Costs
BAT CFO Dragos Constantinescu Takes Office, Returning After Seven Years and Former Asahi Europe Leadership Role
BAT CFO Dragos Constantinescu Takes Office, Returning After Seven Years and Former Asahi Europe Leadership Role
UK Directors Banned After 352,688 Vapes Imported From China Were Misdeclared as Medical Nebulizers in £15 Million Tax Case
UK Directors Banned After 352,688 Vapes Imported From China Were Misdeclared as Medical Nebulizers in £15 Million Tax Case
On-Site Report | After FDA Announces Review of PMTA Framework, CTP Director Details Reform Priorities
On-Site Report | After FDA Announces Review of PMTA Framework, CTP Director Details Reform Priorities
Canada Considers Easing Pharmacy-Only Nicotine Pouch Sales Rules, Potentially Reopening Convenience Store Channel
Canada Considers Easing Pharmacy-Only Nicotine Pouch Sales Rules, Potentially Reopening Convenience Store Channel
PMI Showcases ZYN, IQOS and U.S. Investments at NACS Show 2026
PMI Showcases ZYN, IQOS and U.S. Investments at NACS Show 2026
FOLLOW US ON SOCIAL MEDIA
Contact: info@2firsts.com
Stay up to date.
Submit your email to receive weekly newsletter on the most relevant news of the e-cigarette industry.
© 2026 2FIRSTS. All Right Reserved.
2FIRSTS is only accessible to industry practitioners, researchers, media and other professionals. Access by minors is prohibited.
This website provides services to users outside the Chinese mainland.
English
English
中文