There has been a big buzz in the Philippine e-cigarette industry.
Several sectors are waiting for what comes next after both houses of the Philippines legislature ratified the harmonized version of the Vaporized Nicotine Products Regulation Act at the end of January.
The vape bill consolidates Senate Bill No. 2239 or the “Vaporized Nicotine and Non-Nicotine Products Regulation Act” and House Bill No. 9007 or the “Non-Combustible Nicotine Delivery Systems Regulation Act.”
Update: The Act has lapsed into law, known as Republic Act 11900. There are a few interesting developments as well, which you will find below.
Now a law, the Philippines joined 67 countries worldwide that have regulatory frameworks on vaping. The Vaping Bill aims to regulate the use, manufacture, importation, sale, distribution, and promotion of vaping and heated-tobacco products (HTPs).
Under RA 11900, the Food and Drug Administration (FDA) Department of Trade and Industry (DTI), and the Department of Health (DOH) will have exclusive jurisdictions and regulate vapor products with health claims.
The World Health Organization estimates that 17 million Filipinos continue to smoke cigarettes. Of this count, more than 100,000 Filipinos die every year from smoking-related diseases. Despite all anti-smoking efforts and interventions, only 4 percent will successfully quit every year.
It’s estimated that 4% of Filipinos use e-cigarettes regularly or occasionally as an alternative to tobacco use. As such, the bill is also expected to serve as a pragmatic middle ground for the 96 percent expected to continue to smoke in 2022.
The Philippine e-Cigarette Market
According to a report from 6Wresearch, the country’s E-cigarette Market size is anticipated to register potential growth from 2020 to 2026.
When set against a growing middle-income class and a large young population, the Philippines’ economic dynamism presents a promising consumer demand supported by improving incomes and stable remittances. Though still dominated by the agricultural sector, the economy offers opportunities as a newly-industrialized country, not just for Filipinos but also for foreign businesses.
Here are some requirements needed on how to legally import and sell HTPs (heated tobacco products) in the Philippines:
License to Operate (LTO) from the FDA – applies to all establishments engaged in manufacturing, distribution, importation, exportation, retail sale, and vapor products, including online sale or distribution.Product Batch Notification with the FDA – After the issuance of an FDA Electronic Registration Number (FERN), a prerequisite of pre-assessment of submission 2 The law requires registration of all e-cigarettes before sale or distribution under the FDA Electronic Registration Number (FERN) process and batch declaration process (for e-cigarette refills and cartridges).- Vape products and HTPs are now under the jurisdiction of the Department of Trade and Industry (DTI) and the Department of Health (DOH). This means there is no need to secure a License to Operate and a Product Batch Declaration Certificate from the FDA following the provisions of Republic Act 11900.
- Electronic Filing Payment System (eFPS) Registration – filed with the Philippine Bureau of Internal Revenue (BIR); for electronically filing tax returns, including attachments, if any, and paying taxes (especially excise tax) due thereon, specifically through the internet.
- Various Permits with BIR, like a Permit to Operate with BIR and Import Commodity Clearance from the National Tobacco Administration (NTA)
- Import Accreditation with the Philippine Bureau of Customs
Groups like the Federation of Philippine Industries (FPI), an umbrella group of 168 organizations and companies from various Philippine industries, have endorsed the Vape Bill. In a statement, the FPI expressed confidence that, on top of the health objectives, opening up the economy to a well-regulated vaping and HTP industry will support the government’s economic and revenue initiatives.
How to Import Vape and Heated Tobacco Products (HTP) into the Philippines: A Guide to DTI Registration
If you’re looking to import vape and heated tobacco products (HTPs) into the Philippines, it’s essential to understand the regulatory requirements set by the Department of Trade and Industry (DTI). Compliance with local regulations ensures consumer safety and legal market entry, per Republic Act No. 11900.
This post outlines the DTI certification process, starting with the Philippine Standard (PS) License, followed by the Statement of Conformity (SOC), and including other certifications such as the Import Commodity Clearance (ICC). Every importer must navigate these steps to bring vape and HTP products into the country.
What is the Philippine Standard (PS) License:
A Philippine Standard (PS) License is a certification issued by the Department of Trade and Industry (DTI) that indicates a product meets the Philippine National Standards (PNS) for safety and quality. It is particularly important for products like vape and heated tobacco products (HTPs) that are subject to regulatory scrutiny. This license certifies that your vape or HTP products meet the Philippine National Standards (PNS), ensuring they are safe for public use.
The PS License is mandatory before applying for the Statement of Conformity (SOC), which is needed for every product import.
How to Get a PS License:
- Documentation Submission: Prepare and submit relevant documents such as Quality Management System (QMS) Documentation, ISO Certification, and other technical documentary requirements.
- Factory Audit: If you’re a manufacturer, the DTI will audit your production facility to ensure compliance with quality control standards.
- Product Testing: During the factory audit, the Inspector will withdraw a product sample to submit to accredited laboratories for safety and quality testing to verify they meet PNS.
- License Issuance: Once testing and factory audits are completed successfully, you will be granted the PS License. This allows you to use the PS Mark on your products, signaling compliance with the necessary standards.
Why PS License Is Important:
The PS License is mandatory and must be secured before any further steps can be taken. Without it, your products cannot legally be imported or sold in the Philippines. The PS Mark also enhances your product’s credibility in the market.
What is the Statement of Conformity (SOC)
The Statement of Conformity (SOC) is a document that certifies a product’s conformance with relevant standards and regulations, specifically the Philippine National Standards (PNS) in the context of the Philippines. It is an essential requirement for importing products like vape and heated tobacco products (HTPs) into the country.
Once the PS License is in place, every batch of vape and HTP products you import will require a Statement of Conformity (SOC). The SOC certifies that each shipment complies with the standards verified during the PS License approval.
How to Secure SOC:
- Documentation Submission: Prepare and submit relevant documents such as your PS License, product specifications, and lab test results for the specific batch being imported.
- Verification by DTI: The DTI will review the SOC application and confirm that the batch complies with PNS.
- SOC Approval: Once the SOC is approved, you can proceed with importing and distributing the batch in the local market.
Why SOC Is Important:
A SOC is required for every import of vape and HTP products. Without it, your shipments cannot clear customs or enter the market. The SOC is a safeguard, ensuring that each batch consistently adheres to safety standards.
What is Import Commodity Clearance (ICC)
The Import Commodity Clearance (ICC) is a crucial certification for importing vape and heated tobacco products (HTPs) into the Philippines. Issued by the Department of Trade and Industry (DTI), the ICC ensures that these products comply with local safety and quality standards, protecting consumers and facilitating lawful market entry. This certification is distinct from the Philippine Standard (PS) License and the Statement of Conformity (SOC), confirming that HTPs meet national standards before they can be sold in the Philippine market.
Steps to Get ICC:
- Submit Import Documents: Provide product details, including shipping documents and test results from accredited labs.
- Inspection by DTI: The Bureau of Philippine Standards (BPS) will inspect the products and verify compliance with safety and quality standards.
- Receive ICC Mark: Once approved, the ICC mark is issued, which must be affixed to the products before they are distributed.
Why ICC Matters:
The ICC ensures that all imported products, including vapes and HTPs, are safe for local consumers. Failure to secure an ICC can lead to product confiscation, fines, or even suspension of business operations.
Simplifying the Process with Triple I Consulting
Navigating the DTI’s certification processes for vape and HTP products can be complicated, especially with the multiple licenses and clearances required. Our regulatory consultancy services make the process seamless by offering expert guidance in:
- PS License application and SOC filing.
- Managing product testing and factory audits.
- Preparing and submitting the necessary documents for ICC and other regulatory requirements.
We handle the complexities so you can focus on growing your business and getting your products to market faster. Contact us today through any of the methods below to schedule an initial consultation with one of our experts:
- Contact Us Here
- Fill out the form below
- Call us at: +63 (02) 8540-9623
- Send an email to: info@tripleiconsulting.com