Interpreting The Philippine E-cigarette Regulation Bill: Allow Network Sales, Products Should Have Child Protection Features
On July 25, 2022, the President of the Philippines officially signed and approved the Vaporized Nicotine and Non-Nicotine Products Regulatory Act as an Act of the Republic (RA 11900), effective 15 days from the date of publication. The bill is a merger of H.No 9007 and S.No 2239 (which were passed by the Philippine House of Representatives on January 26, 2022 and the Senate on February 25, 2022, respectively) to regulate the importation, manufacture, sale, packaging, distribution, use and dissemination of vaporized nicotine and non-nicotine products (including e-cigarettes) and new tobacco products.
This issue introduces you to some of the contents of the RA, to help you clearly understand the Philippines e-cigarette regulatory regulations.
Product Conformity Requirements
- The nicotine content of commercially available vaporized products shall not exceed 65 mg/mL (65 mg/mL).
- Vaporized product refill containers shall be childproof, tamper-resistant, and shall be protected from breakage and leakage.
- The Department of Trade and Industry (DTI), in consultation with the Food and Drug Administration (FDA), shall develop technical standards of quality and safety to be met for the registered product in accordance with international standards. (See Technical Regulations Requirements: "Philippines Introduces New Technical Regulations for Mandatory Certification of Electronic Cigarette Products" )
Product registration requirements
- Manufacturers and importers of vaporized nicotine and non-nicotine products, vaporized product devices, heated tobacco product devices, and new tobacco products shall submit to DTI information demonstrating compliance with the requirements for registration before they may sell, distribute, or advertise.
b.For online sales, the Secretary of DTI is authorized to issue an order, after due process, directing the closure of the website, webpage, online application, social media account, or other similar platform of an online seller that does not meet the registration requirements set forth in this Act.
c.DTI and the Bureau of Internal Revenue (BIR) shall also maintain on their websites a monthly updated list of brands of vaporized nicotine and non-nicotine products and new tobacco products registered with DTI and BIR that are eligible for online sales.
a.Allow advertising of vaporized nicotine and non-nicotine products, new tobacco products, and other forms of consumer communication at the point of sale or retail establishment, through direct marketing, and on the Internet.
- Prohibits the sale of vaporized nicotine and non-nicotine products that are proven to be particularly unduly appealing to minors (and are considered unduly appealing to minors if the flavor depiction includes fruit, candy, desserts, or cartoon characters).
Tax labeling requirements
- Vaporized products and supplements, HTP consumables or new tobacco products manufactured or produced in the Philippines for sale or consumption in its country shall be packaged in BIR-regulated packaging and bear the mark or nameplate designated by the BIR to comply with the National Tax Fiscal Identification Requirements Regulations (RA 8424) and other regulations as may be applicable.
- Goods of a similar nature imported into the Philippines shall also be packaged and marked in accordance with the requirements of the BIR as stated above.
Online transaction restrictions
- The sale or distribution of vaporized nicotine and non-nicotine products, their devices, and new tobacco products through the Internet, e-commerce, or other similar media platforms shall be permitted provided that measures are taken to ensure that no person under eighteen (18) years of age shall have access to the site and that the Internet site shall bear the markings required by this Act.
- Only online sellers or distributors who are registered with DTI or the Securities and Exchange Commission (SEC) shall be permitted to transact, and products sold and advertised online shall meet health warning requirements as well as other BIR requirements such as stamp duty, minimum price, or other fiscal markers.
Minimum Age Limit
The minimum allowable age for the purchase, sale and use of vaporized nicotine and non-nicotine products, their devices or new tobacco products shall be eighteen (18) years.
The issuance of Republic Regulation RA 11900 in conjunction with DTI's earlier Departmental Administrative Directive No. 22-06 marks the formal establishment of Philippine e-cigarette regulatory regulations and recommends that relevant manufacturers in need include product compliance requirements in their Philippine market development plans.