Vaporized Nicotine and Novel Tobacco Regulation

Policy and regulatory intent

The State protects and promotes the right to health of the people and instills health consciousness (Section 2).
The State regulates these novel consumer products using internationally accepted product standards to protect citizens from hazards of regulated, unregulated and substandard vapor and heated tobacco products (Section 2).
The government regulates the importation, assembly, manufacture, sale, packaging, distribution, use, advertisement, promotion and sponsorship of Vaporized Nicotine and Non-Nicotine Products, their devices, and Novel Tobacco Products to:
- promote a healthy environment,
- protect citizens from potential hazards,
- reduce harm caused by smoking, and
- prevent sales to minors and illicit trade (Section 2).

Core definitions

“Advertising” means conceptualizing, presenting, making available and communicating to the public through any form of mass media any fact, data or information about attributes, features, quality or availability of consumer products/services/credit, and includes vapor/heated tobacco advertising but excludes non-promotional informational communication (Section 3(a)).
“Celebrity” includes persons who, due to accomplishments/fame/profession, attract public attention (including actors, athletes, war heroes, famous inventors, and social media influencers) (Section 3(b)).
“Child-resistant” refers to containers opened only by using a tool not supplied with the container and complying with existing standards on child-resistant packaging (Section 3(c)).
“Designated Vaping Area (DVA)” is an assigned indoor or outdoor area where use of Vaporized Nicotine and Non-Nicotine Products is allowed (Section 3(d)).
“Heated Tobacco Products (HTPs)” are tobacco products consumed through heating to release an aerosol inhalable without combustion, including products that operate by HTP Device and those that include consumable liquid solutions or gels (Section 3(f)).
“Vapor Products” (Vapor Product Refills) are liquids/solids/gels, with or without nicotine, transformed into an aerosol without combustion by a Vapor Product Device (Section 3(aa)).
“Vaporized Nicotine or Non-Nicotine Products” are both Heated Tobacco Products and Vapor Products that generate nicotine-containing or non-nicotine-containing aerosol without combustion (Section 3(dd)).
“Reduced Risk Statement” is an explicit consumer communication in label/marketing that the product presents less harm than continued smoking of combustible cigarettes (Section 3(v)).
“Novel Tobacco Products” are non-combusted substances in solid or liquid form, including innovations made partly of tobacco leaf or containing nicotine from tobacco, intended as substitutes for cigarettes or other combusted tobacco products (Section 3(n)).
“Product Demonstration” means testing an HTP System/Vapor Product System/Novel Tobacco Product by a trained expert for informing a prospective buyer who is of legal age (Section 3(r)).
“Promotion,” “Promotional,” and “Sponsorship” define promotional events/activities and sponsored contributions for brand promotion (Sections 3(u), 3(v), 3(y)).
“Point-of-Sale” is any location, physical or online, where purchases may occur and may include a product testing area (Section 3(q)).

Packaging, health warnings, and marking rules

Vapor Product Refills, HTP Consumables, and Novel Tobacco Products must comply with packaging requirements (Section 4(a)).
Unit packaging and outside consumer packaging must bear two required health warnings:
- A highly visible, full-color graphic health warning prescribed under Republic Act No. 10646 printed on fifty percent (50%) of the principal display surfaces and occupying fifty percent (50%) of the front panel and fifty percent (50%) of the back panel; DOH designates content/format/specifications (Section 4(a)(i)).
- A textual warning:
  - For products that contain nicotine: “This product is harmful and contains nicotine which is a highly addictive substance. It is not recommended for use by nonsmokers.”
  - For products that do not contain nicotine: “This product may contain a substance that is harmful. It is not recommended for use by nonsmokers.”
- The textual warning must use no more than twenty percent (20%) of the entire area of the graphic health warning, must be clearly legible, and must appear without border/frame or design that reduces the textual warning’s size (Section 4(a)(ii)).
No printing or application may be placed where the health warning is likely to be obscured or covered (Section 4(b)).
No part of the warning may be obliterated, obscured, folded, severed, or become unreadable when the package is opened/closed or when a wrapper is removed (Section 4(c)).
Fiscal marking requirements under Republic Act No. 8424 (National Internal Revenue Code of 1997, as amended) and related regulations apply whenever applicable (Section 4(d)).
For locally manufactured/produced goods for domestic sales/consumption, only packages/marks/brands prescribed by Bureau of Internal Revenue (BIR) may be used (Section 4(d)).
Export goods may not be distributed in the local market (Section 4(d)).
DOH must issue the template and guidelines for the graphic health warning picture/design/content thirty (30) days after the Act’s effectivity (Section 4(e)).
The graphic/text warning packaging rule applies to locally manufactured or imported products introduced in the Philippine market; export-intended goods must bear specified export markings, including “For sale only in _________.” and “Made under authority of _____________,” the BIR-assigned tax number for the domestic manufacturer exporting these products, and fiscal/regulatory markings of the country of final sale (Section 4(f)).
The BIR may allow different and distinct packaging markings requirements for export-intended products to comply with the laws/rules/regulations of the destination country (Section 4(f)).

Design and age-based sale requirements

Vapor Product Refills receptacles must be child-resistant, tamper-resistant, and protected against breakage and leakage (Section 5).
Non-refillable receptacles must not be tampered with and must not be refilled (Section 5).
The minimum allowable age to purchase, sale and use Vaporized Nicotine and Non-Nicotine Products, their devices, or Novel Tobacco Products is eighteen (18) years old (Section 6(a)).
Lack of knowledge of the purchaser’s real age is not a defense for sellers/distributors (Section 6(a)).
Lack of reason to believe the product is for a person below eighteen (18) years of age is also not a defense (Section 6(a)).

Proof-of-age, online sales, and school perimeter ban

Retailers must ensure no person below eighteen (18) years is allowed to purchase Vaporized Nicotine and Non-Nicotine Products, their devices, or Novel Tobacco Products (Section 7(a)).
Retailers must verify age and require presentation of any valid government-issued identification card showing the buyer’s photograph and age or date of birth (Section 7(a)).
Retailers must ensure direct delivery only to individuals who are eighteen (18) years and above (Section 7(a)).
Online sale or distribution through internet websites, e-commerce, or similar media is allowed if retailers/distributors adopt measures to deny access to persons below eighteen (18) years and the website bears required signages (Section 8(a)).
Age for online access must be self-declared in the opening first page of the website (Section 8(a)).
Online sales/distribution are allowed only by online sellers or distributors registered with DTI or SEC, and products sold/advertised online must comply with:
- health warning requirements under the Act, and
- other BIR requirements including tax stamp, minimum or floor price, or other fiscal marks (Section 8(a)).
Delivery of online purchases must comply with Section 7 (Section 8(a)).
The sale, promotion, advertising, and product demonstration of Vaporized Nicotine and Non-Nicotine Products or Novel Tobacco Products within one hundred (100) meters from any point of the perimeter of a school, playground, or facility frequented particularly by minors is prohibited (Section 9(a)).

Point-of-sale signage and product display limits

Point-of-sale establishments must post a clear and conspicuous statement that sale/distribution to or by persons below eighteen (18) years is illegal and that the products are harmful and contain nicotine and are not recommended for nonsmokers; the Act provides an English or Filipino statement (Section 10(a)).
Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products must not be displayed immediately next to products of particular interest to minors (Section 11(a)).

Advertising, promotions, and sponsorship restrictions

Advertisement and other consumer communications are allowed in points-of-sale/retail establishments, through direct marketing, and on the internet if the Act’s guidelines are followed (Section 12(a)).
Product communications must not be targeted to or particularly appeal to persons under eighteen (18) years, and use of youth-appealing markings/characters such as cartoons/anime/manga/animated characters/youth influencers/personality content is prohibited (Section 12(a)(a)).
All product communications must contain the health warning: “Government Warning: This product is harmful and contains nicotine which is a highly addictive substance. This is for use only by adults and is not recommended for use by nonsmokers” (Section 12(a)(b)).
Advertisements must not feature a minor or celebrity or include any celebrity endorsement; manufacturers/importers/sellers may not contract celebrities or health professionals to promote or encourage use (Section 12(a)(c)).
Depictions of vaping/use as a lifestyle attractive to minors, promotion/encouragement of vaping for nonsmokers or minors, or lifestyle promotion using trademarks/brand names/design/manufacturer names targeted at minors are prohibited (Section 12(a)(d)).
Communications must not undermine quit-smoking messages and must not encourage non-tobacco or non-nicotine users to use the products (Section 12(a)(e)).
Communications must not include false or scientifically unsubstantiated information, including regarding product statements, characteristics, health effects, risks, or emissions consistent with Section 18 (Section 12(a)(f)).
Product testing and/or demonstration is allowed in locations that sell these products or their devices (Section 12(a)(g)).
Online advertisements on e-commerce platforms must be visible only after appropriate age verification measures under the Act (Section 12(a)(h)).
Advertisements may not be placed on objects/places outside point-of-sale premises such as vehicles, billboards, posters, streamers (Section 12(a)(i)).
Packaging labeled/presented/marketed with flavor descriptors proven to unduly appeal to minors is prohibited; a flavor descriptor is presumed unduly appealing if it includes reference to a fruit, candy brand, dessert, or cartoon character (Section 12(a)(j)).
No medicinal/therapeutic claim appears on marketing materials or packaging unless approved by FDA pursuant to Republic Act No. 9711 (Section 12(a)(k)).
Explicit reduced risk statements are prohibited unless authorized by the FDA pursuant to the implementing rules and regulations under Section 24 (Section 12(a)(k)).
Authorized/validated/reliable regulator reduced risk statements must be taken into consideration by FDA in resolving an application for reduced risk statement authorization, which must be resolved within eighteen (18) months (Section 12(a)(l)).
The communication restrictions apply to commercial communications and do not prevent a company from providing information regarding its company/products and other non-promotional information (Section 12(a)(m)).

Limits on promotional activities

Promotional activities related to Vaporized Nicotine and Non-Nicotine Products or Novel Tobacco Products must follow specific restrictions (Section 13(a)).
Promotional events/activities including product sampling or offers must be conducted only by trained product experts, must be directed only to persons at least eighteen (18) years old, and no person below eighteen (18) years may participate; participants must provide proof of age (Section 13(a)(a)).
Invitations for promotional events must contain appropriate health warnings (Section 13(a)(a)).
Consumer communications about promotional events must comply with the Act’s advertising communication rules and must clearly mark the age requirement for participation on program materials distributed to consumers (Section 13(a)(b)).
Medicinal claims require FDA approval under Republic Act No. 9711 (Section 13(a)(c)).
Stalls/booths/displays for promotions must be limited to point-of-sale locations or adult-only facilities (Section 13(a)(d)).
Telecommunications about promotional offers/programs/events must include a recorded health warning message in English or Filipino consistent with the Act’s warnings (Section 13(a)(e)).
Manufacturers/distributors/retailers may not place product promotional placement or advertisement, including use of the product, in any video game or in any television program or motion picture authorized for viewing by the general public (Section 13(a)(f)).
Promotional merchandise visible to others when worn/used (t-shirts, caps, sweatshirts, visors, backpacks, sunglasses, writing implements, umbrellas, etc.) may not be distributed/sold/offered with the product brand name/logo/indicia (Section 13(a)(g)).
Brand indicia may not appear on promotional merchandise or elements marketed to or likely to be used by minors (sports equipment, toys, dolls, video games, food); companies must take all available measures to prevent third parties from using brand names/logos/proprietary symbols on products directed toward minors (Section 13(a)(h)).
No advertisements may be placed on shopping bags (Section 13(a)(i)).

Sponsorship limitations and corporate social responsibility

Sponsorship restrictions apply to all Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product promotional sponsorships (Section 14(a)).
Sponsorships are absolutely prohibited in any sport, concert, cultural, or art event (Section 14(a)(a)).
No person below eighteen (18) years may participate in sponsored events; participants must provide proof of age and invitations must contain appropriate health warnings (Section 14(a)(b)).
Consumer communications about sponsored events must comply with advertising rules and must clearly mark age requirements on program materials (Section 14(a)(c)).
Display materials for sponsored events must be limited to point-of-sale locations or adult-only facilities (Section 14(a)(d)).
Telecommunications about sponsored events must include a recorded health warning message in English or Filipino consistent with Act warnings (Section 14(a)(e)).
During sponsored events, no merchandise (including t-shirts, caps, sweatshirts, visors, backpacks, sunglasses, writing implements, school notebooks, umbrellas and other accessories) may be distributed/sold/offered with brand name/logo/indicia (Section 14(a)(f)).
The DTI may impose other sponsorship restrictions consistent with the Act (Section 14(a)(g)).
These restrictions apply to commercial sponsorships and do not prevent corporate social responsibility activities/programs, provided such activities do not bear Vaporized Nicotine and Non-Nicotine Product and Novel Tobacco Product brand name and logo (Section 14(a)(h)).

Use restrictions in public and DVAs

Use of Vaporized Nicotine and Non-Nicotine Products is prohibited in all indoor public places except in DVAs, or in point-of-sale establishments for product demonstrations (Section 15(a)).
Use is absolutely prohibited in specified public places, including:
- centers of youth activity (play schools, preparatory schools, elementary schools, high schools, colleges and universities, youth hostels and recreational facilities for persons under eighteen (18) years),
- elevators and stairwells,
- locations with fire hazards (including gas stations and storage areas for flammable liquids, gas explosives or combustible materials),
- buildings and premises of public/private hospitals, medical/dental/optical clinics, health centers, nursing homes, dispensaries, and laboratories,
- public conveyances and public facilities (airport and ship terminals and train and bus stations, restaurants and conference halls) except for DVAs,
- food preparation areas,
- churches and similar places of worship,
- within buildings/premises of government offices except for DVAs (Section 15(a)(a)-(h)).
DOH, in coordination with concerned agencies, may undertake smoking and vaping restriction awareness campaigns, including posting warning sign images; private sector may be encouraged to undertake similar restriction awareness campaigns, including censoring and not supporting advertisements promoting smoking and vaping (Section 16(a)).
DVAs must comply with standards:
- persons below eighteen (18) years not allowed inside (Section 17(a)(a)),
- signage must include “Vaping Area” and a prohibition on entry of persons below eighteen (18) years and pregnant women (Section 17(a)(b)),
- smoking is not allowed in DVAs (Section 17(a)(c)),
- establishment owner controls the number allowed considering size/location (Section 17(a)(d)),
- DVA must be in open space outdoor, or separate indoor area with proper ventilation (Section 17(a)(e)),
- if indoor, no openings allowing air to escape to smoke/vape-free areas except a single door with automatic door closer (Section 17(a)(f)),
- DVA and ventilation outlets must not be within ten (10) meters from entrances/exits or where people pass/congregate, nor in front of air intake ducts (Section 17(a)(g)),
- combined DVA and buffer zone area must not exceed twenty percent (20%) of total floor area, and in no case less than ten (10) square meters (Section 17(a)(h)),
- no building or conveyance may have more than one (1) DVA (Section 17(a)(i)),
- DVA ventilation system (other than open space and buffer zone) must be independent of building/conveyance ventilation systems (Section 17(a)(j)),
- minors not allowed inside DVA and buffer zone (Section 17(a)(k)),
- no selling/serving/offering of food and beverages in DVA and buffer zone unless DVA is located in a point-of-sale (Section 17(a)(l)).
The Act does not compel establishment owners to establish DVAs and does not prevent more stringent measures to ensure a vape-free environment (Section 17(a)(l)).

Product technical standards and nicotine limit

DTI, in consultation with FDA, sets technical standards for safety, consistency, and quality of products requiring registration based on international standards (Section 18(a)).
No vapor product with nicotine content above sixty-five milligrams per milliliter (65mg/ml) may be sold in the market (Section 18(a)).
Compliance with these product standards is mandatory (Section 18(a)).

Product registration and market authorization

Manufacturers and importers must register with DTI by submitting information demonstrating conformity with Section 18 for:
- HTP Consumable, HTP Device, Vapor Product Refill, Vapor Product Device, and Novel Tobacco Products (Section 19(a)).
Vaporized Nicotine and Non-Nicotine Products, Novel Tobacco Products, Heated Tobacco Product Devices, and Vapor Product Devices may be sold to the general public only after submission of product registration requirements (Section 19(a)).
DTI, upon due process, may order immediate recall, ban, or seizure from public sale/distribution of specified products for failure to comply with Section 19 in relation to Section 18 (Section 19(a)).
Only duly registered products with applicable graphic health warnings may be sold, advertised, or distributed through any means (Section 19(a)).
For online sales, the DTI Secretary may issue an order directing that a noncompliant website/webpage/online application/social media account or similar platform be taken down and prevent noncompliant online sellers from selling online (Section 19(a)).
The DTI Secretary may also order immediate recall, ban, or seizure from public sale/distribution of noncompliant products (Section 19(a)).
DTI and BIR must maintain a list on their websites (updated monthly) of brands of registered products eligible to be sold online (Section 19(a)).
Internet/e-commerce/similar selling platform providers must only allow duly registered online sellers or retailers with DTI and BIR (Section 19(a)).

Absolute prohibition on nicotine shots

Retail or use of nicotine shots and/or concentrates is strictly prohibited (Section 20(a)).

Regulatory jurisdiction and taxation floor price

DTI has exclusive jurisdiction over all issues, requirements, and subject matters related to Vaporized Nicotine and Non-Nicotine Products and their devices and Novel Tobacco Products provided for in the Act (Section 21(a)).
BIR must issue revenue regulations prescribing the floor price or minimum price of Vaporized Nicotine and Non-Nicotine Products or Novel Tobacco Products, taking into account the sum of their excise tax, value-added tax, and a reasonable production cost (Section 22(a)).

Penalties and enforcement consequences

Violations of Section 15 (use in prohibited places) by a person, and violations of Section 17 (DVA standards) by a juridical person result in:
- first offense: PHP 5,000,
- second offense: PHP 10,000,
- third offense: PHP 20,000,
- and business permits/licenses are revoked or cancelled for business entities (Section 23(a)(i)-(iii)).
Violations of Sections 6, 7, 9, 10, 11 and 20 by a retailer impose:
- first offense: fine of PHP 10,000 or imprisonment of not more than thirty (30) days, at court discretion, for selling/distributing/purchasing to/for/from a minor; for succeeding offenses, both penalties apply plus revocation of business licenses/permits for business entities (Section 23(b)(i)).
- if violation is done by an establishment/business entity, the owner/president/manager/most senior officers are liable (Section 23(b)(ii)).
- if a minor is caught selling, buying, or using, DOH and DSWD implement intervention programs including counseling of the minor and the minor’s parent/guardian (Section 23(b)(iii)).
Violations of Sections 8, 12, 13, 14 and 18 by a manufacturer, distributor, or retailer impose:
- first offense: PHP 100,000,
- second offense: PHP 200,000,
- third offense: PHP 400,000 or imprisonment of not more than three (3) years, or both (court discretion),
- and business permits/licenses are revoked or cancelled for business entities (Section 23(c)(i)-(iii)).
Violations of Sections 4 and 5 by a manufacturer, importer, distributor, or retailer impose:
- first offense: PHP 2,000,000 and imprisonment of two (2) years,
- second offense: PHP 4,000,000 and imprisonment of four (4) years,
- third offense: PHP 5,000,000 and imprisonment of six (6) years,
- and business permits/licenses are revoked or cancelled for business entities (Section 23(d)(i)-(iii)).
For online sellers/distributors and online platforms noncompliant with Section 8, DTI must order immediate suspension of trading of the products; they are liable for the fines/penalties under Section 23, and suspension continues until compliance with Section 8 (Section 23 last paragraphs).
BIR must order immediate recall, ban, or seizure of products not registered with BIR, including those sold online; this is without prejudice to appropriate cases and collection of correct taxes/duties and applicable fines/penalties under Republic Act No. 8424 and Republic Act No. 10863 (Section 23).
DTI and BIR must design/promulgate/utilize innovative tools and technologies, in consultation with relevant stakeholders, to ensure only registered products are available in the market (Section 23).
If the guilty officer is a foreign national, the officer must be deported after sentence and/or payment of applicable fines, without need of further deportation proceedings, and is permanently barred from re-entering the Philippines (Section 23).

Implementing rules, transitory period, and separability

DTI must issue implementing rules and regulations (IRR) within three (3) months from effectivity, in consultation with FDA; non-issuance of IRR does not prevent implementation of the Act upon its effectivity (Section 24(a)).
Manufacturers are encouraged to use local tobacco products for vapor products, HTPs, and novel tobacco products sold in the Philippines (Section 25(a)).
Manufacturers, distributors, importers, and retailers are granted an eighteen (18)-month transitory period from issuance of the IRR to comply with requirements (Section 27(a)).
Any invalid or unconstitutional provision does not affect the validity/subsistence of the remainder (Section 28).
All laws, decrees, rules, and regulations or parts inconsistent with the Act are repealed, amended, or modified accordingly (Section 29).