Regulation of Vaporized Nicotine and Novel Tobacco Products

Policy and regulatory intent

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

Core definitions for regulation

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, or credit; it covers Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products advertising and excludes non-promotional informational communication (Section 3).
Designated Vaping Area (DVA) means an assigned indoor or outdoor area where the use of Vaporized Nicotine and Non-Nicotine Products is allowed (Section 3).
Vaporized Nicotine or Non-Nicotine Products means both Heated Tobacco Products and Vapor Products, as novel consumer goods that generate nicotine-containing or non-nicotine-containing aerosol without combustion (Section 3).
Vapor Products (also called Vapor Product Refills) mean the liquid, solid, or gel (with or without nicotine) transformed into an aerosol without combustion by a Vapor Product Device (Section 3).
Heated Tobacco Products (HTPs) mean tobacco products intended to be consumed through heating tobacco sufficient to release an aerosol inhalable without combustion; HTP consumables may include liquid solutions and gels that are heated to generate an aerosol (Section 3).
Novel Tobacco Products mean non-combusted substances in solid or liquid form, including innovations partly made of tobacco leaf or containing nicotine from tobacco, intended to be used as substitutes for cigarettes or other combusted tobacco products (Section 3).
Product Communication, Promotion, and related terms are defined to regulate how these products are publicized, including what counts as promotion, sponsorship, and advertising under Section 3.

Packaging, graphic and textual warnings

Vapor Product Refills, HTP Consumables, and Novel Tobacco Products must comply with packaging health warnings (Section 4).
Unit packaging or any outside consumer packaging must bear:
- A highly visible, full-color graphic health warning prescribed under Republic Act No. 10646 and printed on 50% of the principal display surfaces, occupying 50% of the front and 50% of the back panel; the Department of Health (DOH) designates content, format, and specifications (Section 4(a)(i)).
- A textual health warning:
  - If the product contains nicotine: “This product is harmful and contains nicotine which is a highly addictive substance. It is not recommended for use by nonsmokers.”
  - If the product does 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 20% of the entire area of the graphic health warning and must be clearly legible in contrast by typograph, layout and color, without a border/frame or design that effectively lessens its size (Section 4(a)(ii)).
No printed or applied matter may be placed where the health warning is likely to be obscured or covered, in part or in whole (Section 4(b)), and the warning must remain readable when the package is opened/closed and when any wrapper is removed (Section 4(c)).
The law requires compliance with internal revenue fiscal marking requirements under Republic Act No. 8424 whenever applicable, with specific rules for domestic-manufactured goods and imported goods for local sale; goods intended or offered for export must not be distributed in the local market (Section 4(d)).
Thirty (30) days after effectivity, the DOH must issue the template and guidelines for the specific picture/design/content of the graphic health warning (Section 4(e)).
The health-warning requirements apply to products locally manufactured or imported and introduced in the Philippine market; products intended or offered for export must carry specified markings including “For sale only in _________.”, “Made under authority of _____________,” the BIR-assigned tax number of the domestic manufacturer exporting the products, and required fiscal/regulatory markings of the country of ultimate sale (Section 4(f)).
The Bureau of Internal Revenue (BIR) may allow different and distinct export packaging markings for compliance with the country where the products will be ultimately sold (Section 4(f)).

Child-resistant and tamper-resistant design

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 refilled (Section 5).

Minimum age sales and proof of age

The minimum allowable age for purchase, sale, and use of Vaporized Nicotine and Non-Nicotine Products, their devices, or Novel Tobacco Products is eighteen (18) years old (Section 6).
It is not a defense for the person selling or distributing that the seller did not know or was not aware of the purchaser’s real age (Section 6).
It is not a defense that the seller did not know or had no reason to believe the product was for consumption by a person below eighteen (18) years of age (Section 6).
Retailers must ensure no individual below eighteen (18) years of age is allowed to purchase (Section 7).
Retailers must verify age; presentation of any valid government-issued identification card showing the buyer’s photograph and age or date of birth is required (Section 7).
Retailers must ensure direct delivery only to individuals who are eighteen (18) years old and above (Section 7).

Online trade controls and online registration

Sale or distribution through internet websites, e-commerce, and/or similar platforms is allowed (Section 8).
Retailers or distributors must adopt measures ensuring persons below eighteen (18) years of age are denied access, and the internet website must bear the signages required under the Act (Section 8).
When seeking access, the person’s legal age must be self-declared on the opening first page of the website (Section 8).
Only online sellers or distributors registered with the Department of Trade and Industry (DTI) or the Securities and Exchange Commission (SEC) may sell or distribute online, and products must be compliant with health warning requirements and BIR requirements, including tax stamp, minimum or floor price, or other fiscal marks (Section 8).
Delivery of products purchased online must comply with Section 7 (Section 8).

School-area and point-of-sale rules

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).
Point-of-sale establishments must post, in a clear and conspicuous manner, one of the following statements:
- “The sale or distribution of Vaporized Nicotine and Non-Nicotine Products to or by persons below eighteen (18) years of age is illegal. These products are harmful and contain nicotine which is a highly addictive substance. It is not recommended for use by nonsmokers.”
- “Ang pagbenta at pagbili ng Vaporized Nicotine and Non-Nicotine Products sa at ng mga taong wala pang labingwalong (18) taong gulang ay pinagbabawal. Ang mga produktong ito ay nakakasama sa kalusugan at mayroong nicotine, isang nakakalulong na kemikal. Hindi ito inirerekomenda na gamitin ng mga hindi naninigarilyo.” (Section 10).
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).

Advertising and promotional activity limits

Advertisement and other consumer communications are allowed in points-of-sale or retail establishments, through direct marketing, and on the internet, subject to specific guidelines (Section 12).
Product communications must not be targeted to or particularly appeal to persons under eighteen (18) years of age; youth-appealing markings/characters such as cartoons, anime, manga, animated characters, youth influencers, personalities and the like are prohibited (Section 12(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(b)).
Product communications must not feature a minor and/or a celebrity or contain a celebrity endorsement; manufacturers, importers, and sellers are prohibited from contracting celebrities or health professionals to promote or encourage use (Section 12(c)).
Posts/messages/images depicting vaping or use as a lifestyle particularly attractive to minors, or promoting/encouraging vaping or purchase/use for nonsmokers or minors, are prohibited (Section 12(d)).
Communications must not undermine quit-smoking messages and must not encourage non-tobacco or non-nicotine users to use these products (Section 12(e)).
Communications must not contain false or not scientifically substantiated information, especially regarding product statements, characteristics, health effects, risks, or emissions consistent with Section 18 (Section 12(f)).
Product testing and/or demonstration is allowed in locations that sell the products or their devices (Section 12(g)).
Online advertisements on e-commerce platforms must only be visible after appropriate age verification measures under the Act (Section 12(h)).
Advertisements may not be placed on objects or places outside points-of-sale premises such as vehicles, billboards, posters, and streamers (Section 12(i)).
No product packaged/labeled/presented/marketed with flavor descriptors proven to unduly appeal particularly to minors may be marketed; a flavor descriptor is presumed to unduly appeal to minors if it includes a reference to a fruit, candy brand, dessert, or cartoon character (Section 12(j)).
No medicinal or therapeutic claim may appear on marketing materials or packaging unless approved by the Food and Drug Administration (FDA) under Republic Act No. 9711 (Section 12(k)).
No explicit reduced risk statement may appear unless authorized by the FDA under the implementing rules and regulations under Section 24 (Section 12(k)).
Authorized reduced risk statements validated/accepted/permitted by reliable and mature national regulatory agencies must be taken into consideration by FDA and resolved within eighteen (18) months (Section 12(l)).
These restrictions apply to commercial communications only and do not prevent companies from providing non-promotional information regarding their company and products (Section 12(m)).

Promotional activities and sponsorship restrictions

Promotional events/activities such as product sampling or offers must be conducted only by trained product experts and must be directed only to persons at least eighteen (18) years of age; no person below eighteen (18) years of age may participate (Section 13(a)).
Promotional invitations for such activities must contain appropriate health warnings (Section 13(a)).
Communications to consumers about promotional events must comply with Section 12 and must clearly mark on program materials that the participation age requirement is eighteen (18) years or above, in addition to the required health warning (Section 13(b)).
No medicinal claim may be used in marketing materials or packaging unless approved by the FDA under Republic Act No. 9711 (Section 13(c)).
Stalls, booths, and displays for promotions must be limited to point-of-sale locations or adult-only facilities (Section 13(d)).
Telecommunications concerning promotional offers/programs/events must include a recorded health warning message in English or Filipino consistent with the Act’s warnings (Section 13(e)).
Manufacturers, distributors, and retailers may not place product promotional placement/advertisement using the product in any manner in a video game or in any television program or motion picture authorized by regulatory agencies for public viewing (Section 13(f)).
Promotional merchandise visible to others when worn/used (e.g., t-shirts, caps, sweatshirts, visors, backpacks, sunglasses, writing implements, umbrellas) may not be distributed/sold/offered with the product brand name/logo/indicia (Section 13(g)).
Brand name/logo/indicia may not appear on promotional merchandise or elements of brand-related marketing activities marketed to or likely to be used by minors (including sports equipment, toys, dolls, video games, and food), and the manufacturer/company must take all available measures to prevent third parties from using brand names/logos/proprietary symbols on products directed toward minors (Section 13(h)).
Product advertisements may not be placed on shopping bags (Section 13(i)).
Sponsorships of Vaporized Nicotine and Non-Nicotine Products or Novel Tobacco Products are restricted:
- Sponsorship is absolutely prohibited in any sports, concert, cultural, or art event (Section 14(a)).
- No person below eighteen (18) years of age may participate; participants must provide proof of age; invitations must contain appropriate health warnings (Section 14(b)).
- Consumer communications about sponsored events must comply with Section 12, and the age requirement for participation must be clearly marked (Section 14(c)).
- Sponsored-event display materials must be limited to point-of-sale locations or adult-only facilities (Section 14(d)).
- Telecommunications for sponsored events must include a recorded health warning message in English or Filipino (Section 14(e)).
- During sponsored events, no merchandise/accessories with the brand name/logo/indicia may be distributed/sold/offered (Section 14(f)).
- The DTI may determine other sponsorship restrictions consistent with the Act (Section 14(g)).
- The restrictions apply only to commercial sponsorships and do not prevent corporate social responsibility programs, provided such activities do not bear product brand name and logo (Section 14(h)).

Prohibited public use and DVA standards

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).
Absolute public-place bans apply to:
- Centers of youth activity such as play schools, preparatory schools, elementary schools, high schools, colleges and universities, youth hostels, and recreational facilities for persons under eighteen (18) years old (Section 15(a)).
- Elevators and stairwells (Section 15(b)).
- Locations with fire hazards, including gas stations and storage areas for flammable liquids, gas explosives, or combustible materials (Section 15(c)).
- Buildings/premises of public and private hospitals, medical/dental/optical clinics, health centers, nursing homes, dispensaries, and laboratories (Section 15(d)).
- Public conveyances and public facilities including airport/ship terminals and train and bus stations, restaurants, and conference halls, except for DVAs (Section 15(e)).
- Food preparation areas (Section 15(f)).
- Churches and similar places where people congregate for worship (Section 15(g)).
- Buildings/premises of government offices, except for DVAs (Section 15(h)).
DVAs must meet standards:
- Persons below eighteen (18) years of age must not be allowed (Section 17(a)).
- DVAs must have highly visible signages: “Vaping Area” signage and prohibition on entry of persons below eighteen (18) years of age and pregnant women (Section 17(b)).
- Smoking is not allowed in DVAs (Section 17(c)).
- The establishment owner must control capacity considering the DVA size and location (Section 17(d)).
- The DVA must be an open outdoor space or a separate indoor area with proper ventilation (Section 17(e)).
- If indoors, there must be no opening that lets air escape to the smoke- or vape-free area, except a single door with an automatic door closer (Section 17(f)).
- The DVA and ventilation outlets must not be located in or within ten (10) meters from entrances/exits or where people pass or congregate, or in front of air intake ducts (Section 17(g)).
- The combined area of the DVA and buffer zone must not exceed 20% of the total floor area, and must not be less than ten (10) square meters (Section 17(h)).
- No building or conveyance may have more than one (1) DVA (Section 17(i)).
- The ventilation system for the DVA (other than open space and buffer zone) must be independent from other building/conveyance ventilation systems (Section 17(j)).
- Minors must not be allowed inside the DVA and buffer zone (Section 17(k)).
- No selling/serving/offering of food and beverages in the DVA and buffer zone unless the DVA is located in a point-of-sale (Section 17(l)).
The law does not compel establishment owners to establish DVAs and does not prevent more stringent measures to ensure a vape-free environment (Section 17(l)).

Standards, nicotine limit, and product registration

The DTI, in consultation with the FDA, must set technical product standards for safety, consistency, and quality for products requiring registration based on international standards (Section 18).
No vapor product with nicotine content above sixty-five milligrams per milliliter (65mg/ml) may be sold in the market (Section 18).
Compliance with product standards is mandatory (Section 18).
Manufacturers and importers must register with the DTI by submitting information demonstrating conformity with Section 18 for:
- HTP Consumable
- HTP Device
- Vapor Product Refill
- Vapor Product Device
- 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 the product registration requirements (Section 19(b)).
Upon due process, the DTI may order immediate recall, ban or seizure from public sale or distribution for failure to comply with the registration requirements and conformity standards (Section 19(c)).
Only duly registered products with the applicable graphic health warnings are allowed to be sold, advertised, or distributed (Section 19(d)).
For online sales, the Secretary of the DTI may order a noncompliant website/webpage/online application/social media account/other similar platform taken down and prevent noncompliant online sellers from selling online, and may order immediate recall, ban, or seizure of noncompliant products (Section 19).
The DTI and the BIR must maintain and update monthly a list of brands registered with the DTI and BIR that are eligible to be sold online (Section 19).
Internet/e-commerce/platform providers must only allow duly registered online sellers/retailers with the DTI and BIR (Section 19).

Prohibition on nicotine shots

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

Competent agencies and floor price

The DTI has exclusive jurisdiction over any and all issues, requirements, and subject matters related to Vaporized Nicotine and Non-Nicotine Products and their devices, and Novel Tobacco Products under the Act (Section 21).
The BIR must issue revenue regulations prescribing the floor price or minimum price for 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).

Penalties for violations and liability rules

Section 23(a) penalties apply to violations of Section 15 (if the offender is a person) and Section 17 (if the offender is a juridical person):
- First offense: fine of P5,000
- Second offense: fine of P10,000
- Third offense: fine of P20,000
- Business permits and licenses must be revoked or cancelled (Section 23(a)).
Section 23(b) penalties apply to violations of Sections 6, 7, 9, 10, 11 and 20 if the offender is a retailer:
- First offense: fine of P10,000 or imprisonment of not more than 30 days, at the discretion of the court
- For succeeding offenses: both penalties apply in addition to revocation of business licenses/permits for a business entity/establishment (Section 23(b)(i)).
- If done by an establishment/business entity: the owner, president, manager, or most senior officers are liable (Section 23(b)(ii)).
- If a minor is caught selling, buying or using: DOH and DSWD must implement appropriate intervention programs, including counseling of the minor and the minor’s parent or guardian (Section 23(b)(iii)).
Section 23(c) penalties apply to violations of Sections 8, 12, 13, 14 and 18 if the offender is a manufacturer, distributor, or retailer:
- First offense: fine of P100,000
- Second offense: fine of P200,000
- Third offense: fine of P400,000 or imprisonment of not more than 3 years, or both, at the discretion of the court
- Business permits and licenses must be revoked or cancelled (Section 23(c)).
Section 23(d) penalties apply to violations of Sections 4 and 5 if the offender is a manufacturer, importer, distributor, or retailer:
- First offense: fine of P2,000,000 and imprisonment of 2 years
- Second offense: fine of P4,000,000 and imprisonment of 4 years
- Third offense: fine of P5,000,000 and imprisonment of 6 years
- Business permits and licenses must be revoked or cancelled (Section 23(d)).
Online sellers/distributors and noncompliant online platforms violating Section 8 must be ordered by DTI to immediately suspend trading; they are liable for fines/penalties under Section 23, and suspension continues until compliance with Section 8 requirements (Section 23).
The BIR must order the immediate recall, ban, or seizure from public sale/distribution of products not registered with the BIR, including those sold online, without prejudice to filing cases and collection of correct taxes/duties and applicable fines/penalties under Republic Act No. 8424 (as amended) and Republic Act No. 10863 (Customs Modernization and Tariff Act (CMTA)) (Section 23).
DTI and BIR must design, promulgate, and utilize new and emerging innovative tools and technologies to ensure only registered products are available in the market (Section 23).
If a guilty officer is a foreign national, the officer must be deported after service of sentence and/or payment of applicable fines without need for further deportation proceedings and must be permanently barred from re-entering the Philippines (Section 23).

Implementing rules, transitory compliance, and repeal

Section 24 requires the DTI, in consultation with the FDA, to issue implementing rules and regulations within three (3) months from effectivity.
Non-issuance of the implementing rules does not prevent implementation of the Act upon effectivity (Section 24).
Manufacturers are encouraged to use local tobacco products for Vapor Products, HTPs, and Novel Tobacco Products sold in the Philippines (Section 25).
Agencies must fund implementation through the current year’s national government appropriations of concerned agencies, and thereafter include needed funds in annual General Appropriations Act budgets (Section 26).
Manufacturers, distributors, importers, and retailers must be given an eighteen (18)-month transitory period from the issuance of the implementing rules and regulations to comply with requirements herein (Section 27).
A separability clause preserves the validity of remaining parts if any provision is held invalid or unconstitutional (Section 28).
Inconsistent laws, decrees, rules, and regulations governing issues related to Vaporized Nicotine and Non-Nicotine Products and their devices, and Novel Tobacco Products are repealed, amended, or modified accordingly (Section 29).