Republic Act No. 11900: An act regulating the importation, manufacture, sale, packaging, distribution, use, and communication of vaporized nicotine and non-nicotine products, and novel tobacco products

Eighteenth Congress Third Regular Session

Begun and held in Metro Manila, on Monday, the twenty-sixth day of July, two thousand twenty one.

[ REPUBLIC ACT NO. 11900, July 25, 2022 ]

ANACTREGULATING THE IMPORTATION, MANUFACTURE, SALE,PACKAGING, DISTRIBUTION, USE, AND COMMUNICATION OFVAPORIZED NICOTINE AND NON-NICOTINE PRODUCTS, AND NOVEL TOBACCOPRODUCTS

Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:

Section 1

Short Title. ThisActshall be known as the "VaporizedNicotine and Non-NicotineProducts RegulationAct."

Section 2. Declaration of Policy

It is hereby declared the policy of the State to protect and promote the right to health of the people and instill health consciousness among them.

It is further declared the policy of the State to enact a balanced policy whereby these novel consumer products are properly regulated using internationally accepted product standards in order to protect the citizens from the hazards of regulated, unregulated and substandard Vapor Products and Heated Tobacco Products.

For this purpose, the government shall regulate the importation, assembly, manufacture, sale, packaging, distribution, use, advertisement, promotion and sponsorship of Vaporized Nicotine and Non-Nicotine Products, and their devices, and Novel Tobacco Products in order to promote a healthy environment, protect the citizens from any potential hazards of these novel consumer products, reduce the harm caused by smoking, and ensure that the sale to minors and the illicit trade of Vaporized Nicotine and Non-Nicotine Products, and their devices, and Novel Tobacco Products in the country are prevented.

Section 3. Definition of Terms

For purposes of thisAct, the following terms shall mean:

(a)Advertisingshall refer to the business of conceptualizing, presenting, making available and communicating to the public, through any form of mass media, any fact, data or information about the attributes, features, quality or availability of consumer products, services or credit. For the purpose of thisAct, advertising shall be understood as Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products advertising and shall not include non-promotional communication intended for informational purposes only; (b)Celebrityshall refer to any natural person who, by his or her accomplishments or fame, or by reason of his or her profession or calling, gives the public a legitimate interest in his or her doings, affairs and character. The term includes anyone who has arrived at a position where public attention is focused upon him or her as a person, such as, but not limited to, actors, athletes and other sports personalities, war heroes, famous inventors, social media influencers and explorers among others; (c)Child-resistantshall refer to the type of containers that can be opened only by operating, puncturing or removing one of its functional and necessary parts using a tool that is not supplied with the container and comply with the existing standards on child-resistant packaging; (d)Designated Vaping Area (DVA)shall refer to an assigned indoor or outdoor area where the use of Vaporized Nicotine and Non-Nicotine Products shall be allowed; (e)Distributorshall refer to any entity to whom Vaporized Nicotine and Non-Nicotine Products, or their devices, or Novel Tobacco Products is delivered or sold for purposes of distribution in commerce, except that such term does not include a manufacturer, retailer or common carrier of such product; (f)Heated Tobacco Products (HTPs), also referred to as Heated Tobacco Product (HTP) Consumables or Heat-Not-Burn Product Consumables, shall refer to tobacco products that are intended to be consumed through heating tobacco, either electronically or through other means, sufficient to release an aerosol that can be inhaled, without combustion of the tobacco. HTP Consumables or Heat-Not-Burn Product Consumables may also include liquid solutions and gels that are part of the product and are heated to generate an aerosol. HTPs may or may not operate by means of an HTP Device; (g)Heated Tobacco Product DeviceorHTP Deviceshall refer to the component or combination of components of an HTP System intended to be used in combination with HTP Consumables that generate an aerosol without combustion; (h)Heated Tobacco Product SystemorHTP Systemshall refer to an HTP Consumable and HTP Device that are intended to be used together as a system; (i)Manufacturershall refer to an establishment engaged in any and all operations involved in the production of Vaporized Nicotine and Non-Nicotine Products, or their devices, or Novel Tobacco Products, including preparatory processing, compounding, formulating, filling, refilling, packaging, repackaging, altering, ornamenting, finishing and labeling for the purpose of its storage, sale or distribution; (j)Medicinal or Therapeutic Claimsshall refer to explicit statements made on any product presented as having properties for directly treating, curing, alleviating, or preventing diseases or disorders in persons; (k)Nicotineshall refer to nicotinic alkaloids, including any salt or complex of nicotine, whether derived from tobacco or synthetically produced; (l)Nicotine Mixtureshall refer to the nicotine containing liquid, solid or other non-tobacco substance in the product; (m)Nicotine Shotsshall refer to nicotine in liquid or any other form or substance that is added to or mixed with Vapor Product Refills or cartridges that has the effect of increasing the dosage or nicotine concentration in a refill or cartridge; (n)Novel Tobacco Productsshall refer to all non-combusted substances in solid or liquid form, and innovations, either made partly of tobacco leaf as raw material or containing nicotine from tobacco, intended to be used as a substitute for cigarettes or other combusted tobacco products; (o)Packageshall refer to packs, boxes, cartons, or containers of any kind in which Vapor Products or HTPs, or Novel Tobacco Products are contained when offered for sale to consumers; (p)Principal display surfaceshall refer to the panel of the package that faces the consumer when displayed for sale; (q)Point-of-Saleshall refer to any location, physical or online, where an individual can purchase Vaporized Nicotine and Non-Nicotine Products and their devices, or Novel Tobacco Products, which may include a product testing area; (r)Product Demonstrationshall refer to the testing of an HTP System or Vapor Product System, or Novel Tobacco Product conducted by a trained product expert who shall explain the characteristics, operation and maintenance of the product for the purpose of informing and familiarizing a prospective buyer, who is of legal age for the purpose of thisAct; (s)Product Statementshall refer to an explicit communication to consumers in the product label or marketing which pertains to product performance attributes or an objective description of the contents of the product, quantity of chemicals produced, or how a product works or operates; (t)Promotionshall refer to an event or activity organized by or on behalf of a Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product manufacturer, importer, distributor, or retailer with the aim of promoting a brand of a Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product, which event or activity would not occur if not for the support given to it by or on behalf of the Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product manufacturer, importer, distributor, or retailer. This includes the paid use of Vaporized Nicotine and Non-Nicotine Products or Novel Tobacco Products bearing the brand names, trademarks, logos, and the like by performers in movies, television and other forms of entertainment as well as in other live promotional events such as fairs, trade shows, concerts, and similar events. For the purpose of thisAct, promotion shall be understood as Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product promotion; (u)Promotionalshall refer to theactof publicizing a product to an individual, group or the general public, or promoting awareness of the product brands, for the sole purpose of increasing sales; (v)Reduced Risk Statementshall refer to an explicit communication to consumers in the product label or marketing materials which states that the product presents less risk of harm to the user's health or is less harmful to the user's health than continued smoking of combustible cigarettes; (w)Refillshall refer to a container for holding electronic liquid or Nicotine Mixture; (x)Retailershall refer to any establishment which sells or offers to sell any Vaporized Nicotine and Non-Nicotine Products or their devices, or Novel Tobacco Products directly to an individual, group or the general public; (y)Sponsorshipshall refer to any public or private contribution, whether in cash or in kind, from a third party, in relation to an event, team, or activity made with the aim of promoting a brand of Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product, which event, team or activity would still exist or occur without such contribution. For the purpose of thisAct, sponsorship shall be understood as Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product sponsorship; (z)Tamper-resistantshall refer to the type of packages constructed such that it has one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence that the product or its packaging has been opened, or otherwise comply with standards on tamper-resistant packaging; (aa)Vapor Products, also referred to as Vapor Product Refills, shall refer to the liquid, solid, or gel, or any combination thereof, which may or may not contain nicotine, that is transformed into an aerosol without combustion by a Vapor Product Device; (bb)Vapor Product Deviceshall refer to a device or a combination of devices used to heat a Vapor Product, to produce an aerosol, mist, or vapor that users inhale. These may include combinations of a liquid solution or gel that are heated and transformed into an aerosol without combustion through the employment of a mechanical or electronic heating element, battery, or circuit, and includes, but is not limited to, a cartridge, a tank, or a device without a cartridge or tank; (cc)Vapor Product System, also referred to as electronic nicotine or non-nicotine delivery systems, shall refer to the specific combination consisting of the Vapor Product Refill and Vapor Product Device which, based on the information made available to the consumer by the provider, are intended to be used together; and (dd)Vaporized Nicotine or Non-Nicotine Productsshall refer to both Heated Tobacco Products and Vapor Products, as defined herein, which are novel consumer goods that generate a nicotine-containing or non-nicotine-containing aerosol without combustion.

Section 4. Packaging and Health Warnings

All Vapor Product Refills, HTP Consumables, and Novel Tobacco Products shall comply with the following packaging requirements:

(a)The unit packaging or any outside consumer packaging of Vapor Product Refills, HTP Consumables, or Novel Tobacco Products shall bear the following health warnings: (i)A highly visible, full-color graphic health warning prescribed under Republic Act No. 10646,otherwise known as "The graphic Health Warnings Law,"consistent with the textual health warning required herein, which shall be printed on fifty percent (50%) of the principal display surfaces of Vaporized Nicotine and Non-Nicotine Products or Novel Tobacco Products and shall occupy fifty percent (50%) of the front and fifty percent (50%) of the back panel of the packaging. The content, format, and specifications of the graphic health warning shall be designated by the Department of Health (DOH); and (ii)A textual health warning which states:

(1)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."; and (2) 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 shall usenomore than twenty percent (20%) of the entire area of the graphic health warning and shall appear in clearly legible type and in contrast by typograph, layout and color, without the use of any border, frame or any other design that will effectively lessen the size of the textual warning. (b)Nothing shall be printed or applied on a location where the health warning is likely to be obscured or covered, in part or in whole; (c)Nopart of the warning may be obliterated, obscured, folded, severed or become unreadable when the package is opened or closed or when a wrapper on the package is removed; (d)The internal revenue fiscal marking requirements underRepublicActNo. 8424, otherwise known as the "National Internal Revenue Code of 1997," as amended, and other related regulations, whenever applicable, shall be complied with:Provided, That Vapor Product Refills, HTP Consumables or Novel Tobacco Products manufactured or produced in the Philippines for domestic sales or consumption shall only be in such packages and bear such marks or brands as prescribed by the Bureau of Internal Revenue (BIR):Provided, further, That goods of similar character imported into the Philippines shall likewise be packed and marked in such manner as may be required by the BIR and that innocase shall Vapor Product Refills and/or HTP Consumables intended or offered for export shall be distributed in the local market; (e)Thirty (30) days after the effectivity of thisAct, the DOH shall issue the template, as well as the guidelines with respect to the specific picture, design, or content of the information relating to the graphic health warning that must appear on the product packaging; and (f)This section shall only apply to Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products that are locally manufactured or imported and introduced in the Philippine market. Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products intended or offered for export shall only be subject to the requirement that one (1) side panel of any box or packaging of any form that is used to store or hold containers, reams or cartons, or any other Vaporized Nicotine and Non-Nicotine Product and Novel Tobacco Product packaging for shipping or transport, and one (1) side panel of each packaging primarily intended for retail sale to consumers, shall contain the following markings and information: "For sale only in _________." "Made under authority of _____________," taxnumberassigned by the BIR to the domestic manufacturer that exports these products, and fiscal and regulatory marking requirements of the country where the products will be ultimately sold. The BIR may allow different and distinct packaging markings requirement for Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products produced or manufactured in the Philippines intended or offered for export to comply with the laws, rules, regulations, and issuances of the country where the Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products will be ultimately sold.

Section 5. Tamper-resistant and Child-resistant Design

The receptacles of Vapor Product Refills shall be child-resistant, tamper-resistant, and shall be protected against breakage and leakage.

Non-refillable receptacles shall not be tampered with and refilled.

Section 6. Minimum Age Sales and Purchase

The minimum allowable age for the purchase, sale and use of Vaporized Nicotine and Non-Nicotine Products, their devices, or Novel Tobacco Products shall be eighteen (18) years old.

It shall not be a defense for the person selling or distributing that he or she did not know or was not aware of the real age of the purchaser. Neither shall it be a defense that he or she did not know nor had any reason to believe that the product was for the consumption of a person below eighteen (18) years of age.

Section 7. Proof-of-Age Verification

Retailers shall ensure thatnoindividual below eighteen (18) years of age is allowed to purchase Vaporized Nicotine and Non-Nicotine Products, their devices, or Novel Tobacco Products. It shall be the responsibility of retailers to verify the age of buyers. For this purpose, the presentation of any valid government-issued identification card exhibiting the buyer's photograph and age or date of birth shall be required. Retailers shall ensure direct delivery only to individuals who must be eighteen (18) years old and above.

Section 8. Online Trade

The sale or distribution of Vaporized Nicotine and Non-Nicotine Products, their devices, and Novel Tobacco Products through internet websites or via e-commerce and/or other similar media platforms shall be allowed:Provided, That the retailer or distributor shall adopt measures to ensure that persons below eighteen (18) years of age are denied access thereto and that the internet website shall bear the signages required under thisAct.

In compliance with the aforementioned age restriction, and when seeking access to such media platform, the person's legal age shall be self-declared in the opening first page of the website.

Provided, further, That the sale or distribution of Vaporized Nicotine and Non-Nicotine Products, their devices, and Novel Tobacco Products through internet websites or via e-commerce and/or other similar media platforms shall only be made by online sellers or distributors registered with the Department of Trade and Industry (DTI) or the Securities and Exchange Commission (SEC) and the products being sold and advertised online shall be compliant with the health warning requirements indicated herein, as well as other BIR requirements including tax stamp, minimum or floor price or other fiscal marks:Provided, finally, That the delivery of Vaporized Nicotine and Non-Nicotine Products, their devices, and Novel Tobacco Products purchased online shall also comply with Section 7 of thisAct.

Section 9. Sales and Promotion within School Perimeters

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 other facility frequented particularly by minors shall be prohibited.

Section 10. Point-of-Sale Signage

Point-of-sale establishments offering, selling, or distributing Vaporized Nicotine and Non-Nicotine Products shall post the following statement in a clear and conspicuous manner:

"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." or "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 11

Display of Products. Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products shall not be displayed immediately next to products of particular interest to minors.

Section 12. Product Communication Restrictions

Advertisement of Vaporized Nicotine and Non-Nicotine Products, or Novel Tobacco Products and other forms of consumer communication shall be allowed in points-of-sale or retail establishments, through direct marketing, and on the internet: Provided, That the following guidelines shall apply:

(a)These shall not be targeted to or particularly appeal to persons under eighteen (18) years of age. Markings or characters that are likely to appeal to the youth such as the use cartoons, anime, manga, animated characters, youth influencers, personalities and the like are prohibited;

(b)All product communications shall contain the following 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";

(c)These shall not feature a minor and/or a celebrity or contain an endorsement, implied or express, by a celebrity. Manufacturers, importers, and sellers in their product advertisements are prohibited from contracting celebrities or health professionals to promote or encourage the use of Vaporized Nicotine and Non-Nicotine Products or Novel Tobacco Products;

(d)Any posts, messages, or images by manufacturers, importers, retailers, and distributors depicting vaping or the use of Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products as a lifestyle that is particularly attractive to minors, or promoting or encouraging vaping or the use Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products for nonsmokers or minors, or the purchase or use Vaporized Nicotine and Non-Nicotine Products or the use Novel Tobacco Products, trademarks, brand names, design, and manufacturer's names as a lifestyle targeted at minors shall be prohibited;

(e)These should not undermine quit-smoking messages and should not encourage non-tobacco or non-nicotine users to use Vaporized Nicotine and Non-Nicotine Products or Novel Tobacco Products;

(f)These shall not contain any information that is false, or not scientifically substantiated, particularly with regard to product statements, characteristics, health effects, risks or emissions consistent with Section 18 of this Act;

(g)Product testing and/or demonstration shall be allowed in locations that sell Vaporized Nicotine and Non-Nicotine Products or their devices, or Novel Tobacco Products;

(h)Online advertisements on e-commerce platforms shall only be visible after the appropriate age verification measures under this Act;

(i)No Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product advertisements may be placed on objects or places outside the premises of points-of-sale such as, but not limited to, vehicles of any kind, billboards, posters and streamers;

(j)The sale of Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products that are packaged, labeled, presented, or marketed with flavor descriptors that are proven to unduly appeal particularly to minors shall be prohibited. A flavor descriptor is presumed to unduly appeal to minors if it includes a reference to a fruit, candy brand, dessert, or cartoon character;

(k)No Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product shall have a medicinal or therapeutic claim on its marketing materials or packaging unless such claim is approved by the Food and Drug Administration (FDA) pursuant to Republic Act No. 9711, otherwise known as the "Food and Drug Administration (FDA) Act of 2009." No Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product shall have an explicit reduced risk statement unless authorized by the FDA pursuant to the implementing rules and regulations under Section 24 of this Act;

(l)Reduced risk statements, which are authorized, validated, accepted, or permitted by reliable and mature national regulatory agencies, for Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products shall be taken into consideration by the FDA in its resolution of an application for a reduced risk statement authorization and shall be resolved within eighteen (18) months; and (m) These restrictions apply to commercial communications only and shall not prevent a company from providing information regarding its company, its products and other non-promotional information on Vaporized Nicotine and Non-Nicotine Products or Novel Tobacco Products.

Section 13

Restrictions on Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product Promotional Activities. The following restrictions shall apply to any promotional activity related to Vaporized Nicotine and Non-Nicotine Products or Novel Tobacco Products:

(a)Promotional events and activities, such as, but not limited to, product sampling or product offers, shall only be conducted by trained product experts and must be directed only to person at least eighteen (18) years of age. No person below eighteen (18) years of age shall participate in such promotions. The participants in such promotions shall be required to provide proof of their age: Provided, That the invitation to these promotional events and activities shall contain the appropriate health warnings;

(b)Communications to consumers about promotional events for Vaporized Nicotine and Non-Nicotine Products or Novel Tobacco Products shall comply with the provisions of this Act governing Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product advertising. In addition to the required health warning, the age requirement for participation in any promotional activity must be clearly marked on the program materials distributed to consumers;

(c)No Vaporized Nicotine and Non-Nicotine Products or Novel Tobacco Products shall have a medicinal claim on its marketing materials or packaging unless such claim is approved by the FDA pursuant to Republic Act No. 9711;

(d)All stalls, booths, and other displays concerning Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product promotions must be limited to point-of-sale locations or adult-only facilities;

(e)Telecommunications concerning promotional offers, programs or events must include a recorded health warning message in English or Filipino consistent with the warnings specified in this Act;

(f)No product promotional placement or advertisement shall be made by any manufacturer, distributor, or retailer of any Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product package, including use of the product, in any manner, in a video game or in any television program or motion picture authorized by regulatory agencies concerned for viewing by the general public;

(g)No promotional merchandise such as, but not limited to, t-shirts, caps, sweatshirts, visors, backpacks, sunglasses, writing implements and umbrellas, may be distributed, sold or offered, directly or indirectly, with the name, logo or other indicia of a Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product brand displayed so as to be visible to others when worn or used;

(h)No name, logo, or other indicia of a Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product brand may appear on promotional merchandise or element of a brand-related marketing activity that is marketed to or likely to be used by minors such as, but not limited to, sports equipment, toys, dolls, video games, and food. The manufacturer or company must take all available measures to prevent third parties from using the company's brand names, logos, or other proprietary symbol on products that are directed toward minors; and (i) No Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product advertisements may be placed on shopping bags.

Section 14. Restrictions on Sponsorship

The following restrictions shall apply to all Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product promotional sponsorships:

(a)Sponsorships shall be absolutely prohibited in any sport, concert, cultural, or art event;

(b)No person below eighteen (18) years of age may participate in sponsored events. The participants in the sponsored event shall be required to provide proof of age. Invitations to these events shall contain the appropriate health warnings;

(c)Communications to consumers about Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product sponsored events shall comply with the provisions of this Act governing Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product and advertising. In addition to the mandatory health warning, the age requirement for participation in any sponsored event must be clearly marked on the program materials distributed to consumers;

(d)All display materials concerning Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product sponsored events must be limited to point-of-sale locations or adult-only facilities;

(e)Telecommunications concerning sponsored events must include a recorded health warning message in English or Filipino consistent with the warnings specified in this Act;

(f)No merchandise such as, but limited to, t-shirts, caps, sweatshirts, visors, backpacks, sunglasses, writing implements, school notebooks, umbrellas and other accessories, may be distributed, sold or offered, directly or indirectly, during the sponsored event, with the name, logo or other indicia of a Vaporized Nicotine and Non-Nicotine Product or Novel Tobacco Product brand;

(g)Such other restrictions on the product sponsorship as determined by the DTI consistent with the provisions of this Act; and (h) These restrictions shall only apply to commercial sponsorships and shall not prevent a company from conducting corporate social responsibility related activities and programs: Provided, That such activities shall not bear a Vaporized Nicotine and Non-Nicotine Product and Novel Tobacco Product brand name and logo.

Section 15. Use in Public Place

The use of Vaporized Nicotine and Non-Nicotine Products shall be prohibited in all indoor public places except in DVAs, or in point-of-sale establishments for purposes of conducting product demonstrations.

The use of Vaporized Nicotine and Non-Nicotine Products shall be absolutely prohibited in the following public places:

(a)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;

(b)Elevators and stairwells;

(c)Locations in which fire hazards are present, including gas stations and storage areas for flammable liquids, gas explosives or combustible materials;

(d)Within the buildings and premises of public and private hospitals, medical, dental and optical clinics, health centers, nursing homes, dispensaries and laboratories;

(e)Public conveyances and public facilities including airport and ship terminals and train and bus stations, restaurants and conference halls, except for DVAs;

(f)Food preparation areas;

(g)Churches and other similar places where people congregate for worship; and (h) Within the building and premises of government offices, except for DVAs.

Section 16. Smoking and Vaping Restriction Awareness Campaign

Subject to the provisions of this Act, the DOH, in coordination with other concerned agencies, may undertake smoking and vaping restriction awareness campaigns on the harmful effects of smoking and vaping, which may include information drives and posting of warning sign images in public. As part of the whole-of-society approach for a genuine smoke- and vape-free environment, the private sector shall also be encouraged to undertake restriction awareness campaigns on smoking and vaping, including, but not limited to, censoring and not supporting advertisements promoting smoking and vaping.

Section 17. Standards for Designated Vaping Areas

Designated Vaping Areas (DVAs) shall comply with the following standards:

(a)Persons below eighteen (18) years of age shall not be allowed within the DVA;

(b)Every DVA shall have the following signages highly visible and prominently displayed:

(i)"Vaping Area" signage; and (ii) Prohibition on entry of persons below eighteen (18) years of age and pregnant women.

(c)Smoking shall not be allowed in DVAs;

(d)The number of persons allowed inside shall be controlled by the establishment owner, taking into consideration the size of the DVA and its location;

(e)The DVA shall be in an open space in an outdoor area, or in a separate indoor area with proper ventilation;

(f)If the DVA is located indoors, there shall be no opening that will allow air to escape from the DVA to the smoke- or vape-free area of the building or conveyance, except for a single door equipped with an automatic door closer;

(g)The DVA and its ventilation outlets shall not be located in or within ten (10) meters from entrances, exits or any place where people pass or congregate, or in front of air intake ducts;

(h)The combined area of the DVA and the buffer zone shall not be larger than twenty percent (20%) of the total floor area of the building or conveyance: Provided, That in no case shall such area be less than ten (10) square meters;

(i)No building or conveyance shall have more than one (1) DVA;

(j)The ventilation system for the DVA, other than in open space and for the buffer zone, shall be independent of all ventilation systems for the rest of the building or conveyance;

(k)Minors shall not be allowed inside the DVA and the buffer zone; and (l) There shall be no selling, serving or offering of food and beverages in the DVA and its buffer zone unless the DVA is located in a point-of-sale.

Provided, That nothing in this Act shall compel persons in charge to establish DVAs nor prevent them from instituting more stringent measures in their building and establishment to better ensure a vape-free environment in their premises.

Section 18. Product Standard Requirements

The DTI, in consultation with the FDA, shall set technical standards for safety, consistency, and quality of the products requiring registration in the immediately succeeding section based on international standards: Provided, That no vapor product with a nicotine content above sixty-five milligrams per milliliter (65mg/ml) shall be allowed to be sold in the market. The compliance with these product standards shall be mandatory.

Section 19. Product Registration

All manufacturers and importers of the following products shall register with the DTI by submitting information demonstrating conformity with Section 18 of this Act:

(a)HTP Consumable;

(b)HTP Device;

(c)Vapor Product Refill;

(d)Vapor Product Device; and (e) Novel Tobacco Products. Vaporized Nicotine and Non-Nicotine Products, Novel Tobacco Products, Heated Tobacco Product Devices and Vapor Product Devices may be sold to the general public after submission of the product registration requirements under this Act.

The DTI, upon due process, may order the immediate recall, ban or seizure from public sale or distribution of Vaporized Nicotine and Non-Nicotine Products, HTP Devices, Vapor Product Devices, and Novel Tobacco Products for failure to comply with this section in relation to Section 18 of this Act.

Only duly registered Vaporized Nicotine and Non-Nicotine Products or their devices, or Novel Tobacco Products with the applicable graphic health warnings are allowed to be sold, advertised or distributed through whatever means.

For online sales, the Secretary of the DTI, upon due process, shall have the power to issue an order directing that a noncompliant website, webpage, online application, social media account, or other similar platform be taken down and preventing online sellers, which are noncompliant with the registration requirements provided under this Act, from selling online. The Secretary of the DTI shall order the immediate recall, ban or seizure from public sale or distribution of noncompliant Vaporized Nicotine and Non-Nicotine Products or their devices, and Novel Tobacco Products as provided under this section. The DTI and the BIR shall also maintain a list on their website, to be updated monthly, of brands of Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products registered with the DTI and the BIR that are eligible to be sold online.

Internet websites and/or e-commerce and/or other similar media selling platform providers shall only allow duly registered online sellers or retailers with the DTI and the BIR.

Section 20. Restriction on the Retail and Sale of Nicotine Shots

The retail or use of nicotine shots and/or concentrates shall be strictly prohibited.

Section 21. Jurisdiction

The DTI shall have exclusive jurisdiction over any and all issues, requirements, and subject matters related to Vaporized Nicotine and Non-Nicotine Products, and their devices, as well as Novel Tobacco Products, which are provided for in this Act.

Section 22. Floor Price

The BIR is mandated to issue revenue regulations prescribing the floor price or the 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 23. Penalties for Noncompliance

The following penalties shall apply:

(a)For any violation of Section 15, if the offender is a person; and Section 17, if the offender is a juridical person, the following shall be imposed:

(i)On the first offense, a fine of Five thousand pesos (P5,000.00);

(ii)On the second offense, a fine of Ten thousand pesos (P10,000.00); and (iii) On the third offense, a fine of Twenty thousand pesos (P20,000.00): Provided, That the business permits and licenses, in the case of a business entity or establishment, shall be revoked or cancelled.

(b)For any violation of Sections 6, 7, 9, 10, 11 and 20, if the offender is a retailer, the following shall be imposed:

(i)On the first offense, any person or any business entity or establishment selling, distributing or purchasing Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products to, for or from a minor shall be fined the amount of Ten thousand pesos (P10,000.00) or imprisoned for not more than thirty (30) days, upon the discretion of the court. For succeeding offenses, both penalties shall apply in addition to the revocation of the business licenses or permits in the case of a business entity or establishment;

(ii)If the violation is done by an establishment or business entity, the owner, president, manager, or the most senior officers thereof shall be held liable for the offense; and (iii) If a minor is caught selling, buying or using any Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products, the DOH and the Department of Social Welfare and Development (DSWD) shall implement appropriate intervention programs, including, but not limited to, counseling of the minor and the minor's parent or guardian.

(c)For any violation of Sections 8, 12, 13, 14 and 18, if the offender is a manufacturer, distributor, or retailer, the following shall be imposed:

(i)On the first offense, a fine of One hundred thousand pesos (P100,000.00);

(ii)On the second offense, a fine of Two hundred thousand pesos (P200,000.00); and (iii) On the third offense, affine of Four hundred thousand pesos (P400,000.00) or imprisonment of not more than three (3) years, or both, at the discretion of the court: Provided, That the business permits and licenses, in the case of a business entity or establishment, shall be revoked or cancelled.

(d)For any violation of Sections 4 and 5 of this Act, if the offender is a manufacturer, importer, distributor, or retailer, the following shall be imposed:

(i)On the first offense, a fine of Two million pesos (P2,000,000.00) and imprisonment of two (2) years;

(ii)On the second offense, a fine of Four million pesos (P4,000,000.00) and imprisonment of four (4) years; and (iii) On the third offense, a fine of Five million pesos (P5,000,000.00) and imprisonment of six (6) years: Provided, That the business permits and licenses, in the case of a business entity or establishment, shall be revoked or cancelled. Online sellers and distributors of Vaporized Nicotine and Non-Nicotine Products or Novel Tobacco Products and online platforms that are noncompliant with Section 8 of this Act shall be ordered by the DTI to immediately suspend trading of such products and shall be liable for the fines and penalties imposed under this section. Suspension shall continue until the manufacturer, seller, distributor or online platform has complied with the requirements provided under Section 8 of this Act.

The BIR shall order the immediate recall, ban or seizure from public sale or distribution of Vaporized Nicotine and Non-Nicotine Products or Novel Tobacco Products not registered with the BIR, including those sold online. This is without prejudice to the filing of the appropriate cases and collection of correct taxes and duties, including applicable fines and penalties under Republic Act No. 8424, as amended, and Republic Act No. 10863, otherwise known as the "Customs Modernization and Tariff Act (CMTA)."

The DTI and the BIR, in consultation with relevant stakeholders, shall design, promulgate and utilize new and emerging innovative tools and technologies to ensure that only registered Vaporized Nicotine and Non-Nicotine Products or Novel Tobacco Products are made available in the market.

If the guilty officer is a foreign national, the officer shall be deported after service of sentence and/or payment of applicable fines without need of further deportation proceedings and shall be permanently barred from re-entering the Philippines.

Section 24. Implementing Rules and Regulations

Within three (3) months from the date of effectivity of this Act, the DTI, in consultation with the FDA, shall issue the implementing rules and regulations (IRR) for this Act. The non-issuance of the IRR shall not prevent the implementation of this Act upon its effectivity.

Section 25. Usage of Local Tobacco Products

Manufacturers are encouraged to use local tobacco products for Vapor Products, HTPs and Novel Tobacco Products sold in the Philippines.

Section 26. Appropriations

The amount necessary to implement the provisions of this Act shall be charged against the current year's appropriations of the national government agencies concerned. Thereafter, such funds as may be necessary for the continued implementation of this Act shall be included in the budgets of the national government agencies concerned under the annual General Appropriations Act.

Section 27. Transitory Provision

Manufacturers, distributors, importers and retailers of Vaporized Nicotine and Non-Nicotine Products or their devices, and Novel Tobacco Products shall be given an eighteen (18)-month transitory period from the issuance of the implementing rules and regulations of this Act to comply with the requirements herein.

Section 28. Separability Clause

If any provision or any part hereof is held invalid or unconstitutional, the remainder of the law or the provisions not otherwise affected shall remain valid and subsisting.

Section 29. Repealing Clause

All laws, decrees, rules and regulations or any part thereof which may govern any and all issues, requirements, statements and subject matters related to Vaporized Nicotine and Non-Nicotine Products or their devices, and Novel Tobacco Products which are provided for in this Act, and those other laws, decrees, rules and regulations or any part thereof which are inconsistent with the provisions of this Act, are hereby repealed, amended or modified accordingly.

Section 30. Effectivity

This Act shall take effect fifteen (15) days after its publication in the Official Gazette or in at least two (2) newspapers of general circulation.

Approved,

| (SGD.)VICENTE C. SOTTO III President of the Senate | (SGD.)LORD ALAN JAY Q. VELASCO Speaker of the House of Representatives |

This Act which is a consolidatgion of Senate Bill No. 9007 and Senate Bill No. 2239 was passed by the House of Representatives and the Senate of the Philippines on January 26, 2022 and January 25, 2022, respectively.

MYRA MARIE D. VILLARICA

Secretary of the Senate

MARK LLANDRO L. MENDOZA

Secretary General House of Representatives

For information and research only, and not legal advice. This text may not reflect later amendments. For certified copies, refer to the Official Gazette or the issuing agency.

In plain language