Declaration of Policy
- Protect and promote public health and instill health consciousness.
- Establish a balanced policy to regulate novel consumer products (vaporized nicotine/non-nicotine and novel tobacco products) with international standards.
- Regulate importation, manufacture, sale, packaging, distribution, use, advertisement, promotion, sponsorship.
- Aim to reduce harm caused by smoking, prevent sale to minors, and stop illicit trade.
Definitions of Key Terms
- Advertising: Business communication of product features excluding non-promotional info.
- Celebrity: Any person whose public character draws attention, including social media influencers.
- Child-resistant and tamper-resistant: Packaging standards compliant with safety requirements.
- Designated Vaping Area (DVA): Designated indoor/outdoor areas allowing product use.
- Distributor, Manufacturer, Retailer: Entities involved in product commerce at different stages.
- Heated Tobacco Products (HTPs): Tobacco consumed by heating without combustion.
- Product Demonstration: Testing and explaining product features to adult buyers.
- Promotion and Sponsorship: Activities or events organized to promote these products.
- Vapor Products and Devices: Includes Vapor Product Refills, Devices, and Systems that generate inhalable aerosol.
- Novel Tobacco Products: Non-combusted tobacco or nicotine-containing substitutes.
- Other terms defined cover packaging, proof of age, reduced-risk statements, and nicotine-related substances.
Packaging and Health Warnings
- Packaging must bear 50% full-color graphic health warnings in front and back.
- Textual warnings differ for products containing nicotine and those without.
- Warnings must be clearly visible and not obscured.
- Compliance with BIR fiscal marking rules mandatory.
- DOH to provide specific health warning designs within 30 days of act’s effectivity.
- Exported products have distinct marking requirements.
Child-resistant and Tamper-resistant Packaging
- Vapor Product Refills must comply with child-resistant and tamper-resistant standards.
- Packaging must prevent breakage, leakage, and unauthorized refilling.
Minimum Age for Purchase and Use
- Minimum age set at eighteen (18) years.
- Lack of knowledge regarding buyer’s age is not a defense for sellers.
Proof-of-Age Verification
- Retailers must require valid government-issued ID showing age and photo.
- Delivery only to individuals 18 years and older.
Online Trade Regulations
- Online sale/distribution permitted with age verification and signage on websites.
- Online sellers must be registered with DTI or SEC and comply with health warning and tax requirements.
- Delivery must comply with age verification.
Sales and Promotion Restrictions Near Schools
- Prohibition of sale, promotion, advertising, and demonstration within 100 meters of schools, playgrounds, or facilities frequented by minors.
Point-of-Sale Signage Requirements
- Mandatory posting of specific health warning statements on establishments selling these products.
Product Display Restrictions
- Products must not be displayed alongside items that appeal particularly to minors.
Advertising and Consumer Communication Restrictions
- Allowed only at point-of-sale, direct marketing, or internet under stringent conditions.
- No targeting or appealing particularly to persons under 18.
- Ban on using cartoons, anime, celebrities, and youth influencers.
- Advertisements must include government-mandated health warnings.
- Ban on misleading information or unsubstantiated claims.
- Online ads require age verification.
- Prohibition of advertisements on public spaces and flavored descriptors appealing to minors.
- Medicinal or therapeutic claims prohibited without FDA approval.
- Reduced-risk statements require FDA authorization.
Promotional Activities Restrictions
- Promotional events limited to persons 18+ and conducted by trained experts.
- Mandatory health warnings and clear age requirement labeling.
- No medicinal claims without FDA approval.
- Promotion confined to point-of-sale or adult-only venues.
- No celebrity endorsements or promotional merchandise visible to the public.
- Ban on placement of advertisements in video games or movies.
Sponsorship Restrictions
- Sponsorship prohibited in sports, concerts, cultural, or art events.
- Minors barred from participation.
- Health warnings and age restrictions mandatory in communications and invitations.
- No merchandise distribution with brand names visible during sponsored events.
- Implementation of CSR activities allowed without brand promotion.
Use of Products in Public Places
- Use prohibited indoors except in designated vaping areas or point-of-sale for demonstrations.
- Absolute prohibition in youth centers, hospitals, elevators, transport terminals, food prep areas, churches, and government offices (except DVA).
Awareness Campaigns
- DOH to coordinate smoking and vaping restriction awareness campaigns.
- Private sector encouraged to support restriction awareness initiatives.
Designated Vaping Areas Standards
- Restricted access for persons under 18 and pregnant women.
- Required signage for vaping area and age restrictions.
- No smoking allowed in DVAs.
- Controlled occupancy based on space.
- Indoor DVAs require separate ventilation and physical separation.
- Only one DVA per building or conveyance.
- No sale or serving of food and beverage in DVA except in point-of-sale.
Product Standards
- DTI, with FDA, to establish product safety and quality standards.
- Max nicotine content capped at 65 mg/ml.
- Compliance required.
Product Registration
- Mandatory registration of all manufacturers and importers with DTI.
- Includes HTP consumables, devices, vapor refills, and novel tobacco products.
- DTI may recall, ban, or seize non-compliant products.
- Only registered products with health warnings allowed for marketing, sale, and distribution including online platforms.
- Online sellers must register with DTI and BIR; non-compliance results in takedown orders.
Prohibition on Nicotine Shots
- Retail and use of nicotine shots/concentrates strictly prohibited.
Jurisdiction
- Exclusive jurisdiction over all regulation matters of Vaporized Products and Novel Tobacco Products lies with DTI.
Floor Price
- BIR mandated to set minimum prices considering taxes and production costs.
Penalties for Violations
- Various penalties depending on violation and actor (person or business).
- Fines range from ₱5,000 to ₱5,000,000 and/or imprisonment up to 6 years.
- Revocation or cancellation of business permits for repeated offenses.
- Minor offenders to undergo intervention and counseling.
- Online non-compliance triggers suspension of trading and product recall.
- Foreign offenders deported and barred from re-entry after serving penalties.
Implementing Rules and Regulations
- DTI and FDA to issue IRR within 3 months from effectivity.
- Non-issuance of IRR does not prevent law implementation.
Use of Local Tobacco Products
- Manufacturers encouraged to use local tobacco for products.
Appropriations
- Initial funding charged to current national agencies’ allocations.
- Continued funding to be included in future budget appropriations.
Transitory Provisions
- 18-month transition period post-IRR issuance for compliance by stakeholders.
Separability Clause
- Invalidity of a provision does not affect the rest of the Act.
Repealing Clause
- Repeals laws inconsistent with the Act concerning regulation of vaporized nicotine/non-nicotine and novel tobacco products.
Effectivity
- Law takes effect 15 days after publication in Official Gazette or newspapers.