Republic of the Philippines
HOUSE OF REPRESENTATIVES.
‘Quezon City

SEVENTEENTH CONGRESS
‘Second Regular Session

House Bill No, 2289

Introduced by Hon. Victoria Isabel G. Noel

EXPLANATORY NOTE

Vaporized Nicotine Products (VNP), more commonly known as electronic cigarettes or
electronic nicotine delivery systems, have become more readily available and used in the Philippines
these past years.

A YNP is an electronic device that heats a tobacco solution or blend to a temperature that
allows for the production of a vapor. The vapor produced consists of propylene glycol, vegetable
elycerin, water, flavorings and nicotine, which dissipates into the air almost instantly

The Philippine vape culture is steadily evolving, with vapers groups being formed nationwide
and some organizations maintaining active social media presence and calling for the proper regulation
of vaping in the country. This coupled with the advent and exponential growth in popularity of these
products being sold all over the Philippines demonstrates that there is a need for an appropriate
regulatory framework to govern their sale and use to ensure the safety of the public against
malfunctioning devices, deceptive or unfair business practices and access by minors or non-smokers.

This Bill proposes a regulatory framework for VNPs that takes into consideration and
balances the interests of the general public, along with the stakeholders most interested in their use
and sale.

The first crucial policy consideration is ensuring non-access by minors. Of primordial concern
is that in the absence of regulation, VNPs may attract minors or be purchased by and sold to minors,
who are certainly not meant to be consumers of VNPs. Thus, apart from restricting access to persons
below 18 years old, the Bill provides for rigid standards for communications materials on VNPs and
stiff penalties for the violations to the tune of at least P100,000.00 to P500,000.00 and imprisonment

It is also important to ensure the safety and quality of VNPs that are available in the market.
Thus, this Bill proposes stringent product standards and assessment parameters and product


registration rules prior to market placement. It also includes provisions on adequate warnings and
packaging specifications. As to use, this Bill proposes specific places where publig place VNP use
may be allowed.

While several sectors maintain that VNPs provide for a less harmful altemative to cigarette
smoking, it is clear that VNP use may still pose some health risk to users. Moreover, the vapor
produced still contains nicotine, which is an addictive substance. Thus, there is a need to seriously vet
claims of reduced risk or reduced harm before they are allowed to be used in marketing
‘communications on VNPs. This bill proposes that any such claims be examined by the Philippine
Food and Drug Administration subject to internationally accepted standards.

The immediate passage of this Bill is earnestly requested.

Seti

HON. VICTORIA ISABEL G. NOEL


Republic of the Philippines
HOUSE OF REPRESENTATIVES.
Quezon City

SEVENTEENTH CONGRESS.

Second Regular 53) By

House Bill No.

Introduced by Hon. Victoria Isabel G. Noel

AN ACT
REGULATING THE TRADE OF VAPORIZED NICOTINE PRODUCTS, PARTICULARLY, THE
USE, SALE, PACKAGING, DISTRIBUTION, AND COMMUNICATIONS THEREOF

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

SECTION 1. Short Title. - This Act shall be known as the “Vaporized Nicotine Product
Regulation Act of 2016.”

SEC. 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 promote harm reduction measures particularly
in the fight against cigarette smoking by encouraging the availability of well regulated, significantly
less harmful alternatives to cigarettes for smokers who do not or cannot quit smoking.

SEC. 3. Definitions. As used in this Act, the following terms shall mean —

(a) “Vaporized Nicotine Product” means a product with or without tobacco that generates a
nicotine-containing aerosol without combustion, with or without electronics or any
component of that product, this includes but is not limited to a cartridge, a tank, and the
device without a cartridge or tank. For avoidance of doubt, Vaporized Nicotine Products
with tobacco shall not be considered cigarettes and shall not be covered by Republic Act
No. 9211 or the Tobacco Regulation Act of 2003.

(b) “Ingredient” means any substance that is added to the tobacco or nicotine mixture and
present in the finished product.

(©) “Nicotine” means nicotinic alkaloids, including any salt or complex of nicotine whether
derived from tobacco or synthetically produced.


(@) “Nicotine mixture” means the nicotine-containing liquid, solid or other non-tobacco
substance in the product.

(©) “Refill container” means a receptacle for holding nicotine mixture to refill certain
Vaporized Nicotine Products.

(f) “Emissions” shall refer to substances that are released when a product is consumed as
intended, such as substances found in cigarette smoke, or the aerosol generated by
Vaporized Nicotine Products, or substances released during the process of using
Vaporized Nicotine Products.

(g) “Harmful and Potentially Harmful Constituents (HPHCs)” shall refer to chemical
substances that pose potential health risks such as those identified by the World Health
Organization.

(h) “Reduced exposure claim” means a communication to consumers in the product label or
‘marketing material that the product or its emissions contain a reduced level of, or are free
of, a substance or substances or present a reduced exposure to a substance or substances,
such as HPHCs.

(i) “Reduced risk claim” means a communication to consumers in the product label or
marketing which represents explicitly or implicitly that the product presents a lower risk
or is less harmful than continued cigarette smoking.

(i) “Package” shall refer to packs, boxes, cartons or containers of any kind in which the
electronic component of a Vaporized Nicotine Product is offered for sale to consumers.

(k) “Nicotine receptacle” shall refer to bottles, boxes, cartons, or containers of any kind in
which a nicotine-containing solution or non-combustible tobacco or any related product is
offered for sale to consumers for use with a Vaporized Nicotine Product system.

() “Point-of-sale” shall refer to any location at which an individual can purchase or
otherwise obtain Vaporized Nicotine Products.

(m) “Principal display surface” shall refer to the panel of the nicotine receptacle that faces the
consumer when displayed for sale

(n) “Targeted Communications” shall refer to 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 this Act, targeted communications shall be
understood as Targeted Communications on Vaporized Nicotine Product.

SEC. 4. Packaging Content. The packaging shall contain the following:

(a) A list of all Vaporized Nicotine Product device components; and,

(b) A leaflet or insert containing instructions for handling, proper use, and maintenance. It
shall also include warning against improper usage.


SEC. 5. Health Warnings. — Only nicotine receptacles shall bear textual health warnings with

the following specifications:

(@) Unit packets and any outside wrapping of Vaporized Nicotine Product nicotine
receptacles such as e-juices, tobacco cartridges not intended for combustion, and similar
products, shall carry the following health warning: ‘This product may damage your health
and is addictive"

(b) The health warning frame shall occupy 30% of the lower part of the principal display
surface of the unit packet and any outside wrapping of the nicotine receptacle, The health
warming shall occupy a total area of not less than fifty percent (50%) of the total warning,
frame.

(©) Nothing shall be printed or applied on a location where it is likely to obscure or cover, in
part or in whole, the health warming,

(@) No part of the waming may be destroyed, obscured, folded, severed or become
unreadable when the nicotine receptacle is opened or closed or when a wrapper on the
receptacle is removed.

Vaporized Nicotine Products shall not be covered by Republic Act No. 10643 or the Graphic

Health Warnings Law.

SEC. 6, Minimum Age Sales and Purchase. ~The following acts shall be prohibited:

(a) The sale and distribution, or transfer of Vaporized Nicotine Products by any person to
minors, defined as anyone below eighteen (18) years old.

(b) Purchasing, or otherwise receiving Vaporized Nicotine Products from a minor.

(©) The sale, purchase, and use of Vaporized Nicotine Products by minors.

It shall not be a defense for the person selling or distributing that he/she did not know or was
not aware of the real age of the minor. Neither shall it be a defense that he/she did not know nor had
any reason to believe that the product was for the consumption of the minor to whom it was sold.

SEC. 7. Point-of-Sale Signage. — Point-of-sale establishments offering, distributing, or
selling Vaporized Nicotine Products to consumers shall post the following statement in a clear and
conspicuous manner: “SALE/DISTRIBUTION TO OR PURCHASE BY MINORS OF VAPORIZED
NICOTINE PRODUCTS IS UNLAWFUL” or “IT IS UNLAWFUL FOR VAPORIZED NICOTINE
PRODUCTS TO BE SOLD/DISTRIBUTED TO OR PURCHASED BY PERSONS UNDER 18
YEARS OF AGE.”


SEC. 8. Proof of Age Verification - Retailers shall ascertain that no individual purchasing a
\Vaporized Nicotine Product is below eighteen (18) years of age. In case of doubt, retailers shall verify
the age of the buyer through any valid identification card exhibiting the buyer's photograph and age
or date of birth

SEC. 9. Restrictions on Targeted Communications on Vaporized Nicotine Products —
Communication to the public regarding Vaporized Nicotine Products shall be allowed in points-of-
sale, through direct marketing, and on the intemet, subject to the following restrictions:

(a) They shall not be aimed at or particularly appeal to persons under eighteen (18) years of

age.

(b) They shall not contain cartoon characters or subject that depict humans or animals with
comically exaggerated features or that attribute human or unnatural characteristics to
animals, plants or other objects.

(©) They shall only depict persons who are or who appear to be above twenty-five (25) years
of age.

(@ They shall not show, portray or depict the actual use of, act of using, or puffing of
Vaporized Nicotine Products.

(©) They should not undermine quit-smoking messages and encourage non-tobacco or non-
nicotine users to use the product.

() They do not contain any information or element that is untrue or not scientifically
substantiated, in particular with regard to product characteristics, health effects, risks or
emissions.

(g) They shall allow for adult consumers to learn about the availability of Vaporized Nicotine
Products, receive information about how to use them, try them before purchasing them,
subject to proof of age and certification of smoker status, and receive pre-sale and after-
sales support.

(h) They shall not appear in television, radio, and cinema.

(i) All allowable targeted communications materials for nicotine receptacles shall contain the
health warning: “This product may damage your health and is addictive.” The health

warning shall occupy ten percent of the bottom area of the communication.

SEC. 10. Restrictions on Targeted Communications in Print Media. — Targeted
Communications on Vaporized Nicotine Products shall be permitted in print media so long as the
publication is not intended for minors and generally has an adult readership or subscriber base.


SEC. 11. Public Place Use. ~ The use of Vaporized Nicotine Products indoor in places of
worship, hospitals or other healthcare centers, public conveyances, government offices, and
educational or recreational facilities exclusively intended for minors shall be prohibited.

The use of Vaporized Nicotine Product indoor in all other enclosed places that are open to the
general public, private workplaces, and those places not covered in the preceding enumeration shall
be allowed, provided that the owner, proprietor, operator, possessor, manager or administrator of such
places shall post the following statement in a clear and conspicuous manner at every ingress point of
such places: “USE OF VAPORIZED NICOTINE PRODUCTS IS ALLOWED INSIDE.”

SEC. 12. Product Standards and Assessment. ~ Vaporized nicotine products must comply
with the following:

(a) Vaporized nicotine products shall operate in such a way that no combustion of the
tobacco or nicotine mixture occurs during the entire process of consumption when used as
intended.

(b) All products must be manufactured in accordance with an appropriate quality
management system. The quality management system must ensure batch-to-batch
reproducibility of the products through quality control of both incoming materials and
finished products; prevention of mix-ups; and traceability from raw material supplier to
distributor, with supporting documented evidence and a controlled change management
process.

(©) The substances listed below may not be added in Vaporized Nicotine Products:

i additives that have carcinogenic, mutagenic or reprotoxic properties. in
unburnt form; and

ii, respiratory sensitizers
iii, ethylene glycol

iv. diethylene glycol

v. diacetyl

vi. 2,3-pentanedione

(d) Manufacturers of electrical devices intended to be used in combination with a Vaporized
Nicotine Product shall ensure that such devices comply with applicable electrical safety
standards.

(©) Batteries must comply with applicable industry requirements.

SEC. 13. Tamper-proof and Child-proof Designs. — All receptacles containing nicotine
mixtures must be child-resistant, tamper-resistant and protected against breakage and leakage.


SEC. 14. Market Placing. ~ Manufacturers and distributors must comply with the following:
(@) Three (3) months prior to placing a Vaporized Nicotine Product in the market, all
manufacturers and importers must register their products with and submit information

demonstrating compliance with product standards and assessment requirements to the
Department of Trade and Industry (DTI)

(b) Prior to the presentation of the Vaporized Nicotine Product with any information about
the product’s health effects such as reduced exposure or reduced risk claims, the FDA
may require manufacturers or importers to submit scientific evidence supporting such

consumer communication and health claims

(©) For Vaporized Nicotine Products that are already in-market, all manufacturers or
importers shall be given three (3) months from effectivity of this Act to register their
products and submit information demonstrating compliance with product standards and
assessment requirements in accordance with Sections 14 of this Act.

SEC. 15, Reduced Exposure or Reduced Risk Claims. - There are two claims that
Vaporized Nicotine Products may make: a reduced exposure claim and a reduced risk claim. The
FDA shall be the responsible authority with respect to claims of reduced exposure or reduced risk.

(a) A reduced exposure claim may be made only if:

ii,

ili

iv.

‘The manufacturer characterized the levels of nicotine uptake from Vaporized
Nicotine Products compared to cigarette smoking based on clinical trials;

‘The manufacturer can support the claim with evidence from clinical trials
conducted over a period of at least seven days demonstrating that, compared
to continued cigarette smoking, users who switch completely to the product
show a significant reduction in exposure to one or more HPHCs based on
validated, scientifically-accepted biomarkers of exposure and that the
reductions in exposure are significant enough that a reasonable scientific or
medical expert would anticipate a reduction in risk of disease in smokers who
switched to the product.

‘The manufacturer demonstrates that the average user of a tobacco product,
who is reasonably well-informed and reasonably observant, correctly
comprehends the claim.

Clinical studies must be performed in accordance with ethical principles that
have their origin in the Declaration of Helsinki and be consistent with
reasonable internationally accepted standards.

(b) A reduced risk claim may only be made if:


i, The manufacturer meets the requirements stipulated for reduced exposure
claims; and
ii, ‘The manufacturer can support the claim with clinical studies;
iii, The manufacturer can support the claim with evidence from clinical trials
conducted over a period of at least ninety days demonstrating that:
1. compared to continued cigarette smoking, users who switch
completely to the product in conditions of actual use show a
significant reduction in the level of each biomarker of exposure
to HPHCS or that the reductions are within 20% of the reduction
observed in smokers who quit cigarette smoking over the study
period, and
2. compared to continued cigarette smoking, users who switch
completely to the product in conditions of actual use show a
reduction in risk of harm or harm compared to continued
smoking.

Products substantiated as “reduced exposure” or “reduced risk” pursuant to this Section may make
such claims on product packaging and nicotine receptacles.

(©) To characterize risk reduction in the absence of epidemiological evidence, a manufacturer
may instead demonstrate favorable biological and physiological changes in chosen
clinical risk endpoints as compared to continued smoking. These endpoints need to be
effected by smoking, linked to smoking related disease and reversible after smoking
cessation, The majority of the assessed clinical risk endpoints must shift in the direction
of smoking cessation.

(d) A reduced exposure, or reduced risk claim is permissible only with regard to products for
which adequate post-marketing surveillance is in place. The notification must include the
plans for such post-marketing surveillance and studies to determine the impact of the
marketing of the product on the population.

SEC. 16. Penalties for Noncompliance. ~ The following penalties shall individually apply to
‘manufacturers, importers, distributors, and sellers of Vaporized Nicotine Products as well as their
agents/representatives for any violations of this Act, as may be applicable:
(a) On the first offense, a fine of not more than One hundred thousand pesos (P100,000.00);
(b) On the second offense, a fine of not less than One hundred thousand pesos (P100,000.00)
but not more than Five hundred thousand pesos (P500,000.00); and


(©) On the third offense, a fine of not less than Five hundred thousand pesos (P500,000.00)
but not more than One million pesos (P1,000,000.00) or imprisonment of not more than
five (5) 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.

Non-compliant Vaporized Nicotine Products found in the market for sale or distribution
shall be subject to confiscation.

If the guilty officer is a foreign national, he 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.

SEC. 17. Creation of a Congressional Oversight Committee. — A Congressional Oversight
Committee co-chaired by the Senate Committee on Health and Demography, the Senate Committee
on Trade, Commerce, and Entrepreneurship, the House Committee on Health, and the House
Committee on Trade and Industry, is hereby constituted to monitor and review the implementation of
this Act.

SEC. 18. Implementing Rules and Regulations. ~ Within six (6) months from the date of
effectivity of this Act, the DTI, in consultation with the FDA of the DOH, shall issue the
implementing rules and regulations (IRR) of this Act. The non-issuance of the IRR will not suspend
the effectivity of this Act nor the introduction of new Vaporized Nicotine Products in the market.

SEC. 19. Separability Clause. — If any provision or part hereof, is held invalid or
unconstitutional, the remainder of the law or the provision not otherwise affected shall remain valid
and subsisting,

SEC. 20. Repeating Clause. - Any law, presidential decree or issuance, executive order,
letter of instruction, administrative order, rule or regulation contrary to or is inconsistent with the

provision of this Act is hereby repealed, modified, or amended accordingly.

SEC. 21. Effectivity Clause. ~ This Act shall take effect fifteen (15) days after its publication
in at least two (2) newspapers of general circulation.

Approved,