fs eves

Republic of the Philippines
HOUSE OF THE REPRESENTATIVES
Quezon City

EIGHTEENTH CONGRESS
First Regular Session

HOUSE BILL No. 1508

Introduced by REPRESENTATIVES ALFREDO A. GARBIN, Jr. and
ELIZALDY S. CO

EXPLANATORY NOTE

A wide range of vaporized nicotine products have been introduced in the
Philippines and globally.' They are handheld devices which may be battery operated
that deliver nicotine by vaporizing a nicotine-containing liquid* or by heating, instead of
burning, tobacco. Vaporized nicotine products are generally made up of three basic
parts, an atomizer, a cartridge, and a rechargeable battery. The cartridge stores the
solution (e-juice) that is commonly composed of propyiene glycol, glycerol, nicotine, and
flavorings. The e-juice is heated and turned into vapor by the heating element, the
atomizer. Other products heat tobacco instead of burning it* Designed to mimic the
smoking experience without burning tobacco, many in the public health community have
expressed the view that they are less hazardous alternatives to cigarettes “At the same
time, many have expressed concerns about the safety and quality of such products

With the introduction into the market of e-cigarettes in 2007, vaporized nicotine
products (ie., electronic cigarettes or novel non-combustible tobacco products) are now
becoming an increasingly popular choice among smokers, either on the assumption that
such products pose less risk to conventional smoking-related diseases, or that such
products are vehicles to quitting smoking altogether. There are also many custom
vaporized nicotine products manufactured in the Philippines. However, regulation on the
packaging, use, sale and distribution, and advertising of these products is wanting. This
poses possible dangers to adult consumers, who should be assured by manufacturers
of the quality and safety of such products and informed of the components found in the

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same. There have been reported incidents of exploding batteries or defective electrical
systems which need to be addressed.

Moreover, adult consumers should not be made to believe that such products
indeed have the propensity for harm reduction due to smoking, and manufacturers and
distributors should not be allowed to freely claim nor indirectly imply that such products
are safer alternatives, in the absence of any definitive finding and approval by the
Philippine Food and Drug Administration (FDA) that vaporized nicotine products can be
regarded as reduced risk nicotine-delivery systems.

Vaporized nicotine products should be differentiated in terms of regulation from
conventional cigarettes as studies have consistently concluded that vaporized nicotine
products are significantly safer than conventional tobacco smoking.° This is largely
attributable to the fact that conventional cigarettes release much more carcinogens and
toxins from the combustion process that burns tobacco, whereas vaporized nicotine
products forego the combustion process completely. As a less harmful form of nicotine
delivery, the 2016 report of the Royal College of Physicians (RCP) of the United
Kingdom suggested that e-cigarettes, a kind of vaporized nicotine product, can be an
effective tool in harm-reduction as well as a gateway to smoking reduction and

cessation.

Currently, e-cigarettes are regulated as “health-related devices’, requiring a
medicines license from the Food and Drug Administration (FDA).’ This type of
regulation, however, is too rigid and may restrict further developments due to the
licensing applications required per improvement or change done on the device.*
Medicines require evidence of safety; efficacy at treating or preventing a disease in a
defined dose based on clinical studies; and manufacturing in pharmaceutical facilities.
All these will increase the cost of e-cigarettes and other types of vaporized nicotine
products, which would make conventional tobacco cigarettes more appealing. At the
end of the day, this kind of regulatory regime will kill the fledgling e-cigarette industry,
negate the prospect of harm reduction for the smoking public, and discourage smokers
from switching to safer alternatives to cigarettes. It would also be impractical to regulate
vaporized nicotine products as basic consumer products as this does not have enough

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protection regulations for their potentially toxic components and lack restriction on youth

access.

There are also proposals to regulate vaporized nicotine products as tobacco
products due to their nicotine content, a tobacco derivative. Regulating them in the
exact same way as cigarettes, however, would carry a misleading message that they
are as harmful as tobacco cigarettes. Groups such as Public Health England and the
British Lung Foundation have underscored the importance of regulating vaporized
nicotine products differently from cigarettes.°

This bill will require manufacturers to register their vaporized nicotine products
with the Department of Trade and Industry prior to market placement to ensure that
such products have sufficiently passed quality and safety requirements and avoid
untoward incidents to consumers during use. The following health warning is likewise
mandated on nicotine receptacles of vaporized nicotine products: ‘This product may
damage your health and is addictive,’ in line with their risk profile which is different from
that of conventional cigarettes. Health claims, such as reduced exposure to disease and
reduced risk, can only be made subject to the approval of the FDA and based on
scientifically validated tests. This will prevent the assertion of misleading claims to the
public.

The medical community"? acknowledges that a wide range of novel products is
emerging that eliminates combustion and, as such, can be an integral part of harm
reduction. Also, the current proliferation and availability of such unregulated novel
products in the market today warrants the exigent development of a unique regulatory
scheme without the rigidity of medicine licensing, separate from conventional tobacco
regulation, but stricter than consumer product regulation. This bill proposes the creation
of a new product category and the formation of a new type of regulation for vaporized

nicotine products.

In view of the foregoing, the immediate passage of this bill is earnestly
requested.

ment/news/vaping-in-public-places-advice-for-employers-and-organisat
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Republic of the Philippines
HOUSE OF THE REPRESENTATIVES
Quezon City

EIGHTEENTH CONGRESS
First Regular Session

1508

HOUSE BILL No.

Introduced by REPRESENTATIVES ALFREDO A. GARBIN, Jr. and
ELIZALDY S. CO

AN ACT
REGULATING THE USE, SALE, PACKAGING, DISTRIBUTION, AND.
ADVERTISEMENTS OF VAPORIZED NICOTINE PRODUCTS

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.


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

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

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

(e) “Refill container’ means a receptacle for holding nicotine mixture to refill
certain vaporized nicotine products.

(f) “Emissions” means substances that are released when a product is
consumed as intended, such as substances found in cigarette smoke, or the
aerosol generated by a 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.

“Package” shall refer to packs, boxes, cartons or containers of any kind in

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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


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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” shalll refer to the panel of the nicotine receptacle
that faces the consumer when displayed for sale

(n) “Advertising” shall 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 this
Act, advertising shall be understood as vaporized nicotine product

advertising

SEC. 4. Packaging Content. - The packaging shall contain the following
(a) A list of all vaporized nicotine product device components

(b) A leaflet or insert containing instructions for handling, proper use, and

maintenance. It shall also include warnings against improper usage.

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

warnings with the following specifications:

(a) 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 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 warning shall occupy a total area of not less than fifty

percent (50%) of the total warning frame.


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

(d) No part of the warning may be obliterated, 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 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 (anyone below 18 years old).
(b) Purchasing, or otherwise receiving vaporized nicotine products from @ minor.

(c) 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.”


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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. Advertisement Restrictions. - Advertisements shall be allowed in
Points-of-sale, through direct marketing, and on the internet. The following restrictions
shalll apply to all vaporized nicotine product advertisements:

(a) Advertisements shall not be aimed at or particularly appeal to persons under

eighteen (18) years of age.

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

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

(d) Advertisements shall not show, portray or depict scenes where the actual use
of, act of using, or puffing of vaporized nicotine products.

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

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

(g) Promotional communications 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) Advertisements shall not appear in television, radio, and cinema


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(i) All allowable advertisements and promotional 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 advertisement.

SEC. 10. Restrictions on Advertisement in Print Media. - Advertising and
other promotional communications of vaporized nicotine products shall be permitted so
long as the publication is not intended for minors and generally has an adult readership

or subscriber base.

SEC. 11. Public Place Use. - Use of vaporized nicotine products indoor is
prohibited in places of worship, hospitals or other healthcare centers, public
conveyances, government offices, and educational or recreational facilities exclusively
intended for minors. In all other enclosed places that are open to the general public,
private workplaces and those places not covered in the preceding enumeration,
vaporized nicotine product use 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 the 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 contro! of both

incoming materials and finished products; prevention of mix-ups; and


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traceability from raw material supplier to distributor, with supporting
documented evidence and a controlled change management process
(c) 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

respiratory sensitizers.

ethylene glycol
iv. diethylene glycol
v. diacetyl
vi. 2,3-pentanedione
(4) 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.

(e) 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:

(a) Three (3) months prior to placing a vaporized nicotine product in the market,
all manufacturers and importers must register their products with the
Department of Trade and Industry (DT!) and submit information
demonstrating compliance with product standards and assessment
requirements.

(b) Manufacturers or importers intending to present the product with any

information about the product's health effects such as reduced exposure or


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reduced risk claims, must submit scientific evidence supporting such

consumer communication to the Food and Drug Administration (FDA)

(c) For products that are already in-market, they shall be given three months to

register their products with the DTI and submit information demonstrating

compliance with product standards and assessment requirements. Any

health claims for in-market products shall also be submitted to the FDA for

approval

SEC. 15. Health 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

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The manufacturer characterizes 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 tobacco
product who is reasonably well-informed and reasonably observant

and circumspect correctly comprehends the claim


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iv. 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;

ili, 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
(c) 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,


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(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 penaities shall
individually apply to manufacturers, importers, distributors, and sellers of vaporized
nicotine products as well as their agents/representatives for any violation of this Act

(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 more than Five hundred thousand
pesos (P500,000.00); and

(c) On the third offense, a fine of 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 and the House Committee on Health, is hereby constituted to monitor

and review the implementation of this Act


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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 Department
of Health, shall issue the implementing rules and regulations of this Act. The non
issuance of the IRR will not suspend the effectivity of this Act or 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. Repealing 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,