HUUSE WF R=PRESENTATIVES

RECEIVED
Republic of the Philippines pate 25 AUG 2016
HOUSE OF REPRESENTATIVE$ i
Quezon City sive:__(00

SEVENTEENTH CONGRESS BY:
First Regular Session

House Bill No.3 330 RECISTRATION UNIT
} BILLS a\r AEX SERVICE

Introduced by Rep. Rodel M. Batocabe, Rep. Alfredo A. Garbin, Jr., and Rep.
Christopher 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 propylene 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
same. There have been reported incidents of exploding batteries or defective electrical
systems which need to be addressed.

* hup/onlinelibrary.wiley.com/doi/10.1 1 /add.13394/abstract; https://gume.georgetown.eduinews/Top-Tobacco-
Contra Experts-To-FDA-Studies-oF E-cgs-Susyest-More-Benfit-Than-Harm

2 http://www.ash.org.uk/files/documents/ASH_715.pdf

3 http:/onlinelibrary.wiley.com/doi/10.111 /add. st
ei/Jocumentsleters/MargartChan nat



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 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

$ http://www nebi.nlm.nih.gow/pme/articles/PMC4 I 1087 I/pdf/10.1177_20420986 14524430.pdf ;
http://ournals.plos.org/plosone/article?id=10.137/journal.pone.0122544 ;
https://www.heartland.org/sites/default/files/tob_control-2016-manzoli-tobaccocontrol-2015
6 hitps://www.replondon, ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reductis
7 DOH Administrative Order 2014-0008

* http://www clivebates.com/?p=1252

52822_O.pdf



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,

a

RODEL M. BATOCABE Au |ARBIN, JR. CHRISTOPHER S. CO

° https://www.gov.uk/government/news/vaping-in-public-places-advice-for-employers-and-organisations
© http://www.clivebates.com/2p=2185


Seorauaune

Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

SEVENTEENTH CONGRESS
First Regular Session

3339

House Bill No. 9° *

Introduced by Rep. Rodel M. Batocabe, Rep. Alfredo A. Garbin, Jr., and Rep.
Christopher 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


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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.

(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
which the electronic component of a vaporized nicotine product is offered for

‘sale to consumers.


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(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) “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 a 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
shall 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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() 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 shail 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


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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
ii. respiratory sensitizers.
ili. 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.

(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 (DTI) 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
reduced risk claims, must submit scientific evidence supporting such

consumer communication to the Food and Drug Administration (FDA).


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(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:

i

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.

. 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:


222 i. The manufacturer meets the requirements stipulated for reduced

223 exposure claims; and

224 ii, The manufacturer can support the claim with clinical studies;

225 iii, The manufacturer can support the claim with evidence from clinical
226 trials conducted over a period of at least ninety days demonstrating
227 that,

228 4. compared to continued cigarette smoking, users who switch
29 completely to the product in conditions of actual use show a
230 significant reduction in the level of each biomarker of
231 exposure to HPHCs or that the reductions are within 20% of
232 the reduction observed in smokers who quit cigarette smoking
233 over the study period, and

234 2. compared to continued cigarette smoking, users who switch
235 completely to the product in conditions of actual use show a
236 reduction in risk of harm or harm compared to continued
237 smoking.

238 Products substantiated as “reduced exposure” or “reduced risk” pursuant to this Section

239 may make such claims on product packaging and nicotine receptacles.

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

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

250 population.


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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 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.

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.


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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,