Republic of the Philippines
House of Representatives
Quezon City

SEVENTEENTH CONGRESS
Third Regular Session
House Bill No,__ 8671

Introduced by Representative Jose Enrique S. Garcia Ill

EXPLANATORY NOTE

International experts and health ministries worldwide are one in recognizing the detrimental
effects of nicotine addiction and the health risks that unrestricted use, sale, distribution,
‘advertisement, promotion, and sponsorship of electronic cigarette devices or e-cigarette and
nicotine-containing e-liquids may have on the population.

In the recent Conference of Parties to the World Health Organization Framework
Convention on Tobacco Control (WHO FCTC), State parties were asked to regulate novel and
‘emerging tobacco products either by banning or putting restrictions on their manufacturing,
importation, distribution, presentation, and sale—taking into account the imperative of a high level
of protection for human health.

‘More than 27 countries including Argentina, Austria, Belgium, Brazil, Brunei, Colombia,
Egypt, Indonesia, Jordan, Malaysia, Mexico, Oman, Panama, Singapore, Taiwan, Tajkistan,
Thailand, Turkey, United Arab Emirates, Uruguay, Venezuela have banned the use, sale and
distribution of e-cigarettes. Many more have established strong regulations that put public health
interests—especially of the youth, who are most vulnerable to nicotine addiction—above
‘commercial rights,

In the Philippines, “backyard manufacturing” of e-cigarette flavorings and e-juices have
become rampant. The fact that local manufacturers could mix their own juices and flavorings sans
public disclosure of the ingredients and solutions used is very alarming. Unless, sooner halted, this
“backyard manufacturing” could no longer be controlled.

Electronic cigarette products are similarly untested for electrical or mechanical safety and
this has resulted to injuries. In fact, media reports of exploding e-cigarette products have become
increasingly common, with more than 200 reports of related explosions all over the world. In the
Philippines, the recent case of a minor who fell victim to the explosion of an e-cigarette device
attests to the need of subjecting these products to rigorous testing and quality control. There was
also a reported incident of illegal importation at an airport of e-cigarette products, which were found
to contain illegal drugs.

Retailers in the country rarely sell the products without nicotine. Most e-juices contain
nicotine and some even have misleading descriptions; for instance, some locally manufactured e-
juice state that they “may contain nicotine” in their labels. For a chemical that is known to be a
health hazard and highly addictive, nicotine use is especially dangerous to the youth. Numerous
‘scientific studies have shown that nicotine “rewires” the brain towards lifelong addiction, causing
‘multiple negative behavioral and mental issues.

‘The widespread availability and populanty of flavored e-cigarettes among the youth is also
undeniable. Vape shops’ close proximity to schools and other places frequented by minors is highly
suggestive that e-cigarette manufacturers and retailers are targeting the younger segment of the
Population. The initiation of e-cigarette use among the youth will lead to lifelong addiction. This
addiction would ensure that the industry has sustained income from their habitually dependent
consumers for decades. Moreover, studies have shown that children and adolescents who take up


the habit of e-cigarettes end up smoking cigarettes, as well. In other words, the use of e-cigarettes
|s a gateway to smoking. This worrisome phenomenon has been scientifically documented
worldwide.

‘Numerous studies have also consistently found that e-cigarette use re-normalizes and
promotes cigarette smoking. As a matter of fact, while marketed as an alternative to tobacco use,
a recent study by the University of California revealed that the use of e-cigarette actually reduces
the likelihood that people would quit smoking. Instead of quitting tobacco, they just eventually
become dual users. This is also the experience in the United Kingdom based on a 12-month
prospective study published in 2018. This correlation makes e-cigarettes especially dangerous to
non-smokers and the youth,

‘The State should not and cannot tolerate any form of addiction. It is, therefore, urgent that
these products are banned from the market until they are scientifically proven to be safe and non-
addictive.

‘Support for this bills eamestly sought from my colleagues.

May

JOSE EN! 8. GARCIA Ii
District, Bataan


Republic of the Philippines
House of Representatives
Quezon City
‘SEVENTEENTH CONGRESS
Third Regular Session

House Bill No,_ 8671

Introduced by Representative Jose Enrique S. Garcia Ill

AN ACT
RESTRICTING THE IMPORTATION, MANUFACTURE, USE, SALE, DISTRIBUTION AND
ADVERTISEMENT OF ELECTRONIC CIGARETTES AND FOR OTHER PURPOSES

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 “Electronic Cigarette Restriction
Act.”

‘SECTION 2. Declaration of Policy. tis the policy ofthe State to protect the populace from
hazardous products and promote the right to health and instil health consciousness among them.
|tis likewise the policy of the State to adopt a preventive approach whereby unless scientifically
proven to be safe, the public shall not be exposed to products that may have detrimental or
hazardous effect on health. For these purposes, the government shall institute a policy to prohibit
the importation, manufacture, use, sale, and distribution of electronic cigarettes until they are
Cleared to be safe in order to promote a healthy environment and protect the citizens from the
hazards of e-cigarette use.

‘SECTION 3. Definition of Terms. — For purposes of this Act, the following terms shall mean:

a. “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

bout the attributes, features, quality, or availabilty of consumer products, services, or credit. For
the purpose of this Act, advertising shall be understood as e-cigarette advertising;

b. “Electronic cigarettes" or “e-cigarettes” refer to devices, often resembling cigarettes,
cigars or pipes, designed to deliver nicotine or related substances to users in the form of vapor.
‘They are also known as electronic nicotine delivery systems (ENDS);

. “Ingredient” means any substance that is added to the mixture and present in the finished
product;

d, “Nicotine” means nicotinic alkaloids, including any salt or complex of nicotine whether
derived from tobacco or synthetically produced;

e. “Nicotine container” shall refer to bottles, boxes, cartons, or containers of any kind in
which a nicotine-containing product is offered for sale to consumers for use with an e-cigarette
Product system;

f. "Nicotine mixture” means the nicotine-containing liquid, solid or other non-tobacco
substance in the product;

@. “Package” shall refer to packs, boxes, cartons, or containers of any kind in which a
nicotine product is offered for sale to consumers for use with a e-cigarette product system;


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f° means a container for holding nicotine mixture to refill certain e-

SECTION 4. Prohibition on Importation, Manufacture, Use, Sale or Distribution of E-
Cigarettes. — Unless duly issued with a Certificate of Product Registration (CPR) by the Food and
Drugs Administration (FDA), the importation, manufacture, use, sale or distribution of e-cigarettes,
the ingredients, receptacles, packages and containers associated thereto by any person, whether
‘natural or juridical, is hereby prohibited.

SECTION 5. Transition Period. — All existing importers, manufacturers, sellers, distributors
and retailers of e-cigarettes, including their ingredients, receptacles, packages and containers are
hereby given a period of three (3) months from the effectivity of this Act to apply for and submit to
the FDA the application and relevant requirements for the issuance of the CPR.

‘The FDA shall assess, evaluate and decide whether or not to grant the application under
such rules and standards that it shall promulgate, within six (6) months from receipt of the
application and complete submission of requirements. Provided, That the applicants may continue
in business until such applications shall have been acted upon by the FDA. Provided, further, That
should the application be denied or disapproved, the applicant concemed shall have three (3)
‘months to wind down its operation and completely cease business operation after such period. Any
Continuation of operation beyond the 3-month period may be summarily abated by the FDA without
prejudice to any administrative, civil or criminal penalties that may be imposed pursuant to this Act.
Provided, finally, That the issuance of a CPR shall not constitute as an absolute right to engage in
the importation, manufacture, sale or distribution of e-cigarette in any locality in the county.

‘All existing importers, manufacturers, sellers, distributors and retailers who fail to apply for
a CPR and comply with the requirements of the FDA within three (3) months from the effectivity of
this Act shall be deemed to be illegally engaged in business and shall be summarily abated and
penalized in the same manner as that provided for in the immediately preceding paragraph.

SECTION 6. Role of Local Govemment Units. ~ All local government units (LGUs)
‘concerned shall revoke any business license issued or shail not issue or renew such license to any
importer, manufacturer, seller, distributor or retailer of e-cigarette who fail to comply with the
requirements of this Act.

Recognizing the indispensable role of LGUs in the effective implementation of this Act and
consistent with their primary responsibilty to maintain a healthy environment, the government
hereby adopts a localized approach in the control and regulation of e-cigarettes. All LGUs are
hereby enjoined to enact their respective ordinances regulating the manufacture, use, sale or
distribution of e-cigarettes in their localities. Such ordinances shall be consistent with and
‘complement the minimum regulations promulgated by the FDA and the provisions of this Act.
Provided, That notwithstanding the issuance of a CPR by the FDA to any importer, manufacturer,
seller, distributor or retailer of e-cigarettes, the LGUs shall not be precluded from adopting more
stringent measures, including the prohibition of manufacture, use, sale or distribution of e-cigarette
in the locality in the exercise of their power under the general welfare clause.

SECTION 7. Ban On Advertisements, Promotions and Sponsorships. ~ All forms of
advertisements and promotions of e-cigarette are prohibited.

Electronic cigarette importers, manufacturers, sellers or distributors are also prohibited from
directly or indirectly sponsoring any sport, concert, cultural, art or any public event. This ban
includes sponsorship of any individual and team athletes, artists, or performers for the purpose of
Promoting the product.

SECTION 8. Penalties. — A fine of not less than P500,000.00 but not more than
P1,000,000.00 or an imprisonment of not more than six (6) years or both, at the discretion of the
court shall be imposed for violation of the provisions of Sections 5, 6 and 7 of this Act.

If the violation is committed by a partnership or corporation, the penalty of imprisonment
shall be imposed upon the managing partner, board of directors or corporate officers who, shall
likewise be held solidarity liable for any fine imposed. If the violation is committed by a foreign
corporation, its license to do business in the Philippines shall be cancelled and the directors and


BSSSBesan

all officers of such foreign corporation who are not citizens of the Philippines shall, in addition to
the penalties imposed above, be deported and barred from re-entry into the Philippines.

SECTION 9. Implementing Agency. ~ The FDA shall be the implementing agency of this
‘Act. For this purpose, the FDA, in coordination with the Department of Health and the Department
‘of Science and Technology, shall promulgate the implementing rules and regulations (IRR) within
thirty (30) days from the effectivity ofthis Act. Said IRR shall include standards on safety, efficacy
‘and quality of the device, refill container, ingredient mixture, dose of nicotine, packaging and
labeling, among others.

‘SECTION 9. Appropriation. — The amount as may be necessary to implement the provisions
of this Act shall be charged against the current year's appropriations of the FDA. Thereafter, such
funds as may be necessary for the continued implementation of this Act shall be included in the
‘budget of the FDA under the annual General Appropriations Act.

SECTION 10. Separability Clause. ~ If any provision or part of this Act is subsequently
declared unconstitutional or invalid, the remaining provisions or parts thereot not affected shall
remain in full force and effect.

SECTION 11. Repealing Clause. — Department of Health Administrative Order No. 2014-
008 dated May 17, 2014, is hereby repealed. All other laws, decrees, ordinances, administrative
‘orders, rules and regulations, or any part thereof, which are inconsistent with this Act are likewise
repealed or modified accordingly.

SECTION 12. Effectivity. - This Act shall take effect fifteen (15) days after its publication in
the Official Gazette or in any newspaper of general circulation.

Approved.