Republic of the Philippines
House of Representatives
Quezon City

TWENTIETH CONGRESS
First Regular Session

House Bill No. ~ 1969 _

EXPLANATORY NOTE

The passage of Republic Act No. 11900 or the “Vaporized Nicotine and Non-
Nicotine Products Regulation Act” transferred regulatory oversight over vaporized
nicotine and non-nicotine products (VNNPs) from the Food and Drug Administration
(FDA) to the Department of Trade and Industry (DT!), a move that raised constitutional,
legal, and public health concerns. The regulation of products with known or potential
health effects should fall squarely under the jurisdiction of a health-based regulatory
agency.

This bill seeks to amend RA 11900 and reestablish the FDA's primary authority
over VNNPs, consistent with the following:

« RA 9711 (FDA Act of 2009), which grants the FDA the mandate to regulate
products affecting health, including “health-related devices’ and substances
intended to affect body function;

* RA 11467 and Executive Order No. 106, which both affirm FDA's regulatory
role over VNNPs;

* Supreme Court jurisprudence in DOH v. PTI, which upheld FDA's jurisdiction
over tobacco products;

* The 1987 Constitution, which imposes a duty on the State to protect and
promote the right to health; and

* The WHO Framework Convention on Tobacco Control (FCTC) and related
international obligations.

This bill ensures coherence in public health policy, affirms the constitutional
right to health, and prevents regulatory fragmentation.

Previously filed in the 19th Congress, this Representation participated in the
deliberations for this bill at the committee level. Support of this bill is earnestly
requested from my colleagues.

MARIA ARIGELA S. GARCIA
Thirp Pistrict, Bataan


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Republic of the Philippines
House of Representatives
Quezon City

TWENTIETH CONGRESS,
First Regular Session

House Bill No. 1969

Introduced by Representative Maria Angela S. Garci

AN ACT AMENDING REPUBLIC ACT NO. 11900,

OTHERWISE KNOWN AS THE “VAPORIZED NICOTINE AND NON-NICOTINE
PRODUCTS REGULATION ACT,” TO TRANSFER THE REGULATORY
AUTHORITY OVER VAPORIZED NICOTINE AND NON-NICOTINE PRODUCTS.
FROM THE DEPARTMENT OF TRADE AND INDUSTRY TO THE FOOD AND
DRUG ADMINISTRATION, AND FOR OTHER PURPOSES.

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

SEC. 1. Amendment to Section 4 of Republic Act No. 11900. — The
definition of the term “competent authority” is hereby amended to read as follows:

“COMPETENT AUTHORITY” refers to the Food and Drug Administration
(FDA), under the Department of Health (DOH), which shall have primary jurisdiction
and regulatory authority over the manufacture, importation, sale, packaging,
distribution, use, advertising, promotion, sponsorship, and product registration of
vaporized nicotine and non-nicotine products, and novel tobacco products.

SEC. 2. Transfer of Regulatory Functions. — All regulatory functions over
vaporized nicotine and non-nicotine products previously assigned to the Department
of Trade and Industry under RA No. 11900, including the issuance of standards,
enforcement mechanisms, and administrative sanctions, are hereby transferred to the
Food and Drug Administration (FDA).

SEC. 3. Inclusion of VNNPs as Health Products under RA 9711. — For the
avoidance of doubt, vaporized nicotine and non-nicotine products, including their
components such as e-liquids, nicotine salts, cartridges, and devices, are hereby
deemed health-related devices or substances under Section 10(f) and (g)(3) of
Republic Act No. 9711 (FDA Act of 2009), and shall be subject to all applicable
provisions thereof.

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SEC. 4. Additional Amendments. — The following provisions are hereby
inserted into Republic Act No. 11900, as amended:

(a) Minimum Age Restriction. — No person shall sell, distribute, or
otherwise make available vaporized nicotine and non-nicotine products,
including novel tobacco products, to any person below twenty-one (21) years
of age. Proof of age shall be required prior to purchase.

(b) Ban on Advertising, Promotion, and Sponsorship. — All forms of
advertising, promotion, and sponsorship of vaporized nicotine and non-nicotine
products, including point-of-sale marketing, product placements, online and
social media promotions, and the display of brand logos or imagery on store
signages, are hereby prohibited. This prohibition shall be enforced in the same
manner and to the same extent as those applicable to tobacco products under
existing laws and regulations.

SEC. 5. Repealing Clause. — All provisions of Republic Act No. 11900,
including but not limited to Sections 5, 6, 13, and 16, and related provisions of the
Implementing Rules and Regulations that assign or imply primary regulatory authority
to the DTI over VNNPs, are hereby repealed or amended accordingly. All other laws,
executive orders, rules, or regulations inconsistent with this Act are hereby repealed
or modified accordingly.

SEC. 6. Implementing Rules and Regulations. - The Food and Drug
Administration, in coordination with the Department of Health and relevant
stakeholders, shall promulgate the rules and regulations necessary to implement this
Act within sixty (60) days from its effectivity.

SEC. 7. Separability Clause. — |f any provision of this Act is held invalid or
unconstitutional, the other provisions not so declared shall remain in force and effect.

SEC. 8. Effectivity. — This Act shall take effect fifteen (15) days after its
Publication in the Official Gazette or in a newspaper of general circulation.

Approved,