Republic of the Philippines
HOUSE OF REPRESENTATIVES
Constitution Hills, Quezon City

Sixteenth Congress
First Regular Session

HOUSE BILL NO.

4620

Introduced by Representative Catherine Barcelona-Reyes, M.D.

EXPLANATORY NOTE

As a state policy, the 1987 Philippine Constitution has adopted the right to health of
the people. This is embodied in Section 15, Article II of the 1987 Philippine Constitution.
The people are the strength of the nation; thus, the State must place the welfare of the people
at the top of its priorities. Subsumed in the welfare of the people is their health. The State
shall do everything to protect the health of its people.

This bill seeks to implement Article II, Section 15 of the 1987 Philippine Constitution
by informing the people of the difference between drugs, which are stamped with an
approval of therapeutic claim by the Food and Drug Administration, and food/dietary
supplements, which are not given such approval. This can only be done by printing
disclaimers on the packaging of food/dietary supplements that effectively give the message

that these do not have any proven therapeutic claim.

The State promotes the right to health of the people through this act by ensuring that
the people are properly informed that these food/dietary supplements have no proven
therapeutic claim. Given an informed choice, the people may then know to which they must

allocate their resources — either to proven drugs or to non-proven food/dictary supplements ~


in the event that they should get sick. Given an informed choice, the people will know the

difference between these two products.

The passage of this legislative measure is carnestly sought.

HON. CATHERINE BARCELONA-REYES, M.D.
First District, Catharines Norte
Representative


Republic of the Philippines
HOUSE OF REPRESENTATIVES
Constitution Hills, Quezon City

Sixteenth Congress
First Regular Session

HOUSE BILLN 4620

‘ative Catherine Barcelona-Reyes, M.D,

Introduced by Rep

AN ACT
TO ENSURE HEALTH PROTECTION THROUGH VISIBLE
DISCLAIMERS ON FOOD/DIETARY SUPPLEMENTS PACKAGING/BOTTLES

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

assembled:

Section 1. Short title. This Act shall be known as “The Expanded No-Approved-
Therapeutic-Claim Label Act of 2014”

Section 2, Declaration of Principles. The State shall protect and promote the right to
health of the people and instill health consciousness among them, The State shall also protect

consumers from trade malpractices and from hazardous products.

Section 3. Purpose. The purpose of this Act is to ensure that:
a. Disclaimers on dietary supplements effectively are very visible enough to inform the
people of the lack of any approved therapeutic claim on the part of these supplements.
b. Packaging of food/dietary supplements do not mislead the people into believing that
these have the same proven effects of drugs which are approved by the Food and Drug

Administration.


Section 4. Definitions of Terms.

isclaimer” means warning labels specified under Section 5 of this Act that inform
the people that food/dietary supplements do not have an approval of therapeutic claim
by the Food and Drug Administration.

b. “Food/dietary supplements” mean products registered as such which are not given an
approval of therapeutic claim by the Food and Drug Administration.

¢. “Display surface” pertains to the packaging of food/dietary supplements.

Section 5, Disclaimer. Within one-hundred twenty (120) days from the effectivity of
this Act, food/dietary supplements found in the market shall bear, in a highly visible font and
print and in both English and Filipino, the phrase, “NO APPROVED THERAPEUTIC
CLAIM BY THE FOOD AND DRUG ADMINISTRATION. THIS MANUFACTURED
PRODUCT HAS NO SCIENTIFICALLY-PROVEN HEALTH BENEFIT” as prescribed
herein:

a. The disclaimer shall be printed on at least fifty percent (50%) of the display surface
of these food/dietary supplements.

b. Nothing shall be printed on the location prescribed where it is likely to obscure or
cover the disclaimer, in part or in whole.

c. The disclaimer shall be printed in a highly visible font in capital letters, both in

English and Filipino.

Section 6. Costs. All printing costs for the disclaimer on food/dictary supplements

shall be shouldered by the manufacturers.

Section 7. Prohibition on Sale. No person or legal entity shall sell or commercially
distribute or display any food/dietary supplement without ensuring that the packaging meets

the disclaimer requirement under this Act.


Section 8. Penalties for Non-Compliance.
a. The following penalties shall apply to manufacturers, importers, and exporters of

food/dietary supplements for failure to comply with Section 5 of this Act or any

violation of this Act:

-On the first offense, a fine of not more than Five-Hundred Thousand Pesos

(P500,000) shall be imposed;

-On the second offense, a fine of One Million Pesos (P1,000,000) shall be imposed;

-On the third offense, both a fine of Two Million Pesos (P2,000,000) and

imprisonment of not more than one year. The business permits and licenses, in the

case of a business entity or establishment shall also be revoked or cancelled.

If the guilty officer is an alien, he shall be summarily deported after the finding of

probable cause on the second offense and shall be forever barred from re-entering the

Philippines.

b. The following penalties shall apply to distributors and retailers of food/dietary
supplements as well as their agents for failure to comply with Section 7 or for any
violation of this Act:

On the first offense, a fine of not more than One Thousand Five Hundred Pesos
(P1,500) shall be imposed;

On the second offense, a fine of Five Thousand Pesos (P5,000) shall be imposed;

On the third offense, either a fine of not more than Ten Thousand Pesos (P10,000) but
not less than Five Thousand Pesos (P5,000), or imprisonment of not more than one
year, or both at the discretion of the court. The business permits and licenses, in the
case of a business entity or establishment shall also be revoked or cancelled.

If the guilty officer is an alien, he shall be summarily deported after the finding of
probable cause on the second offense and shall be forever barred from re-entering the

Philippines.

Section 9. Administrative Power. The Department of Health is hereby charged with
the implementation and enforcement of the provisions of this Act. Within six (6) months
from the effectivity of this Act, the Department of Health shall formulate guidelines and


regulations to facilitate the implementation of this Act. The Department of Health, through
the Philippine Food and Drug Administration, is hereby authorized to:

a. Promulgate rules governing the hearings on alleged violations of this Act. The

hearings shall be summary in nature and shall be conducted by means of position

papers and affidavits. Decisions must be rendered by the Department of Health no

longer than thirty (30) days after filing.

b. Impose, after due notice and hearing, fines of up to Five Million Pesos (P5,000,000),
the proceeds of which will be used for health promotion campaigns of the Department
of Health.

Section 10. Separability Clause. If any clause, provision, paragraph, or part thereof
shall be declared unconstitutional or invalid, such judgment shall not affect, invalidate, or
impair any other part thereof but such judgment shall merely be confined to such clause,
provision, paragraph or part directly involved in the controversy in which such judgment has

been rendered.

Section 11. Repealing Clause. All other laws, decrees, executive orders and other
administrative issuances and parts thereof which are inconsistent with the provisions of this

Act are hereby modified, superseded, or repealed accordingly.

Section 12. Effectivity. This Act shall take effect fifteen (15) days following its
publication in the Official Gazette or in a major daily newspaper of national circulation in the

Philippines.

Approved.