Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City, Metro Manila

FIFTEENTH CONGRESS
First Regular Session

2189

HOUSE BILL NO.

INTRODUCED BY REPRESENTATIVE PEDRO P. ROMUALDO

EXPLANATORY NOTE

The Department of Health has issued Administrative Order No. 2010 — 0008, 2010 —
0008, which will require herbal food and dietary supplements manufacturers to
translate into Filipino in all their advertising and promotional materials. The issuance of
this would promote responsible advertising and infomercials about the many herbal
products and food’ supplements that flood the market today. The public must be
forewarned of the dangers of self-medication and of ignoring their maintenance
medicines. This policy does not stifle promotion and restrict the growth of alternative,
preventive and curative health modalities.

We are proposing certain safeguards for the protection of the end-consumers. The
manufacturers, advertisers and marketers must ensure that interested buyers and loyal
patrons of herbal food and dietary supplements are fully aware of what these products
are all about and how it affects their health. The public must be informed if these
products pass and are consistent with certain health and consumer standards such as:
good manufacturing practices (GMP), consistent with the recommended daily intake
(RDD, consistent with the recommended daily allowance (RDA), has the prescribed
nutrient value and comply with health standards imposed by existing health regulatory
agencies such the Department of Health and Food and Drug Administration.

‘There has been an alarming proliferation in the market of well-commercialized herbal
and alternative medicines which might pose danger to our public health system and
imperil the lives of the unknowing and non-discriminating public. Today,
manufacturing firms and distributors of herbal food and dietary supplements have
resorted to utilizing powerful marketing and advertising tools to entice the public to try
and patronize their products such as tapping showbiz and sports personalities to
endorse various products.

With the convincing marketing strategy of advertisers of these various products, it is
only prudent to warn the public about its use, potential risks to their health and
disadvantages of “self-medication”. Thus, there is need to provide safeguards to protect
consumers and the prospective buyers of these products which consists of teas, tablets,
soaps, whitening creams, slimming pills, diet supplements and the like.

The warning “No Therapeutic Claims” and its real classification as “FOOD
SUPPLEMENTS” must be highlighted in the packaging, infomercials and handouts of
these products as well as its potential adverse effects or contraindications to people's
health if use in combination with prescribed medicines for certain ailments especially
those with heart ailments, diabetes milletus, hypertension, high cholesterol levels,
kidney or lung problems. People should be able to differentiate that these are NOT
DRUGS but are food supplements only. The accessibility of these products in various
stores like malls, drugstores, dry and wet markets and highly populated sidewalks


makes it easy for the public to purchase and try these products without need of any
prescription or advice from a reputable licensed health professional.

In addition, the promotion of traditional and alternative healthcare as espoused by
Republic Act No. 8423 otherwise known as the Traditional and Alternative Medicine Act
(TAMA) is the government's primordial concern to educate and disseminate to the
public adequate information and guide on the rational, appropriate, proper application
and safe use of drugs and alternative medicines;

It is the job of the Department of Health, Food and Drugs Administration as well as the
Nutrition Council of the Philippines in cooperation with the Department of Trade and
Industry to ensure the compliance of quality and safety standards by manufacturers,
distributors and sellers of these herbal and alternative medicines including the provision
of accurate detailed information about these products and its responsible advertising.

‘The approval of this bill is earnestly sought.

Representative
Lone District of Camiguin


Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City, Metro Manila

FIFTEENTH CONGRESS

First Regular Session

HOUSE BILL NO. 2189

INTRODUCED BY REPRESENTATIVE PEDRO P. ROMUALDO

AN ACT
REQUIRING MANUFACTURERS, DISTRIBUTORS AND SELLERS OF HERBAL
MEDICINES, SUPPLEMENTARY HEALTH PRODUCTS AND ALTERNATIVE
HEALTHY FOODS TO STRICTLY CONFORM TO ADVERTISEMENT STANDARDS
IN THE MANUFACTURE, DISTRIBUTION AND SALE OF THESE PRODUCTS IN
THE LOCAL OR INTERNATIONAL MARKET AND FOR OTHER PURPOSES

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

SECTION 1.. Role of Government Agencies. - The Department of Health, Food and Drugs
Administration, the Nutrition Council of the Philippines in cooperation with the Department of
Trade and Industry shall ensure the strict compliance of quality and safety standards by
manufacturers, distributors and sellers of herbal and alternative medicines. It shall create a joint
committee whose membership will come from these agencies and from the affected industry to
implement appropriate advertising policies and guidelines for the compliance of manufacturers,
distributors and sellers of these products in the country.

SECTION 2. Produet Markings. - All herbal products, alternative medicines and health
supplements must be labeled with the following words in English, Filipino and Visayan
languages in their packaging, advertising, marketing and promotional materials:

“1.) IMPORTANT WARNING: ‘ NO APPROVED THERAPEUTIC CLAIMS’;

2.) MAHALAGANG PAALALA: “ANG PRODUKTONG ITO AY HINDI GAMOT AT
HINDI DAPAT GAMITING PANGGAMOT SA ANUMANG URI NG SAKIT”;

3.) MAHINUNGDANON NGA PAHINUMDUM: KINING PRODUKTO DILI
TAMBAL UG DILI ANGAY NA HIMOON NGA TAMBAL SA BISAN UNSA NGA
SAKIT™.

These words must be placed at the back of the label of the bottle and box of the products. For
easy reference, the print must be colored red, green or blue. In promoting, marketing and
advertising these products and supplements, these words must be printed in very large fonts.

SECTION 3. Monitoring and Penalties. - The agencies concerned shall monitor the strict
compliance of these policies and shall recommend to the Department of Trade and Industry and
the local government units the suspension or revocation of licenses and permits of these
manufacturing firms, distributing companies and advertising entities in their area of jurisdiction
for failure to comply with any provisions of this Act.


Any business entity involved in the manufacture, distribution, sale, advertising, marketing and
promotion of the herbal products and food supplements that will not comply with any provisions
of this Act shall be penalized by the Department of Health with a fine of Fifty thousand pesos (P\
50,000.00) but not more than one hundred thousand pesos (P\100,000.00) for its first offense. A
fine of one hundred thousand pesos (P\ 100,000.00) but not more than two hundred fifty-
thousand pesos (P\ 250,000.00) shall be imposed to second time violators. A fine of two hundred
fifty thousand pesos (P\ 250,000.00) but not more than five hundred thousand pesos (P\
500,000.00) shall be imposed to third time violators. For more than four violations, a fine of One
million pesos (P\ 1,000,000.00) but not more than Five million pesos (P\ 5,000,000.00) shall be
imposed to violators of this Act and a one (1) year suspension of its permits and licenses.

ON 4. Appropriations. The budgets in the General Appropriations Act of the current
year of the Department of Health and Department of Trade and Industry shall be tapped for the
monitoring and compliance of this Act. In the succeeding years, the amount necessary to handle
this function will be included in the budget including hiring of additional personnel to focus on
the implementation of this Act.

SECTION 5. Implementing Guidelines. — The Department of Health, the Department of Trade
and Industry, the Food and Drug Administration and the Nutrition Council of the Philippines in
coordination with various stakeholders shall draft the implementing guidelines of this Act within
‘two (2) months from the approval of this Act. Affected industries and business entities shall be
given a period of six (6) months from the approval of this Act to strictly comply with the
requirements provided in Section 2 of this Act.

SECTION 6. Separability Clause. — If any section or provision of this Act is declared
unconstitutional or invalid, the other sections or provisions not affected thereby shall continue to
be in force and effect.

ICTION 7. Repealing Clause. ~ All acts, decrees, executive orders, rules and regulations, part
s thereof inconsistent with the provisions of this Act are hereby repealed or modified
accordingly.

‘CTION 8. Effectivity Clause. — This Act shall take effect upon its approval.

Approved,