FOURTEENTH CONGRESS OF THE 
) 
REPUBLIC OF THE PHILIPPINES 
1 
Third Regular Session 
1 
Introduced by Senator Richard J. Gordon 
EXPLANATORY NOTE 
Our Constitution, under Article XIII, Section 12; provides that the State shall establish 
and maintain an effective food and drug regulatory system and undertake appropriate health 
manpower development and research, responsive to the country's health needs and 
problems. 
Adverse events arising from consumption of herbal medicines may be due to any 
one of a number of factors. These include the use of the wrong species of plant by mistake, 
adulteration of herbal products with other, undeclared medicines, contamination with toxic or 
hazardous substances, over dosage, misuse of herbal medicines by either health care 
providers or consumers and use of herbal medicines concomitantly with other medicines. 
Furthermore, herbal medicines are often used for self care; thus, there is a great need to 
educate consumers and public in their proper use. However, herbal medicines and food or 
dietary supplements marketed and distributed in our country are currently not being required 
to undergo testing by the Bureau of Food and Drugs. 
Analysis of adverse events related to the use of herbal medicines is more 
complicated than in the case of conventional pharmaceuticals. The general lack of 
knowledge about herbal medicines within national drug authorities and the lack of 
appropriate evaluation methods are factors that further delay the creation or updating of 
national policies, laws and regulations for traditional medicines, contemporarylalternative 
medicines and herbal medicines. 
This bill seeks to establish standards for and adopt measures to regulate the 
manufacture, importation, marketinglpromotion, and distribution of herbal medicines and 
food or dietary supplements to protect the consuming public against unscrupulous 
passage of this bill is earnestly sought. 
manufacturers, importers and distributors of the same. 
In 


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: 
i: 
T i  ti'; 
FOURTEENTH CONGRESS OF THE 
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[> .; f .: 9:. 
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, 
REPUBLIC OF THE PHILIPPINES 
1 
Third Regular Session 
1 
9 fi!jG 11 pn :47 
S. No. 
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SENATE 
R"rG!!\f6r\ 
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Introduced by Senator Richard J. Gordon 
AN ACT REGULATING THE MANUFACTUREl IMPORTATION, MARKETING/ 
PROMOTION, AND DISTRIBUTION OF HERBAL MEDICINES, FOOD SUPPLEMENTS 
AND SIMILAR PREPARATIONS AND ESTABLISHING STANDARDS WITH RESPECT 
THERETO FOR CONSUMER HEALTH PROTECTION 
Be it enacted by the Senate and the House of Representatives of the Philippines in 
Congress assembled: 
Section 1. Title. - This Act shall be known as the "Herbal Medicine and Food 
Supplement Act 'I 
Section 2. Declaration of Policy. - It is hereby declared the policy of the State to 
ensure safe and good quality of herbal medicines, food supplements, and nutriceuticals as 
this term is defined herein, in whatever form and to regulate the production, sale, marketing 
and promotion, and distribution of the same to protect the health of the people. 
Section 3. Objecfives. - In the implementation of the foregoing policy, the 
Government shall: 
(a) Establish standards and quality measures .for herbal medicines and food dietary 
supplements 
to 
protect the consuming 
public against 
unscrupulous 
manufacturers, importers and distributors; and, 
(b) Adopt measures to regulate and prevent unsubstantiated claims from 
manufacturers and advertisers that tend to suggest that their products intend to 
cure certain diseases or to improve or positively alter physical condition thus, 
misleading the consuming public. 
Section 4. Definition of Terms. -For the purpose of this Act, the term: 
(a) "Herbal medicine" refers to the preparation and/or combination of any plant 
seeds, berries, roots, leaves, bank, or flowers for medicinal purposes. It includes 
traditionally used herbal products; 


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(b) “Food or dietary supplement” means a product, other than tobacco, intended to 
supplement the diet that bears or contains one or more of the following dietary 
ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a 
dietary substance for use by man to supplement the diet by increasing the total 
dietary intake, or a concentrate, the metabolite, constituent, extract or 
combination of any ingredient heretofore mentioned, the term also includes 
nutriceuticals; 
(c) ”Nutriceuticals” refer to common food products that have been modified 
potentially by genetic engineering to have enhanced nutritional characteristics 
andlor pharmaceutical application; 
(d) ”Traditionally used herbal products” refer ,to preparations from plant materials 
whose claimed application(s) islare based only on traditional !experience of long 
usage over time, which should be at least five (5) years or more as documented 
in medical, historical and technological literature; 
(e) “Label” means,’a display of written, printed, or graphic matter upon the immediate 
container of any article and a requirement made by or under the authority of this 
Act, that any word, statement, or other information appearing on the label shall 
not be considered to be complied with unless such word or statement, if there be 
any, of the retail package of such article, are easily legible through the outside 
container or wrapper; 
(f) “Drugs” mean - 
(1) Articles recognized in the official United States Pha’rmacopoeia, official 
Momeopathic Pharmacopoeia of the United States, official national 
Formulary or any supplement to any of them; 
(2) Articles intended for use in the ‘diagnosis, cure, mitigation, treatment or 
(3) Articles, other than food, intended to affect the structure or any function of 
the body of man or animals; and 
(4) Articles intended for use as component of any articles specified under 
numbers (I), 
(2) or (3) of this section but does not in4lude devices or their 
components, parts or accessories. 
(9) “AdulferafedlSubstandard herbal medicines or foodldietary $upplements” refer to 
those supplements manufactured or packed under the following !conditions: 
prevention of diseases in man or other animals; 
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(1) If the methods used in, or the facilities or controls used for its manufacture 
do not conform to or are not operated or administered in conformity with 
current good manufacturing practices to assure that it meets the 
requirements of this Act, as to safety, quality and effipacy, and has the 
identity and strength and meets the quality and pulity characteristics 
which it purports or is represented to possess; 
(2) If it has been mixed or packed with any substance or any substance of 
which has been partially or wholly substituted, so as to reduce its safety, 
efficacy, strength or purity; 
(3) If its strength differs from, or its efficacy, quality or purity falls below the 
standards as prescribed by the Department of Health or that which it 
purports or is represented to possess; 
(4) If it contains filthy, putrid or decomposed substance which may affect its 
safety, efficacy, or good quality or is manufactured; prepared or held 
under unsanitary conditions whereby it may have beei contaminated with 
dirt or filth or if its container is composed, in whole or in part, of any 
poisonous or deleterious substance which may render the contents 
injurious to health. 
(h) “Manufacturer” refers to any person who manufactures, assembles and 
processes herbal medicines, foodldietary supplements and similar preparations, 
except that if they are manufactured, assembled or processed: for another person 
who attaches his own brand name to the consumer products; the latter shall be 
deemed the manufacturer; 
(i) 
“Imporfer” refers to any person who shall import or bring! into the Philippines 
herbal medicines, foodldietary supplements and similar preparations manufactured 
from another country; 
(j) “Distributor” refers to any person to whom herbal melicines, foodldietary 
supplements and similar preparations are, delivered to or sol$ to for purposes of 
distribution in commerce; 
(k) “Special dietary uses”, as applied to food for man, means particular, as 
distinguished from general, uses of food as follows: 
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(1) Uses for supplying particular dietary needs which xist by reason of a 
physical, physiological, pathological or other 
including but not 
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limited to the conditions of diseases, convalescence, prpgnancy, lactation, 
allergic hypersensitivity to food, being underweight or oleweight; 
(2) Uses for supplying particular dietary needs which exist by reason of age, 
including but not limited to the ages of infancy and childhood: 
(3)'Uses for supplementing or fortifying the ordinary or usual diet with any 
vitamin, mineral or other dietary property. Any such particular use of food 
is a special dietary use, regardless of whether such food also purports to 
be or is represented for general use. 
(I) "~~rketinglpromofion" 
refers to the dissemination of information about a product, 
product line, brand or company. It includes promotion in media Le., television, 
newspapers, internet, mobile phones, and all other kinds of promotion such as sales 
promotion, sponsorship, product placement, endorsements, merchandising, direct 
mall, trade shows and the like. 
Section 5. Prohibited Acts. - The following.acts and the causing thereof are hereby 
prohibited: 
(a) The manufacture, sale, offering for sale, or transfer of any,herbal medicine or 
food dietary supplement, and the like that are misbranded or adulterated or 
substandard: 
(b) Falsely representing in its marketinglpromotion that a herbal medicine or food/ 
dietary supplement can improve or positively alter physical conditions or sure 
illnesses regardless of any disclaimer such as "No approved therapeutic claim" 
and the like through print, TV or radio and any other forms ofmass media; 
(c) Forging, counterfeiting, simulating or falsely representing; or without proper 
authority, using any mark, stamp, tag label or other ibentification device, 
authorized or required by regulations promulgated under the provisions of this 
Act; 
(d) The alteration, mutilation, destruction, obliteration or removal of the whole or any 
part of the labeling of, or the doing of any act with respect to herbal medicine or 
food/ dietary supplement which results in 'such article being adulterated or 
misbranded; 
(e) The unsubstantiated statement in the labeling of any herdal medicine or food/ 
dietary supplement or in any advertising or sales promotion /relating to such drug 
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that the use or application of such drug is effective or has /a tendency to be 
effective as a cure for a certain illness or disease. 
Section 6. Penalties. - 
(a) Any person who violates any of the provisions of this Act shall, upon conviction, 
be subject to imprisonment of not less than six (6) months aud one (1) day, but 
not more than five (5) years, andlor a fine of not less than One Thousand Pesos 
(PI ,OOO), upon discretion of the Court. ’I, 
(b) Any herbal medicine or foodldietary supplement that is adulterated or 
misbranded when introduced into the domestic commerce may be seized and 
held in custody pending proceedings, without hearing or court order, when the 
Secretary of Health has probable cause to believe from facts found by him or any 
officer or employee of the Bureau of Food and Drug (BFAD) that the misbranded 
article is fraudulent or would be in a material respect misleading, thus causing 
injury or damage to purchasers or consumers. 
Section 7. Standards for Herbal Medicine or FoodlDietary Supplements. - 
(a) All manufacturers or distributors of herbal medicines or foodldietary supplements, 
prior to marketing, sale, and/or distribution of their products to the public, shall 
submit said products for registration with the BFAD in accordance with A 0  no. 
23-C s.2000 for over-the-counter medicine and other pertinent rules and 
regulations. 
(b) Whenever, in the judgment of the Secretary of Health, such action will promote 
honesty and fair dealing in the interest of the consumers, he shall, upon 
recommendation of the BFAD Director, promulgate regulations for any herbal 
medicine or foodldietary supplement, fixing and establishing a reasonable 
standard($ of quality. 
Section 8. Adulterated herbal medicine or foodldietary supplement - An herbal 
medicine or foodldietary supplement shall be deemed to be adulterated: 
(a) If it bears or contains any poisonous or deleterious substance which may render 
it injurious to health; but in case the substance is not an added substance, such 
food shall not be considered adulterated under this clause if the quantity of such 
substance in such food does not ordinarily render it injurious to health; 
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(b) If its label does not contain the mandatory warning in both the English and 
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Filipino language: "THIS IS NOT A DRUG AND HAS NO APPROVED 
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THERAPEUTIC CLAIMIS. ANG PRODUKTONG IT0 AY 'HINDI GAMOT AT 
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HINDI NAPATUNAYANG NAKAGAGALING NG ANUMANG KARAMDAMAN." 
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(c) If any word, statement or other information required by or under authority of this 
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Act to appear on the label or labeling is.not prominently placed thereon with such 
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consciousness and in such terms as to render it likely to be read and understood 
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by an ordinary individual under customary conditions of purchase and use; 
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(b) If any substance has been added or mixed thereto or packed therewith so as to 
increase its bulk or weight, or reduce its quality or strength,: or make it appear 
better or of greater value than it really is; 
(c) If it is a confectionary and it contains any alcohol or non-nutritive article or 
substance except harmless coloring, harmless flavoring, harmless resinous glass 
not in excess of four-tenths of one per centum, natural: glum and pectin: 
Provided, that this paragraph shall not apply to any confectiodary by reason of its 
containing less than one half of one centum by volume of aliohol derived solely 
from the use of flavoring extracts; 
Section 9. Misbranded herbal medicine or foodldietary supplement - An herbal 
medicine or foodldietary supplement shall be deemed misbranded: 
(a) If its label is false or misleading in any particular manner subject further to the 
requirement in Section 7 hereof; 
(d) If it purports to be or is represented,.in its literature or in print, radio or TV 
advertisements, as a drug that can improve or positively alter physical conditions, 
or cure an illness but is labeled as a food or dietary supplement 
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with no approved 
therapeutic claim and does not provide the mandatory warning provided under 
paragraph (b) of this section. 
(e) If it purports to be or is presented for special dietary uses, unless its label bears 
such information concerning its vitamins, minerals and other: dietary properties as 
the Secretary of Health determines to be, and by reguldtions, prescribes as 
necessary in order to fully inform the purchasers as to its value for such uses; 
(0 If it bears or contains any artificial .flavoring, artificial boloring or chemical 
preservatives, unless it bears labeling stating the fact: Provibed, that to the extent 
that the compliance with the requirements of this parag(aph is impracticable, 
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Approved, 
exemptions shall be established by regulations promulgated by the Secretary of 
Section 10. Registration License. - The BFAD shall prescribe rules, regulations for 
registration, testing and issuance of licenses of herbal medicines or foodldietary 
supplements using the same standards required of other pharmaceutical products. 
Section 11. Suspension/Revocation of Permit -Whenever the Qecretary of Health 
finds in domestic commerce, after investigation, that a class of herbal medicine or 
foodldietary supplement may be injurious to health, he shall promulgbte regulations, in 
accordance with the recommendations of the Food and Drug Administrator, for the 
suspension of the permit issued to manufacturers', processors or packers of such herbal 
medicine or foodldietary supplement, after notice, if it is found that any of the conditions of 
the permit have been violated, 
Section 12. Repealing Clause. - All provisions of laws, rules and regulations which 
Section 13. Separability Clause. -If any of the provisions of this Act is declared 
Section 14. Effecfivify. - This Act shall take effect fifteen (15) days after its 
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are in conflict with this Act are hereby repealed or modified accordingly. 
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invalid, the other provisions not affected thereby shall remain in full forceiand effect. 
publication in the Official Gazette or in a newspaper of general circulation 
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