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FOURTEENTH CONGRESS OF THE REPUBLIC 
) 
OF THE PHILIPPINES 
1 
Second Regular Session 
-1 
EXPLANATORY NOTE 
This bill seeks to establish standards for and adopt measures to regulate the 
manufacture, importation, marketing/promotion, and distribution of herbal medicines 
and food or dietary supplements to protect the consuming public against unscrupulous 
manufacturers, importers and distributors of the same. 
Herbal medicines and food or dietary supplements marketed and distributed in 
our country are currently not being required to undergo testiug by the Bureau of Food 
and Drugs. 
In fact, there is 110 law or agency that regulates the manufacture, 
marketing and promotion, and distribution of the same. 
Inasmuch as it is necessary to encourage the use of alternative medicines as 
well as the developinent of herbal and other food suppleinents in line with our 
traditional medical practices, it is also imperative to protect the consumers and the 
public from possible health hazards. In fact, random testing of herbal medicines and 
food or dietary supplement show that some actually contain chemical products and 
other drugs that are not clearly indicated on their labels. If left unchecked and 
unregulated, these alteruative medicines may pose serious threats and cause dire 
medical consequences to public health. 
Our Constitution, under Article 11, Section lS, provides that “The State shall 
protect and promote the right to health of the people and instill health consciousness 
among them.” Thus, it is incumbent upon Congress to enact a measure that will not 
only address this concern but, more importantly, guarantee accessibility of the public 
to safe and affordable medicines. 
For these reasons, the passage of this bill is earnestly sought. 


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FOURTEENTH CONGRESS OF THE REPUBLIC 
) 
OF THE PHILIPPINES 
1 
Second Regular Session 
) 
’3 
FEE 17 pT:cl 
Introduced by Senator Juan Ponce Enrile 
AN ACT 
REGULATING 
THE 
MANUFACTURE, 
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 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. ” 
Section 2. Declnrntion 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. Objectives. - In the implementation of the foregoing policy, the Government 
shall: 
(a) Establish standards and quality measures for herbal medicines and fooddietary 
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; 
(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 
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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) “Nutriceuticuls ” refer to common food products that have been modified potentially 
by genetic engineering to have enbanced nutritional characteristics and/or 
pharmaceutical application; 
(d) “Traditionally used herbal products ” refer to preparations from plant materials whose 
claimed application(s) is/are 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 Pharmacopoeia, 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 
prevention of diseases in man or other animals; 
(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 (l), (2) or (3) of this section but does not include devices or their 
components, parts or accessories. 
(g) “Adulteruted/Substandurd herbal medicines or food/dietary supplenzents” refer to 
those supplements manufactured or packed under the following conditions: 
(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 efficacy, and has the identity and strength and 
ineets the quality and purity characteristics which it purports or is represented 
to possess; 
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(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 been 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, food/dietary supplemeiits 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) “hiporter” refers to any person who shall import or bring into the Philippines herbal 
medicines, food/dietary supplements and similar preparations manufactured from 
another country; 
(j) “Distributor” refers lo any person to whom herbal medicines, food/dietary 
supplements and similar preparations are delivered t or sold 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: 
(1) Uses for supplying particular dietary needs which exist by reason of a 
physical, physiological, pathological or other condition, including but not 
limited to the conditions of diseases, convalescence, pregnancy, lactation, 
allergic hypersensitivity to food, being underweight or overweight; F 
(2) Uses €or supplying particular dietary needs which exist by reason of age, 
including but not limited to the ages o f  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) “Marketing /promotion” refers to the dissemination of information about a product, 
product line, brand or company. It includes promotion in media i.e., television, 
newspapers, internet, mobile phones, and all other kinds of promotion such as sales 
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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 marltetingipromotion 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 lilte through print, TV or radio and any other forms of inass media; 
(c) Forging, counterfeiting, simulating or falsely representing or without proper 
authority, using any mark, stamp, tag label or other identification 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 herbal medicine or food/ dietary 
supplement or in any advertising or sales promotion relating to such drug 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 G. 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 and one (1) 
day, but not more than five (5) years, :and/or a fine of not less than One Thousand Pesos 
(P 1,000), upon discretion of the Court. ”, 
< 
(b) Any herbal medicine or food/dietary 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 I .  Standards for Herbal Medicine or FoodLDietary Supplenzents. - (a) All 
manufacturers or distributors of herbal medicines or food/dietary 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 AO 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 
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BFAD Director, promulgate regulations for any herbal medicine or fooadietary supplement, 
fixing and establishing a reasonable standard(s) of quality. 
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Section 8. Adulterated herbal nzcrlicirze or foodhlietnry supplenzent. - An herbal 
medicine or food/dietary 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; 
(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 o f  
four-tenths of one per centum, natural glum and pectin: Provided, that this paragraph 
shall not apply to any confectionary by reason of its containing less than one half of 
one centum by volume of alcohol derived solely from the use of flavoring extracts; 
Section 9. Misbraizderl herbal niediciiie or foodklietnry suppleinent. - 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; 
(b) If its label does not contain the mandatory warning in both the English and Filipino 
language: “THIS IS NOT A DRUG AND HAS NO APPROVED THERAPEUTIC 
CLAIM/S. 
ANG PRODUKTONG IT0 AY HINDI GAMOT AT HINDI 
NAPATUNAYANG NAKAGAGALING NG ANUMANG KARAMDAMAN.” 
(c) If any word, statement or other information required by or under authority of this Act 
to appear on the label or labeling is not prominently placed thereon with such 
consciousness and in such terms as to render it likely to be read and understood by an 
ordinary individual under customary conditions of purchase and use; 
(d) If it purports to be or is represented, in its literature or in print, radio o; 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 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 
informatioil concerning its vitamins, minerals and other dietary properties as the 
Secretary of Health determines to be, and by regulations, prescribes as necessary in 
order to fully inform the purchasers as to its value for such uses; 
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(9 If it bears or contains any artificial flavoring, artificial coloring or chemical 
preservatives, unless it bears labeling stating the fact: Provided, that to the extent that 
the compliance with the requirements of this paragraph is impracticable, exemptions 
shall be established by regulations promulgated by the Secretary of Health. 
Section 10. RegisfrntiodLicense. - The BFAD shall prescribe rules, regulations for 
registration, testing and issuance of licenses of herbal medicines or foodidietary supplements 
using the same standards required of other pharmaceutical products. 
Section 11. Suspension/Revocation of Permit. - Whenever the Secretary of IHealth finds 
in domestic commerce, after investigation, that a class of herbal medicine or food/dietary 
supplement may be injurious to health, he shall promulgate 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 food/dietary 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 are 
in conflict with this Act are hereby repealed or modified accordingly. 
Section 13. Separability Clause. -If any of the provisions of this Act is declared invalid, 
the other provisions not affected thereby shall remain in full force and effect. 
Section 14. Effectivity. - This Act shall take effect fifteen (15) days after its publication 
in the Official Gazette or in a newspaper of general circulation 
Approved, 
. 
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