Art. 20. Declaration of Policy. - The State shall ensure safe and good quality
of food, drugs, cosmetics and devices, and regulate their production, sale, distribution and advertisement to protect the
health of the consumer.
Implementing Agency. - In the implementation of the foregoing policy, the State, through the Department of Health,
hereby referred as the Department, shall, in accordance with the provisions of this Act:
(a) establish standards and quality measures for food, drugs, devices and cosmetics;
adopt measures to ensure pure and safe supply of foods and cosmetics, and safe, efficacious and good quality of drugs and
devices in the country;
(c) adopt measures to ensure
the rational use of drugs and devices, such as, but not limited to, banning, recalling or withdrawing from the market drugs
and devices which are unregistered, unsafe, inefficacious or of doubtful therapeutic value, the adoption of an official National
Drug Formulary, and the use of generic names in the labeling of drugs;
strengthen the Bureau of Food and Drugs.
Art. 22. Rules and Regulations on Definitions and Standards.
- Whenever in the judgment of the Department, such action will promote honesty and fair dealing in the interest of consumers,
it shall promulgate rules and regulations fixing and establishing a reasonable definition and standard of identity, a reasonable
standard of quality and/or reasonable standard of fill of containers for food, drugs, cosmetics or devices.
Art. 23. Adulterated Food. - A food shall be deemed to be adulterated:
(1) 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 does not ordinarily render it injurious to health;
if it bears or contains any added poisonous or deleterious substance other than one which is (i) a pesticide chemical in or
on a raw agricultural commodity, (ii) a food additive, (iii) a color additive, for which tolerances have been established
and it conforms to such tolerances;
(3) if it consists
in whole or in part of any filthy, putrid or decomposed substance, or if it is otherwise unfit for food;
if it has been prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth, or
whereby, it may have been rendered injurious to health;
(5) if it is,
in whole or part, the product of a diseased animal or of an animal which has died other than by slaughter;
if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents
injurious to health; or
(7) if it has passed its expiry
(b) (1) If any valuable constituent has been, in whole or
in part, omitted or abstracted therefrom and the same has not been substituted, by any healthful equivalent of such constituent;
if any substance, not a valuable constituent, has been added or substituted or in part therefor;
if damage or inferiority has been concealed in any manner; or
if any substance has been added thereto or packed therewith so as to increase its bulk or weight, reduce its quality or strength,
or make it appear better or of greater value than it is.
(c) if it is,
or bears or contains a color additive which is unsafe under existing regulations: Provided, That the Department shall
promulgate regulations providing for the listing of color additives which are harmless and suitable for use in food for which
tolerances have been established;
(d) if it is confectionary,
and it bears or contains any alcohol or non-nutritive article or substance except harmless coloring, harmless flavoring, harmless
resinous glass not in excess of four-tenths (4/10) of one per centum (1%) natural gum and pectin: Provided, That this
clause shall not apply to a safe non-nutritive article or substance if, in the judgment of the Department as provided by regulations,
(1) such article or substance is of practical functional value in the manufacture, packaging or storage of such confectionery,
(2) if the use of the substance does not promote deception of the consumer or otherwise results in adulteration or mislabeling
in violation of any provision of this Act, and (3) would not render the product injurious or hazardous to health: Provided,
further, That this paragraph shall not apply to any confectionery by reason of its containing less than one-half (1/2)
of one per centum (1%) by volume of alcohol, derived solely from the use of flavoring extracts, or to any chewing gum by reason
of its containing harmless non-nutritive masticatory substance: Provided, finally, That the Department may, for the
purpose of avoiding or resolving uncertainty as to the application of this clause, promulgate regulations allowing or prohibiting
the use of particular non-nutritive substances;
(e) if it is oleomargarine,
margarine or butter and any of the raw materials used therein consists in whole or in part of any filthy, putrid or decomposed
substance, or such oleomargarine, margarine or butter is otherwise unfit for food;
if it has not been prepared in accordance with current acceptable manufacturing practice established by the Department through
Art. 24. Regulation
of Unprocessed Food. - The provincial, municipal and city governments shall regulate the preparation and sale of
meat, fresh fruits, poultry, milk, fish, vegetables and other foodstuff for public consumption, pursuant to the Local Government Code.
Art. 25. Tolerance
for Poisonous Ingredients in Food. - Any poisonous or deleterious substance added to any food shall be deemed to
be unsafe, except when such substance is required or can not be avoided in its production or can not be avoided by good manufacturing
practice. In such case, the Department shall promulgate regulations limiting the quantity therein in such extent as he finds
necessary for the protection of public health, and any quantity exceeding the limits so fixed shall be deemed to be unsafe.
In determining the quantity of such added substance to be tolerated in different articles of food, the Department shall take
into account the extent to which the use of such article is required or can not be avoided in the production or manufacture
of such articles and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substance.
Art. 26. Unsafe Food Additives, Exceptions for Conformity with Regulation. - A food additive,
with respect to any particular use or intended use, shall be deemed unsafe unless: chanrobles law
it and its use or intended use conforms to the terms of an exemption for being solely intended for investigational use by
qualified experts; or
(b) it and its use or intended
use is in conformity with a regulation issued by the Department prescribing the conditions under which such additives may
be safely used.
Petition for Regulation of Food Additive. - Any person may, with respect to any intended use of a food additive,
file with the Department a petition proposing the issuance of a regulation prescribing the conditions under which such additives
may be safely used.
The Department shall (1) establish
a regulation prescribing, with respect to one or more proposed uses of the food additive involved, (i) the conditions under
which a food additive may be safely used including, but not limited to, specifications as to the particular food, classes
of food, in which such additive may be used, (ii) the maximum quantity which may be used, or permitted to remain in or on
such food; (iii) the manner in which such additive may be added to or used in or on such food, and (iv) any directions or
other labeling or packaging requirement for such additive deemed necessary to assure the safety of such use, and shall notify
the petitioner of such order and the reasons for such action; or (2) deny the petition and notify the petitioner of and the
reasons for such action.
The Department may, at any time
upon his own initiative, issue a regulation prescribing, with respect to any particular food additive, the conditions under
which such additive may be safely used and the reasons thereof, and cause the publication of the same.
Art. 28. Effectivity of Regulations. - The regulations promulgated under the preceding articles
shall take effect fifteen (15) days after its publication in a newspaper of general circulation but the Department may stay
such effectivity if, after issuance of such order, a hearing is sought by any person adversely affected by such order.