Food, Drug, Cosmetic Act: Safety Law

State policy and regulatory objectives

Section 2 declares State policy to ensure a safe and good quality supply of food, drug and cosmetic, and to regulate production, sale, and traffic of such items to protect public health.
Section 3(a) requires establishment of standards and quality measures for food, drug, and cosmetic.
Section 3(b) requires adoption of measures to ensure a pure and safe supply of food, drug, and cosmetic in the country.

Food and Drug Administration creation

Section 4 creates the Food and Drug Administration in the Department of Health, under the Office of the Secretary.
Section 4(a) assigns the Administration the duty to administer and supervise implementation of the Act and its implementing rules.
Section 4(b) requires the Administration to provide for collection of samples of food, drug and cosmetic.
Section 4(c) authorizes the Administration to analyze and inspect food, drug and cosmetic for purposes of enforcing the Act.
Section 4(d) authorizes the Administration to establish analytical data as the basis for preparing standards and to recommend standards of identity, purity, quality and fill of container.
Section 4(e) authorizes the Administration to issue a certificate of compliance with technical requirements to serve as a basis for issuance of a license and to conduct spot-checks for compliance regarding operation of food, drug and cosmetic manufacturers and establishments.
Section 4(f) authorizes the Administration to levy, assess, and collect fees for inspection, analysis and testing of products and materials submitted for compliance.
Section 4(g) requires certification of batches of anti-biotic and anti-biotic preparations in compliance with the Act.
Section 5 establishes two divisions: (a) Inspection and Licensing Division for inspection of establishments engaged in manufacture and sale; and (b) Laboratory Division for tests, analyses, and trials.

Administration leadership and staffing

Section 6 requires the Food and Drug Administration to have a Food and Drug Administrator appointed by the Secretary of Health, subject to Civil service rules and regulations.
Section 6 provides that the Administrator’s compensation is determined by the Secretary of Health.
Section 7 requires the Secretary of Health to provide additional personnel needed for the Administration’s functions and duties.
Section 8 transfers to the Food and Drug Administration the powers, functions, duties, equipment, supplies, records, files, personnel, and balance of appropriations of the Division of Food and Drug Testing and the Board of Food Inspection, and related personnel engaged in food and drug control work within the Bureau of Health Services.

Board of Food and Drug Inspection

Section 9 converts the existing Board of Food Inspection into the Board of Food and Drug Inspection.
Section 9(a)-(i) specifies the Board’s composition, including representatives from the Department of Health, Department of Agriculture and Natural Resources, Department of Commerce and Industry, Commissioner of Customs, Office of the Solicitor-General, a technical member designated by the Food and Drug Administrator with the approval of the Secretary of Health, and presidents (or authorized representatives) of the Philippine Medical Association, Philippine Dental Association, and Philippine Pharmaceutical Association.
Section 9 fixes Board per diem at twenty pesos per meeting, hearing or investigation actually attended, but capped so that total per diem shall not exceed two hundred pesos per month.
Section 9 mandates the Board to hold hearings and conduct investigations relating to administration of the Act, investigate processes of manufacture, and submit reports recommending food and drug standards for adoption.
Section 9 provides that Board decisions are advisory to the Food and Drug Administrator.

Definitions that govern the Act

Section 10(a) defines “Board” as the Board of Food and Drug Inspection.
Section 10(b) defines “Secretary” as the Secretary of Health.
Section 10(c) defines “Department” as the Department of Health.
Section 10(d) defines “Person” to include individual, partnership, corporation and association.
Section 10(e) defines “Food” to include: (1) articles used for food or drink for man; (2) chewing gum; and (3) articles used for components of any such article.
Section 10(f) defines “Drug” to include items recognized in specified official compendia, items intended for diagnosis/cure/mitigation/treatment/prevention of disease in man or animals, items intended to affect body structure or function (other than food), and components of specified articles; it excludes devices and their components/parts/accessories.
Section 10(g) defines “Device” as instruments/apparatus/contrivances (and components/parts/accessories) intended for diagnosis/cure/mitigation/treatment/prevention in man or animals or intended to affect structure/function of the body.
Section 10(h) defines “Cosmetic” as articles applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance, and components of such articles.
Sections 10(i)-(l) define “Label,” “Immediate container” (excluding package liners), and “Labeling” (including labeling content upon containers/wrappers and accompanying matter).
Section 10(l) defines “New drugs” under two conditions: drugs not generally recognized as safe under labeled conditions, and drugs that have become recognized safe through investigations but not generally used to a material extent or for a material time under those conditions.
Section 10(m) governs misbranding determination when labeling is alleged to be misleading by directing consideration of representations and the extent labeling fails to reveal material facts and consequences under prescribed or customary use.
Section 10(n) defines “Food additive” as any substance expected to become a component or otherwise affect characteristics of food, including production/manufacturing/processing/packing/transport/holding, unless generally recognized safe through scientific procedures under intended conditions of use.

Prohibited acts and criminal penalties

Section 11 prohibits, and the causing of, the following acts:
- Section 11(a) manufacture, sale, offering for sale, or transfer of any food, drug, device or cosmetic that is adulterated or misbranded.
- Section 11(b) the adulteration or misbranding of any food, drug, device, or cosmetic.
- Section 11(c) refusal to permit entry/inspection as authorized under Section 27 or refusal to allow samples to be collected.
- Section 11(d) giving a false guaranty or undertaking referred to in Section 12(b) (subject to stated good-faith reliance exceptions and conditions described there).
- Section 11(e) forging/counterfeiting/simulating or falsely representing, or using without proper authority, any mark/stamp/tag/label/identification device authorized or required by regulations.
- Section 11(f) using to one’s advantage or revealing (other than to the Secretary, Department officers/employees, or courts in relevant judicial proceedings) any information acquired under authority of Section 9 or concerning a trade secret entitled to protection.
- Section 11(g) altering/mutilating/destroying/obliterating/removing labeling, or doing any other labeling-related act while the article is held for sale, resulting in adulteration or misbranding.
- Section 11(h) using on drug labeling or in drug advertising any representation that an application is effective under Section 21 or that the drug complies with Section 21.
- Section 11(i) using in labeling, advertising, or other sales promotion any reference to any report or analysis furnished under Section 26.
Section 12(a) provides that any person convicted of violating Section 11 is punishable by imprisonment of not less than six months one day, but not more than five years, or a fine of not less than one thousand pesos, or both, at the Court’s discretion.
Section 12(b)(1) provides that no person shall be subject to Section 12(a) penalties for sale/offering/transfer and delivery made in good faith if, upon the Board’s or a duly designated officer/employee’s request, the person furnishes the name and address of the purchaser/source and copies of all documents pertaining to delivery.
Section 12(b)(2) provides that no person shall be subject to Section 12(a) penalties for violation of Section 11(a) if the person established a guaranty/undertaking signed by, and containing the name and address of, the person residing in the Philippines from whom the article was received in good faith.
Section 12(b)(3) provides a further good-faith defense where the adulteration exists because of a coal-tar color not permissible under regulations if the person establishes a guaranty/undertaking signed by, and containing the name and address of, the manufacturer of the coal-tar color stating that such color is permissible under applicable regulations.
Section 12(c) provides that any adulterated or misbranded article introduced into domestic commerce may be seized and held in custody pending proceedings under Section 26(d) without a hearing or court order.
Section 12(d) authorizes seizure without a hearing or court order when the Secretary has probable cause from facts found that a misbranded article is dangerous to health, or the labeling is fraudulent, or would materially mislead to the injury or damage of the purchaser or consumer.

Food standards: identity, quality, fill

Section 13 authorizes the Secretary, upon recommendation of the Food and Drug Administrator, to promulgate regulations establishing for any food (under its common or usual name) a reasonable definition and standard of identity, a reasonable standard of quality, and/or reasonable standards of fill of container to promote honesty and fair dealing for consumer interest.
Section 13 provides that no definition and standard of identity and no standard of quality shall be established for fresh or dried fruits and fresh or dried vegetables.

Adulterated and misbranded foods

Section 14 deems a food adulterated in these cases:
- Section 14(a)(1) it bears/contains any poisonous or deleterious substance rendering it injurious to health, except added-substance quantities not ordinarily rendering it injurious.
- Section 14(a)(2) it bears/contains added poisonous or added deleterious substance other than an allowed pesticide chemical in or on raw agricultural commodity under established tolerances, and it must conform to such tolerances.
- Section 14(a)(3) it consists in whole or in part of filthy, putrid, or decomposed substance, or is otherwise unfit for food.
- Section 14(a)(4) it was prepared, packed, or held under unsanitary conditions causing contamination or rendering it injurious to health.
- Section 14(a)(5) it is product of diseased animal or animal which died otherwise than by slaughter.
- Section 14(a)(6) its container is made, in whole or in part, of poisonous or deleterious substance rendering contents injurious to health.
- Section 14(b)(1) valuable constituent omitted/abstracted unless substituted by healthful equivalent.
- Section 14(b)(2) injurious substance added or substituted.
- Section 14(b)(3) damage or inferiority concealed in any manner.
- Section 14(b)(4) added/mixed/packed to increase bulk/weight, reduce quality/strength, or make it appear better/greater value.
- Section 14(c) it bears/contains coal-tar color other than one permissible under existing regulations.
- Section 14(d) confectionery that contains alcohol or non-nutritive article/substance except permitted items listed, with specific volume and category exceptions, including permitted less-than-threshold alcohol derived solely from flavoring extracts and permitted harmless non-nutritive substances in chewing gum.
- Section 14(e) oleomargarine/margarine/butter where raw material includes filthy/putrid/decomposed substance or the product is otherwise unfit.
Section 15 deems a food misbranded in these cases:
- Section 15(a) labeling is false or misleading in any particular.
- Section 15(b) offered for sale under name of another food.
- Section 15(c) imitation unless label uses uniform size/prominence “imitation” and the name of the food imitated immediately thereafter.
- Section 15(d) container is misleading in form/manner/filling.
- Section 15(e) package form label requirements are missing: (1) name and place of business of manufacturer/packer/distributor; and (2) accurate quantity in terms of weight, measure, numerical count; with regulations allowing reasonable variations and exemptions for small packages.
- Section 15(f) required label information not prominently placed with conspicuousness to be read/understood by ordinary individual under customary purchase/use.
- Section 15(g) it is represented as a food with a prescribed identity standard unless it conforms and label bears the food name specified and common names of optional ingredients as required.
- Section 15(h) it is represented as meeting a prescribed quality standard or fill standard unless it meets and label states it falls below the applicable standard in the manner specified by regulations.
- Section 15(i) label fails to bear required common/usual name(s) of food and ingredients (with described rules for spices, flavorings, colorings and exemptions by regulation when impracticable or deceptive/unfair competition).
- Section 15(j) special dietary use representation without required labeling of vitamin/mineral/other dietary properties as determined and prescribed by regulations.
- Section 15(k) artificial flavoring/coloring/chemical preservative use without labeling stating that fact, with exceptions and rules for butter/cheese/ice cream.
Section 16(a) allows emergency permit control: if sale/distribution of a class of food may be injurious and cannot be adequately determined after entry into commerce, the Secretary must promulgate regulations for temporary permits with conditions for manufacture/processing/packing in specified localities; after effective date, no person may manufacture/sell/offer for sale/transfer such food without holding the Secretary-issued permit.
Section 16(b) authorizes the Secretary to suspend immediately upon notice any permit issued under Section 16 if permit conditions are violated.
Section 16(c) grants officers/employees designated by the Secretary access to permit-holder factories/establishments for checking permit condition compliance; denial of access is a ground for permit suspension until access is freely given.
Section 17(a) deems poisonous or deleterious substances added to food unsafe except when required or cannot be avoided; the Secretary must promulgate regulations limiting the quantity for public health protection, and any quantity exceeding limits is unsafe.
Section 17(b) directs the Secretary to promulgate regulations listing coal-tar colors that are harmless and suitable for use in food.

Drugs and devices: adulteration and misbranding

Section 18 deems a drug or device adulterated in these cases:
- Section 18(a)(1)-(4) filthy/putrid/decomposed substance, insanitary contaminated preparation/packing, poisonous or deleterious containers, and coal-tar color other than permissible one for coloring only.
- Section 18(b) official compendium drugs whose strength differs or quality/purity falls below standards, with provisions allowing the Secretary to prescribe tests/methods of assay when current methods are insufficient; and the Act allows labeling to plainly state differences so the drug is not deemed adulterated under this paragraph when plainly stated.
- Section 18(c) where it is not subject to Section 18(b) and strength/quality/purity differs from what it purports to possess.
- Section 18(d) mixing/packing that reduces quality/strength or substitution wholly/partly for the drug.
Section 19 deems a drug or device misbranded in these cases:
- Section 19(a) labeling is false or misleading.
- Section 19(b) missing package-label requirements: name/place of business of manufacturer/packer/distributor and accurate quantity in weight/measure/numerical count; with regulations permitting variations and exemptions for small packages.
- Section 19(c) required label information not prominently placed with conspicuousness and in terms likely to be read/understood.
- Section 19(d) drug for use by man contains specified narcotic or hypnotic substances/derivatives designated as habit forming unless label bears name/quantity/proportion and the required juxtaposed statement **“Warning”May be habit forming.
- Section 19(e) drug not solely designated by a compendium-recognized name unless label bears required common/usual name(s), active ingredient names with quantities/proportions, including listed ingredient-specific disclosure rules; and exemptions by regulation where compliance is impracticable.
- Section 19(f) lacks adequate directions for use and adequate warnings against dangerous pathological conditions or by children, and against unsafe dosage/method/duration, in manner/form necessary for protection; with regulatory exemptions where directions are not necessary for public health protection.
- Section 19(g) represented as a compendium-recognized-name drug unless package and labeling are as prescribed in the compendium, subject to modified packing method with Secretary’s consent.
- Section 19(h) drug liable to deterioration unless packaged appropriately and label includes required precautions statement as the Secretary requires by regulations.
- Section 19(i) misleading container, imitation, or sale under name of another drug.
- Section 19(j) dangerous to health when used in dosage/frequency/duration prescribed, recommended or suggested in labeling.
- Section 19(k) penicillin/streptomycin/chlortetracycline/chloramphenicol/bacitracin/other antibiotic drugs or derivatives unless from a batch with an effective certificate of release issued pursuant to Section 22(a), with exemptions by regulation for classes removed by operation of Section 21(a), (b) and (c).

Drug and device exemptions and prescription dispensing controls

Section 20(a) directs the Secretary to promulgate regulations exempting drugs and devices from labeling or packaging requirements where, in accordance with trade practice, they are processed, labeled, or repacked in substantial quantities at establishments other than the original processing/packing place, provided the products are not adulterated or misbranded under the Act upon removal from the repacking establishment.
Section 20(b)(1) requires specified drugs intended for use by man be dispensed only under conditions:
- Section 20(b)(1)(A) habit-forming drugs.
- Section 20(b)(1)(B) drugs unsafe except under supervision of a practitioner licensed to administer.
- Section 20(b)(1)(C) new drugs limited to investigational use, dispensed only upon written prescription, or oral prescription promptly reduced to writing and filed by the pharmacist, or refilling authorized by prescriber in original or oral order promptly reduced to writing and filed by pharmacist.
Section 20(b)(1) provides that dispensing contrary to these rules is an act resulting in the drug being misbranded while held for sale.
Section 20(b)(2) provides that drugs dispensed by filling/refilling a written prescription are exempt from most Section 19 requirements and certain packaging requirements if the label bears: dispenser name/address, serial number and date of prescription or filling, prescriber name, patient name if stated, and directions/cautionary statements contained in the prescription.
Section 20(b)(3) authorizes the Secretary by regulation to remove drugs subject to Section 19(d) and Section 21 requirements from Section 20(b)(1) when those requirements are not necessary for public health protection.
Section 20(b)(4) provides that a drug subject to Section 20(b)(1) is deemed misbranded if, at any time prior to dispensing, its label fails to bear the caution statement “Caution: Food, Drug and Cosmetics Law prohibits dispensing without prescription.” and that drugs not subject are deemed misbranded unless they bear that caution statement before dispensing.

New drug applications and approval process

Section 21(a) prohibits any person from manufacturing, selling, offering for sale, or transferring any new drug unless an application filed under Section 21(b) is effective for that drug.
Section 21(b) allows any person to file an application with the Secretary through the Food and Drug Administration.
Section 21(b) requires the application to submit: (1) full reports of investigations showing whether the drug is safe for use; (2) full list of component articles; (3) full statement of composition; (4) full description of methods used and facilities/controls for manufacture/processing/packing; (5) such samples as the Secretary requires; and (6) specimens of proposed labeling.
Section 21(c) requires the Secretary to act within one hundred and eighty days after filing (or additional period agreed by the Secretary and applicant), either to approve the application or give notice of an opportunity for a hearing to determine approvability.
Section 21(d) mandates the Secretary to issue an order refusing to approve when, after due notice and hearing, any of specified grounds exist, including inadequate tests, unsafe results, inadequate manufacturing methods/facilities/controls for identity/strength/quality/purity, insufficient information, lack of substantial evidence for claimed effects, or labeling that is false or misleading in any particular.
Section 21(e) provides that application effectiveness may be suspended by Secretary order after due notice and opportunity for hearing if clinical experience/tests show the drug is unsafe under conditions of use basis of effectiveness, or if the application contains any untrue statement of material fact; the order must state the findings.
Section 21(f) provides that an order refusing to permit an application to become effective is revoked whenever the Secretary finds the facts require.
Section 21(g) directs promulgation of regulations exempting drugs intended solely for investigational use by qualified experts investigating safety and effectiveness.

Antibiotic certification of batches

Section 22(a) directs the Secretary, through regulations, to provide for certification of batches of drugs composed wholly or partly of specified antibiotics (penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other anti-biotic drug) or derivatives.
Section 22(a) provides that a batch is certified only if it has identity, strength, quality and purity characteristics the Secretary prescribes in regulations necessary to ensure safety and efficacy of use; otherwise it shall not be certified.
Section 22(a) provides that prior to the effective date of the relevant regulations, the Secretary shall issue a release instead of certification for any batch which, in his judgment, may be released without risk as to safety and efficacy, and that such release prescribes an expiration date and other conditions for ceasing effectiveness for the batch and portions thereof.
Section 22(a) defines “anti-biotic drug” for purposes of Section 22 and Section 19(k) as any drug intended for use by man containing any quantity of a chemical substance produced by micro-organism that inhibits or destroys micro-organism in dilute solution, including chemically synthesized equivalents.
Section 22(b) requires the Secretary to promulgate regulations exempting drugs or classes from Section 22 and Section 19(k) requirements when those requirements are not necessary to insure safety and efficacy of use.
Section 22(c) mandates regulations exempting from any requirement of Section 22 and Section 19(k):
- (1) drugs stored/processed/labeled/repacked at establishments other than where manufactured, provided compliance upon removal from such establishments;
- (2) drugs conforming to applicable identity/strength/quality/purity standards intended for use in manufacturing other drugs; and
- (3) investigational use by qualified experts to investigate safety and efficacy.

Cosmetics: adulteration and misbranding

Section 23 deems a cosmetic adulterated in these cases:
- Section 23(a) poisonous or deleterious substances rendering it injurious under labeled or customary use conditions, with a proviso exception for coal-tar hair dye meeting required conspicuous caution legend and adequate preliminary-test directions; it also defines “hair dye” as excluding eyelash and eyebrow dyes for purposes of the paragraph.
- Section 23(b) filthy/putrid/decomposed substance.
- Section 23(c) insanitary preparation/packing/holding leading to contamination or injuriousness to health.
- Section 23(d) poisonous or deleterious container composition rendering contents injurious.
- Section 23(e) not a hair dye and contains coal-tar color other than permissible.
Section 24 deems a cosmetic misbranded in these cases:
- Section 24(a) labeling is false or misleading.
- Section 24(b) package form lacking label with manufacturer or distributor name/place of business and accurate quantity statement, subject to reasonable variations and small package exemptions by regulations.
- Section 24(c) required labeling information not prominently placed with conspicuousness likely to be read/understood under customary purchase/use.
- Section 24(d) container misleadingly made, formed, or filled.

Label exemptions for repacking and processing

Section 25 requires the Secretary to promulgate regulations exempting cosmetics from labeling requirements where, consistent with trade practice, cosmetics are processed, labeled, or repacked in substantial quantities at establishments other than the original processing/packing site, provided cosmetics are not adulterated or misbranded upon removal from those establishments.

Rules, joint regulations, hearings, and prosecution referral

Section 26(a) requires the Secretary of Health, upon recommendation of the Food and Drug Administrator, to issue rules and regulations necessary to enforce the Act.
Section 26(b) requires the Commissioner of Customs, Commissioner of Internal Revenue, and Secretary of Health to jointly prescribe regulations for efficient enforcement of Section 30, except as otherwise provided therein, based on recommendation of the Food and Drug Administrator, and effective at a time the Secretary of