Law Summary
Declaration of Policy
- State policy to ensure safe and good quality food, drugs, and cosmetics.
- Regulation of production, sale, and traffic of these products to protect public health.
- Government established standards and quality measures.
- Ensures pure and safe supply nationwide.
Creation of the Food and Drug Administration (FDA)
- FDA created under the Department of Health.
- Administers and supervises the Act's implementation.
- Powers include sample collection, analysis, inspection, data establishment, standard recommendations.
- Issues certificates of compliance, licenses, and levies fees.
- Certifies batches of antibiotics and related preparations.
- Two Divisions: Inspection and Licensing, Laboratory.
- Administrator appointed by Secretary of Health.
- Transfer of certain Bureau of Health Services functions and personnel to FDA.
Board of Food and Drug Inspection
- Composed of representatives from Health, Agriculture, Commerce, Customs, Solicitor-General office, medical, dental, and pharmaceutical associations.
- Holds hearings, investigations concerning the Act.
- Recommends food and drug standards.
- Decisions are advisory to the FDA Administrator.
Key Definitions
- "Food": articles used for food or drink, chewing gum, components thereof.
- "Drug": recognized articles for disease diagnosis, cure, prevention, or body function affecting articles.
- "Device": instruments for diagnosis, cure, prevention of diseases.
- "Cosmetic": articles for cleansing, beautifying, altering appearance.
- Various labeling and packaging definitions.
- Definitions of "new drugs" and "food additives."
Prohibited Acts
- Manufacture or sale of adulterated or misbranded food, drugs, devices, or cosmetics.
- Adulteration or misbranding itself.
- Refusal of inspection or collection of samples.
- False guaranty or undertaking.
- Forgery or misuse of identification marks.
- Disclosure or improper use of trade secrets.
- Alteration or removal of labeling resulting in adulteration or misbranding.
- Misleading labeling or advertising claims.
Penalties
- Imprisonment (6 months to 5 years), fines (minimum ₱1,000), or both.
- Exceptions when sales made in good faith with adequate guaranties.
- Seizure of adulterated or misbranded articles without prior court hearing when health is at risk.
Food Standards and Adulteration
- Secretary empowered to establish definitions, standards of identity, quality, and fill for food.
- Adulterated food examples: contains poisonous substances, filthy or decomposed parts, unsanitary processing, product of diseased animals, unsafe containers.
- Concealment of damage, substitution, or addition affecting quality or weight.
- Specific provisions on confectionery and margarine.
Misbranded Food
- False or misleading labeling.
- Sold under another food's name or imitation without proper labeling.
- Misleading container.
- Label must show manufacturer info and content quantity.
- Label prominence and special dietary use disclosures required.
- Disclosure of artificial flavors, colors, or preservatives.
Emergency Permit Control
- Secretary may issue permits with conditions for potentially injurious food.
- Suspension for violating permit conditions.
- Inspection rights with permit-holding operators.
Regulation of Poisonous Ingredients in Food
- Limits on poisonous or deleterious substances allowed.
- Secretary promulgates related regulations including permissible coal-tar colors.
Adulterated Drugs and Devices
- Includes filthy substances, unsanitary conditions, poisonous containers, non-permissible coloring.
- Failure to meet official compendium standards or label deviations.
- Substitution or quality/strength reduction.
Misbranded Drugs and Devices
- False or misleading labeling.
- Required label content: manufacturer, quantity, drug name, active ingredients, warnings.
- Specific restrictions on habit-forming substances.
- Proper directions and warnings mandatory.
- Unique packaging standards.
- Prohibition of dangerous drugs without certification.
Exemptions for Drugs and Devices
- Drugs processed or repacked elsewhere may be exempted from labeling if compliant.
- Dispensing rules for habit-forming or dangerous drugs requiring prescription.
- Labels must warn against illegal dispensing.
Regulation of New Drugs
- New drugs need approved application filed with the FDA containing safety, composition, manufacturing, labeling info.
- Secretary has 180 days to approve or deny application with possible hearings.
- Grounds for denial include inadequate safety tests, unsafe results, inadequate manufacturing controls, false or misleading labeling.
- Suspension or revocation of approval under certain conditions.
- Exempt investigational use drugs.
Certification of Antibiotic Drugs
- Certification system for batches of certain antibiotics to ensure safety and efficacy.
- Release certificates prior to regulation implementation.
- Exemptions may be promulgated.
Adulterated Cosmetics
- Contains poisonous substances, filthy components, unsanitary conditions, toxic containers.
- Exceptions for hair dyes with caution labels.
Misbranded Cosmetics
- False or misleading labeling.
- Required label content: manufacturer, distributor, content quantity.
- Label prominence requirements.
- Misleading container shapes or fills.
Administration, Regulations, Hearings, and Criminal Actions
- Secretary issues rules and regulations for enforcement.
- Customs and revenue commissioners coordinate on import-export enforcement.
- Board conducts hearings and investigations.
- Notice and hearing before Board for adulteration or misbranding findings.
- Criminal prosecutions referred to Justice Department.
- Minor violations may be dealt with written warnings.
Factory Inspections and Sampling
- Authorized officers may inspect premises or vehicles and collect samples.
- Receipts given for samples collected.
- Analysis results must be shared with owners.
Publicity and Information Dissemination
- Secretary may publicize health dangers or consumer deception.
- Collection and reporting of investigation results permitted.
Imports and Exports Regulation
- Samples taken from shipments for FDA examination.
- Articles adulterated, misbranded, or restricted may be refused entry or destroyed.
- Bond or permit systems for conditional release and relabeling.
- Import-related expenses charged to owners or consignees.
- Exported articles exempt from domestic adulteration/misbranding provisions if conforming to foreign laws and labeled for export.
Financing
- Appropriations for FDA operations.
- Income from fees goes to the General Fund.
Repealing Clause and Effectivity
- Invalid provisions do not affect remaining portions.
- Conflicting laws and rules repealed.
- Law effective upon approval.