Law Summary
Aim of the Code
- To ensure safe and adequate nutrition for infants.
- To protect and promote breastfeeding.
- To ensure proper use of breastmilk substitutes and supplements when necessary.
- To provide adequate, consistent, and objective information.
- To regulate marketing and distribution appropriately.
Scope of the Code
- Applies to marketing and related practices of:
- Breastmilk substitutes, including infant formula.
- Other milk products, foods, beverages marketed as partial or total breastmilk replacement.
- Feeding bottles and teats.
- Covers product quality, availability, and informational use.
Key Definitions
- "Breastmilk Substitute": Any marketed food as partial or total breastmilk replacement.
- "Complementary Food": Food complementing breastmilk or formula when insufficient.
- "Container": Packaging of a product for retail sale.
- "Distributor": Entities marketing products wholesale or retail.
- "Infant": Person 0-12 months old.
- "Health Care System": Institutions/organizations involved in maternal and infant health.
- "Health Worker": Personnel (professional or not) working in health care system.
- "Infant Formula": Industrially formulated breastmilk substitute per Codex Alimentarius.
- "Label": Any descriptive matter on product container.
- "Manufacturer": Entity engaged in producing relevant products.
- "Marketing": Promotion, selling, advertising, distribution, and information services.
- "Marketing Personnel": Persons involved in marketing these products.
- "Sample": Small quantities provided free.
- "Supplies": Products provided free or low cost for social purposes.
Information and Education Responsibilities
- Government must ensure objective, consistent infant feeding information.
- Educational materials must include:
- Benefits and superiority of breastfeeding.
- Nutritional material, breastfeeding preparation and maintenance.
- Negative effects of partial bottle feeding on breastfeeding.
- Difficulty reversing decision not to breastfeed.
- Proper use of infant formula if necessary, including social and financial implications.
- Materials must avoid idealizing breastmilk substitute use.
Regulations on Marketing to the General Public and Mothers
- Advertising and promotional materials must have inter-agency committee approval.
- No direct or indirect giving of samples, supplies, or gifts to the public or health personnel unless specified.
- No point-of-sale advertising or promotions that induce consumer sales.
- Pricing policies that provide lower prices over long term not restricted.
- No distribution of promotional gifts or utensils to pregnant women or mothers.
- Marketing personnel prohibited from advertising directly or indirectly to pregnant women or mothers, except as provided.
- Donations allowed only upon Ministry of Health request or approval.
Health Care System Obligations
- Ministry of Health to promote breastfeeding and provide information and training.
- Health facilities not to be used for promotion or display of covered products.
- No manufacturer-paid representatives allowed in health care facilities.
- Health education to emphasize hazards of improper use of substitutes.
- Infant formula feeding demonstrations only for those unable to breastfeed properly.
Obligations and Restrictions on Health Workers
- Must promote breastfeeding and be familiar with nutrition and Code responsibilities.
- Manufacturer-provided information to professionals must be scientific and factual.
- No inducements to health workers or families by manufacturers or distributors.
- Samples to health workers only for research or evaluation under Ministry rules.
- Health workers shall not give infant formula samples to mothers or families.
- Manufacturers may assist with research and education under Ministry regulation.
Restrictions for Marketing Personnel
- Not allowed to perform educational functions directed to pregnant women or mothers as part of job.
Container and Labeling Requirements
- Containers must provide necessary usage information without discouraging breastfeeding.
- Clear, conspicuous messages required including:
- "Important Notice"
- Statement of breastfeeding superiority
- Use only on health worker advice
- Preparation instructions and health hazard warnings
- No pictures or text idealizing formula use.
- No terms like "humanized" or "materialized" allowed.
- Warning on labels for modified food products regarding sole infant nourishment.
- Labels must comply with Bureau of Food and Drugs regulations.
Quality Standards
- High recognized standard quality required to protect infant health.
- Products must comply with Codex Alimentarius and hygienic practice codes.
- Retail outlets prohibited from opening containers to sell by smaller units to prevent contamination.
Implementation and Monitoring
- Creation of inter-agency committee with Health, Trade, Justice, and Social Services ministers.
- Committee powers: review, approve/disapprove, regulate marketing materials.
- Ministry of Health responsible for overall implementation and enforcement.
- Ministry empowered to promulgate implementing rules, call assistance, prosecute violations, and exercise necessary functions.
Sanctions and Penalties
- Violations punishable by 2 months to 1-year imprisonment or fines from PHP 1,000 to 30,000 or both.
- Responsible officers in corporations or entities also liable.
- Licenses, permits or authorities of violators may be suspended or revoked on repeated violations upon Ministry recommendation.
Repealing and Separability Clauses
- Conflicting laws and issuances repealed or modified accordingly.
- Invalidity of any provision does not affect the remainder of the Code.
Effectivity
- The Code takes effect 30 days after publication in the Official Gazette.