## Facts

- A national executive issuance established a code regulating the marketing of breastmilk substitutes and related products, requiring pro-breastfeeding messaging and hazard warnings to curb misleading promotion.
- The health department issued revised implementing rules (RIRR) that tightened restrictions on advertising, promotion, sponsorships, labeling, and health/nutrition claims for covered products and referenced international standards and World Health Assembly (WHA) resolutions.
- Industry members challenged the RIRR as effectively imposing a near-total advertising ban and adding enforcement mechanisms and penalties not found in the enabling code.
- The challenge targeted, among other provisions, a “total effect” rule that prohibited promotional materials whose overall impact was to promote covered products, arguing vagueness and exposure to arbitrary enforcement.
- The association filed a petition for certiorari and prohibition with injunctive relief; interim relief issued to stop enforcement pending review.

## Issues

1. Whether the health department’s RIRR were valid implementing regulations or contained ultra vires provisions that amended or expanded the enabling code.
2. Whether key RIRR restrictions on advertising and promotion violated constitutional protections for commercial speech, including due process limits against vagueness and overbreadth.
3. Whether the agency could give binding domestic effect to WHA resolutions and related international instruments through regulation absent specific legislative incorporation.

## Decision

- The court upheld the agency’s general authority to issue implementing rules to protect infant and child health and to regulate marketing of breastmilk substitutes as a public-health measure.
- The court partly granted the petition and invalidated specific RIRR provisions that went beyond the enabling code or violated constitutional limits.
- The court struck down (or disallowed enforcement of) provisions functioning as an overly broad/blanket restriction on truthful, non-misleading promotion of lawful products beyond what the enabling code authorized.
- The court invalidated the “total effect” standard as impermissibly vague, given its uncertain boundaries and exposure to arbitrary enforcement with penal or quasi-penal consequences.
- The surviving portions of the RIRR could be implemented, but only insofar as they remained within statutory bounds and constitutional constraints.

## Legal Principles

- Implementing regulations must be consistent with, and cannot amend, expand, or extend, the statute or executive issuance they implement; agencies may “fill in details” but may not create new substantive prohibitions or penalties without authorization.
- Public health is a legitimate subject of regulation under delegated police power; stringent controls on marketing practices may be permissible when grounded in the enabling law’s policy and text.
- Commercial speech is protected but more regulable than other speech; restrictions must not operate as a blanket ban on truthful, non-misleading advertising absent sufficient legal basis and constitutional justification.
- Due process forbids vague regulatory standards, especially where violations trigger penal or quasi-penal sanctions; regulated parties must have fair notice of prohibited conduct and enforcement must not invite arbitrary application.
- International codes and WHA resolutions may guide interpretation and policy but do not become binding domestic law without legislative incorporation or clear domestic legal authorization; agencies cannot rely on them alone to enlarge statutory duties.

## Conclusion

The court sustained the health department’s power to regulate breastmilk-substitute marketing to protect infant health, but it limited that power by invalidating RIRR provisions that exceeded the enabling code or imposed vague and overly broad restrictions on commercial speech, while allowing enforcement of the remaining, statutorily grounded rules.


Pharmaceutical & Health Care Ass'n of the Phil. v. Duque, G.R. No. 173034 (Phil. Oct. 9, 2007)