Law Summary
Purpose of the Administrative Order
- To revise the directive on the phrase "No Approved Therapeutic Claim" in advertisements and promotions of food/dietary supplements.
- To enhance consumer protection by improving the clarity and accuracy of health-related information.
- To promote public health and consumer welfare through sound information and education.
Scope and Definition of Food/Dietary Supplements
- Covers owners, manufacturers, distributors, advertisers, and agents of food/dietary supplements.
- Includes media and advertising entities involved.
- Defines food/dietary supplements as processed foods meant to supplement the diet containing vitamins, minerals, herbs, amino acids, or other dietary substances.
- Clarifies these supplements are not conventional foods nor substitutes for drugs or medicines.
Prohibition of False, Deceptive, or Misleading Marketing
- Strictly prohibits dissemination of false or misleading advertisements by any medium intended to induce purchase.
- Advertisements must comply with RA 3720, RA 9711, RA 7394, and their implementing rules.
Change in Phrase Usage in Marketing Materials
- The phrase "No Approved Therapeutic Claim" is no longer allowed.
- Mandates use of the phrase in Filipino: "MAHALAGANG PAALALA: ANG (NAME OF PRODUCT) AY HINDI GAMOT AT HINDI DAPAT GAMITING PANGGAMOT SA ANUMANG URI NG SAKIT."
- Specifies size, font (Arial or Tahoma), and position requirements for print and visual media.
- Audio advertisements must clearly voice the phrase at the end.
- Audio-visual materials must display and voice the phrase throughout and at the end.
Enforcement and Oversight Responsibilities
- FDA, Advertising Standards Council, and media outlets must enforce compliance.
- Responsible parties (manufacturers, advertisers, etc.) must adhere strictly to directives.
Additional Advertising Directives
- Only FDA-registered and approved products may be advertised or promoted.
- Misrepresentation of FDA registration status is prohibited.
- Claims made must be FDA-approved and consistent with labeling.
- Special claims require substantiation with scientific evidence approved by the FDA.
- Advertising must not be false, misleading, or create erroneous impressions about product qualities.
- Products must meet prescribed standards to avoid misleading comparisons.
- References to laboratory reports require FDA approval.
- Medical practitioners and health workers cannot endorse or promote food/dietary supplements, and activities involving them sponsored by supplement entities are prohibited.
Consequences for Non-Compliance
- Violating advertisements or promotions are deemed misbranded and violate RA 9711.
- FDA may issue cease and desist orders and seizing authority.
- Penalties include sanctions after due process consisting of notice and hearing.
Legal Provisions on Order Validity
- If any provision is declared unconstitutional, the remainder remains effective (Separability Clause).
- Previous inconsistent issuances related to supplement advertisement are repealed (Repealing Clause).
Effectivity
- The Order takes effect immediately upon publication in two national newspapers.
- Issued by the Secretary of Health on March 18, 2010.