Title
Change in Therapeutic Claim Phrase for Supplements
Law
Doh Administrative Order No. 2010-0008
Decision Date
Mar 18, 2010
A Philippine law, DOH Administrative Order No. 2010-0008, prohibits the use of the phrase "No Approved Therapeutic Claim" in advertisements for food/dietary supplements, instead requiring a standard message stating that the product is not a medicine; non-compliance may result in penalties and cessation of advertising.
A

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.

Analyze Cases Smarter, Faster
Jur helps you analyze cases smarter to comprehend faster, building context before diving into full texts. AI-powered analysis, always verify critical details.