Title
Supreme Court
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.

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.

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