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This document provides an advisory regarding food supplement advertising requirements in light of a preliminary injunction issued by a Manila court against the implementation of FDA Administrative Order 2010 0008. Until the court lifts its order, advertisements and labels must contain the notice "NO APPROVED THERAPEUTIC CLAIMS" as required by earlier BFAD regulations, not the revised notice specified in the Administrative Order. Materials with the original notice will be accepted but those containing the revised notice outlined in the Order will not be required to be pulled pending further clarification from the FDA on compliance.
This document provides an advisory regarding food supplement advertising requirements in light of a preliminary injunction issued by a Manila court against the implementation of FDA Administrative Order 2010 0008. Until the court lifts its order, advertisements and labels must contain the notice "NO APPROVED THERAPEUTIC CLAIMS" as required by earlier BFAD regulations, not the revised notice specified in the Administrative Order. Materials with the original notice will be accepted but those containing the revised notice outlined in the Order will not be required to be pulled pending further clarification from the FDA on compliance.
This document provides an advisory regarding food supplement advertising requirements in light of a preliminary injunction issued by a Manila court against the implementation of FDA Administrative Order 2010 0008. Until the court lifts its order, advertisements and labels must contain the notice "NO APPROVED THERAPEUTIC CLAIMS" as required by earlier BFAD regulations, not the revised notice specified in the Administrative Order. Materials with the original notice will be accepted but those containing the revised notice outlined in the Order will not be required to be pulled pending further clarification from the FDA on compliance.
This Advisory is being issued in response to queries on the effect of the Preliminary Injunction issued by the Regional Trial Court, Branch 30, Manila, in SP.C.A. NO. 10-123429, last May 28, 2010, against the implementation of FDA Administrative Order 2010 0008 requiring that all advertisements and labels of food supplements should contain the following:
MAHALAGANG PAALALA: ANG (NAME OF PRODUCT) AY HINDI GAMOT AT HINDI DAPAT GAMITING PANGGAMOT SA ANUMANG URI NG SAKIT
Until an Order is issued by the Court lifting the same, the applicable notice on advertising materials and labels is the one required under BFAD Memorandum Circular No. 25 s. 1992 and No. 02 s. 1999 which is:
NO APPROVED THERAPEUTIC CLAIMS
Subject to other requirements under the ASC Rules and Regulations and ASC Standards of Advertising, materials bearing the notice No Approved Therapeutic Claims for covered products shall be accepted for screening.
We are making representations with the FDA to clarify the matter of compliance of advertising materials containing the notice: Ang (name of product) ay hindi gamot at hindi dapat gamiting panggamot sa anumang uri ng sakit, as the same were made in good faith. In the meantime, materials containing the said revised notice shall NOT be required to be pulled out unless the Advertiser voluntarily revises/pulls out the same.
Republic of The Philippines Rep. by The Bureau of Food and Drugs (BFAD) Now Food and Drugs Administration vs. Drugmaker's Laboratories, Inc. and Terramedic, Inc