Classification Guidance on Ginkgo Biloba Use

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BFAD BUREAU CIRCULAR NO. 02, S. 2004: Classification Guidance on Ginkgo Biloba Use

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Title Supreme Court: Classification Guidance on Ginkgo Biloba Use

Law: Bfad Bureau Circular No. 02, S. 2004

Decision Date: Feb 10, 2004

BFAD temporarily defers the implementation of previous regulations on Ginkgo Biloba, classifying it as food for doses under 40mg without health claims, while considering it a drug for higher doses and advising against long-term use and interactions with certain medications.

administrative law

drug classification

A

Temporary Deferment of Previous Circular Implementation

Implementation of Bureau Circular No. 09, s. 2003 concerning Ginkgo Biloba is temporarily deferred.
BFAD continues to accept applications for initial and renewal registration during this deferment.
The deferment aims to allow review and re-evaluation of safety data.

Safety Advisories and Usage Guidelines

Advises against usage of Ginkgo Biloba for periods of 6 months or longer.
Recommends not to use Ginkgo Biloba concurrently with warfarin or other thrombolytic agents.

Review and Re-evaluation Process

BFAD is currently collating materials and information to reassess the safety of long-term use.
Results of the safety review are expected to be disclosed after approximately two months from the circular's date.

Authority and Issuance

The directive was issued by the Bureau of Food and Drugs (BFAD).
Signed and adopted by Prof. Leticia-Barbara B. Gutierrez, M.S., Director IV, on February 10, 2004.

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