[ BFAD BUREAU CIRCULAR NO. 02, S. 2004, February 10, 2004 ]
GINKGO BILOBA
For the guidance and information of all concerned, BFAD has decided to defer temporarily the implementation of BUREAU CIRCULAR No. 09, s. 2003.
The classification of Ginkgo Biloba remains as FOOD for those preparations containing less than 40mg, as long as, there is no claim of treating, preventing or mitigating disease.
Ginkgo Biloba is also classified as DRUG if:
It is advised that Ginkgo Biloba should not be taken for 6 months and longer and it should not be used with warfarin and other thrombolytic agents.
BFAD, in the meantime, will continue accepting applications for initial and renewal registration.
At the present time, the Bureau is re-evaluating the safety of the long-term use of Ginkgo Biloba. Materials and information are presently being collated. Results of this review will be made known after 2 months.
Adopted: 10 Feb. 2004
(SGD.) PROF. LETICIA-BARBARA B. GUTIERREZ, M.S.
Director IV
The classification of Ginkgo Biloba remains as FOOD for those preparations containing less than 40mg, as long as, there is no claim of treating, preventing or mitigating disease.
Ginkgo Biloba is also classified as DRUG if:
(1) the amount is 40mg up to 120mg
(2) there are vaunted therapeutic claims
It is advised that Ginkgo Biloba should not be taken for 6 months and longer and it should not be used with warfarin and other thrombolytic agents.
BFAD, in the meantime, will continue accepting applications for initial and renewal registration.
At the present time, the Bureau is re-evaluating the safety of the long-term use of Ginkgo Biloba. Materials and information are presently being collated. Results of this review will be made known after 2 months.
Adopted: 10 Feb. 2004
Director IV