Question & AnswerQ&A (BFAD BUREAU CIRCULAR NO. 02, S. 2004)
Ginkgo Biloba preparations containing less than 40mg are classified as FOOD, provided there are no claims of treating, preventing, or mitigating diseases.
Ginkgo Biloba is classified as a DRUG if the amount is between 40mg and 120mg or if there are therapeutic claims made about treating, preventing, or mitigating disease.
It is advised that Ginkgo Biloba should not be taken for six months or longer.
The circular warns that Ginkgo Biloba should not be used together with warfarin and other thrombolytic agents due to potential adverse interactions.
BFAD is re-evaluating the safety of the long-term use of Ginkgo Biloba and is collating materials and information for this review.
Yes, BFAD will continue to accept applications for initial and renewal registration of Ginkgo Biloba products.
Classification affects the regulatory requirements: FOOD products have less stringent controls, whereas DRUG products require registration and adherence to drug regulatory standards due to their therapeutic claims or dosage.
Making therapeutic claims on preparations with less than 40mg could lead to reclassification as a DRUG, subjecting the product to stricter regulations and possible penalties if unregistered or misrepresented.