DECISION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL
No. HK.00.05.4.62647

ON
PROHIBITION TO DISTRIBUTE TRADITIONAL DRUGS AND FOOD SUPPLEMENTS
THAT CONTAIN KAVA-KAVA PLANT

THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL,

Considering:

• a. that in order to protect the public from the side effects or toxicity of the use of materials and prepared products traditional drugs and food supplements, then the safety of their use in circulation shall be monitored continuously;
• b. that recently, in many counties, occurrences of side effects that are related to hepatotoxic risk from the use of traditional drugs/food supplements which contain kava-kava have been reported;
• c. that in order to improve consumer protection in Indonesia from the possible side effect risks referred to in item b above, it is necessary to prohibit the use of kava-kava, both as materials and in the form of finished preparation of traditional drugs and food supplements.

In view of:

• 1. Law RI No. 23/1992 on Health Affairs;
• 2. Government Regulation RI No. 72/1998 on Safety of Pharmaceutical Products and Medical Devices;
• 3. Presidential Decree RI No. 103/2001 on Status, Duties, Authorities, Organizational Structure of Non Departmental Governments;
• 4. Regulation of the Minister of Health RI No. 246/Menkes/Per/V/1990 on Industrial Business License of Traditional Drugs and Registration of Traditional Drugs;
• 5. Regulation of the Minister of Health RI No. 1297/Menkes/Per/XI/1998 on Circulation of Imported Traditional Drugs;
• 6. Regulation of the Minister of Health RI No. 382/Menkes/Per/VI/1989 on Food Registration.

DECIDES:

To stipulates:

DECISION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL ON TRADITIONAL DRUGS AND FOOD SUPPLEMENTS THAT CONTAIN KAVA-KAVA PLANT.

First:

To prohibit production and circulation of traditional drugs and food supplements which contain kava-kava plant.

Second:

To revoke approval of registration of traditional drugs and food supplements which contain kava-kava plant.

Third:

To withdraw from circulation all traditional drugs and food supplements as contemplated above as soon as possible as from the stipulation of this decision.

Fourth:

AT the latest within 3 (three) months as of the stipulation of this decision, all traditional drugs and food supplements that contain kava-kava plant must have been withdrawn from circulation.

Fifth:

Violation of this decision shall be disciplined in accordance with the prevailing statutory regulations.

Sixth:

This decision comes to effect as of the date of stipulation.

Stipulated in: Jakarta
On: August 26, 2002
The Head of National Agency of Drug and Food Control,
Sgd
H. SAMPURNO
NIP.140087747