1. Definition & classification
As per BPOM Regulation No. 27 of 2022 on Control of the Importation of Drugs and Food into Indonesian Territory, health supplements are products intended to complement nutritional needs; maintain, enhance and/or improve health functions; have nutritional value and/or physiological effects; contain one or more ingredients in the form of vitamins, minerals, amino acids, and/or other non-plant ingredients that can be combined with plants.
2. Competent authority
Badan Pengawas Obat dan Makanan (BPOM)
BPOM is responsible for protecting public health through the control of and supervision on food products, traditional medicine, cosmetics, pharmaceuticals, biopharmaceuticals, and health supplements. To be specific, BPOM is tasked to issue import permits for food products and oversee the distribution of food products in Indonesia.
3. Market access approval
3.1 Circulation permit
In Indonesia, in order to obtain the circulation permit of health supplements, business operators are required to register their products with BPOM. For imported products, the applicants shall be local importers. In principle, the circulation permit shall be valid for five years, and can be prolonged via re-registration. For the specific registration procedures and requirements, please refer to Criteria and Administration of Health Supplement Registration.
3.2 Import permit
To import health supplements into Indonesian territory, a SKI Post Border, i.e., an import permit from BPOM applied by local importers with circulation permit, shall be obtained. Each SKI Post Border is valid for one single importation only. Local importers shall finish the importation within seven days from the date of receiving SKI Post Border. For the specific application procedures and requirements, please refer to BPOM Regulation No. 27 of 2022 on Control of the Importation of Drugs and Food into Indonesian Territory.
4. Product compliance
4.1 Product requirements
The quality requirements for health supplements are specified in BPOM Regulation No. 17 of 2019 on Health Supplement Quality Requirements, including the permitted auxiliary materials, the maximum limits of contaminants, the quality requirements for finished products, as well as the determination methods of active ingredients.
In addition, Annex 7 of Criteria and Administration of Health Supplement Registration provides the list of permitted vitamins, minerals, amino acids and other ingredients. Annex 8 lists the forbidden ingredients in health supplements.
The labeling requirements for health supplements can be referred to Part 3 of Chapter 2 of Criteria and Administration of Health Supplement Registration. Besides, in January 2022, BPOM proposed a draft targeted at the labeling of health supplements.
Besides, Indonesia will mandate halal certification for both local and imported foods and beverages since October 17, 2024, which required product labels to show halal or non-halal information. Please refer to Indonesia Halal Food Regulation for more details.
The use of claims for health supplements is guided by Regulation Number 19 of 2022 concerning Guidelines for Claiming Health Supplements. The Guidelines divide claims into three types, namely, general claim, functional claim, and disease risk reduction claim. Besides, the corresponding scope and examples are detailed. Furthermore, the Guidelines list the supporting documents for claims, and examples of permitted/forbidden claims.