Indonesia Health Supplement Regulation

Badan Pengawas Obat dan Makanan (BPOM)

BPOM is a vital institution in safeguarding public health through its regulation of health supplements. By approving products for market entry, monitoring their safety, educating the public, inspecting production facilities, and staying informed through research, BPOM ensures that health supplements available in Indonesia are safe, reliable, and beneficial for consumers.

BPOM Regulation No. 16 of 2019 on Supervision of Health Supplements

It provides general supervision requirements for health supplements in Indonesia, involving general principles, production, packaging, labeling, advertising and surveillance.

BPOM Regulation No. 32 of 2022 on Criteria and Administration of Health Supplement Registration

It sets forth the registration requirements for and procedures of health supplements. It also stipulates the health supplement registration standards include product safety, efficacy and quality, as well as labeling requirements.

BPOM Regulation No. 27 of 2022 on Supervision of the Importation of Drugs and Food into Indonesian Territory

It stipulates the requirements for the importation of drugs and food products, including health supplements. It provides guidelines on the application of import license for health supplements.

BPOM Regulation No. 28 of 2023 on Amendments to BPOM Regulation No. 27 of 2022 on Supervision of the Importation of Drugs and Food into Indonesian Territory

It changes the requirements for application of import license for health supplements, replacing SKI Post Border with SKI Border. 

BPOM Regulation No. 24 of 2023 on Safety and Quality Requirements for Health Supplements

It details safety and quality requirements for health supplements in Indonesia. These requirements cover both product ingredients and finished products.

BPOM Regulation No. 10 of 2024 on Labeling of Natural Medicines, Quasi Medicines and Health Supplements

It stipulates detailed rules for the labeling of health supplements in Indonesia, covering general requirements, mandatory and optional labeling items, etc.

Regulation No. 19 of 2022 on Guidelines for Claiming Health Supplements

It provides guidelines for the use of claims for health supplements by the establishment of classification and positive list of claims.

1

Single Business Number (NIB)

2

Individual Tax Number (NPWP)

3

Importer recommendations issued by Online Single Submission (OSS) for new importers

4

Certificate of Good Manufacturing Practice (GMP) of manufacturer from country of origin

5

Letter of authorization stating person in charge of company account

1

Master formula

For pre-registration

2

Letter of authorization for person in charge of product registration

3

Statement letter of company responsibility for document authenticity

4

Certificate of Free Sale (CFS) or Certificate of Pharmaceutical Product (CPP) that has been legalized by the Indonesian Embassy / Consulate General or Apostille legalization by an authorized official in the country of origin

5

LoA/ Letter of authorization for distribution from industry in the country of origin

6

Good Manufacturing Practice certificate or other equivalent documents

7

Product composition (per batch)

For registration

8

Detail of manufacturing process

9

Certificate of analysis of raw material

10

Certificate of analysis of finished product

11

Specification and analytical method of finished product

12

Specification of packaging material

13

Batch numbering system

14

Safety test result from an accredited laboratory in Indonesia

15

Certificate of analysis of capsule shell or gelatine, Bovine Spongiform Encephalopathy (BSE) free certificate, halal certificate from authorized institution and statement letter of BSE free capsule (for hard capsule/ soft capsule/ gelatin material)

16

Chloramphenicol test (for product containing honey and other honey-derived materials)

17

Protocol and result of stability test

18

Packaging design

19

Supporting data regarding safety and efficacy

20

Toxicity test result (if required)

21

Origin and gaining process of certain material (if any)

22

Halal certificate for raw material from non-marine origin (if any)

23

Picture of original packaging from each angle

1

Original NIB

2

Original application letter signed by the director or the proxy of board of directors

3

Duly stamped, original statement of the person in charge

4

Original Import Power of Attorney

5

HS Code list of commodities to be imported

6

Front view and back view photos of the warehouse and office

7

Warehouse address where the product is stored

1

Marketing Authorization approval

/

2

Certificate of analysis

Ÿ It must be provided by the manufacturer or an accredited laboratory.

Ÿ It must include the following information:

- name and address of the manufacturer;

- name of products;

- testing parameter based on the provisions;

- test results;

- analysis method;

- batch number/lot number/production code;

- production date;

- expiration date.

3

Invoice

Product name, packaging, and packaging size listed on the invoice must match the product name, packaging, and packaging size listed on the Marketing Authorization. Otherwise, the application must be supported with the reference letter from the manufacturer.

4

Other supporting documents

/

Dosage forms

• Permitted: oral preparations, including powder, instant powder, effervescent powder, tablet, lozenge, coated tablet, effervescent tablet, chewable tablet, capsule, soft capsule, chewable gummy, film sheet, oral gel, oral liquid (solution, oral spray, emulsion, syrup, suspension)

• Forbidden: intravaginal, eye drops, parenteral, suppositories

Active ingredients

• Permitted: 29 vitamins and minerals, 13 amino acids, 7 other substances, as listed in List of Vitamins, Minerals, Amino Acids, and Other Substances Permissible for Use in Health Supplements with Limitation

• Forbidden: 94 plant substances, 6 animal substances, 5 types of minerals, as listed in Prohibited Substances for Health Supplements

Auxiliary ingredients

• Categorization: preservatives, colorants, sweeteners, flavorings, anti-caking agents, emulsifiers, glazing agents, stabilizers, solvents, and other inactive ingredients.

• Permitted: 15 dyes, 7 synthetic dyes, 9 sweeteners, 6 artificial sweeteners, 6 preservatives, 7 antioxidants, and 19 others, as listed in Maximum List of the Use of Additives

Contaminants

• Residue limits of solvents used to extract active substances originated from natural materials:

  Ethanol ≤ 1% or 10,000 ppm

  Methanol ≤ 0.3% or 3,000 ppm

  n-Hexane ≤ 0.029% or 290 ppm

  Ethyl acetate ≤ 0.5% or 5,000 ppm

• Heavy metal limits:

  Cadmium (Cd) ≤ 1 mg/kg or mg/L or ppm

  Lead (Pb) ≤ 5 mg/kg or mg/L or ppm

  Arsenic (As) ≤ 5 mg/kg or mg/L or ppm

  Mercury (Hg)≤ 0.5 mg/kg or mg/L or ppm

• Alcohol limits: no more than 1% in the form of oral liquid preparations.

• Microbial limits: click here for more details.

Test parameters for finished products

Click here for more details.

General requirements

• Both local and imported health supplements must be labeled before distribution in Indonesia.

• Labeling information must be displayed on both primary and secondary packaging, as well as on product brochures/leaflets, and must be directly printed or securely attached to the container and/or packaging.

• The labeling information must be objective, complete and non-misleading.

Mandatory labeling items

a) Product name and dosage form;

b) Name and address of business operators;

c) Name and address of the contract giver and/or the contract recipient;

d) Name and address of the licensor and/or licensee;

e) Net content, net weight, and/or quantity;

f) Composition;

g) Additional ingredients;

h) Claims of efficacy/benefits;

i) Use instructions;

j) Contraindications, side effects, interactions, and warnings;

k) Distribution Permit Number;

l) Production code;

m) Expiry date;

n) Storage conditions;

o) 2D Barcodes;

p) Logo or text of health supplements;

q) Other information (e.g., halal label, alcohol content, information on the origin of certain material).

Notes:

1. Except for item (f) (g) (h) (i), all other items must be placed in positions that are easy to see and read on product labels.

2. Items (a) to (e) must be indicated on the primary packaging. If the primary packaging has a labeling area of less than 10 cm², item (b) can be indicated on the secondary packaging.

3. For products with restricted sizes and packaging shapes, labeling items can be indicated in other forms, such as hanging labels, brochures, display panels, shrink wrap, etc.

Optional labeling items

a) Nutrient content;

b) Quality assurance document;

c) Consumer service information;

d) Image, logo, and/or text information;

e) Gluten free, alcohol free, and no additives;

f) Low lactose and lactose free;

g) Clinical tested;

h) Description of achievements in marketing or awards.

General claims

• General claims describe the biochemical and physiological process of nutrients in maintaining a healthy and balanced diet.

• Benefits are obtained from supplements beyond the daily diet.

• Supplementation of vitamins, minerals, and amino acids are important for a kid's development

• Vitamin C supplementation

• Iron supplementation

• Supplementation of vitamins and minerals for older adults

• Maintaining a balanced lifestyle

At least one of the following scientific data research supports the claim determination:

a. A valid reference from a book, journal, dissertations, or other research;

b. Literature on the utilization of active substances historically throughout time (e.g research and published documents).

There must be a reasoning explanation for the combination.

Function claims

Function claims relate to specific beneficial effects of health supplements on normal biological functions or activities in the body. These claims relate to positive effects in maintaining/supporting healthy organ/body system functions.

• Keeping bones and teeth strong and healthy

• Maintaining a healthy digestive system

• Increasing appetite

• Increasing breast milk supply

• Maintaining a healthy joint

• Improving skin health

The relevant sources of data must be included at least one in the final product to support the determination of the claims:

a. Scientific proof from the conclusions of human studies. In circumstances where the endpoint of human testing is not achievable, a surrogate endpoint may also be adopted.

b. Authoritative reference text, monograph, or pharmacopeia.

Additional verification of at least one from the secondary data obtained is necessary to support the claims:

a. Data from scientific experiments performed on animals.

b. A collection of historical and empirical use (e.g classic texts and published documents).

c. Proof from scientific reviews that have been published.

If there is no evidence in the final product for new combinations, there must be justification for the reason for the dose of each component as well as proof of no harmful interactions.

Disease risk reduction claims

• Claims that link the consumption of a health supplement with a reduced risk of a disease.

• A chronic disease carried on by several factors meets the disease criteria for this claim.

• Dietary and lifestyle changes can reduce the probability of developing these diseases.

• Minimizing the risk of osteoporosis

Claims must be validated by primary evidence, which requires the following:

a. Scientific data from human intervention studies (clinical trials) of the completed item or products that share the same composition.

b. At least one of the following data has additional evidence supporting:

- Authoritative reference work, such as a monograph or pharmacopeia.

- Scientific advice from authorities in other nations.

- Published scientific reviews (scientific reviews or meta-analyses)

1

Vitamin A (≤5000 IU)

• Vitamin A supplementation.

• Assisting in vitamin A demands.

• Maintaining vision and eye health.

• Promoting the digestive and respiratory systems.

• Boosting skin health.

2

Beta-carotene (≤ 20,000 IU)

• Beta-carotene supplementation.

• Assisting with beta-carotene intake.

• Maintaining vision and eye health.

3

Vitamin B1 (≤ 100 mg)

• Vitamin B1 supplementation.

• Assisting with vitamin B1 demands.

• Preserving the nervous systems in regular operation.

• Aiding the body from using carbohydrates for energy.

4

Vitamin B2 (≤ 50 mg)

• Vitamin B2 supplementation.

• Assisting with vitamin B2 demands.

• Aiding the body from using carbohydrates for energy.

5

Vitamin B3 (≤ 100 mg)

• Vitamin B3 supplementation.

• Assisting with vitamin B3 demands.

• Promoting tissue regeneration and the body's capability to obtain energy from food.

6

Pantothenic acid (≤ 100 mg)

• Vitamin B5 supplementation.

• Assisting with vitamin B5 demands.

• Assisting the body in obtaining energy from carbohydrates and fats.

7

Vitamin B6 (≤ 100 mg)

• Vitamin B6 supplementation.

• Assisting with vitamin B6 demands.

• Adding substantially to maintain the nerve system's proper functioning.

• Promoting tissue regeneration and the body's capability to obtain energy from food.

8

Vitamin B12 (≤ 200 mg)

• Vitamin B12 supplementation.

• Assisting with vitamin B12 demands.

• Adding substantially to maintain the nerve system's proper functioning.

• Required for the generation of red blood cells.

9

Folic Acid (≤ 800 mg)

• Folic acid supplementation.

• Assisting with folic acid demands.

• Folic acid supplements for prenatal and nursing mothers.

• Assisting pregnant and nursing women in meeting their folic acid needs.

• Required for the generation of red blood cells.

• Contributing to fetal growth and development.

10

Folic Acid (≤ 1000 mg: special products for pregnant women)

• Folic acid supplements for prenatal and nursing mothers.

• Assisting pregnant and nursing women in meeting their folic acid needs.

• Required for the generation of red blood cells.

• Contributing to fetal growth and development.

11

Biotin

(≤ 500 mg)

• Biotin supplementation.

• Assisting with biotin demands.

• Assisting the body in obtaining energy from carbohydrates and fats.

12

Vitamin C (≤ 500 mg)

• Vitamin C supplementation.

• Assisting with vitamin C demands.

• Nutrient supplements with vitamin C can assist with issues including thrush, bleeding gums, and reduce inflammation after surgery or illness.

• Promoting the production of collagen.

13

Vitamin C

(500 – 1000 mg)

• Vitamin C supplementation.

• Assisting with Vitamin C demands.

• Helping maintain body immunity.

• Nutrient supplements with vitamin C can assist with issues including thrush, and bleeding gums, and reduce inflammation after surgery or illness, as well as for the elderly.

• Promoting the production of collagen.

14

Vitamin D (≤ 400 IU)

• Vitamin D supplementation.

• Assisting with vitamin D demands.

• Maintaining bone health.

• Maintaining body immunity

15

Vitamin E (≤ 100 IU)

• Vitamin E supplementation.

• Assisting with vitamin E demands.

16

Vitamin E (≥100 IU)

• Vitamin E supplementation.

• Assisting with vitamin E demands.

• Promoting healthy skin.

17

Calcium (≤ 1200 mg)

• Calcium supplementation.

• Assisting with calcium demands.

• Calcium supplementation in children for bone and teeth growth.

• Maintaining and enhancing bone density.

• Calcium supplementation to preserve bone density in pregnant and nursing women.

18

Magnesium (≤ 600 mg)

• Magnesium supplementation.

• Assisting with magnesium demands.

19

Iron (≤ 30 mg)

• Iron supplementation.

• Assisting with iron demands.

• Producing red blood cells and hemoglobin.

20

Selenium (≤ 200 mcg)

• Selenium supplementation.

• Assisting with Selenium demands.

• Maintaining healthy skin and hair.

21

Fluor

≤0.7 mg (Toddler)

≤1.5 mg (Teenager)

≤3 mg (Adult)

As a supplement to support meeting fluoride demands.

22

Chromium (≤ 200 mcg)

• Chromium supplementation.

• Assisting with chromium demands.