Indonesia Unveils Regulation on Labeling of Health Supplements

On June 25, 2024, Indonesia Food and Drug Supervisory Agency (BPOM) issued Regulation No. 10 of 2024 on Labeling of Natural Medicines, Quasi Medicines and Health Supplements, which regulates the inclusion of information on the labeling of these three types of products. In particular, this report only focuses on the labeling requirements for health supplements.  

General labeling requirements 

• Both local and imported health supplements must be labeled as per this regulation 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:

• 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. Optional labeling items, such as quality assurance and consumer contact information, are specified in Annex I of this regulation.

• 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.

• 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.

• Detailed requirements for each labeling item are specified in Part 2: Labeling Information of this regulation.

Language requirements 

Only item (a) (product name) can be in languages other than Indonesian Bahasa. All other labeling items must be in Indonesian, Arabic numerals, and Latin alphabet. If not, corresponding translations must be attached. Translations should preferably be in Indonesian. If there's no corresponding Indonesian words for the foreign terms on the label, a third language can be used for the translations.

Forbidden information 

• Statements that the product is free from certain ingredients when it actually contains them, either accidentally or as a carry-over ingredient/compound

• Images or information related to health workers, religious figures, and public officials, and acting as such information, texts, or images that offend certain ethnicities, religions, races, and/or groups

• Information about raffles, competitions, or prizes

• Information, texts, or images that are contrary to or prohibited by statutory provisions

• Information that creates an image/perception contrary to the norms of decency, ethics, or public order

• Visualization or other information that is excessive or unrelated to health supplements

• Information that creates misleading perceptions regarding product safety/efficacy/benefits and quality

Market surveillance 

All labeling information must be consistent with the Distribution Permit. If discrepancies are found, business operators must take corrective actions by submitting the following information to BPOM:

• Old packaging stocks;

• Production code;

• Expiry date;

• Sample of packaging that includes a sticker.

Based on BPOM's evaluation results, business operators can choose to use stickers on original labels or to re-print new labels.

Enforcement and penalties 

This regulation took effect immediately upon its publication. However, health supplements with Distribution Permits obtained prior to this regulation can enjoy a grant period, and must adjust their labels within 24 months.

Violations of this regulation are subject to the following administrative penalties:

• Warning;

• Product withdrawal;

• Product destruction;

• Temporary suspension of market activities;

• Cancellation/revocation of Distribution Permit;

• Public announcement.

For translation of this regulation, please feel free to reach out to us via [email protected].