Indonesia Seeks Comments on the Labeling of Health Supplements

On Jan. 3, 2022, Indonesia FDA (BPOM) issued a notice regarding the proposed labeling requirements of health supplements, and announced to seek public comments till Jan. 10, 2022.

Critical Points Revealed by the Draft 

General Principle 

• For imported health supplements, importers shall put a mark which conforms to the corresponding Distribution Permit on the products when entering Indonesia.

• The labeling information shall be indicated both on the primary and the secondary packaging, and shall be directly or firmly printed on the container or the packaging. Stickers can be used when necessary modifications are required after approved by the BPOM.

• The information on the label shall be objective, complete and non-misleading.

Mandatory Labeling Items 

a) product name;

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) size, content and net weight;

f) composition;

g) additives;

h) usability claims;

i) use instructions;

j) contraindications, side effects, warnings and cautions;

k) Distribution Permit Number;

l) batch number/production code;

m) expire date;

n) storage method;

o) text of health supplements;

p) halal label;

q) alcohol content;

r) 2D Barcodes;

s) information on the origin of certain materials.

Notes: It is mandatory to indicate only item a-e on the primary packaging, which directly contacts with the product content. Besides, for the product with less than 10 cm² labeling area, it is allowed to indicate item b and k on the secondary packaging, which indirectly contacts with the product content.

Labeling Language 

Only item a (product name) can be languages other than Indonesian. All other labeling items can only consist of Indonesian, Arabic numerals and Latin alphabet; if not, corresponding translations shall be attached. Translations are preferred to be Indonesian. When there's no corresponding Indonesian words as the counterpart of the foreign language on the label, a third language can be used for the translations.

Images and Logos 

• The images of animals or plants can be used only when products contain animal or plant derived active ingredients.

• The images of fruits can be used only when products contain fruit juice.

• The logo or text of pure veganism can be used when products don't contain animal components or animal processed products, such as honey.

• The logo of organic product can be used when the organic components account for at least 95% of the product weight (excluding food additives). For imported products with organic claims, an equivalence evaluation for the organic recertification in Indonesia is requested.

Halal Information 

If the product contains pork and/or its derivative, or the product contains some ingredient comes from pork and/or its derivative, it is necessary to indicate non-halal information on the product label. The information can be expressed in the form of image, logo or text. In addition, if the product contains some ingredient obtained during the process of contacting with pork-sourced ingredients, the information contains "in the manufacturing process, it came into contact with pork-sourced ingredients" shall be indicated.