Indonesia to Amend the Quality Requirements for Health Supplements

On September 22, 2022, Indonesia Food and Drug Administration (BPOM) unveiled the draft of Amendment to Regulation of the Food and Drug Supervisory Agency Number 17 of 2019 concerning Quality Requirements for Health Supplements. Public comments can be sent to [email protected] prior to October 3, 2022. Major proposed revisions and changes mainly pertain to appendixes of the regulation, where detailed quality requirements for health supplements are stipulated:

Appendix 1: Health supplements that may contain pollutants with health risk

The current regulation specifies four categories of health supplements that may contain pollutants with health risks, along with potential pollutants and maximum limits. Another seven categories are added into the proposed amendment, such as health supplements containing cayenne extract, for it may contain benzyl piperazine. Notably, "imported product" is also one of the seven newly-added categories, for it may contain psychotropic drugs and narcotics that health supplements shall be free of. 

Appendix 2: Residue limits of extraction solvent 

Apart from ethanol, n-hexane, and ethyl acetate, methanol is included in this appendix with its proposed maximum residue limit in final products, that is, 0.3% or 3,000 ppm.  

Appendix 3: Maximum limits of additives' use 

In this appendix, maximum limits requirements for synthetic dyes are further detailed by varying limits depending on different dosage forms. Besides, for the additive cetyl alcohol, the current maximum limit is 100,000 mg per kg of the product. However, the amendment requires the limit of cetyl alcohol to comply with Good Manufacturing Practices without providing a specific limit value.

Appendix 4: Quality requirements for finished products 

In part B of this appendix, the test parameters for finished product in three forms (chewable tablet, oral gel and sheet film) are newly added. The test requirements for microorganism and heavy metal contamination are updated: the acceptable standard for microorganism contamination resulted from health supplements containing probiotics is established; the contamination limits of chrome and lead are revised. In addition, this amendment introduces the test requirements for natural active ingredients and nano-carrier products.

Appendix 4A: Types of certain crude drug powders 

It is a new appendix to the amendment, in which 11 types of crude drug powders are specified, such as royal jelly and bee pollen.

Appendix 5: Medicinal chemicals for qualitative tests of certain claims 

The amendment details the requirements for required medicinal chemicals used for qualitative tests of "male stamina" claims.

Apart from the revisions from the appendixes above, there are several minor changes in other parts of the regulation. Examples include: the test parameter "weight uniformity" for finished products is revised to "weight/volume uniformity"; the application submission method for the review of a product whose quality requirements are not specified in the regulation is changed from "in writing" to "by electronically means".

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