Indonesia Unveils the Guidelines for Claiming Health Supplements

On August 8, 2022, Indonesia Food and Drug Administration (BPOM) unveiled Regulation Number 19 of 2022 concerning Guidelines for Claiming Health Supplements (hereafter as the "Guidelines"), which came into force immediately after the promulgation with a two-year grace period.

As per the Guidelines, it is mandatory for business operators (e.g., manufacturers, importers and sellers) to indicate health supplement claims on the packaging. The Guidelines mainly cover the definition of health supplement claims, claim types, supporting documents for claims, and examples of permitted/forbidden claims, and apply to both Indonesia domestic and imported health supplements. Details are as follows:

1. Background 

More and more health supplements with diverse claims are circulating on the Indonesian market, which may lead to the misuse of claims and health supplements themselves, thus pose a risk to consumers' safety and health. Under this context, the Guidelines were developed to promote the development of and clear the chaos in the industry, also to support innovation on product claims, referring to ASEAN Guideline on Claims and Claims Substantiation for Health Supplement.

2. Basic principles 

All the claims for health supplements must comply with the following principles:

• Indonesian language must be correctly used in the claims;

• Objective, complete and non-misleading information must be used in the claims;

• The claims should be designed to meet nutritional needs, maintain and/or improve health functions, and/or have physiological effects on health status instead of the purpose of preventing and treating diseases;

• Safe, helpful and the latest supporting documents must be submitted to BPOM for the approval;

• The claims should not imply that the health supplement intend to replace the daily diet and encourage excessive use of health supplements;

• The claims should not be misleading, ambiguous or false, e.g., supplements that are allowed to claim skin health improvement actually claim for beauty;

• The claims should not lack scientific or empirical evidences, e.g., vitamin or mineral supplements with claims to increase height;

• The claims should not be related to human appearance, aging, mental state, study ability and sexual competence.

3. Claim types and examples 

The Guidelines divide claims into three types, namely, general claim, functional claim, and disease risk reduction claim. Besides, the corresponding scope and examples are also detailed. For example, general claim refers to the claim that describes the biochemical and physiological process of nutrients in maintaining a healthy and balanced diet, such as supplementation of vitamins, minerals and amino acids for growing kids. The full content of claim types and examples can be found at the end of this article.

4. Supporting documents for claims 

For different types of claims, different levels of proof and supporting documents will be required for the approval from BPOM. For example, to obtain the approval for disease risk reduction claims, high level of proofs needs to be submitted to BPOM, such as scientific data from human intervention studies of the completed item or products that share the same composition, authentic and reliable research like dissertations and other research, the scientific assessment of the proper authorities in other jurisdictions, or published scientific review. The full content of supporting documents for claims can be found at the end of this article.

5. Known and registered claims 

The Guidelines provide the catalogue of known and registered claims for health supplements, including 22 materials such as Vitamin A, Folic Acid and Biotin with related claim examples. Take Vitamin A for instance, recognized and registered claims include Vitamin A supplementation, assisting with Vitamin A demands, maintaining vision and eye health, promoting the digestive and respiratory systems, and boosting skin health. The full content of supporting documents for claims can be found at the end of this article.

Please click the download button to view the full list of claim examples, required supporting documents and registered claims. If you need the full English version of this Guidelines, please feel free to contact us.