Indonesia Issues Guidelines for Health Supplement Claims

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September 26, 20223E Global Research TeamBlog

On 8 August 2022 the National Food and Drug Control Agency (Badan Pengawas Obat dan Makana (BPOM)) issued BPOM Regulation No. 19 of 2022 on Guidelines for Health Supplement Claims. This regulation aims to ensure the transparency, safety, consistency, and quality standards for health supplement products in Indonesia. The formulation of this draft referred to the Association of Southeast Asian Nations (ASEAN) “Guidelines on Claims Substantiation for Health Supplements. This regulation took effect on 8 August 2022.

3E Review

In general, this regulation sets out the required practices businesses must follow when making claims about health supplements. The regulation covers the overall aspects of health supplement products, specifically in conducting their activities, providing claims, and including information in their product labeling. It also aims to prevent misleading or exaggerated claims and/or the overuse of health supplement products that could harm consumers. Businesses in the health supplement industry shall comply with the guidelines of best practices as provided in the annex section of this regulation.

The following articles contain some of the key provisions of the regulation:

  • Article 2 provides information about the health claims businesses can include on the packages of health supplements. The claims they want to use must be provided when registering health supplement products.
  • Article 3 provides the guidelines for the claims, which consist of the following information:
    • Basic principles
    • Type of claims and proof
    • Supporting documents on the claims (e.g., scientific reviews/publications)
  • Article 4 specifies that businesses are responsible for the validity of the statements and the supporting documents.
  • Article 5 stipulates that BPOM must carry out evaluation procedures on the claims.
  • Article 6 sets out a timeframe for the enforcement of this regulation, which will be 24 months from the date it took effect.

3E Analysis

Businesses and producers of health supplements should review this regulation, especially the annex section, to ensure the claims of their products meet the standards stipulated in this regulation. Businesses are required to provide accurate information supported by scientific documentation to avoid misleading information and misuse of health supplement products. The health supplement products that already have been distributed must comply with this regulation within 24 months after this regulation went into effect—or by 8 August 2024.