[Updated] Indonesia Unveils New Regulation for Health Supplements Advertising

On March 11, 2022, Indonesia Food and Drug Administration (BPOM) announced to solicit comments for the draft of Advertising Supervision of Traditional Medicines, Quasi Medicines, and Health Supplements. Comments can be sent to [email protected] prior to March 25, 2022.

In Indonesia, only health supplements obtained corresponding distribution permits are allowed to be advertised via image, text or other forms on media. The holder of the distribution permit needs to be responsible for the information contained in advertisements, and ensures advertisements conform to BPOM regulations.

1. General Principle 

The information conveyed in advertisements must be:

• Objective. The information should be based on the existing facts and not deviate from the nature of the efficacy / benefit and safeness of health supplements. The draft stipulates 12 specific requirements to ensure the objectivity, such as, the information in advertisements must be consistent with that approved in distribution permits, and safety statements, including "safe", "no side effect", "no risk", etc., shall not be contained in advertisements.

• Complete. A health supplement advertisement must contain the following information:

  a) Product name;

  b) The holder's name of the distribution permit;

  c) The number of distribution permit (only on visual advertising media);

  d) Text like "Read instructions for use";

  e) Text like "Read cautions" for certain products.

• Non-misleading. That is, the information must be true, accurate and not excessive. It is not allowed to take advantage of the public's concerns about certain conditions / issues, and shall not cause misleading perceptions. 15 specific requirements are stipulated in the draft to guarantee the authenticity and accuracy of the information. For example, discounts, rebates or bonuses shall not be used as promotional activities in product adverting.

More specific advertising requirements can be found in the annex of this draft. 

2. Use of Language 

Advertisements must be in Indonesian. However, universally understood terms in foreign languages can be exempted no matter if there’re corresponding terms in Indonesian or not. If the advertisement is specially placed in a region or targeted at consumers in a specific region, local language can be used in the advertisement.

3. Advertisement Review 

Advertisements of health supplements need to be granted approval by BPOM. The holder of the distribution permit shall register with the advertisement review system first, then submit the application for advertisement review with required materials and documents. After that, the advertisement review group will give a final decision after reviewing. During the review process, the applicant may be required to modify or supplement materials.

Notes: when the distribution permit is still in validity, and the ad still conforms to relevant standards and requirements, the approval of advertisement review remains valid.

4. Transitional Period 

Applications for approval of advertisement review submitted before the enactment of this regulation will still be proceeded based on the current legislation.

In addition, for advertisement approval issued based on the current legislation, it remains valid until the expiration of the distribution permit of the health supplements mentioned in the advertisement as long as it still meets the regulatory requirements of advertisement.

For the full English version of the draft, please email [email protected].

Here's a recommended upcoming webinar for stakeholders to learn more requrements about health supplements in Indonesia and the whole ASEAN region: Update on ASEAN Harmonization of Health Supplements Requirements - Impact & Tips, click the link to join us!