What are Indonesia's requirements for efficacy claims on natural medicines?

In Indonesia, an efficacy claim (a statement that explicitly or implicitly indicates a natural-medicine ingredient has a positive, beneficial effect on human health) is mandatory information on the label of a natural-medicine product, and business entities must properly state it on the label when submitting a registration application. The efficacy-claim guidelines cover drafting principles, claim categories, the basis of argument, supporting materials and model examples. The drafting principles require: objective, rigorous wording with no exaggeration or misleading content; conformity with the legal definitions of traditional herbal medicine (Jamu), standardized herbal medicine and phytopharmaceuticals; and consideration of product safety, effectiveness and proper medication guidance. The business entity bears full legal responsibility for the completeness, authenticity, accuracy and legal validity of the supporting documents. If there is no corresponding model example in the guidelines, the submitted claim must first undergo a special review by BPOM.

What are the three categories of natural-medicine efficacy claims in Indonesia?

Natural-medicine efficacy claims fall into three categories: 1) Traditional Health Use — traditionally used to help maintain health; 2) Traditional Treatment — traditionally used to help relieve symptoms or treat a disease or condition in accordance with the principles of traditional medicine, except for diseases that may increase risk to the patient such as cancer, liver disease and immune-system disease; 3) Scientifically Established Treatment — helps relieve symptoms, disorders or conditions as proven by scientific evidence. Scientifically established treatment claims must be supported by efficacy research-trial data (preclinical and/or clinical data) and corresponding literature, with complete research results rather than just an abstract.

Guidelines on Efficacy Claims for Natural Medicines

Indonesian regulation requires efficacy claims to be mandatory information on the labels of natural-medicine products. This article covers term definitions, the mandatory-claim requirements, the principles for drafting claims, the three claim categories, and the types of evidence required.

Definition of terms

This regulation defines the following terms:

1. Natural-medicine ingredient: a single ingredient, a mixture of ingredients, or a finished product derived from plants, animals, microorganisms, minerals and other natural resources, including combinations of the above natural ingredients; such ingredients, used for generations or proven to have definite efficacy, safety and stable quality, based on traditional experience and/or scientific evidence, are used for health maintenance, health promotion, disease prevention, condition management and bodily recovery.

2. Natural-medicine efficacy claim (hereinafter “efficacy claim”): any form of statement that explicitly or implicitly indicates that a natural-medicine ingredient has a positive, beneficial effect on human health.

3. Business entity: a natural person, legal person or unincorporated body established, registered and operating within the sovereign jurisdiction of the Republic of Indonesia, engaged independently or in partnership in commercial activities related to natural-medicine products.

Mandatory requirements for efficacy claims

1. The efficacy claim is mandatory information to be stated on the label of a natural-medicine product.

2. When a business entity submits a registration application for a natural-medicine product, it must properly state the efficacy claim on the product label.

3. The business entities referred to in paragraph (2) include traditional-medicine enterprises, small traditional-medicine enterprises, micro traditional-medicine enterprises, importers of natural-medicine products, and all market entities that lawfully operate a natural-medicine-product sales business.

4. The drafting and labeling of the efficacy claim referred to in paragraph (2) must follow the relevant efficacy-claim guidelines and be based on the registration-review results.

Scope and content of the efficacy-claim guidelines

1. The efficacy-claim guidelines referred to in Article 2 paragraph (4) are used as the basis for: a. enterprises properly drafting and labeling efficacy claims; b. the Food and Drug Supervisory Agency carrying out technical review of efficacy claims based on traditional experience and/or scientific evidence.

2. The efficacy-claim guidelines mainly contain: a. principles for drafting efficacy claims; b. categories of efficacy claims; c. the basis of argument for efficacy claims; d. supporting materials for efficacy claims; e. model examples of efficacy claims.

3. The efficacy-claim guidelines listed in paragraph (2) are published uniformly in the annex to this agency's regulation.

Entity responsible for the materials

The business entity bears full legal responsibility for the completeness, authenticity, accuracy, and legal validity of the supporting documents attached to the efficacy claim.

Review of efficacy claims without model examples

1. If there is no corresponding model example in the efficacy-claim guidelines, the efficacy claim submitted by the business entity must first undergo a special review by the Food and Drug Supervisory Agency.

2. The review process in paragraph (1) is carried out in accordance with the Food and Drug Supervisory Agency's natural-medicine-product registration standards and procedures.

Re-evaluation of efficacy claims

The Food and Drug Supervisory Agency may, in light of scientific and technological developments in the natural-medicine field, carry out a post-market re-evaluation of the efficacy claims of approved natural-medicine products.

Principles for drafting natural-medicine efficacy claims

Drafting natural-medicine efficacy claims must strictly follow these principles:

1. The wording is objective and rigorous, with no exaggeration or misleading content;

2. It conforms to the legal definitions of traditional herbal medicine (Jamu), standardized herbal medicine, phytopharmaceuticals and other natural-medicine ingredients;

3. It takes into account product safety, effectiveness of use, and proper medication guidance;

4. According to the type of efficacy claim, it is supported by high-quality, strongly relevant, legally valid argumentative evidence appropriate to the raw-material ingredients, dosage, production process and method of use;

5. It enables consumers to choose products rationally based on the efficacy claim, avoiding cognitive bias and misunderstanding;

6. Specific efficacy claims must incorporate risk analysis and add warnings and precautions. Example: claims in categories such as diarrhea, hypertension, diabetes, body fat and blood-lipid regulation must include warnings and caution notices;

7. The same product may bear multiple efficacy claims, with the wording of each claim logically consistent and each supported by the corresponding level of evidence. Example: helping people with diarrhea firm up stool, adsorb intestinal toxins, and reduce the frequency of bowel movements.

Categories of natural-medicine efficacy claims

Natural-medicine efficacy claims fall into the following three categories:

1. Traditional health-use claims;

2. Traditional treatment-use claims;

3. Scientifically established treatment-use claims.

Of these, scientifically established treatment-use claims must be supported by efficacy research-trial data and corresponding literature.

Type	Scope	Example claim
Traditional Health Use	Traditionally used to help maintain health	Helps maintain health
Traditional Treatment	Traditionally used to help relieve symptoms, or to treat a disease or medical condition in accordance with the principles of traditional medicine, except for diseases that may increase risk to the patient, such as cancer, liver disease and immune-system disease	Helps relieve symptoms, or treats a disease or condition in accordance with the principles of traditional medicine
Scientifically Established Treatment	Helps relieve symptoms, disorders or medical conditions as proven by scientific evidence, which corroborates the principles of traditional medicine	Treats disease

Evidence for natural-medicine efficacy claims

There are three main types of evidence for natural-medicine-ingredient efficacy claims:

1. Evidence for traditional health-use claims based on documented traditional use and knowledge, including: a. pharmacopoeias/official monographs; or b. written tradition in the form of classical manuscripts (classical literature); c. textbook/journal references; d. undocumented Indonesian oral tradition, which can be substantiated by: 1) a written statement from a traditional leader; 2) a written statement from the local government; 3) a written statement from academia; or 4) interviews with the community/traditional leaders.

2. Evidence for traditional treatment claims based on documented traditional medicine, including: a. pharmacopoeias/official monographs; or b. written tradition in the form of classical literature; c. textbook/journal references; d. undocumented Indonesian oral tradition and evidence, from sources: 1) a written statement from a traditional leader; 2) a written statement from the local government; 3) a written statement from a scholar; or 4) interviews with the community/traditional leaders.

3. Evidence for scientifically established treatment derived from scientific data, as follows: 1) the evidence must be presented in the form of scientific data (preclinical and/or clinical data); 2) other evidence, including: a. official compilations/monographs; or b. written tradition in the form of classical texts; c. textbook/journal references; d. undocumented Indonesian oral tradition and evidence, from sources: 1) a written statement from a traditional leader; 2) a written statement from the local government; 3) a written statement from a scholar; or 4) interviews with the community/traditional leaders.

Efficacy claims must be supported by sufficient evidence. Because the use of natural medicines is based primarily on accumulated experience and historical knowledge, their efficacy claims must consider the rationality of the ingredient or formula. Efficacy data supporting a “scientifically established treatment” must come from preclinical studies and/or clinical trials. The research documents supporting the efficacy data must contain the complete research results, not just an abstract.

FAQ

What are Indonesia's requirements for efficacy claims on natural medicines?: In Indonesia, an efficacy claim (a statement that explicitly or implicitly indicates a natural-medicine ingredient has a positive, beneficial effect on human health) is mandatory information on the label of a natural-medicine product, and business entities must properly state it on the label when submitting a registration application. The efficacy-claim guidelines cover drafting principles, claim categories, the basis of argument, supporting materials and model examples. The drafting principles require: objective, rigorous wording with no exaggeration or misleading content; conformity with the legal definitions of traditional herbal medicine (Jamu), standardized herbal medicine and phytopharmaceuticals; and consideration of product safety, effectiveness and proper medication guidance. The business entity bears full legal responsibility for the completeness, authenticity, accuracy and legal validity of the supporting documents. If there is no corresponding model example in the guidelines, the submitted claim must first undergo a special review by BPOM.
What are the three categories of natural-medicine efficacy claims in Indonesia?: Natural-medicine efficacy claims fall into three categories: 1) Traditional Health Use — traditionally used to help maintain health; 2) Traditional Treatment — traditionally used to help relieve symptoms or treat a disease or condition in accordance with the principles of traditional medicine, except for diseases that may increase risk to the patient such as cancer, liver disease and immune-system disease; 3) Scientifically Established Treatment — helps relieve symptoms, disorders or conditions as proven by scientific evidence. Scientifically established treatment claims must be supported by efficacy research-trial data (preclinical and/or clinical data) and corresponding literature, with complete research results rather than just an abstract.

FAQ

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