Guidelines on Claims of Efficacy for Natural Medicines - Standards and Regulations - Indonesian Registration Compliance - Jacob's Star

Standards and Regulations

Guidelines on the Declaration of Efficacy of Natural Medicines

2026-05-09

Terminology Definition


This regulation defines the following terms:

1. Natural medicinal ingredients: Refers to single ingredients, mixed ingredients, or finished products derived from plants, animals, microorganisms, minerals, and other natural resources, including combinations of the aforementioned natural ingredients; such ingredients have been used for generations or have been proven to have definite therapeutic effects, safety, and stable quality, and are used for health preservation, health promotion, disease prevention, symptom management, and physical rehabilitation based on traditional experience and/or scientific evidence. 2.Declaration of efficacy of natural medicines(hereinafter referred to as "Efficacy Statement"(This refers to any form of text that explicitly or implicitly suggests that natural medicinal ingredients have positive and beneficial effects on human health.) 3.Commercial entities: Refers to a market entity that is established, registered and operated within the sovereign jurisdiction of the Republic of Indonesia, and that is an individual, legal person or unincorporated entity, and engages in commercial business activities related to natural medicine products, either independently or in partnership.


Efficacy claims are mandatory.


1. The efficacy claim is on the label of a natural medicine product.Required information2. When submitting a registration application for natural medicine products, commercial entities must include a standardized efficacy statement on the product label. 3. The commercial entities referred to in paragraph (2) of this article include traditional medicine enterprises, small traditional medicine enterprises, micro traditional medicine enterprises, importers of natural medicine products, and various market entities that operate the sales business of natural medicine products in accordance with laws and regulations. 4. The preparation and labeling of the efficacy statement in paragraph (2) of this article must follow the relevant guidelines for efficacy statements and be based on the registration review results.

Scope and content of the efficacy claim guidelines


1. The efficacy statement guidelines referred to in Article 2, Paragraph (4) of these Regulations shall serve as the basis for the following work: a. Enterprises shall standardize the preparation and labeling of efficacy statements; b. The Food and Drug Administration shall conduct technical reviews of efficacy statements based on traditional experience and/or scientific evidence. 2. The efficacy statement guidelines shall mainly include the following: a. Principles for preparing efficacy statements; b. Types of efficacy statements; c. The basis for the argumentation of efficacy statements; d. Supporting materials for efficacy statements; e. Example of efficacy statements. 3. The efficacy statement guidelines listed in Paragraph (2) of this Article shall be uniformly published in the appendix to these Regulations.


Data ResponsibilityThe business entity provides supporting documentation for the efficacy claims.Completeness, authenticity, accuracy and legal validityBear full legal responsibility.


Efficacy claim review without example1. If there is no corresponding example in the efficacy claim guidelines, the efficacy claim submitted by the business entity must be subject to a special review by the Food and Drug Administration. 2. The review process in paragraph (1) of this article shall be carried out in accordance with the relevant provisions of the Food and Drug Administration's standards and procedures for the registration of natural medicine products.


Efficacy claims reassessed

The Food and Drug Administration may, in conjunction with the latest scientific and technological developments in the field of natural medicines, conduct reviews of efficacy claims for approved natural medicine products already on the market.Post-event reassessment。Principles for Compiling Statements of Efficacy of Natural MedicinesThe following principles must be strictly followed when drafting efficacy claims for natural medicines: 1. The statements must be objective, rigorous, and free from exaggeration or misleading claims; 2. They must conform to the legal definitions of traditional herbs (Jamu), standardized herbs, botanicals, and other natural medicine ingredients; 3. They must consider product safety, efficacy, and standardized usage guidelines; 4. Based on the type of efficacy claim, they must be accompanied by high-quality, strongly relevant, and legally valid supporting evidence, including information on raw materials, dosage, manufacturing process, and application method; 5. They should facilitate consumers' rational product selection based on efficacy claims, avoiding cognitive biases and misunderstandings; 6. Specific efficacy claims must be combined with risk analysis, and supplemented with warnings and precautions. > Example: Claims for diarrhea, hypertension, diabetes, body fat, and blood lipid regulation must include warnings and cautionary reminders. 7. Multiple efficacy claims may be made for the same product, with each claim logically consistent and supported by corresponding levels of evidence. > Example: Helps people with diarrhea to consolidate stools, absorb intestinal toxins, and reduce bowel movement frequency.


Natural Medicine Efficacy Declaration Classification

Claims regarding the efficacy of natural medicines fall into the following three categories: 1. Claims for traditional health maintenance uses; 2. Claims for traditional therapeutic uses; 3. Claims for scientifically validated therapeutic uses. Among these:Scientifically validated statement of therapeutic useIt is necessary to provide supporting evidence, including efficacy research data and corresponding literature.

Table 1. Types and Scope of Application of Efficacy Claims for Natural Medicines

Type

type

Scope

scope

Maintenance Claims

Health in general

Traditional (Traditional

Health Use)

Traditional health care uses

 

Traditionally used to help

maintain health

Traditionally used to help maintain health

 


Helps maintain health

Helps maintain health 

 

Traditional Claims for

Treatment (Traditional

Treatment)
The claims of traditional therapies（Traditional therapy）

 

 

 

Traditionally used for

help relieve symptoms, or

treat diseases or medical conditions as appropriate

with the principles of traditional medicine,

except for diseases that can be

increase the risk to sufferers

including cancer, liver disease, and

diseases of the immune system

Traditionally, it has been used to help relieve symptoms or treat diseases or medical conditions according to the principles of traditional medicine, but not diseases that may increase the patient's risk, such as cancer, liver disease, and immune system disorders.

 


Helps relieve symptoms, or

treat diseases or medical conditions as appropriate

with the principles of traditional medicine

It can help relieve symptoms or treat diseases or conditions based on traditional medical principles.

 

Medical Claims

Scientifically Proven

(Scientifically

Established Treatment)

Scientifically proven treatment claims

To help relieve/alleviate

symptoms or disorders or medical conditions

proven by scientific evidence, which

strengthen the principles of treatment

Traditional

Scientific evidence confirms that it helps alleviate various types of [conditions/conditions].Symptoms, discomfort and physical ailmentsThis also corroborates and confirms the conditioning principles of traditional medicine.


Treating disease

Treating diseases



Evidence for claims of efficacy of natural medicines


There are three main types of evidence for claims about the efficacy of natural medicine ingredients:

 

1. Evidence based on claims of traditional health uses based on documented traditional uses and knowledge, including:

a. Pharmacopoeia/Official Monographs; or

b. The written tradition of classical manuscripts (classical documents);

c. Textbook/journal references;

d. Unrecorded Indonesian oral traditions can be verified in the following ways:

1) Written statements from traditional leaders;

2) A written statement from the local government;

3) A written statement from the academic community; or

4) Interviews with community/traditional leaders

 

2. Evidence based on documented claims of traditional medicine practices.

include:

a. Pharmacopoeia/Official Monographs; or

b. The written tradition of classical document forms;

c. Textbook/journal references;

d. Unrecorded Indonesian oral traditions and evidence

 

source:

1) Written statements from traditional leaders;

2) A written statement from the local government;

3) A written statement from the scholar; or

4) Interviews with community/traditional leaders

 

3. Evidence for scientifically established therapies derived from scientific data, specifically as follows:

1) 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. The written tradition of classical text forms;

c. Textbook/journal references;

d. Unrecorded Indonesian oral traditions and evidence, sources:

    1) Written statements from traditional leaders;

    2) A written statement from the local government;

    3) A written statement from the scholar; or

    4) Interviews with community/traditional leaders

 


Claims of therapeutic efficacy must be supported by sufficient evidence. Since the use of natural medicines is primarily based on accumulated experience and historical knowledge, their efficacy claims must consider the rationale behind the ingredients or formulation.Efficacy data for “scientifically established therapies” must come from preclinical studies and/or clinical trials. Supporting research documentation must include complete study results, not just abstracts.


Latest News