Standards and Regulations

To ensure that non-pharmaceutical products successfully pass the approval process of the Indonesian Food and Drug Administration (FDA)To regulate product labeling claims and ensure compliance with BPOM (Best Practices for Manufacturing Organizations) requirements for registration in Indonesia, and to mitigate registration and market circulation risks, this guideline is hereby formulated. This guideline applies to all products intended for sale in the Indonesian market that require BPOM non-pharmaceutical registration. All labeling claims (including all claims on product labels and instructions for use) must strictly adhere to the following core guidelines.

I. Core Claims and Standards Requirements

Labelling information claims and intended use claims for non-pharmaceutical products must strictly comply with...For BPOM (Bill of Materials) registration of non-pharmaceutical products, any statements that violate regulatory requirements are strictly prohibited. Specific requirements are as follows:

1. Claims of pharmacological, therapeutic, or disease-preventing effects are strictly prohibited.Labeling information must not claim that the product has pharmacological effects, must not use any wording intended to treat, describe as having drug-like properties, or prevent disease, and is prohibited from using terms involving medical terminology. For example, it must not contain...Use medical terms and descriptions related to diseases such as "gingivitis" and "haste" to avoid misleading consumers into equating the product with medication.

2.Claims targeting specific disease groups or people experiencing side effects of diseases are strictly prohibited.Product labeling information must not explicitly target individuals suffering from specific diseases or experiencing side effects due to specific diseases. For example, it must not include such claims.Claims such as "for moisturizing psoriasis patients" or "suitable for skin care for diabetic patients" are prohibited from targeting people with diseases as the intended user group.

3. Claims of altering physiological functions through specific mechanisms are strictly prohibited.Products must not claim to permanently restore, improve, or alter human physiological functions through pharmacological, immune, or metabolic mechanisms. Claims must focus on the product's fundamental functions and must not involve statements that interfere with human physiological functions.

4. The claims must be objective, truthful, and not misleading.All labeling information must be based on the actual characteristics of the product, and must be objective and truthful. It must not exaggerate product efficacy, fabricate product effects, or use vague or ambiguous statements to mislead consumers.The BPOM review body ensures that the claimed content is consistent with the actual function of the product.

5. Claims require evaluation in conjunction with complete sentence structure.The compliance assessment of product label information claims must be conducted comprehensively on a sentence-by-sentence basis, and should not involve breaking down sentences into fragments or taking things out of context. Even if an individual word is compliant, if it forms an illegal claim when combined with the complete sentence structure (such as implying treatment or disease association), it will still be considered non-compliant.

6.Claims must be verifiable.All claims on product labels must be supported by verifiable evidence, including product testing reports and relevant compliance certificates, to ensure the claims are true and credible and can be substantiated through scientific testing and practical verification.BPOM review and market supervision requirements.

II. Supplementary Explanation of Compliance Claims

1. The labeling information claims referred to in this guide cover all claims on product labels and instructions, and must fully comply with the above specifications to ensure that every claim complies with BPOM regulatory requirements.

2. Labeling information for non-pharmaceutical products must be strictly distinguished from that of pharmaceutical products, avoiding the use of drug-related statements prohibited by the BPOM, ensuring that the product positioning is consistent with the claimed content, and complying with the regulatory definition of non-pharmaceutical products.

3. If the product label information claims to involve special effects, relevant verification materials must be prepared in advance to ensure that the claimed content is traceable and verifiable, so as to avoid BPOM registration failure or market violation penalties due to the inability to provide supporting materials.