Label Claim Guidelines for Non-Drug Product Registration with Indonesia's BPOM

To help non-drug products pass registration with Indonesia's National Agency of Drug and Food Control (BPOM), to regulate label-claim conduct, keep claims compliant with BPOM requirements, and avoid registration and market-circulation risks, these guidelines are established. They apply to all products intended for sale in Indonesia that require non-drug BPOM registration. Label-claim information (all claims on product labels and instructions) must strictly follow the core rules below. I. Core Claim Requirements Label claims and intended-use claims for non-drug products must strictly comply with BPOM non-drug registration requirements; any statement violating regulations is prohibited: 1. No pharmacological, therapeutic, or disease-prevention claims: claims must not state that the product has pharmacological effects, nor use any wording intended to treat, characterize as a drug, or prevent disease, nor use medical terminology. For example, disease-related medical terms such as “gingivitis” or “halitosis” must not appear, to avoid misleading consumers into treating the product as a drug. 2. No claims targeting specific disease groups or those with disease side-effects: claims must not explicitly target people with a specific disease or side-effects from it. For example, “for moisturizing psoriasis patients” or “for skin care of diabetic patients” are not allowed; disease-affected groups must not be set as the target user group. 3. No claims of altering physiological function through a specific mechanism: the product must not claim to permanently restore, improve, or change human physiological function through pharmacological, immune, or metabolic mechanisms. Claims must focus on the product's basic function, without interventional statements about human physiology. 4. Claims must be objective, truthful, and non-misleading: all claims must be based on the product's actual characteristics—objective and truthful, without exaggerating efficacy or fabricating effects, and without vague or ambiguous wording that misleads consumers or BPOM reviewers. 5. Claims are evaluated as complete sentences: compliance is judged sentence by sentence, not by fragments taken out of context. Even if individual words are compliant, a full sentence that forms a non-compliant claim (e.g., implying treatment or disease association) is still deemed non-compliant. 6. Claims must be truthful and verifiable: every claim must have verifiable evidence, including test reports and compliance certificates, so it can be substantiated through scientific testing and verification to meet BPOM review and market-supervision requirements. II. Supplementary Notes on Compliant Claims 1. The label claims addressed here cover all claims on product labels and instructions; each must comply with the above rules. 2. Non-drug product claims must be clearly distinguished from drug products, avoiding BPOM-prohibited drug-related wording, so that product positioning matches the claims. 3. If claims involve special efficacy, prepare verification materials in advance so claims are traceable and verifiable, avoiding registration failure or penalties due to missing evidence.