Herbal products can be categorized into 2 categories as follows:
1) High-risk product category means herbal products with an indication to use for the therapy, treatment and alleviation of, or the prevention of, diseases as follows:
1.1 products for the therapy, treatment and alleviation of, or the prevention of, serious forms of illnesses or diseases;
1.2 products which could be misused;
1.3 products which require special use control for consumer safety;
1.4 products which are sterile injections or products for human eyes;
1.5 products of which the dosage form and method of application are complicated or difficult to administer into the body;
1.6 products which may cause serious adverse effects or require strong safety control.
Serious forms of illness or disease mean symptoms, diseases or illnesses of which the diagnosis or treatment requires a qualified healthcare professional or is beyond the ability of a consumer to self-treat or correctly self-diagnose without regular consultation with a qualified healthcare professional, e.g., alcoholism, anxiety state, infectious respiratory syndromes, psychotic conditions, inflammatory and debilitating arthritis, addiction (except for nicotine addiction), arteriosclerosis, asthma, cancer, congestive heart failure, convulsions, dementia, depression, diabetes, gangrene, glaucoma, haematologic bleeding disorders, hepatitis, hypertension, nausea and vomiting of pregnancy, obesity, rheumatic fever, septicaemia, sexually transmitted diseases, strangulated hernia, thrombotic and embolic disorders, thyroid disease, ulcer of the gastro-intestinal tract.
2) Non-high risk product category means products which are not high-risk products, including products with low risks and wide safety margins, having indications, purposes of use, properties, or health benefit claims which are related to the strengthening of health, health enrichment, prevention of malnourishment, reduction of the risks of diseases, as well as the therapy, alleviation or treatment or the prevention of unusual symptoms or non-serious forms of illnesses or diseases.
Non-serious forms of illness or disease mean symptoms, diseases or illnesses apart from those of serious forms of illnesses or diseases and include symptoms, diseases or illnesses that can naturally resolve on their own after a certain period of time, or if left untreated, can be expected to improve, but not as much as if treated with a product.
For more information, please refer to the Guidelines on Preparation of Documents for Herbal Products Application.