National Policy on Traditional Medicine and Regulation of Herbal Medicines - Report of a WHO Global Survey
(2005; 168 pages) Ver el documento en el formato PDF
Índice de contenido
Ver el documentoAcknowledgements
Ver el documentoExecutive summary
Ver el documentoAcronyms, abbreviations and definitions
Ver el documentoWHO Regions
Abrir esta carpeta y ver su contenido1. Introduction
Abrir esta carpeta y ver su contenido2. National policy on traditional medicine and complementary/alternative medicine
Cerrar esta carpeta3. The regulatory situation of herbal medicines
Ver el documento3.1 Law or regulation on herbal medicines
Ver el documento3.2 Regulatory status of herbal medicines
Ver el documento3.3 Claims
Ver el documento3.4 Pharmacopoeias
Ver el documento3.5 Monographs on herbal medicines
Ver el documento3.6 Manufacture of herbal medicines
Ver el documento3.7 Safety and herbal medicines
Ver el documento3.8 Registration system for herbal medicines
Ver el documento3.9 Herbal medicines and the essential drug list
Ver el documento3.10 Post marketing surveillance of herbal medicines
Ver el documento3.11 The sale of herbal medicines
Ver el documento3.12 Annual market sales of herbal medicines
Abrir esta carpeta y ver su contenido4. Member States, WHO and herbal medicines
Abrir esta carpeta y ver su contenido5. Country summaries
Ver el documentoReferences
Ver el documentoAnnex 1. Text of survey instrument
 

3.3 Claims

These questions focused on the types of claims that may be made about herbal medicines under laws or regulations. Definitions of the different types of claims were provided on the survey form. The possible categories of claims were medical claims, health claims, nutrient content claims, structure/function claims, no claims or other claims.

For the purposes of this study, medical claims are defined as those claims specified to treat, cure or prevent a disease or restore, correct or modify physiological functions. Most often products with medical claims have to be registered by the medical products agency before they may be placed on the market (9).

A definition for health claims was given in the survey, based on the one developed by the Swedish Food Administration (10), which states that health claims include any statement, suggestion or implication in labelling or advertising that a product carries a specific health benefit, but not nutritional claims nor medicinal claims. The term health claim further includes claims that refer to nutrient function and recommended dietary practice.

Nutrient content claims involve the indication that a particular product is rich or low in a nutritional component, such as fibre or fat (10). Structure/function claims link a substance to an effect on a structure or function of the body (8).

Member States were first asked whether claims could be made about herbal medicines in their country; if they answered “yes”, they were then asked to choose those categories of claims that could be made in accordance with the law or regulation for herbal medicines. An overwhelming majority of responding countries indicated that herbal medicines are sold with claims (73%, 103 countries, see Figure 16).


Figure 16. Number of Member States that allow the sale of herbal medicines with claims

Of those countries indicating that herbal medicines are sold with claims, all 103 provided details about the categories of claims that are allowed by law or regulation (Figure 17). The most common claims made are medical claims, which was chosen by 87% of the responding countries. Health claims were indicated by 60% of the countries, followed by nutrient content claims and structure/function claims, chosen by 48% and 38% of the countries, respectively.

Six countries choose the option of including other claim categories; those given include the following: cultural use claims, effects against bewitchment, sorcery and accidents, cosmetic claims and traditional use claims.

While the results clearly indicate a tendency for medical and health claims to be made for herbal medicines, there is also a clearly a problem with the way the question was worded and interpreted. The form of the question clearly indicates that the claims chosen should represent only those allowable by law or regulation, yet several countries chose claim categories as well as the category “No claim can be made according to the law”.

The meaning of these responses is complex. As five countries who chose “no claim” and other claim categories have more than one regulatory category, it would seem that different regulatory statuses could have specific claims which may be made by law. However, there is a chance that the question may have been misinterpreted, with countries selecting claims that are made about herbal medicines that are not necessarily regulated or sanctioned by law, but rather represent claims made without regulatory oversight or requirements.


Figure 17. Types of claims legally allowed

Ir a la sección anterior
Ir a la siguiente sección
 
 
El Portal de Información - Medicamentos Esenciales y Productos de Salud de la OMS fue diseñado y es mantenido por la ONG Human Info. Última actualización: le 29 agosto 2014