Herbal Remedies: Consumer Protection Concerns
"Suitable for migraine, kidney stones, sexual stress, frost-bite..."
Von Kumariah Balasubramaniam / Health Action International HAI
There are more effective, safe and good quality modern pharmaceuticals available today than ever before. However, it is paradoxical that consumers, particularly in the developed countries, are purchasing and using more and more herbal remedies. There is evidence that some of the herbal remedies in the market are not safe, effective and of good quality. This raises the issue of consumer safety.
"Maintains Healthy Cholesterol: Reduces Total Cholesterol, Reduces LDL ‘Bad’ Cholesterol, Reduces Triglycerides and Increases HDL ‘Good’ Cholesterol." - "Suitable for migraine, weak heart, hernia, menstrual pain, kidney stones, rheumatism, sexual stress, impotence, frost-bite, internal and external cancer and infection." The first claim appears on the label of Cholestin, a recently launched cholesterol lowering natural ‘dietary supplement’ in the US. The second is an advertisement for ‘Tea of Longevity’, a herbal tea, which appeared in a daily newspaper in Malaysia in 1995. A 150 mg pack of this herbal tea costs between RM160-240 (US$ 50-80). This is equivalent to about 10 days wages of an unskilled worker in Malaysia. These health claims have not been approved by the respective drug regulatory agencies in either country. They are addressed directly to the consumer and reflect the major concerns consumers have on the way herbal remedies are marketed. The extent of consumer concern is also evident from the fact that since 1990 the US Congress has received more mail on the regulation of herbal remedies than any other issues including Bosnia, the Gulf War, Somalia, gun control, tax reform and health care reform!
What herbal remedies are the people in advanced industrialised countries such as the US and Western Europe and those in poor developing countries in sub-Saharan Africa and South Asia, consuming? The morbidity patterns are different and so is the pattern of utilisation of modern pharmaceuticals between developed and developing countries. What then is the pattern of utilisation of herbal remedies, and what are the consumer concerns in these countries?
To examine, study and analyse the utilisation of herbal remedies in developed and developing countries, it will be useful to classify herbal remedies into the following three categories: Phytomedicines sold as over-the-counter products in modern dosage forms; dietary supplements, containing herbal products, in modern dosage forms; and traditional medicine, consisting of either crude, semi-processed or processed medicinal plants and herbs. Phytomedicines and dietary supplements are used by consumers in developed countries and those in the urban areas of developing countries.
The traditional medicine are available at two levels:
- Traditional beliefs, norms and practices based on centuries old experiences of trials and errors, successes and failures at the household level. These are passed through oral tradition and may be called, "people’s health culture", home remedies or folk remedies. These have a vital place in primary health care in developing countries. A very good example was the universal availability of home made, cereal based oral rehydrating fluids in all cultures in developing countries till they were displaced by the commercial varieties of oral rehydrating solutions which have been skillfully and aggressively marketed by the drug industry.
- A codified system of traditional medicine at the level of the traditional healer.
Herbal remedies and traditional medicine
In the context of developing countries, consumer protection concerns cannot be realistically studied by examining herbal remedies in isolation. They should be taken together with traditional medicine. Traditional medicine includes the indigenous knowledge available in the community, the traditional healers and the means by which they provide health care, namely herbal remedies. Consumer protection and safety are closely related to herbal remedies, the prescribing practices of traditional healers and the health care systems in which they operate.
Traditional medicine, according to the World Health Organization (WHO) is believed to serve the health needs of about 80 per cent of the world’s population. It is relevant to note that in the US because of the difficulty of approving herbs as over-the-counter drugs and the limitations placed on health claims for dietary supplements, particularly for herbs, there is a suggestion to create a third category - traditional medicines.
While there is a distinct difference between the patterns of utilisation of traditional medicine/herbal remedies in the developed and developing countries, consumer concerns are the same the world over. These include: safety; efficacy; quality; costs; unethical promotion; and irrational use of traditional medicine and herbal remedies.
Consumers believe that sharing of information on consumer protection measures between developed and developing countries would be advantageous to both for the following reasons:
- Developed countries have effective and efficient regulatory control over modern pharmaceuticals. These may serve as useful models to enact appropriate legislation to regulate herbal remedies;
- Developing countries have had several centuries of experience with the use of traditional medicine in health care. developed countries may find this experience useful;
- Neither developed nor developing countries have an effective regulatory mechanism to ensure the safety, effiacacy and quality of herbal remedies;
- Almost all herbal remedies marketed in developed and developing countries are OTC products, although some of these are known to be toxic;
- In both developed and developing countries a herbal medicine, if marketed as food, is not regulatet; but if the same product is marketed as a traditional medicine, it is regulated;
- In all developed and most developing countries, there are no systems, self-regulatory or otherwise, for the training, certification and registration of traditional healers or herbalists. Consumers have no guarantee that the traditional healer or the herbalists whom theyy visit to obtain health care have the necessary qualifications.
In both developed and developing countries, there are no comprehensive integrated national policies on herbal remedies to regulate the market and ensure that all herbal remedies in the market are safe, effective, of good quality, of reasonable cost and are used rationally. Policy recommendations have to be based on a critical analysis of empirical data on traditional medicine and herbal remedies in developed and developing countries. This data will include patterns of utilisation and consumers’ perceptions of traditional medicines and herbal remedies; existing legislation to control and regulate the herbal remedies market; the marketing and promotional practices of the herbal drug industry; the training, certification and registration of traditional healers and herbalists; and the role that traditional medicines and herbal remedies play in the overall health care services of a country in providing health care to its people.
A major recommendation follows from this conclusion - the need for guidelines on developing national policies on herbal remedies. These guidelines can serve as a model for individual countries to develop their own national policies on traditional medicines and herbal remedies including appropriate legislation.
Extract of an article by Dr Kumariah Balasubramaniam published in "Hai news", No. 97, October 1997. The full text includes the lay-out of guidelines on developing national policies on herbal remedies. Balasubramaniam is the Pharmaceutical Advisor of the Consumers International Regional Office for Asia and the Pacific (CI-ROAP) in Penang, Malaysia, and co-editor of Hai news.