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Quality problems

When you buy a bottle of aspirin and it says that it contains 90 tablets, each one of which contains 50mg of aspirin, you can be reasonably confident, within a few percentage points, that is what you will be consuming. This is because any legal manufacturer will be licensed for this, on the condition that he can be inspected at any time and must provide proof that each step of the manufacture was monitored and that the starting materials were all accounted for in the final product. Failure to comply with the terms of inspection will lead to the manufacturer having his licence withdrawn and he will go out of business.

In many parts of the world there are no such controls on the manufacture of herbal products. There is a real possibility that the herbal product you have just bought does not contain what is stated on the label.

In studies on herbal products bought in USA stores, conducted by the independent quality monitoring service consumerlab.com, 10 of 16 valerian products tested were inferior. Substandard or adulterated samples were also seen in 12 out of 19 ginseng products, 5 out of 11 echinacea products, and 6 out of 14 St John’s wort products. Similar levels of substandard products have been identified in unregulated markets in other parts of the world. For example about a third of black cohosh sold around the world may be related species of Actaea from Asia with different and potentially dangerous properties. Adulteration of several Chinese herb remedies with potentially kidney-harming Aristolochia or fang chi is still identified many years after this issue was highlighted in a serious outbreak of kidney failure and cancer in Belgium.

In the USA and many other countries around the world there is no requirement that the manufacturer of herbal products has to meet independent quality criteria. (However in coming years the Food and Drug Administration will require herbal manufacturers to meet the requirements of food manufacturing practice.) By contrast in the European Union some herbs may be classified as Herbal Medicinal Products and their manufacture has to meet medicinal standards. Similar requirements apply for herbal products sold with therapeutic intent in Japan, Australia, and Canada.

The standards required for the production of medicines are known as pharmaceutical Good Manufacturing Practice (pGMP). It is important to note that no company can claim to comply with pGMP unless there is a regulatory framework for this: pGMP involves external verification of standards. It only works with the surprise knock on the door from an inspector outside the company.

Pharmaceutical GMP is a specialized system of quality assurance which is extremely exacting and comprehensive. Manufacturers operating under pharmaceutical GMP must comply with a code of practice. Procedures and observances under GMP include:

  • validation of equipment and processes;
  • documented Standard Operating Procedures covering every aspect of manufacture;
  • documented cleaning and calibration logs for equipment;
  • control of the manufacturing environment, air and water;
  • quarantining and unique identification and testing of raw materials, labels and packaging;
  • in the case of herbal ingredients, identification must be confirmed by comparison with a verified reference material for that particular plant part and species;
  • discrete batch identification for products;
  • comprehensive batch record documentation;
  • reconciliation of raw materials, product, packaging and labels;
  • quarantining and testing of finished products;
  • documented release-for-sale procedures;
  • testing of stability of finished products;
  • documentation of customer complaints and recall procedures.
  • in the case of plant products testing for microbiological quality and screening for contaminants such as pesticides, heavy metals and radioactivity.

The need for such standards is clear. Throughout history manufacturers of medicines have been found wanting. Severe penalties were listed for substandard manufacture in ancient Egypt, Greece and other early civilisations; independent systems of monitoring have been set up around the world for over a thousand years, and in 1841 Jacob Bell, founder the Royal Pharmaceutical Society of Great Britain, noted “In reviewing the history of pharmacy in all ages we find that fraud has always prevailed to a remarkable extent”.

The main problem in the variation in quality standards is that it is extremely difficult for most people to know which products are good. In most sales outlets around the world high quality and unregulated products are mixed together with only the higher price of certified quality being a guide. Matters are made worse with sometimes spurious claims for quality from the unregulated sector, claims that the consumer finds impossible to verify.

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contact us           Where to find us? Last Updated: 14 September 2011