Reliance on pre-packaged self-medication is not a modern phenomenon. In earlier centuries those who could not afford physicians’ fees bought their ready-made remedies from peddlers in the market place. The difference is that, instead of being mixed by peddlers and apothecaries, today’s products are processed in factories and distributed by wholesalers in the same way as prescription drugs. Vitamins, minerals, diet supplements, plus herbal and homeopathic remedies, are all pre-processed to some extent and pre-packaged for our convenience. Processing raising the question of what the term ‘natural’ means. It is widely used on OTC labels suggesting that swallowing a ‘natural’ product is much better than one that is factory or laboratory produced.
Herbal remedies are valued as ‘natural’ medications because they are derived from plants, but ironically it is this very characteristic that makes them variable in quality and composition. Not only that – herbs ‘naturally’ have built in microbial flora to protect them from predators which may cause unwanted effects in humans. The constituents of raw herbs ‘naturally’ vary. Active ingredients are influenced by the soil content in which they are grown, the time they are harvested, the use of pesticides or the part of plant that is used. Root herbs and those harvested at ground level are prone to contamination from the soil in which they grow. For example, herbal teas made of nettles and those made from valerian root have been found to contain faecal matter and grit.[ix] Herbs, like other plants are subject to deterioration and decomposition. So, to ensure purity and maintain their quality, most herbals are processed to some extent. Finding out how OTC remedies are processed and packaged helps us to understand a few of the possible pitfalls in self-medication.
All medicine, whether it is prescribed by a doctor or sold over-the-counter, includes one or more active ingredients. The active chemical substance is usually referred to as a ‘drug’, since it affects the processes of the mind or body, and is used in the treatment or prevention of disease or other conditions that are considered abnormal or unhealthy. Sometimes another substance is added to make the ingredients more stable and convenient for use.[x] But the main processing methods used today are those pioneered by the eighth century Arab pharmacists. Infusion, evaporation and distillation are used to produce extracts, so that the remedies can be sold in the form of pills, syrups, tinctures and pastes. Vitamins are also processed, although some are synthesized. Minerals usually undergo transformation into compounds to make them more palatable or more readily absorbed. The main processing difference is that modern technology is employed.
Consumers have no way of knowing whether OTC medications are properly labelled or carefully manufactured—we take them on trust. Unfortunately, the herbal industry is so competitive and profitable; this leads to some disreputable practices. Substitution of cheaper ingredients is not uncommon. There are instances of inadequate labelling, inadequate measurement of active ingredients, and unjustifiable claims of efficacy. Careless production in the effort to make a quick profit is a recipe for low quality products. Fortunately, in all developed countries there are statutory authorities whose job it is to protect us from inadequate processing procedures and fraud.
Vigilance by statutory authorities, such as the US Food and Drug Administration (FDA), is vital. The FDA polices the various consumer protection laws on labelling and processing. The FDA provides a database, Natural Products Alert (NAPRALERT) which regularly publishes warnings about products. One American state has challenged this activity on the grounds that the FDA is restricting the public’s right of access to remedies and is therefore restricting trade. An ‘Access to Medical Treatment Act’ was introduced in Minnesota to prevent the FDA from interfering with the sale and distribution of unproven drugs and devices. While this challenge may have some validity, the product warnings provide such a useful service to consumers that other countries have similar authorities.
In all western countries, information on drug alerts or product withdrawals is promulgated through newspaper advertisements and the internet. In the UK the Food Standards Agency, established by an Act of Parliament in 2000, has a similar role to the FDA. The National Poisons Unit provides a database of adverse effects. In Australia the Therapeutic Goods Administration (TGA) oversees dietary supplements and complementary medicines. The Australia Register of Therapeutic Goods (ARTG) lists medicines considered to be low risk and registers those that fall outside this category. For example, three hundred and nineteen gingko preparations, seven hundred and eighty-four fish oil dietary supplements and twenty-four varieties of saw palmetto products are low-risk listed, whereas pills containing codeine are registered.
The TGA publishes ‘Urgent medicine and medical device recall notices’ that have three categories of urgency. The vital contribution of these services is illustrated by three stories of product investigations—two occurred in Australia and the other in the United States of America:
In January 2003, the TGA became aware of adverse reactions to a travel sickness remedy. Of the eighty-seven consumers who had taken a particular batch of the preparation, nineteen were hospitalized with a variety of symptoms including hallucination, disorientation, hysteria and vomiting. The tablets were immediately recalled from the market. Known as Travacalm, this travel sickness remedy was produced by Pan Pharmaceuticals, the largest manufacturer of OTC herbal products in Australia. The TGA commenced an exhaustive investigation of all Pan Pharmaceuticals products seizing computer records and auditing manufacturing procedures. It found serious irregularities such as a lack of adequate testing and the manipulation of test results for a number of ingredients. There was also substitution of ingredients from unauthorized sources, a lack of proper cleaning practices when switching from production of one product to another, and a lack of control of the amount of active ingredients. Some Travacalm tablets were reported to have seven times the prescribed amount of hyascine while others had none.[xi]
By April 2003, more than seven hundred products had been withdrawn from retailers’ shelves and a twenty-four-hour consumer ‘helpline’ was opened. The TGA list of the recalled products covered several broadsheet pages in The Age. The recall was complicated. Many products were sold under the labels of at least ten different companies in Australia and overseas, all of which had to be identified and notified. The manufacturing company had their licence suspended for six months pending further investigations and later went into liquidation. Although other Australian manufacturers have a blemish-free reputation and continue manufacturing, the effect of the recall devastated retailers. Trust in herbal remedies declined to such an extent that sales dropped by thirty per cent.
Stories about the lack of proper product control are certainly not uncommon. In the US, it was found that out of twenty-five echinacea (purple coneflower or Sampson root) products purchased between October and November 2000, six did not have adequate ingredient labelling as required by law. Five of the remaining nineteen samples failed tests because they either did not have the expected levels of a constituent they were supposed to contain, or had no detectable levels of one or more of the constituents.[xii] Plant substitution has also been a problem. It has been estimated that fifty to ninety per cent of echinacea sold in the USA, up until 1991, was actually Missouri snakeroot (an American Indian herb).
The lack of an active ingredient in thirty-eight bottles of Vital brand Vitamin B Complex capsules was potentially far more serious. Many women of childbearing age take foliate supplements to help prevent birth defects of the brain and spinal cord, such as the neural tube defects associated with spina bifida. The label on this product mentioned that supplementation is recommended when the body might be low in nutrients and cited pregnancy as one example. The label also suggested that one capsule containing four hundred micrograms of folic acid was the recommended dose per day. Alas, the capsules labelled as containing four hundred micrograms of folic acid contained only forty micrograms.
Control of the labelling and processing of herbal remedies is difficult because many plants are known by more than one name, often depending on the country or region of origin. Naming problems not only confuse consumers, they can lead to inappropriate substitution by producers, either ignorantly or deliberately, as a cheaper alternative. Unscrupulous producers can also include additives that do not appear on the label. For example, non-herbal substances, such as prescription drugs or toxic metals (mercury) have been found in imports labelled ‘Chinese herbal medicine’, although they were manufactured in other Asian countries. In some cases of imported herbs, unwitting