One who may receive or is receiving services.
Nutritional Profile Energy value (calories per serving): Moderate Protein: High Fat: High Saturated fat: Moderate Cholesterol: High Carbohydrates: Low Fiber: None Sodium: Moderate to high Major vitamin contribution: Vitamin A, riboflavin, vitamin D Major mineral contribution: Iron, calcium
About the Nutrients in This Food An egg is really three separate foods, the whole egg, the white, and the yolk, each with its own distinct nutritional profile. A whole egg is a high-fat, high-cholesterol, high-quality protein food packaged in a high-calcium shell that can be ground and added to any recipe. The proteins in eggs, with sufficient amounts of all the essential amino acids, are 99 percent digestible, the standard by which all other proteins are judged. The egg white is a high-protein, low-fat food with virtually no cholesterol. Its only important vitamin is riboflavin (vitamin B2), a vis- ible vitamin that gives egg white a slightly greenish cast. Raw egg whites contain avidin, an antinutrient that binds biotin a B complex vitamin for- merly known as vitamin H, into an insoluble compound. Cooking the egg inactivates avidin. An egg yolk is a high-fat, high-cholesterol, high-protein food, a good source of vitamin A derived from carotenes eaten by the laying hen, plus vitamin D, B vitamins, and heme iron, the form of iron most easily absorbed by your body. One large whole egg (50 g/1.8 ounce) has five grams fat (1.5 g satu- rated fat, 1.9 g monounsaturated fat, 0.7 g polyunsaturated fat), 212 mg cholesterol, 244 IU vitamin A (11 percent of the R DA for a woman, 9 percent * Values are for a whole egg. of the R DA for a man), 0.9 mg iron (5 percent of the R DA for a woman, 11 percent of the R DA for a man) and seven grams protein. The fat in the egg is all in the yolk. The protein is divided: four grams in the white, three grams in the yolk.
The Most Nutritious Way to Serve This Food With extra whites and fewer yolks to lower the fat and cholesterol per serving.
Diets That May Restrict or Exclude This Food Controlled-fat, low-cholesterol diet Low-protein diet
Buying This Food Look for: Eggs stored in the refrigerated dair y case. Check the date for freshness. NOTE : In 1998, the FDA and USDA Food Safety and Inspection Service (FSIS) proposed new rules that would require distributors to keep eggs refrigerated on the way to the store and require stores to keep eggs in a refrigerated case. The egg package must have a “refrigera- tion required” label plus safe-handling instructions on eggs that have not been treated to kill Salmonella. Look for: Eggs that fit your needs. Eggs are graded by the size of the yolk and the thick- ness of the white, qualities that affect appearance but not nutritional values. The higher the grade, the thicker the yolk and the thicker the white will be when you cook the egg. A Grade A A egg fried sunny side up will look much more attractive than a Grade B egg prepared the same way, but both will be equally nutritions. Egg sizes ( Jumbo, Extra large, Large, Medium, Small) are determined by how much the eggs weigh per dozen. The color of the egg’s shell depends on the breed of the hen that laid the egg and has nothing to do with the egg’s food value.
Storing This Food Store fresh eggs with the small end down so that the yolk is completely submerged in the egg white (which contains antibacterial properties, nature’s protection for the yolk—or a developing chick embryo in a fertilized egg). Never wash eggs before storing them: The water will make the egg shell more porous, allowing harmful microorganisms to enter. Store separated leftover yolks and whites in small, tightly covered containers in the refrigerator, where they may stay fresh for up to a week. Raw eggs are very susceptible to Salmonella and other bacterial contamination; discard any egg that looks or smells the least bit unusual. Refrigerate hard-cooked eggs, including decorated Easter eggs. They, too, are suscep- tible to Salmonella contamination and should never be left at room temperature.
Preparing This Food First, find out how fresh the eggs really are. The freshest ones are the eggs that sink and lie flat on their sides when submerged in cool water. These eggs can be used for any dish. By the time the egg is a week old, the air pocket inside, near the broad end, has expanded so that the broad end tilts up as the egg is submerged in cool water. The yolk and the white inside have begun to separate; these eggs are easier to peel when hard-cooked. A week or two later, the egg’s air pocket has expanded enough to cause the broad end of the egg to point straight up when you put the egg in water. By now the egg is runny and should be used in sauces where it doesn’t matter if it isn’t picture-perfect. After four weeks, the egg will float. Throw it away. Eggs are easily contaminated with Salmonella microorganisms that can slip through an intact shell. never eat or serve a dish or bever age containing r aw fr esh eggs. sa lmonella is destroyed by cooking eggs to an inter nal temper atur e of 145°f ; egg-milk dishes such as custar ds must be cooked to an inter nal temper atur e of 160°f. If you separate fresh eggs by hand, wash your hands thoroughly before touching other food, dishes, or cooking tools. When you have finished preparing raw eggs, wash your hands and all utensils thoroughly with soap and hot water. never stir cooked eggs with a utensil used on r aw eggs. When you whip an egg white, you change the structure of its protein molecules which unfold, breaking bonds between atoms on the same molecule and forming new bonds to atoms on adjacent molecules. The result is a network of protein molecules that hardens around air trapped in bubbles in the net. If you beat the whites too long, the foam will turn stiff enough to hold its shape even if you don’t cook it, but it will be too stiff to expand natu- rally if you heat it, as in a soufflé. When you do cook properly whipped egg white foam, the hot air inside the bubbles will expand. Ovalbumin, an elastic protein in the white, allows the bubble walls to bulge outward until they are cooked firm and the network is stabilized as a puff y soufflé. The bowl in which you whip the whites should be absolutely free of fat or grease, since the fat molecules will surround the protein molecules in the egg white and keep them from linking up together to form a puff y white foam. Eggs whites will react with metal ions from the surface of an aluminum bowl to form dark particles that discolor the egg-white foam. You can whip eggs successfully in an enamel or glass bowl, but they will do best in a copper bowl because copper ions bind to the egg and stabilize the foam.
What Happens When You Cook This Food When you heat a whole egg, its protein molecules behave exactly as they do when you whip an egg white. They unfold, form new bonds, and create a protein network, this time with molecules of water caught in the net. As the egg cooks, the protein network tightens, squeez- ing out moisture, and the egg becomes opaque. The longer you cook the egg, the tighter the network will be. If you cook the egg too long, the protein network will contract strongly enough to force out all the moisture. That is why overcooked egg custards run and why overcooked eggs are rubbery. If you mix eggs with milk or water before you cook them, the molecules of liquid will surround and separate the egg’s protein molecules so that it takes more energy (higher heat) to make the protein molecules coagulate. Scrambled eggs made with milk are softer than plain scrambled eggs cooked at the same temperature. When you boil an egg in its shell, the air inside expands and begins to escape through the shell as tiny bubbles. Sometimes, however, the force of the air is enough to crack the shell. Since there’s no way for you to tell in advance whether any particular egg is strong enough to resist the pressure of the bubbling air, the best solution is to create a safety vent by sticking a pin through the broad end of the egg before you start to boil it. Or you can slow the rate at which the air inside the shell expands by starting the egg in cold water and letting it warm up naturally as the water warms rather than plunging it cold into boiling water—which makes the air expand so quickly that the shell is virtually certain to crack. As the egg heats, a little bit of the protein in its white will decompose, releasing sulfur that links up with hydrogen in the egg, forming hydrogen sulfide, the gas that gives rot- ten eggs their distinctive smell. The hydrogen sulfide collects near the coolest part of the egg—the yolk. The yolk contains iron, which now displaces the hydrogen in the hydrogen sulfide to form a green iron-sulfide ring around the hard-cooked yolk.
How Other Kinds of Processing Affect This Food Egg substitutes. Fat-free, cholesterol-free egg substitutes are made of pasteurized egg whites, plus artificial or natural colors, flavors, and texturizers (food gums) to make the product look and taste like eggs, plus vitamins and minerals to produce the nutritional equivalent of a full egg. Pasteurized egg substitutes may be used without additional cooking, that is, in salad dressings and eggnog. Drying. Dried eggs have virtually the same nutritive value as fresh eggs. Always refrigerate dried eggs in an air- and moistureproof container. At room temperature, they will lose about a third of their vitamin A in six months.
Medical Uses and/or Benefits Protein source. The protein in eggs, like protein from all animal foods, is complete. That is, protein from animal foods provides all the essential amino acids required by human beings. In fact, the protein from eggs is so well absorbed and utilized by the human body that it is considered the standard by which all other dietary protein is measured. On a scale known as biological value, eggs rank 100 ; milk, 93; beef and fish, 75; and poultry, 72. Vision protection. The egg yolk is a rich source of the yellow-orange carotenoid pigments lutein and zeaxanthin. Both appear to play a role in protecting the eyes from damaging ultraviolet light, thus reducing the risk of cataracts and age-related macular degeneration, a leading cause of vision of loss in one-third of all Americans older than 75. Just 1.3 egg yolks a day appear to increase blood levels of lutein and zeaxanthin by up to 128 percent. Perhaps as a result, data released by the National Eye Institute’s 6,000-person Beaver Dam ( Wisconsin) Eye Study in 2003 indicated that egg consumption was inversely associated with cataract risk in study participants who were younger than 65 years of age when the study started. The relative risk of cataracts was 0.4 for people in the highest category of egg consumption, compared to a risk of 1.0 for those in the lowest category. External cosmetic effects. Beaten egg whites can be used as a facial mask to make your skin look smoother temporarily. The mask works because the egg proteins constrict as they dry on your face, pulling at the dried layer of cells on top of your skin. When you wash off the egg white, you also wash off some of these loose cells. Used in a rinse or shampoo, the pro- tein in a beaten raw egg can make your hair look smoother and shinier temporarily by filling in chinks and notches on the hair shaft.
Adverse Effects Associated with This Food Increased risk of cardiovascular disease. Although egg yolks are high in cholesterol, data from several recent studies suggest that eating eggs may not increase the risk of heart disease. In 2003, a report from a 14-year, 177,000-plus person study at the Harvard School of Public Health showed that people who eat one egg a day have exactly the same risk of heart disease as those who eat one egg or fewer per week. A similar report from the Multiple R isk Factor Intervention Trial showed an inverse relationship between egg consumption and cholesterol levels—that is, people who ate more eggs had lower cholesterol levels. Nonetheless, in 2006 the National Heart, Lung, and Blood Institute still recommends no more than four egg yolks a week (including the yolk in baked goods) for a heart-healthy diet. The American Heart Association says consumers can have one whole egg a day if they limit cholesterol from other sources to the amount suggested by the National Cholesterol Education Project following the Step I and Step II diets. (Both groups permit an unlimited number of egg whites.) The Step I diet provides no more than 30 percent of total daily calories from fat, no more than 10 percent of total daily calories from saturated fat, and no more than 300 mg of cholesterol per day. It is designed for healthy people whose cholesterol is in the range of 200 –239 mg/dL. The Step II diet provides 25– 35 percent of total calories from fat, less than 7 percent of total calories from saturated fat, up to 10 percent of total calories from polyunsaturated fat, up to 20 percent of total calories from monounsaturated fat, and less than 300 mg cho- lesterol per day. This stricter regimen is designed for people who have one or more of the following conditions: • Existing cardiovascular disease • High levels of low-density lipoproteins (LDLs, or “bad” cholesterol) or low levels of high-density lipoproteins (HDLs, or “good” cholesterol) • Obesity • Type 1 diabetes (insulin-dependent diabetes, or diabetes mellitus) • Metabolic syndrome, a.k.a. insulin resistance syndrome, a cluster of risk fac- tors that includes type 2 diabetes (non-insulin-dependent diabetes) Food poisoning. Raw eggs (see above) and egg-rich foods such as custards and cream pies are excellent media for microorganisms, including the ones that cause food poisoning. To protect yourself against egg-related poisoning, always cook eggs thoroughly: poach them five minutes over boiling water or boil at least seven minutes or fry two to three minutes on each side (no runny center) or scramble until firm. Bread with egg coating, such as French toast, should be cooked crisp. Custards should be firm and, once cooked, served very hot or refrigerated and served very cold. Allergic reaction. According to the Merck Manual, eggs are one of the 12 foods most likely to trigger the classic food allergy symptoms: hives, swelling of the lips and eyes, and upset stomach. The others are berries (blackberries, blueberries, raspberries, strawberries), choco- late, corn, fish, legumes (green peas, lima beans, peanuts, soybeans), milk, nuts, peaches, pork, shellfish, and wheat (see wheat cer ea ls).
Food/Drug Interactions Sensitivity to vaccines. Live-virus measles vaccine, live-virus mumps vaccine, and the vac- cines for influenza are grown in either chick embryo or egg culture. They may all contain minute residual amounts of egg proteins that may provoke a hypersensitivity reaction in people with a history of anaphylactic reactions to eggs (hives, swelling of the mouth and throat, difficulty breathing, a drop in blood pressure, or shock).... eggs
Action: choleretic, hepatic, circulatory stimulant.
Uses: Circulatory disorders, varicose veins, menstrual problems, to protect against hardening of the liver in alcohol consumers. Rheumatism, gout. Heavy legs.
Preparations: Tea: 1 teaspoon to each cup boiling water; infuse 15 minutes. Dose: half a cup thrice daily. Powder, capsules: 250mg. 3 capsules thrice daily before meals. (Arkocaps) ... chrysanthemum (golden)
Healthwatch England website... healthwatch england
Treatment The disease is prevented or cured by adding to the diet, foods such as fresh meat, eggs, milk, liver, and yeast extracts, as well as nicotinic acid – in addition to improving the general conditions of life.... pellagra
In Britain, for instance, preventive medicine is usually taken to encompass a range of activities whose purpose is:
to reduce the chance of a person contracting a disease or becoming disabled.
to identify either an increased susceptibility to develop a disease, or an early manifestation of a disease at a stage which will still allow treatment to be e?ective. The American College of Preventive Medi
cine (1983) de?ned it as ‘a specialised ?eld of medical practice composed of distinct disciplines which utilise skills focusing on the health of de?ned populations in order to promote and maintain health and well-being and to prevent disease, disability and premature death’.
However de?ned, the spectrum of activities encompassed by preventive medicine is wide and includes actions, such as counselling about lifestyle, where there may not be a clear cut-o? between a preventive and a curative act. For example, advice about smoking and exercise to a recent victim of a myocardial infarction (see under HEART, DISEASES OF) is both essential to treatment and preventive against a future attack. Action aimed at a whole population – such as the addition of ?uoride to drinking-water to protect against dental caries (see under TEETH, DISORDERS OF) – is part of a population-based public-health strategy but would also be widely regarded as preventive medicine.
A common and widely accepted classi?cation of preventive medicine is as follows:
Primary prevention which aims at the complete avoidance of a disease (for example, by immunising a child against an infectious disease – see IMMUNISATION).
Secondary prevention which aims at detecting and curing a disease at an early stage before it has caused any symptoms. This requires ‘screening’ procedures to detect either the early pre-symptomatic condition, or a risk factor which may lead to it. (An example of the former is cervical cytology, where a sample of cells is scraped from the cervix of the UTERUS and examined microscopically for abnormality.
An example of the latter is CHOLESTEROL measurement as part of assessing an individual’s risk of developing ischaemic heart disease (see under HEART, DISEASES OF). If it is signi?cantly raised, dietary or drug treatment can be advised.)
Tertiary prevention aims at minimising the consequences for a patient who already has the disease (e.g. advising people to take more exercise and stop smoking after a heart attack).
Many prefer to limit the term ‘preventive medicine’ to primary and secondary prevention, emphasising the focus on risk-reducing interventions targeted at ‘well’ individuals. Others prefer the wider emphasis because of the importance of a preventive approach in reducing further disability by recognising and treating symptoms early. This can be particularly important in older people, where, for example, vigorous treatment of an orthopaedic problem can enable the patient to maintain physical mobility with all the bene?ts to health that brings. Whether primary, secondary or tertiary prevention, some form of screening question or test is normally necessary to identify a problem.
The range and extent of opportunities for prevention are expanding as research identi?es the causes of diseases and more e?ective treatment becomes feasible. Inevitably there is economic and political debate about the cost-e?ectiveness of prevention versus cure, as well as about the ETHICS. The situation varies in relation to the natural history of the speci?c disease. Some conditions can easily be prevented but once contracted cannot be cured
(e.g. RABIES); others are easily cured but are not yet preventable.
Screening Screening involves carrying out tests either to identify a treatable disease at a very early stage, before it has caused symptoms or damage; or to identify a risk factor which can lead to a disease. The tests might be by simple questioning (e.g. ‘Do you smoke cigarettes?’ – this predicts a considerable increase in the risk of chronic bronchitis, heart disease, bronchial cancer and many other diseases, and enables targeted advice and help to stop smoking to be given). Other screening tests involve carrying out complex special investigations such as blood tests or the microscopic investigations of cells – for example, for precancerous changes.
Many conditions can be identi?ed at an early stage before they cause symptoms or signs of disease and in time for e?ective treatment to be carried out. Inevitably, some of the screening tests proposed can be expensive (particularly if used in large populations), painful or inaccurate and may not improve the results of treatment. Screening can also provoke considerable anxiety in those waiting for tests or results. Therefore, over the years considerable research has been carried out into the appropriateness and ethics of screening, and the World Health Organisation in 1968 identi?ed a set of rules for evaluating screening tests:
The condition sought should be an important health problem, for which there should be an accepted treatment for patients with recognised disease.
Facilities for diagnosis and treatment should be available if a case is found.
The screening test or examination must be suitable and valid. A false positive test will cause massive anxiety and also considerable expense in proving that there is no disease. Similarly, false negatives can lead people to be reassured and to ignore serious symptoms until too late. If large numbers of positive tests or false positives occur during a screening programme, health services can be swamped.
The test, and any treatment as a possible result, should be acceptable. For example, there is little point in screening for a fetal abnormality which, if found, would lead to a recommendation for termination if the mother will refuse it on religious or moral grounds.
Screening tests also need to be considered from an economic perspective and the cost of case-?nding (including diagnosis and treatment of patients diagnosed) balanced in relation to possible expenditure on medical care as a whole.
Finally the programme should re?ect the natural history of the disease, and case-?nding should normally be a continuing process and not a ‘once for all’ project. If these rules are followed, considerable
bene?ts can result from well-planned and well-managed screening programmes, and they form an important part of any health-care system. The extent to which manipulation of genetic material will be added to more traditional approaches such as counselling, immunisation and drug treatment cannot yet be predicted but, as time goes by, it is often likely to be ethical and social controls which limit developments rather than technical and scienti?c limits.... preventive medicine
Aims and objects. To develop a coordinated scientific framework to assess phytopharmaceuticals. To promote acceptance of phytopharmaceuticals, especially within the therapy of general medical practitioners. To support and initiate clinical and experimental research in phytotherapy. To improve and extend the international accumulation of scientific and practical knowledge.
National associations represented.
Federal Republic of Germany: Gesellschaft fu?r Phytotherapie e.V.
The Netherlands: Nederlandse Vereniging voor Fytotherapie.
Belgium: Socie?te? Belge de Phytothe?rapie, Belgische Vereniging voor Phytotherapie. France: Institut Francais de Phytothe?rapie.
United Kingdom: British Herbal Medicine Association.
Switzerland: Schweizerische Medizinische Gesellschaft fu?r Phytotherapie.
The Scientific Committee, with two delegates from each member country, has embarked on a programme of compiling proposals for European monographs on the medicinal uses of plant drugs. This task is expected to take about ten years to complete.
In preparing monographs the Committee assesses information from published scientific literature together with national viewpoints as expressed by delegates or included in the results of national reviews. Leading researchers on specific plant drugs are invited to relevant meetings and their contributions substantially assist the Committee’s work. Draft monographs prepared by the Scientific Committee are circulated for appraisal and comment to an independent Board of Supervising Editors, which includes eminent academic experts in the field of phytotherapy.
The monographs are offered to regulatory authorities as a means of harmonising the medicinal uses of plant medicines within the EC and in a wider European context. Phytotherapy (Herbalism) makes an important contribution to European medicine. ... escop
The smoking of tobacco is the most serious public-health hazard in Britain today. It causes 100,000 premature deaths a year in the United Kingdom alone. In addition to the deaths caused by cigarette smoking, it is also a major cause of disability and illness in the form of myocardial infarction (see HEART, DISEASES OF), PERIPHERAL VASCULAR DISEASE, and EMPHYSEMA. Tobacco-smoking is also a serious hazard to the FETUS if the mother smokes. Furthermore, passive smoking – inhalation of other people’s tobacco smoke – has been shown to be a health hazard to non-smokers.
Composition In addition to vegetable ?bre, tobacco leaves contain a large quantity of ash, the nature of this depending predominantly upon the minerals present in the ground where the tobacco plant has been grown. Of the organic constituents, the brown ?uid alkaloid known as NICOTINE is the most important. The nicotine content of di?erent tobacco varies, and the amount absorbed depends upon whether or not the smoker inhales. Nicotine is the substance that causes a person to become addicted to tobacco smoking (see DEPENDENCE).
Tobacco smoke also contains some 16 substances capable of inducing cancer in experimental animals. One of the most important of these is benzpyrene, a strongly carcinogenic hydrocarbon. As this is present in coal tar pitch, it is commonly referred to in this context as tar. Other constituents of tobacco smoke include pyridine, ammonia and carbon monoxide.
Nicotine addiction is a life-threatening but treatable disorder, and nicotine-replacement treatment is available on NHS prescription. This includes the provision of bupropion – trade name Zyban®. The availability of this drug – which should be used with caution as it has unwelcome side-effects in some people – and the introduction of specialist smoking-cessation services to provide behavioural support to people who wish to stop smoking should result in a reduction in tobacco-related diseases. Given the critical position of nicotine in leading people to become addicted to smoking, it is anomalous that there are no e?ective government regulations covering the sales of tobacco. Because it is not a food, tobacco is not regulated by the Food Standards Agency; it is not classi?ed as a drug so is not controlled by legislation on medicines. Furthermore, despite being a consumer product, tobacco is exempt from the Consumer Protection Act (1987) and other government safety regulations. So the NHS is left to try to ameliorate the serious health consequences – lung cancer, cardiovascular disease, peripheral vascular disease, chronic bronchitis, and emphysema – of a substance for which there are no e?ective preventive measures except the willpower of the individual smoker or non-smoker. (Escalating taxation of tobacco seems to have been circumvented as a deterrent by the rising incidence of smuggling cigarettes into Britain.)
Action on Smoking and Health (ASH) is a small charity founded by the Royal College of Physicians in 1971 that attempts to alert and inform the public to the dangers of smoking and to try to prevent the disability and death which it causes.... tobacco
Alternatives. Teas. Alfalfa, Clivers, Yarrow, Motherwort.
Tablets/capsules. Poke root, Kelp, Motherwort.
Formula. Equal parts: Bladderwrack, Motherwort, Aniseed, Dandelion. Dose. Powders: 500mg (two 00 capsules or one-third teaspoon). Liquid extracts: 1 teaspoon. Tinctures: 2 teaspoons in water thrice daily. Black Cohosh. Introduced into the medical world in 1831 when members of the North American Eclectic School of physicians effectively treated cases of fatty heart.
Diet. Vegetarian protein foods, high-fibre, whole grains, seed sprouts, lecithin, soya products, low-fat yoghurt, plenty of raw fruit and vegetables, unrefined carbohydrates. Oily fish: see entry. Dandelion coffee. Reject: alcohol, coffee, salt, sugar, fried foods, all dairy products except yoghurt.
Supplements. Daily. Broad-spectrum multivitamin including Vitamins A, B-complex, B3, B6, C (with bioflavonoids), E, Selenium. ... heart – fatty degeneration
To establish efficacy of treatment for a named specific disease by herbs, the DHSS requires scientific data presented to the Regulatory authorities for consideration and approval.
A product is not considered a herbal remedy if its active principle(s) have been isolated and concentrated, as in the case of digitalis from the Foxglove. (MAL 2. Guidance notes)
A herbal product is one in which all active ingredients are of herbal origin. Products that contain both herbal and non-vegetable substances are not considered herbal remedies: i.e. Yellow Dock combined with Potassium Iodide.
The British Government supports freedom of the individual to make an informed choice of the type of therapy he or she wishes to use and has affirmed its policy not to restrict the general availability of herbal remedies. Provided products are safe and are not promoted by exaggerated claims, the future of herbal products is not at risk. A doctor with knowledge and experience of herbal medicine may prescribe them if he considers that they are a necessary part of treatment for his patient.
Herbalism is aimed at gently activating the body’s defence mechanisms so as to enable it to heal itself. There is a strong emphasis on preventative treatment. In the main, herbal remedies are used to relieve symptoms of self-limiting conditions. They are usually regarded as safe, effective, well-tolerated and with no toxicity from normal use. Some herbal medicines are not advised for children under 12 years except as advised by a manufacturer on a label or under the supervision of a qualified practitioner.
World Health Organisation Guidelines
The assessment of Herbal Medicines are regarded as:–
Finished, labelled medicinal products that contain as active ingredients aerial or underground parts of plants, or other plant material, or combinations thereof, whether in the crude state or as plant preparations. Plant material includes juices, gums, fatty oils, essential oils, and any other substances of this nature. Herbal medicines may contain excipients in addition to the active ingredients. Medicines containing plant material combined with chemically defined active substances, including chemically defined, isolated constituents of plants, are not considered to be herbal medicines.
Exceptionally, in some countries herbal medicines may also contain, by tradition, natural organic or inorganic active ingredients which are not of plant origin.
The past decade has seen a significant increase in the use of herbal medicines. As a result of WHO’s promotion of traditional medicine, countries have been seeking the assistance of WHO in identifying safe and effective herbal medicines for use in national health care systems. In 1989, one of the many resolutions adopted by the World Health Assembly in support of national traditional medicine programmes drew attention to herbal medicines as being of great importance to the health of individuals and communities (WHA 42.43). There was also an earlier resolution (WHA 22.54) on pharmaceutical production in developing countries; this called on the Director-General to provide assistance to the health authorities of Member States to ensure that the drugs used are those most appropriate to local circumstances, that they are rationally used, and that the requirements for their use are assessed as accurately as possible. Moreover, the Declaration of Alma-Ata in 1978 provided for inter alia, the accommodation of proven traditional remedies in national drug policies and regulatory measures. In developed countries, the resurgence of interest in herbal medicines has been due to the preference of many consumers for products of natural origin. In addition, manufactured herbal medicines from their countries of origin often follow in the wake of migrants from countries where traditional medicines play an important role.
In both developed and developing countries, consumers and health care providers need to be supplied with up-to-date and authoritative information on the beneficial properties, and possible harmful effects, of all herbal medicines.
The Fourth International Conference of Drug Regulatory Authorities, held in Tokyo in 1986, organised a workshop on the regulation of herbal medicines moving in international commerce. Another workshop on the same subject was held as part of the Fifth International Conference of Drug Regulatory Authorities, held in Paris in 1989. Both workshops confined their considerations to the commercial exploitation of traditional medicines through over-the-counter labelled products. The Paris meeting concluded that the World Health Organisation should consider preparing model guidelines containing basic elements of legislation designed to assist those countries who might wish to develop appropriate legislation and registration.
The objective of these guidelines, therefore, is to define basic criteria for the evaluation of quality, safety, and efficacy of herbal medicines and thereby to assist national regulatory authorities, scientific organisations, and manufacturers to undertake an assessment of the documentation/submission/dossiers in respect of such products. As a general rule in this assessment, traditional experience means that long-term use as well as the medical, historical and ethnological background of those products shall be taken into account. Depending on the history of the country the definition of long-term use may vary but would be at least several decades. Therefore the assessment shall take into account a description in the medical/pharmaceutical literature or similar sources, or a documentation of knowledge on the application of a herbal medicine without a clearly defined time limitation. Marketing authorisations for similar products should be taken into account. (Report of Consultation; draft Guidelines for the Assessment of Herbal Medicines. World Health Organisation (WHO) Munich, Germany, June 1991) ... herbal medicine
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