FAQ

Q. Why should I use herbal products?

The decision to use herbs for their health promoting value is, as with all health decisions, a personal one. There are, however, many good reasons to consider herbal products as complements to your own health care. The best reason, however, may be the fact that herbs and herbal products, with their incredibly wide use throughout time and place, continue to provide real health benefits while maintaining a remarkable safety profile. Readily available natural substances were the first medicines used by humans. Primitive and ancient civilizations as well as contemporary cultures throughout the world have always relied on herbs to provide the benefits that have been observed with their use - a major part of which are derived from plants. In our own time and culture, most herbs are available in the form of "herbal supplements." These products are found in the form of teas, tablets, capsules, liquid extracts, and others. We now have ready access to products that bring the herbal traditions from all over the world in a variety of convenient forms. In addition, scientific inquiries continue to develop our knowledge of the benefits of plants, and often validate the observations made over the past centuries.

Q. Are herbal supplements effective?

Botanicals have remained a primary source of traditional medicine for millennia. They have made contributions over the last centuries to the development of some of the most widely used and effective modern drugs. In the last several decades, there has been a resurgence of research in the clinical efficacy of herbs. The results of such studies often verify that the empirical observations of the past centuries were accurate.

But can a consumer have confidence in the claims made for the products that are available in the market? To begin with, Federal labeling law and regulations for supplements limit allowable claims to those for which a manufacturer "has substantiation that such statement is truthful and not misleading". The manufacturer therefore has a legal burden to assure that the claim that is made for their products has scientific evidence to back it up. Because there is a greater acceptance of herbal therapies by conventional physicians in Europe, a significant body of clinical data supporting the use of herbs has been developed there. More recently, a number of U.S. companies have designed clinical studies for their branded products. It is estimated that there are over 1,000 clinical trials now being undertaken in the U.S. to increase our knowledge about herbs. The National Institutes of Health has even set up a center with a special focus on "alternative" medicine, and is now concentrating much of its resources on the study of herbal products.

Q. How soon can I expect to notice the benefits of an herbal product?

Herbs are rich mixtures of diverse natural compounds. Although the effects of certain herbs will be observed within a short time after consumption, others are more subtle and provide their health promoting benefits gradually. If you have ever used ginger root (Zingiber officinale) or peppermint leaf (Mentha × piperita) tea to promote healthy digestion, you know that you can feel the comforting effects of these herbs almost as you drink the soothing brew. The effect of ephedra (Ephedra spp.) in promoting bronchodilation or better breathing is usually felt within ten or twenty minutes of use. The sense of well-being that results from the use of kava root (Piper methysticum) should manifest in only a short time when using a well manufactured product. Similarly, all of the herbs that contain anthrones, such as rhubarb root (Rheum) or cascara sagrada bark (Frangula purshiana), will produce a laxative effect within a half a day or so.

Other herbs are known to produce noticeable benefits only after several days or weeks. For example, improvement in sleep when using an extract of valerian root (Valeriana officinalis) has been shown to be somewhat dependent on continued use. With saw palmetto (Serenoa repens), the berries of which are used to promote the health of the prostate, the full benefits have been shown in one study to be achieved after 12 to 18 months ). Other herbs, such as those that are rich in antioxidants, work to improve your health without a noticeable effect.

Q. How are herbal supplements regulated?

All supplements, including herbs, vitamins, minerals, etc., must conform to Federal regulations that control their manufacture, labeling, and advertising. In order to sell an herbal supplement, a manufacturer must meet many different Federal (and sometimes state) regulations, and must also adhere to state and local health and business regulations. Since supplements are legally classified as a specifically defined type of food, all supplements are required to be manufactured to the same high standards that are required of all foods. These mandated good manufacturing practices establish basic guidelines to assure that supplements are manufactured under sanitary conditions that result in properly identified products that are not contaminated or adulterated, and that are fit for consumption. Any supplement that does not conform to these basic guidelines is subject to regulatory action by FDA. In addition, all supplement products are required by law to provide certain information about their formulation.

Like foods, supplements must provide consumers with nutritional information. Unlike foods, supplements must state the quantity of each of the contained ingredients, or of the "proprietary blends" that make up a product. All herbal products are required to identify the parts used of each of the plant ingredients, and to label them with their commonly accepted names. One of the areas of the most detailed Federal regulation of supplements is in the area of product claims, whether on product labels or in advertising.

Q. What are "standardized" herbs?

The herbal marketplace has seen the introduction of a number of "standardized" botanical extracts. The purpose of standardization is commonly believed to be control of the content of one or several "marker" compounds, which are perceived of as those constituents in the plant that are responsible for its therapeutic activity. In fact, standardization - when properly performed - entails a lot more than merely controlling the content of a particular marker compound. Rather, standardization consists of the body of information and manufacturing steps that ensure product consistency from one batch to the next. As such, it comprises a wide variety of raw material and process controls, as well as use of a consistent recipe.

The goal in standardizing an extract is to control the complete chemical composition of the extract, rather than one particular identified constituent or group of constituents. The heightened interest in standardized products is due to the belief that standardization is directly related to the potency of the extract. This is not necessarily the case and can unfortunately lead to a "more is better" perception. It is important to know that the use of marker compounds is not essential to the production of quality botanical products and that many companies market high quality and consistent herbal extracts without reference to these. In addition, any manufacturing process that is too specifically concentrated on maximizing one constituent may place an undue emphasis on that single compound. On the other hand, there can be value in a manufacturing process that implements measures to control the entire spectrum of an herb's constituents and that also includes attention to marker compounds. Consumers should understand that label information about markers is usually provided to communicate product consistency and a degree of quality control rather than potency.

Herbal Products : Regulation

Today in the United States, herbal products can be marketed only as food supplements. An herb manufacturer or distributor can make no specific health claims without FDA approval.

Two features of European drug regulation make that market more hospitable to natural remedies. First, it costs less and takes less time in Europe to approve medicines as safe and effective. This is especially true of substances that have a long use history and can be approved under the "doctrine of reasonable certainty." European guidelines for the assessment of herbal remedies follow up on WHO’s Guidelines for the Assessment of Herbal Medicines, which state that a substance’s historical use is a valid way to document safety and efficacy in the absence of scientific evidence to the contrary.

France, where traditional medicines can be sold with labeling based on traditional use, requires licensing by the French Licensing Committee and approval by the French Pharmacopoeia Committee. Germany considers whole herbal products one active ingredient; this makes it simpler to define and approve the product. The German Federal Health Office regulates products such as ginkgo and milk thistle extracts so that potency and manufacturing processes are standardized. England generally follows the rule of prior use; that is, years of use with apparent positive effects and no evidence of detrimental side effects constitute enough evidence---in lieu of other scientific data---that the product is safe.

In Japan, China, and India, patent herbal remedies composed of dried and powdered whole herbs or herb extracts, often in tablet form, are the rule. Traditional herbals are the backbone of China’s medicine. Japan’s traditional medicine, kampo, is similar to and historically derived from Chinese medicine but includes traditional medicines from Japanese folklore. Herbal medicines are the staple of medical treatment in many developing countries and are used for many types of ailments.

Herbs & Herbal Products : Safety

Plants that enjoy broad culinary and therapeutic usage are generally safe. We can flavor our food with any number of herbs to make a meal more flavorful. We can appreciate a delicious cup of peppermint leaf or ginger root tea, or benefit from the soothing properties of marshmallow root or the bark of slippery elm. We can take an herbal supplement containing dandelion root or saw palmetto berries, or any number of the other herbs. Although allergies and reactions have been recorded for a few herbs that are widely used in foods and supplements, such individual concerns are also seen with many foods, and do not diminish the safety profile of the many herbs that are generally recognized as safe. On the other hand, and as everyone knows, there are any number of plants that are highly toxic, even deadly. Every ten-year-old hiker knows to stay away from poison ivy (Toxicodendron spp.) when walking in the woods. The death sentence imposed on Socrates by an Athenian jury 2400 years ago was carried out with a fatal dose of hemlock (Conium maculatum). The poison curare, a blend of several equatorial rain forest plants (e.g., species of Chondrodendron, Curarea and Strychnos is used by some South American hunter cultures to make their arrows more deadly. In our times, the "concrete jungle" of Los Angeles, two young boys died from ingesting a few leaves of the ubiquitous oleander (Nerium oleander). Federal law and good common sense, however, prevent the use of any such highly toxic plant in products that are readily available to consumers.

Federal law requires that every food product, including herbal supplements, is free of "adulteration" and is not "misbranded." This legal language translates into a requirement that all foods and supplements have a reasonable expectation of safety when offered for sale and when used as directed. So manufacturers of soups, cereals, and supplements all have an obligation to sell only safely made and properly labeled goods, and can find their products subject to seizure should they fail to do so. In addition, manufacturers of herbal products are specifically required to limit their ingredients to either those that were already in the market prior to passage of landmark legislation in 1994 or those that a company can convincingly show, by providing information to the Food and Drug Administration, to be safe. What that means is that any manufacturer who wants to introduce a new herbal ingredient must first provide FDA with information that shows that the herb will be "reasonably expected to be safe" Additionally, the safety of herbal products as a general class has been well established by both their long history of traditional use worldwide and by their broad contemporary use by a significant proportion of the population, estimated to be nearly half of the U.S. population.

There are so few credible reports of unexpected side effects due to herbal products that most experts consider problems with herbal products to be of only minor or occasional concern. In a decade old article written on the subject of herbal safety, a noted authority on the subject concluded, "...side effects or toxic reactions associated with herbal medicines in any form are rare. In fact, of all classes of substances reported to cause toxicities of sufficient magnitude to be reported in the United States, plants are the least problematic." This is not to say that every herbal ingredient that is sold as an ingredient in a supplement is appropriate for every consumer or in any quantity. Responsible and informed use by consumers is essential to insure that herbal products maintain their established safety profile. Accurate product labeling must provide consumers with all information that is material to the use of the product, and such disclosure is required by Federal law.

Herbal Medicine : Modern day Medicines

Herbs, are being rightfully reinstated at the forefront of modern medicine. Certainly the wealth of articles that appear daily in the press would confirm that their age-old value is being increasingly recognised and that recent research not only validates their ancient medicinal uses but also takes this a few steps further by helping us to understand the biochemical mechanisms involved. Substantial sums of money are being poured into research into the world of plant medicines as scientists continue to search for remedies for devastating illness such as heart disease and cancer. Recently we have heard how a substance derived from the bark of an African willow tree could revolutionise the treatment of cancer by initiating a new way to stop tumour growth. Extracts from the bark of the African Bush Willow (Combretum caffrum) have been shown to shut down blood vessels supplying oxygen and nutrients to tumours, thereby inhibiting their growth. Similarly, research has shown that numerous other herbs look hopeful for cancer treatment, including the American yew tree, the Madagascan periwinkle, borage and a Chinese herb called campotheca.

The world of herbal medicine offers a wide range of applications and treatments on several different levels, ranging from everyday over-the-counter remedies for more symptomatic relief of minor ailments, to individualised prescriptions prepared specifically for patients after in depth consultation with a qualified medical herbalist. Certainly herbs have their place as self-help for minor infections, coughs, colds, catarrh, stomach upsets, indigestion, constipation and so on. The wealth of information that abounds today about herbs is enabling people to make increasingly informed decisions about the specific remedies they choose to self-administer.

Self-help using herbs may well be suitable for straightforward and minor complaints but for more complex and chronic problems, and to enable a greater understanding of specific patterns of health and their treatment, consulting a qualified medical herbalist may well be preferable. After an in depth consultation the practitioner will use his/her skill and expertise to analyse and understand the patient and their symptoms and to treat accordingly. A herbal prescription, tailor-made to the individual patient is designed to help create the conditions that enable healing. Such a prescription may consist of anything from 1–15 different herbs and will be subject to review during the follow-up consultation. A discussion of diet and lifestyle will also be involved and the practitioner will advise accordingly. People with hormonal imbalances, gynaecological problems and menopausal problems, chronic stress-related symptoms, heart and circulatory disease, skin problems, bowel symptoms such as Crohn’s disease and irritable bowel syndrome, as well as chronic infections, would be well advised to consult a medical herbalist.

Those who are attracted to trying herbal medicine in one form or another are very often people with a love of plants and flowers and a respect for the miraculous world of nature, or they may simply be referred to a remedy or a practitioner by personal recommendation. It is interesting that as gardening continues to be one of the most popular leisure pursuits in this country, even if as a city dweller one only has a patio, balcony or window box, people are increasingly growing herbs. Fascinated not only by their attractive shapes and colours, delicious tastes and often wonderful scents, there is something that people find about growing or being among herbs in the garden that has a subtle healing effect of its own.

Complementary and Alternative Medicine