The Herbal Standardization Process

Over the past years, recognized world authorities on botanical alternative medicine have defined, and established, specific standards of excellence for herbal extracts. Viable Herbal Solutions fully complies with these standards to insure our customers that all ingredients used within our extensive product portfolio is of the highest quality standards. Most importantly, we standardize for the individual key compounds which have been empirically and scientifically proven to be the most advantageous for the human system. As a result, our standardization process guarantees a consistent and appropriate level of each plant's medicinal elements within each of the product formulations we sell.

Identifying the key beneficial compounds for optimized product performance.

An enormous amount of empirical and scientific research has identified specific plant compounds that show great advantage for the human body. Our researchers are continuously reviewing both current & historical analyses on the efficacy of a multitude of world-wide medicinal plants to evaluate their performance, limitations, optimal dosages, contra-indications, and applications. In fact, because our researchers of natural medicine recognize the documented contribution of these specific key compounds, we predominantly use standardized herbal extracts throughout our product development and production processes.

Determining the optimal level of key components.

Why are some herbs standardized as high as 80% (total weight by volume) for their key compounds, while others are as low as 0.8%. Here are some of the reasons:

  • In its natural state, a plant contains only a certain level of its key compounds. For example, Valerian Root naturally contains a fairly low percentage of "valerenic acid", while Milk Thistle naturally contains a fairly high level of "silymarin".
  • As a result of both empirical and scientific data, the optimal "human consumption" level of each key compound can be precisely defined, and that's the level that VHS standardizes for. For example, studies have shown that Valerian extract with 0.8% "valerenic acid" yields superior medicinal value on average for the human body. On the other hand, our Milk Thistle extracts are standardized to contain 80% "silymarin" because this level has been demonstrated to provide the greatest natural biological advantage.
  • Each plant within a genus has it's own unique chemical profile. Our manufacturing facility uses only herbal extracts that have been analyzed and tested to provide a consistent chemical profile (composition), and therefore predictable results.
  • Sometimes more is better; and at other times….it is not. In some cases, such as with Bilberry, a higher concentration of its key medicinal compounds creates a more beneficial herbal extract. Yet in other cases, such as with Kava Root, standardizing at too high a concentration level means losing other compounds that are essential to the plant's synergistic effects on the body.

Understanding the terms 'standardization' and 'concentration'.

The words "standardization" and "concentration" have two distinctly different definitions:

  • Standardization is adjusting a solution so as to maintain consistency & repeatability in its composition, and
  • Concentration is adjusting a solution so as to increase its strength, density, and/or effectivity

In cases where the key compound has not been clearly identified, an herbal material can be concentrated to yield a higher degree of all of the plant's compounds in a smaller volume (than the plant itself). Therefore, for example, with a 50:1 herbal concentration, you would have 50 mg. (milligrams) of extract which would have equivalent composition and effectiveness to 2,500 mg. of raw plant material. However, when we have identified the key compound(s) of an herbal material, we can both concentrate, and standardize, the herbal material to yield an optimal percentage of that specific compound.

  • Is concentration alone an accurate assessment of an herbal product's potency? No, it is not. Many manufacturers describe the strength of their herbal supplements only by their concentration (e.g., Ginkgo Biloba extract 50:1). However, in terms of potency, this description is virtually meaningless. For example, if the Ginkgo leaves used to make the extract contained little or no ginkgoheterosides (their key compound), then they are worthless as an herbal source, and no amount of concentration from those leaves can change that fact.
  • All herb's can be concentrated, but not all herbs can be standardized. The majority of Viable Herbal Solutions' product ingredients are herbal extracts that are both concentrated and standardized.

Standardized products provide greater value for your dollar.

When an herbal product is not standardized, you have absolutely no idea how much of the herb's key compound(s) you are actually getting, or if these levels are the same from one product capsule to the next. Without standardization, you may not even get the herb that you are paying for. For example, recent independent studies have shown that many Ginseng products in the marketplace today actually contain little, or no, ginsenosides, and many so-called "Echinacea products" are not even Echinacea.

To illustrate the importance of choosing a standardized herbal product, let's look at Saw Palmetto Berry. Studies have shown that the best Saw Palmetto extracts are standardized to contain 85%-95% fatty acids and sterols, at a dosage of 160 mg. twice daily. To get that equivalent with dried powdered berries, an individual would have to consume forty to fifty 500-mg tablets each and every day. In terms of key compounds, one bottle of standardized Saw Palmetto extract is equal to about 17 bottles of the non-standardized product. Obviously, the standardized product is clearly the better value.

Standardized Extracts are more Cost Effective.

One of the great misconceptions that many practitioners still hold regarding standardized extracts is that they are more expensive than herbal forms, such as alcohol-based tinctures and fluid extracts (also see: Understanding Herbal Preparations). The fact of the matter is that if you calculate product cost based upon the delivery of an effective dosage, then the standardized extract is a real bargain. An important fact to remember is that there is relatively little herb content in either tinctures or fluid extracts; what consumers end up paying for with these types of natural preparations is the alcohol, the bottle, and the cost of shipping.

Therefore, the reasons for the tremendous cost differences per delivery of an effective dosage of key herbal compounds noted earlier for standardized extract products are

  1. more effective extraction of active compounds (as well as "non-active" compounds), and
  2. complete removal of any solvent (alcohol and other suspension fluids).

About.....Effective Dosage.

The effectiveness of any herb or herbal product from a pharmacological perspective is dependent upon providing an effective dosage of the active compounds. Regardless of the form of the herbal preparation, clinical effectiveness requires efficient delivery of an active dosage within the body. Standardization for the level of active components, or key biological markers, is the only real means to assure an appropriate delivery of an effective dosage for the user.

Since the herbal industry in the United States is not regulated like it is in Europe, manufacturers are prohibited by the Food and Drug Administration (FDA) from making specific health claims. Nonetheless, some manufacturers of tinctures and bulk herb products do make such health claims. Some of these companies will utilize research featuring a specific highly-concentrated standardized extract to promote their tinctures, freeze-dried, alcohol-free, or even crude herb preparations even though their preparations may bear absolutely no resemblance from a chemical perspective to the herbal preparation used in the study. This practice is either based on ignorance or blatant deceit for profit.

Manufacturers selling tinctures and crude herbs are often upset by this point of view. No ne is picking on them; we are simply stating a scientific fact - that in order for any herbal preparation to be clinically effective, it must provide an effective dosage. This view should not be viewed as controversial. Unfortunately, the controversy arises from the fact that, from a pharmacological perspective, it is unlikely that the dosage schedules recommended on most herbal tinctures are sufficient to produce any real biological effect. While tinctures of such potentially toxic herbs such as gelsemium, aconite, belladonna, and digitalis might produce a pharmacological effect when given at low dosages, for most herbs in use today it is very difficult to produce a beneficial pharmacological effect when the herb is administered in tincture form in a cost effective manner. The administration of small dosages of herbs in tincture form is an offshoot of the homeopathic and eclectic use of "mother tinctures" and "specific medicines." At the very best, it could be stated that the effectiveness of these preparations, and their ability to exert pharmacological effects, have not been proven for all but a few botanicals. If a natural medicine, whether it is a tincture, standardized extract, or nutrient, is truly clinically effective, it should be able to stand up to scientific scrutiny and rationale.

Several time-proven systems of herbal medicine are based upon delivering much higher levels of key herbal compounds than can easily be obtained via the use of tinctures. Specifically, these methods include the use of highly concentrated standardized extracts from Europe, and the use of herbal preparations in Traditional Chinese Medicine (TCM) and Ayurveda.

As a result, herbal medicine is not going to be very popular with consumers if it is not very effective. The greater the effectiveness, the greater the popularity. The tremendous growth noted in the United States over the past decade is primarily the result of an influx of high-quality, standardized extracts into the U.S. marketplace. For years, consumer acceptance of herbal medicine in the United States has struggled because of the insistence of some herbal practitioners to hold on to 'outdated' and 'unsubstantiated' views. Fortunately today, more people than ever are getting undeniable beneficial results with herbal medicines, mainly because they are using more effective products. Unfortunately, there is still a great deal of confusion among both health professionals and consumers.

While the future looks extremely promising for herbal medicine in the United States, ultimately what will determine its degree of success will be the acceptance of more reliable herbal products (i.e. compound products manufactured from standardized extracts) by healthcare providers and consumers.