Growth, Manufacture, Quality

How Companies Grow, Manufacture, & Store Herbal Products

“Without an integrated understanding of life, our individual and collective problems will only deepen and extend.”
– Jiddu Krishnamurti –

How can I know I am getting good quality herbs?

A good rule of thumb is that a good quality product gives you results within a reasonable period of time based on its expected action(s). Understanding that, I can say that there are infinite good ways to prepare and manufacture herbs, infinite bad ways, and infinite ways in between. Read labels, and ask your store manager or health care practitioner about the company.

How many herbal medicine companies are there?

In its 1999 Source Book, Whole Foods magazine listed more than 2,000 companies and organizations–a virtual explosion in recent years, with sales into the billions of dollars.

How do we know these companies are doing a good job of manufacturing their products?

The FDA is responsible for regulation of the herbal medicine industry. There is currently controversy about the quality of the job they are doing.  Some critics say the FDA is not strict enough, while others say the government is too oppressive. In an ideal world, we know that if a company follows government GMPs (good manufacturing practices) and other regulations, we can be reasonably certain the product is safe in terms of correct plant material content, potency and purity.  In the real world, government regulation is sparse, and it is pretty much impossible for an individual to know, without a private investigation, whether or not a particular company is following good manufacturing practices. Recent changes in the herbal medicine and supplement industry have driven the creation of independent third-party certifications. We will discuss the system, started by the National Nutritional Foods Association (the industry’s largest trade association), in more detail when we talk about safety.

What has the government done about regulation so far?

In 1994 Congress passed the Dietary Supplement Health and Education Act (DSHEA), regulating labeling and sales of herbs and other supplements. This was a great relief to those who fought hard for its passage because it broke a long-standing FDA policy of either restricting natural medicines as if they were drugs, or treating them as simple foods.

If the government does a good job of regulating herbal manufacturing, which may involve changing the laws, it will hopefully winnow out the good company practices from the bad. Fortunately, herbal medicines have rarely caused serious harm. We all want that to continue. However it is true that while most herbs heal, there are still herbs that can kill. Positive changes are taking place rapidly, but this process is far from complete, so your best bet right now is to educate yourself as much as you can.

Making a Quality Product

The beginning of all good herbal medicine, and the first and most essential step in making good quality end products, is the growing and harvesting of good quality herbs. However, what exactly does the phrase “good quality” mean?  I think the best example here is the production of French grapes for wine. Bardolino, for example is a light, red, slightly sweet wine produced in the Veneto region of Northern Italy. Bardolino is best drunk when young. On the other hand, Barolo, one of the most highly regarded Italian red wines, is made from Nebbiolo grapes grown in Piedmont. The wine is dark, full-bodied and high in tannins and alcohol. It improves over decadesof aging. With this analogy we can see at once that not all wine is the same, nor are all grapes the same. This holds true for herbs as well.

There are many, many variations and nuances of herb quality which depend on numerous factors. The Chinese have a saying that illustrates one part of this puzzle. “Ginseng root grown in Sichuan is a laxative.” This means that the tonic herb ginseng (Panax ginseng), which usually grows in the cold North, completely changes its properties when grown in the different soil and warmer climate of Sichuan province.

Herbs grown from seeds with good genetics under the correct climatic conditions, and with healthy soil, clean air, and the nurturing of a skilled grower who knows when and how to harvest the plants at their peak, will be the best possible quality and provide the best medicine. I hope that in the future good herb growers become identified and well-known like French wine vintners.

Processing and Storage

Like the different kinds of grapes and methods of preparing and bottling we find in winemaking, there are many different methods of herbal processing, all with subtle differences too complex and numerous to quantify in a simple number. Naturally, each company will claim its processes and products are the best.

There are at least three rich sources of historical knowledge of herb storage and preparation. The first isHand made Ayurvedic pills the writings of the Eclectic physicians, and the second and third are the medicine-making traditions of TAM and TCM. In China, medicine making is a four-year University course. The knowledge of Ayurvedic medicine making has barely begun to come to this part of the world. This kind of practical knowledge is usually handed down by apprenticeship to only the most trusted students.

After harvesting, producers begin the various forms of extraction and preparation, which include drying, separating, isolating and many other processes. Herbs that have been collected in the wild (a discipline called wildcrafting), or grown and then only dried, are called crude herbs. Crude herbs have not been shredded, ground, crushed, mixed or extracted. Each company has its own methods and proprietary processes for preparing their herbal products.

Traditional Methods of Processing and Storage

Traditional doctors have their own methods of processing and storage, and have done just fine without modern intervention. Researchers in Nara, Japan have stored samples of ginseng root (Panax ginseng), licorice root (Glycyrrhiza glabra) and rhubarb root  (Rheum emodi) that have been shown to retain their active properties for over 1,200 years. Similarly, in India there are samples of stored ghee (clarified butter) over 100 years old which have been shown to be medicinally effective. On the other hand, with herbs such as red clover blossoms (Trifolium pratense) or echinacea (Echinacea species), vital components can be damaged or lost within minutes of harvesting if extreme care is not used.

This takes us back to one of my earlier points, the importance of having a philosophy of reverence for Nature to guide your choices, and what can happen if you apply science without that restraint. In the last century, the first scientific food processors gave us the gift of a new purified chemical called white sugar. We took the bait and ran with it, and added sugar to thousands of food products. Further down the historical road, we were told that adding pesticides to our soil would control the growth and proliferation of insects but would not harm us. Chemical preservatives added to foods will make them last forever on the shelf, and will do us no harm, right?

Quality Control

Quality control is the process of assuring that herbal products actually have the characteristics the manufacturers claim. All herbal manufacturers need to have some form of quality control. This will vary depending on the size of the company and the type of product they are manufacturing, and there is no simple formula for quality. However, there are some basicsyou should know.

First of all, you have to distinguish suppliers from distributors and manufacturers. Suppliers of raw materials are the farmers or collectors inthe wild, who then sell their products to manufacturers. Manufacturers may sell directly to thepublic or to stores, or sell to co-packers or distributors who then forward the product to the public or to stores. Responsibility for quality control starts with growers, moves to manufacturers, and ends up in the hands of distributors and retailers.

Once the product ends up in your home, you yourself become responsible for quality control. For example, you must discard preparations that have expired, and make sure products are properly stored and refrigerated.

To stay in business today, companies must get into alignment with government regulated GMPs. This requires a lab. The job of the lab is to ensure two things, purity and potency.

The Lab

The laboratories in which herbal products are manufactured are quite large and sophisticated. They usually range from 1,000-2,000 square feet in size, have two or more well-trained employees on site, and house several major pieces of equipment with names like HPLC (High performance liquid chromatography), GC (gas chromatography), UV/VIS (Ultraviolet/Visible spectrophotometer) and AA (Atomic Absorption spectroscopy). They also need hardness testers, analytical balances, rotoevaporators, disintegration/dissolution apparatus, chemicals and solvents etc. The cost of all this space and equipment runs into the hundreds of thousands of dollars. The larger companies who can afford this expense do all the analysis in-house using their own equipment, while the others use outside testing labs. As a matter of fact, most companies that have labs on the premises still utilize outside third-party analysis to ensure objectivity.

The company, once it has access to a lab, must then set up standard operating procedures unique to its own needs. Safety equipment might include hoods to exhaust particles and fumes, and explosion-proof areas if performing gas chromatography and other volatile tests. Documentation standards are also part of this process, to ensure that there are traceable lot numbers and paper trails that establish a chain of custody identifying the movement of each herb, bottle, chemical or other material.

Quality Control Step By Step

1. The first essential step in quality control is correct identification of raw material. This requires that every manufacturer have someone on staff who is trained in this field to check each batch of product when it arrives, to ensure that it is what it’s supposed to be. This practice has not changed in eons. When I lived in Nepal at my teacher’s herbal medicine clinic, one of the family members (an herbalist) was assigned to make sure that arriving material was of good quality and was the correct plant substance.

2. The second step in quality control is microbiological testing to see if the levels of bacteria are within normal limits. In traditional cultures, the products are cooked down and concentrated to make them hygienic. The modern lab can perform chemical tests to check for undesirable components such as insecticides, pesticides, heavy metals and solvents.

3. Then comes disintegration/dissolution testing. Here in the U.S., various pills and capsules are tested to see if your body can assimilate them. Ditto for Nepal, where the size, softness and ingredients of pills are established with good assimilation in mind.

4. Assays (chemical tests) are performed to ensure potency. This does not simply mean that there is enough of a particular substance at the time of manufacture, but also that there is some allowance for degradation. With herbs, the type, the form and the method of packaging must be researched to determine the expiration date, which is then stamped on the bottle.

5. At the end of each test, the company records results and creates a certificate of analysis (C of A) for each batch.

The Tricky World of Standardization

Standardization is the hottest issue in the world of herbal manufacturing.  Companies have invested a lot of money in convincing consumersto believe in “standardization,” a term usedto describe the process of testing for certain chemical markers to make sure herbs are potent enough.

You want to establish that the herb is of high quality, ensuring that you get enough of the herb to do its job. There are high-quality and low-quality herbs. Therefore, we need to use scientific testing to ensure quality control. If a product contains specified chemical components, then it will work. If the essential constituents are absent or present in insufficient amounts, then it will not work. The concept of standardization is relatively simple.

Standardization has a place in herbal medicine, but herbs are not simply containers for chemicals. They are living things. Therefore, it is natural that there will be differences in chemical composition depending on soil conditions, genetics, rainfall, age, and the time or day or season of collection.  When I was young, I wanted to make sure I got a good tasting watermelon. My dad, who grew up on a farm, taught me that if the watermelon was picked at the right time, was properly sized, had a nice color, and made a good thumping sound on its belly, it would taste good. By the same token, good starting material, good soil, good farming, absence of poisonous chemicals, and good harvesting make for a healthy plant, and if the plant is healthy, it will most likely have sufficient concentrations of the essential constituents.

This idea came to life for me when “Herbal Ed” Smith of Herb Pharm reported in June 1999 that he was at a conference where the results of potency testing were announced. He was pleasantly surprised to discover that his company’s herbs were the most potent in every measure, though he had not tested them. He had simply done what he always did from day one–employ good, time-tested organic farming methods.

And to throw a contrarian idea into the mix, we also know that in the presence of certain stressors such as low water levels and poor soil conditions, plants will increase the production of certain beneficial phytochemicals as a defensive reaction.

Problems with Standardization

Although many effective methods of making herbal medicines have worked fine in the past, the further test of identifying an individual marker is now being performed for quality assurance. Of course, the determination of which constituents to look for as markers is a hotly debated issue, and varies from company to company.

One obvious drawback is the existing practice of spiking–adding some of the marker substance to create the illusion of a healthy batch of plants or medicines. As each new chemical becomes known to the public and sexier than the next, there is a rush to believe that this component is the “right” one, the only one that can ensure results.

One of the best-known examples of standardization is St. John’s wort, which is standardized to 0.3 percent of the chemical called hypericin, long believed to be the key anti-depressant chemical in the herb. Seeing this marker on the label will tell you that you have a consistent batch of herb that will produce the intended (but unlisted) result, a reduction in depression. The other 99.7 percent of the product is comprised of various other substances. This example is instructive. One problem developed when it turned out that hypericin is an anti-viral compound and has nothing to do with depression. There is now the assumption that having it there assures the presence of the anti-depressant compound or groups of compounds that make St. John’s wort effective. It may even be that the anti-depressive effect comes from a detoxification effect on the liver.

There are no set rules in the industry on how to do this for each herb. The most optimistic views dictate that it will take at least five years to standardize standardization for the mostpopular herbs, and decades to do the rest. Each plant is unique. As I write this book, even though standards are placed on bottles, each company isusing its own methods, and there are large variations from batch to batch, bottle to bottleand even in the same bottle over time. Nonetheless, pretty much everyone agrees that standardization is inevitable.

Standardizing Standardization

The great American herbalist David Winston warns us that standardization has not been standardized yet. Different companies use different markers, or different levels of the same markers, or different methods of testing for marker compounds. He also point out that whenever different compounds are chosen as “active ingredients” for different herbs, there is a chance that suppliers will get a substandard batch (low on the chemical markers) and mix it with a batch higher in the desired marker to compensate for the difference. Some bulk suppliers have told me that they have detected external chemicals in plant batches, added most likely in an attempt to fool the testing labs into accepting low-quality materials from dubious sources. If the standardized herbs were “organic” (assuming the word remains meaningful) it would be better.

Something in me distrusts commercial herbal crops grown with pesticides, purchased from underpaid third-world workers, then cooked up and concentrated until certain chemical markers reach standardization levels. The end result may have the right amount of XYZ acid, but who is fooling whom? If you don’t believe me, take an organic carrot and a store-bought one of similar size and place them on the counter of your kitchen. Find out which one tastes sweeter, and which one disintegrates first.

Good Medicine-Making

One of the time-honored traditions of making a good medicine is to simply tincture (extract with alcohol) healthy plants, which pulls out a subset of the plants numerous ingredients to make the medicine. If the plants are of good quality, and the method of production is consistent, the results will be equally consistent. The assumption here is that utilizing the synergistic effects of the whole plant is the best way to go. I mention this because I am afraid that we may lose sight of the fact that there is much more to making good herbal medicines than standardization. Standardizing our aforementioned wines to specific levels of alcohol or chemical constituents will not replace the importance of the soil, the genetics and the aging process, nor will it ensure taste.  The same cautions apply to the production of herbal medicines.

Might Feedback Be Part of the Answer?

Nature is variable, and it is not natural or even possible to take exactly the same amount of a particular natural chemical into your system each time. Even if you standardize the herbs, you can’t standardize the patient. Dr. Mana (my Ayurvedic teacher) told me many years ago that some patients are large, some small, some weak, some strong, some nervous, some sluggish, some irritable, some old and some young.  All patients have a different digestive capacity, which determines how they assimilate the herbs. Even in the same patient this will change from morning to night, and from day to day. The herbs themselves vary depending on the genetics, the method of preparation, and the length of time elapsed from production to market.

The traditional herbalist handles this by figuring out the digestive capacity and individual needs of the patient, and prescribing a starting dose of herbs. In three days or a few weeks the patient comes back, and the dosage is adjusted according to the results. It is a feedback system. In this way, the medicines are adjusted until each individual patient gets exactly what his/her system needs. It takes into account our individuality.

Good Companies Using Good Science

Companies that have good philosophies to guide them and good scientists to figure out the details are likely utilizing science appropriately and making good products. Like French winemakers, they can usually make better products than a home brewer.  Those who think only of the bottom line are likely torepeat the mistakes of the early foodprocessors. That said, there are many enlightened consumers and companies demanding high quality herbs from trusted natural sources. Many of themnow depend on their own network of growers working under contract to ensure the integrity of the plant materials. The raw material suppliers must provide certificates of analysis with their deliveries to manufacturers.

Other companies have gone beyond this, and have found innovative new ways to make good products. Natrol, another example of a good company with strong philosophical roots, has developed a testing system using multiple markers to ensure quality, while still paying strict attention to other quality issues.

Wolfgang Aulenbucher, vice president of sales and marketing for the well-respected raw materials company East Earth Herbs, offers a very interesting outlook in an article entitled, “Quality is Key with Herbal Extracts.” In it, he describes how his company has determined the best way to grow the herbs it uses, and actually sends horticulturists into the field on a daily basis to determine when to pick the herbs (Antoniak, 1998).

The Bottom Line

In spite of all this, I go back to my basic experience of having my health restored by drinking plain old dried or fresh herbs brewed into a tea. I agree with Jim Duke, PhD, renowned phytochemist and former director of the USDA botanical division, who says that eventually science will find a health benefit and value for virtually every component we find in herbs.  Until then, I think our priority should be finding healthy organic herbs, using the wisdom of science and tradition to make them palatable, and consuming them with love.


Good Medicine Tip – Shelf Lives of Herbal Products

The shelf life of a product should be stamped on the container. If it is not, these general guidelines can be used:

•  Crude herbs stored in tightly closed containers made of plastic or dark glass will retain their properties for at least six months if they are placed in a cool, dark, dry location.

• Alcohol-based liquid tinctures are usually good for up to three years. They may still be good for several more years, but different chemicals in the tincture may cause subtle changes over time, as wine bottlers well know.  For this reason I keep tinctures for a maximum of three years.

• Glycerin-based herb tinctures are good for six months to one year.

• Capsules and tablets should be used within six months of opening, and within 3 years of manufacture. If there are strong bitter herbs in the formula, they can last up to 6 years or longer

• Salves and oils are good for six months to one year, and should be stored in the refrigerator after you get them home.

However, often organoleptic testing, using your sense of taste and smell is your best guide to a products quality. This interesting article  shows that some pills are still good 30 years past their expiration date.