By Albert Y. Leung, Ph.D.
The recent action by the New York Attorney General has drawn much criticism from different experts on the analytical method it used – DNA barcode testing. Yet the important issue is not a testing method, because no one single method, no matter how sophisticated, can do the job by itself anyway, especially when we are dealing with complex herbs and not a pure chemical like aspirin. The point is that the NY AG has unwittingly revealed one of the key defects surrounding herbal supplements, which has caused so many of the problems and controversies over decades. It is the use of inappropriate sciences (even wrong paradigms) to identify and characterize herbs.
Herbal supplements are an extremely complicated subject. They contain many chemicals, most unknown but working together to produce the effects we seek in traditional herbs as alternatives to conventional drugs. These effects cannot be arbitrarily assigned to a few marker compounds, and designate them as the ones responsible. But this is exactly what has been practiced for decades, while all along, traditional herbal products have been made from herbs, starting with the raw herbs or their total extracts from which nothing herbal is removed. There are still small companies making true herbal supplements this way, from raw herbs to finished products. This type of herbal supplements is what the consumers had in mind before the Dietary Supplement Health and Education Act of 1994 was passed. I believe they still want them. However, unbeknownst to them, what they are getting now are no longer true herbal supplements that come with the traditional benefits known for the herbs through centuries or millennia of human experience. Instead, some ‘herbal’ supplements nowadays can simply be chemicals from herbs/plants (toxic or not) formulated into a matrix of inert fillers, excipients, carriers, or whatever is needed to fill up a capsule or the bulk of a tablet. This type of product is now in the news because of the NY AG’s recent action. It has raised a simple question: why herbal supplements contain no herbs? The answer may lie in Big Pharma’s influence all these years after direct-to-consumer drug advertising were first permitted on TV in the mid-1980’s under President Ronald Reagan’s tenure.
Apparently, these herbal supplements without herbs are legal and can be marketed and sold as ‘herbal’ supplements as long as they satisfy some marker chemical requirements. These non-traditional herbal supplements, more appropriately called “chemical supplements” or plain “unapproved new drugs” are made mostly by, or for, the large chains which have little herbal expertise, but plenty of know-how in formulating and manufacturing drug and vitamin products. They produce huge volumes of these ‘chemical’ supplements which have drawn all kinds of extracts suppliers, especially from China and India, offering ‘high-purity’ extracts at prices often below the raw material costs. By ‘high-purity’ they don’t mean the extract; they mean the chemicals. For example, Chinese or American ginseng root usually contains only 1%-3% total ginsenosides. A good traditional high-quality water extract may contain 5%-6% ginsenosides, along with the rest of ginseng’s complement of active ingredients some may be more important than the marker ginsenosides. If you use it to make a ginseng supplement, say, using 10g of this 5%-ginsenosides extract per 100g of finished bulk product, your finished product would have 10g of this real ginseng extract of which 0.5g is analyzable ginsenosides and 9.5g consists of the other ginseng components (polysaccharides, short-chain peptides, steroids, ginseng pectin, choline, flavonoids, volatile oil, and many others). The balance of the formulation (90g) would be carriers, including rice powder, hydrolyzed starch, etc. or anything legally allowed. This would be what I consider a real herbal product/supplement.
In contrast, if you want to formulate an ‘equivalent’ herbal ginseng supplement using a so-called ‘high-purity’ ginseng ‘extract,’ standardized to 98% ginsenosides (basically 100% pure), all you need is mix 0.5g of this ‘extract’ with 99.5g of inert fillers like those used in the above herbal supplement. The resulting product would meet the criteria of required chemical markers and thus would be legal to be marketed and sold as an ‘herbal’ supplement. This product would obviously contain no herbal (botanical, plant) elements, only targeted chemicals, hence the DNA barcode test would not find any herb in such a product. Incidentally, highly purified chemicals (‘extracts’) from herbs are now readily available, including tea catechins, milk thistle silymarin, ginsenosides, resveratrol from the Chinese herb huzhang, and many others. Nowadays, dietary supplements seem to be a mixed-up bunch of herbs and chemicals (aka vitamins, amino acids, nutraceuticals, phytochemicals, phytonutrients, etc.). The ‘scientific’ support for most of the new herbal supplements are market driven and the methodology used basically follows the drug paradigm that is well established for drugs but not appropriate for anything involving herbs. If a chemical is isolated and totally separate from its parent herb, then it should be treated as a new chemical because it has no more connection to the herb; and it should not be called an herbal supplement. This should be only for consumers who don’t mind taking in another new chemical daily in their diet and are willing to bear the long-term consequences. However, for millions of educated Americans like me who have grown up with traditional herbs and know how toxic drugs are, taking these modern drugs is our last resort; we want to have the option of getting herbal supplements we know to have prior human safe- and beneficial-use history behind them.
All the above has led me to ask this question: “What exactly is an herbal supplement – is it an herb or a drug?” And this is the tentative title of a book I have been working on for almost 6 months, after having earlier lost my herbal-supplement business due to my 2 major customers’ having switched to cheaper imitation (adulterated) products. It will document my experiences with herbs and commercial herbal products, inappropriate herb research, product development, manufacture, politics, cronyism, academic empire building, marketing, adulteration, confusion and a myriad of associated unresolved issues that have resulted in wasting billions yearly of our tax dollars and producing ongoing controversies. Most of these still-ongoing issues have been discussed in my newsletter, Leung’s Chinese Herb News (ISSN# 1523 5017), published between 1996 and 2004. Although many improvements in herbal supplements have been made over the past 2 decades, many other problems remain, along with the alarming trend of true herbal supplements heading more and more towards chemical drugs marketed as herbal supplements but without herbal elements. All these are possible because, for over 2 decades, our experts in government, industry, and academia have stuck to using the drug approach with drug technology in identifying and characterizing herbs and herbal supplements for numerous reasons, including complacency, peer pressure, and financial indebtedness, among others. However, the drug technology, although developed and well-established for pure-chemical drugs, is totally inadequate for herbs that are made up of multiple active chemicals unique to each herb. By not clearly differentiating between single-chemical drugs and multicomponent herbs in our research, we have generated enormous amounts of ambiguous and/or useless biological, medical and related data sitting in our databases ready to be tapped and disseminated to perpetuate the status quo. I only realized this maybe 15 years ago that I had been a guilty party in spreading wrong information and/or misinformation after the Second Edition of my Encyclopedia of Common Natural Ingredients used in Food, Drugs, and Cosmetic (Wiley, 1996) was already published. I tried to rectify this for its Third Edition, but found it a close-to-impossible task, because it would entail checking the herb material(s) used in every single test in the papers reporting the research results, not just relying on the judgment of their authors or the prestige of the journals, because sometimes they were the worst offenders. So I did not participate in its revision despite its revised title: “Leung’s Encyclopedia of Common Natural…” which I assume was for marketing purposes.
Now, back to the present. Herbal supplements would soon reach the point of no-return if this is allowed to continue – fewer and fewer true herbal supplements versus a steady increase of more and more potentially toxic chemical drugs. At present, the so-called alternative is nothing but more of the same chemical drugs from an alternative source – herbs. For decades, I had been outspoken on this and had seen progress, especially in the FDA’s recent mandate of requiring HPTLC fingerprinting for testing herbal supplements besides the usual marker chemicals. This is the same fingerprinting technique we had used for testing our products for years before FDA mandated it. However, this progress is just cosmetic. It is unlikely to change the general thinking of the experts involved in this field. I had been observing the trending of herbal supplements towards purer and purer chemicals and I didn’t like what I saw, especially after the Dietary Supplement Health and Education Act was passed in 1994, because this would mean the end of alternatives to modern drugs. Hence, I decided to write a nontechnical book that would tell the whole story about herbal supplements so that the American public would at least be aware of what has been going on without their knowledge. Then, about 2 months ago, when the NY AG came out with his action that had generated the ensuing controversy, with various experts weighing in, I realized that the testing method was not the real issue and I needed to speak out sooner. As mentioned earlier, the real and most important issue is the lack of an appropriate alternative technology to deal with multi-chemical herbs, as the current drug technology is incapable of handling them. Since my scientific colleagues don’t seem to get it or are simply towing the company line in continuing to use the wrong technology on herbs, I want to let the intelligent American public know the other side of the story which they usually don’t get from the usual experts. The above is only a glimpse of the way how some simple and complex traditional herbal medicines (especially Chinese tonics), handed down by our ancestors over centuries or millennia, and made popular by the hippie generation 50 years ago, evolved into their current often-unrecognizable herbal supplements devoid of herbs.
[Sent to NYTImes & Marty.Mack@ag.ny.gov on 3/29/2015]
