October 5, 2010
by Mark Blumenthal
One of the pieces of good news for the entire herb and dietary supplement industry is in 2009, a year in which most retail consumer product sales either experienced significant declines or, at best, remained flat, the sales of herbal dietary supplements actually increased significantly compared to sales in 2008. Total sales for all herbal dietary supplements in all channels of trade increased 4.8 percent, based on aggregated sales data provided by Information Resources Inc., Nutrition Business Journal and SPINS. Sales in the natural food channel increased 4.48 percent and sales in the mainstream retail outlets rose by 14.38 percent, according to the annual Herb Market Report published in HerbalGram 86.
Positive news also came from continued clinical research on herb and plant-derived ingredients and proprietary products, with clinical trials and/or systematic reviews being published on such increasingly popular herbs such as aloe (Aloe vera), andrographis (Andrographis paniculata), chamomile (Matricaria recutita), green tea (Camellia sinensis), milk thistle (Silybum marianum), pelargonium root (Pelargonium sidoides), rose hips (Rosa canina) and turmeric (Curcuma longa), as well as relative newcomers chokeberry (Aronia melanocarpa var. elata), saffron (Crocus sativa) and others.
As usual, in the past few months, at least one big story in the mainstream media has created much interest and sent strong negative messages to consumers and all other areas of the general public. The September issue of Consumer Reports created a media feeding frenzy for several days when its cover storyThe 12 Most Dangerous Supplements,reprised a similar story which the magazine ran in 2004, but this time changing some of the herbs and other dietary supplements listed in its Dirty Dozen supplements. Consumer Reports editor was featured on talk shows and almost every major network covered the story. The trade associations issued obligatory press releases, the American Herbal Products Associations (AHPA) being probably the most insightful. The Council for Responsible Nutrition (CRN) was able to involve in the most media, with CRNs president, Steve Mister, writing an op-ed piece in USA Today.
In the area of reports in medical journals that have had a negative impact on consumer and professional perspectives on dietary supplements, particularly herbs, in February, the Journal of the American College of Cardiology (JACC) issued what it termed a State of the Art review article on herbal dietary supplements and their effect on patients taking cardiovascular drugs. The article is full of all kinds of errorsboth of commission and omissionand was obviously written by people (at the time, at the Mayo Clinic) who have very little knowledge of herbs and herbal medicine, and was peer reviewed by (presumably) cardiologists with little or no knowledge of herbs. The article does not merit the term state of the art and should not have ever been published. Unfortunately, despite efforts by the American Botanical Council (ABC) and others, the editors of the journal apparently dug in their heels, and aside from publishing only three letters calling attention to some of the errors, refused to retract the article. Without retraction, it will sit in the literature and will be uncritically cited for years, hence, adding further confusion to an already confusing situation.
In the area of GMPs (good manufacturing practices) and quality control, some issues are of concern to responsible elements of the botanical community. In addition to the most unfortunate occurrences of intentional adulteration of herbal extracts with active pharmaceuticals ingredients (APIs)an obviously intentional and criminal activitythere are also other instances of what are probably the intentional adulteration of botanical extracts, now termed economically motivated adulteration. One such adulteration is the addition of synthetic dyes (called amaranth dye, an approved food coloring) to bilberry (Vaccinium myrtillus) extract. The hulls of Chinese black soybean (Glycine max), a source of anthocyanins, are also known to be added to bilberry extract. The U.S. Pharmacopeia (USP) and the European Pharmacopoeia have both published the same validated analytical method to detect these two adulterants.
In addition, chemical analysis has determined Asian ginseng root (Panax ginseng) has been adulterated with extract of ginseng leaf in order to sell extracts with relatively high levels of ginsenosides, the primary active compounds in ginseng. While the ginseng leaf contains the same ginsenosides as found in the root, analysis of some commercial ginseng root extracts standardized to high levels of ginsenosides shows a different profile of these ginsenosides, suggesting adulteration with leaf extract. So long as the extract is labeled as being from the root only, the extract is adulterated and illegal.
The popularity of pomegranate (Punica granatum) juices has spurred the use of their concentrates and pomegranate extracts in dietary supplements. Some pomegranate extracts are sold with claims of being standardized at 40 percent and up to 70 percent ellagic acid (EA), one of the many biologically active phenolic compounds in pomegranates. But raw pomegranate material contains about only 3 percent EA, while a few more percent may be created during the extraction process, bringing a natural extract up to about 5 percent, i.e., unless the extract is a concentrate of many times the amount of pomegranate by weight to the weight of the extract. However, to complete this concentration requires much more pomegranate biomass, and some of the extracts concentrated to 40 percent to 70 percent EA sell for prices that are significantly lower than the cost of the estimated equivalent amount of the needed raw pomegranate material, raising the probability EA is added to the pomegranate extract from other sources. Although EA is found in other fruit, the pulp of some woods, which is available at very low prices, is the probable source of the EA in some low-cost pomegranate extracts claiming high EA levels.
Of considerable concern among ethical, responsible sellers of quality botanical extracts as well as reputable third-party testing laboratories is the alleged presence of so-called dry-labbingthe practice of providing a false certificate of analysis (C of A) for a raw material or extract. According to industry analytical experts, some laboratories engage in falsifying lab analysis reports to ensure the false specifications of a customer, who may be either the seller of an ingredient or the purchaser, and who wants to ensure the customer has some form of evidence that the ingredient it uses in one or more of its products meets a certain specification. Hence the name dry-labbing where, allegedly, no real analytical work has been done, because no liquid chemical standards or reagents needed for proper analysis has been used.
Speaking of herbal extracts, ABC is engaged in producing a peer-reviewed white paper reviewing all the solvents utilized in the botanical extract industry as well as for production of various natural food items (e.g., isolated soy protein, etc.). Such solvents include various alcohols (ethanol [grain alcohol], methanol, isopropyl alcohol), acetone ethyl acetate, benzene, hexane and numerous others. The white paper will include the chemical properties of each solvent and reasons for use, the pharmacology and toxicology, the residue levels allowed in foods, drugs and cosmetic ingredients as determined by domestic and/or international compendia and other authoritative bodies, environmental issues related to improper disposal, and more. Excessive solvent residue levels may or may not be a significant issue in the dietary supplement and natural foods industries. As it currently stands, only some producers of raw materials routinely disclose solvent residue levels on C of As provided to customers, and not all testing laboratories routinely test for their presence.
Mark Blumenthal is the founder and executive director of the American Botanical Council (ABC), an independent, nonprofit organization dedicated to disseminating accurate, reliable and responsible information on medicinal plants. Blumenthal is the editor of HerbalGram , an international, peer-reviewed quarterly journal, and HerbClip, ABCs reviews of recent scientific literature on herbs.
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