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I’m sure most everyone is familiar with the name Patch Adams and the feature movie, starring Robin Williams, which was based on his life story. Not a doctor who is a clown but a clown who happens to be a medical doctor, Hunter “Patch” Adams used some extremely unconventional approaches to healing his patients. Dressing up as a clown while treating patients, Patch Adams believed very strongly in the use of laughter as medicine in helping people heal. Although I was unable to attend Expo East, Aloecorp’s Jeff Barrie was there and expressed to me how deeply touched he was when listening to Patch Adams. Jeff was impressed by Patch’s compassion and higher purpose in life, and said that the overall theme of the keynote that rings again and again in his mind is the word “caring.” He said that Patch Adams stressed the importance of human beings truly caring for and wanting to help other human beings. And Patch said he believed that the natural products industry is a more caring industry than most--filled with more caring people. I’m sure I speak for many who are familiar with his story when I say that Patch Adams is a huge inspiration. For those of us in the natural products industry, let us also aspire to be more caring people. We can do this by continuing to produce quality products that positively affect the health of the world. Let us commit to carrying on the vital research that allows for more educated consumers, as well as producers of natural products. Please, let us come from a place of integrity and compassion in producing products that are unadulterated, that are not over-processed, and that are not overly-hyped in product claims. Let us move to create new and improved products that are scientifically proven to address our wellbeing, and thus create a healthier, happier and safer world. Patch Adams formed the Gesundheit Institute in 1972 to provide an atmosphere of a more personalized and caring approach to medicine. To learn more about this remarkable Institute and all it embodies, visit www.patchadams.org. For the history behind the making of the Patch Adams movie, go to www.patchadams.com.
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The International Aloe Science Council (IASC), the preeminent Aloe Industry nonprofit organization that promotes Aloe vera and its benefits worldwide, has been working with the CTFA to address this issue, as Aloe vera has been safely used in a wide range of skin care and nutritional supplement products for many, many years. The CTFA challenge was not prompted by any problems, but was raised strictly because of concerns about the presence in Aloe vera raw materials of the aloe anthraquinone, called aloin, which has a laxative effect (and has traditionally been used in pharmaceutical products). During the Aloe vera manufacturing process, only negligible, trace amounts of this ingredient remain present, at about 50 or less parts per million. However, some age-old confusion persists regarding the biological components used in Aloe vera cosmetic and skin care raw material ingredients, such as the aloe from the inner filet or whole leaf, as compared to the anthraquinone (found in tubular bundles clinging to the inner side of the aloe leaf), which is not a primary component of Aloe vera raw materials. The IASC has an opportunity to re-address the aloin situation, and is committed to getting to the core of this problem in defining the role that aloin plays, or doesn’t play, in processed raw material ingredients. Two steps have already been taken. The first was to collect sixty routinely processed Aloe vera raw materials used in many forms, such as single strength, concentrates and powders, from both the inner filet and whole leaf material. The IASC has since blinded those samples and delivered them to an independent lab for Gas Chromatography/Mass Spectroscopy testing on each product. The laboratory tests were completed and submitted to the CTFA for evaluation, with results pending. In addition, a special meeting of raw material manufacturers took place to review and revise Aloe Industry association standards for a range of conditions and terms for the production of Aloe vera raw materials, creating more uniformity and acceptance by regulatory bodies. Aloe vera nomenclature was discussed, and the group agreed to a variety of terms that clearly and correctly identify exactly what part of the aloe plant is used in what format. Some examples of this include preserved Aloe vera L. liquid (Aloe Barbadensis), raw Aloe vera L. ground whole leaf (Aloe Barbadensis), raw Aloe vera L. liquid (Aloe Barbadensis) whole leaf, etc. The IASC Executive Committee is currently reviewing these revised terms, and you may read the tentative reports on the IASC web site at www.iasc.org. Once again, Aloecorp and many other raw material suppliers salute the IASC for its quick response to an industry-wide issue. The bottom line is that Aloe vera has been safely used for thousands of years in countless products, and the goal of the IASC in working with the CTFA is to once again support the safety and efficacy of Aloe vera for use in finished goods products. ___________________________________________________
The International Aloe Symposium was held on the 10th anniversary of the formation of the CAP (Creation of Aloe Pharmaceuticals) Team, a consortium of researchers working to isolate bioactive components of Aloe vera. The cumulative results of their work have been impressive, as you will see. The following papers were presented at the symposium and I include a brief summary of the results that, in consideration of space, does not include a complete description of experimental conditions. Details can be supplied upon request. Efficacy of Dietary Aloe vera Intake in Rat: Suppression of Oxidative Stress and Hepatic Cholesterol Byung Pal Yu, Byung Ou Lim: University of Texas Health Science Center, San Antonio, TX USA, Graduate School of East-West Medical Sciences, Kyunghee University, Seoul, Korea Rats were fed lab chow supplemented with aloe to determine the effects on oxidative stress and hepatic cholesterol. Long-term aloe supplementation did not cause any adverse effects in the experimental animals as evidenced by data on food intake, growth rate and microscopic tissue analyses. Phospholipid peroxidation was reduced, and superoxide dismutase and catalase were enhanced. Total hepatic cholesterol was reduced as much as 40%, depending on the aloe preparation and mode of administration. A novel angiogenic factor derived from Aloe vera gel: β-sitosterol, a plant sterol Kyu-Won Kim: College of Pharmacy, Seoul National University Vascularization is an essential process in wound healing. Aloe vera gel and its extracts were examined for their angiogenic effects on the chorioallantoic membrane (CAM) of chick embryo. Out of three compounds purified from aloe gel, β-sitosterol showed potent angiogenic activity. β-sitosterol from aloe stimulated neovascularization in the mouse Matrigel plug assay and the motility of human umbilical vein endothelial cells in an in vitro wound migration assay. The presenter concludes that β-sitosterol is a novel plant-derived angiogenic factor that may have potential pharmaceutical applications for the management of chronic wounds. New Drug Development for Allergic Disease with Aloe vera Single Component (Alprogen) Jai Youl Ro and Young In Park: Department of Pharmacology Sungkyunkwan University School of Medicine, Graduate School of Biotechnology, Korea University This study aimed to purify alprogen form Aloe vera and assess its effects on mediator releases caused by mast cell activation in vitro and in vivo. Alprogen significantly decreased histamine and leukotriene D4 release, and blocked Ca2+ influx during mast cell activation. Protein kinase and phospholipase D activities were decreased by alprogen in a dose dependent manner. Alprogen also inhibited PLA2 activity during mast cell activation. IL-4, IL-8, and TNF- were inhibited by alprogen in human mast cell activation. In an in vivo rhinitis and asthma model, alprogen inhibited allergic nasal symptoms, decreased respiratory airway resistance in sensitized guinea pigs, inhibited OVA-induced microvascular dye leakage, inhibited histamine concentration in the nasal lavage fluid, and inhibited accumulation of mast cells and eosinophils in the nasal mucosal and lung tissues in sensitized mice and guinea pigs. Over the next couple of months I will report further on the presentations made at the 2003 International Aloe Symposium in Seoul. In this first of a series of articles on the symposium, I would like to thank Mr. Bill Lee, Chairman of Namyang Aloe, who inspires and nurtures Aloe vera research worldwide, and the fine people at Namyang Aloe, Mr. Sun Tack Oh & Mr. Kim Jae Seung (and others) who organized a truly exceptional symposium. ___________________________________________________
Immune cells possess receptors on their surfaces that recognize and bind the polysaccharide (lipopolysaccharide) (LPS) that is present in the cell walls of many bacteria. Research has shown that some polysaccharides containing glucans, mannans and/or xylans mimic the response elicited by LPS in vivo, resulting in dose-dependent stimulation of immune cells such as monocytes, macrophages and cytokine production. Aloe polysaccharides, which contain mannose, were found to mimic LPS and stimulate immune cells in this manner. However, the specific response from various aloe samples was inconsistent. For this reason, a research team at Unigen Pharmaceuticals fractionated aloe polysaccharides by molecular weight and tested them in a series of immune bioassays. The results of that testing show that the 50 - 200 kDa molecular weight range of aloe polysaccharides were significantly more reactive with immune cells than higher and lower molecular weight polysaccharides found in native aloe. In the UVB-suppressed contact hypersensitivity bioassay the 50 – 200 kDa range of polysaccharides restored immune response by 75% compared with the 5 – 10 kDa range (6%), the 10 – 50 kDa range (15%) and the 2,000 kDa and above range (25%). The Unigen research team also reported significantly greater macrophage activation and cytokine release by aloe gel that was treated to enhance the 50 – 200 kDa molecular weight range compared with native (unmodified) aloe gel. The patented method for modification and stabilization of aloe polysaccharides developed from this research is, of course, the method Aloecorp uses in manufacturing all of its aloe raw materials. Understanding the mechanism of action for the immunomodulatory activity of aloe polysaccharides has enabled Aloecorp to standardize aloe raw materials in manufacturing and insure that its aloe consistently retains the bioactivities explicated by researchers. Standardization of the bioactives in a processed therapeutic product is essential. If the aloe you use does not contain standardized polysaccharide content, then it’s like near-beer. You’d better like the taste, because that’s all you’re guaranteed to get. To submit an “Ask Ken”
question or to provide comments, send an email to ___________________________________________________
Efforts to defeat S.722 have yielded tremendous results. Thousands of telephone calls have been made, and letters and e-mails sent, to Senators and Representatives in the House letting our members of Congress know that we do not want S.722 to pass. We still have a long hard fight ahead of us. Consumers Union, the nonprofit publisher of Consumer Reports, has endorsed Senate Bill S.722. Two longtime champions of the Nutraceutical Industry, Senator Orrin Hatch (R-Utah) and Senator Tom Harkin (D-Iowa) have introduced legislation to increase funding to enable the Food and Drug Administration (FDA) to fully implement the DSHEA. The “DSHEA Full Implementation and Enforcement Act” (S.1538) would provide the FDA with the funding it needs to ensure that the DSHEA, passed in 1994, is carried out as Congress had intended. Another key component of S.1538 would also increase funding for the National Institutes of Health’s (NIH) Office of Dietary Supplements. The measure includes a provision that would authorize appropriations for the NIH Office of Dietary Supplements to expand research and development of consumer information on dietary supplements. For years the FDA has lagged behind in enforcing the DSHEA. The FDA has blamed a lack of money, power and personnel to adequately regulate supplements. S.1538 will provide the FDA with enough funds to properly implement the DSHEA. Under this new bill, the FDA will also be required to file reports annually to congress regarding how they are regulating dietary supplements. The FDA will be held accountable if they fail to do the job the DSHEA had intended the FDA to do. It is no myth that Senate Bill S.722 is a serious threat to the Dietary Supplement Industry. Even though we have strong allies in the Senate and the House, those of us in the Industry must do all we can to see that Senate Bill S.722 is defeated and Senate Bill S.1538 is approved. The fact is we still need to spread the word and make sure our customers and colleagues are aware of these two important bills. I urge you again to log on to www.congress.org, enter your zip code and write your elected officials letting them know you oppose Senate Bill S.722 and favor Senate Bill S.1538. ___________________________________________________ FTC Law and
Supplement Advertising—Who’s Minding the Store?*
Usually when we consider regulatory compliance for dietary supplements, we of course think of FDA law and specifically the Dietary Supplement Health and Education Act (“DSHEA”). The FDA primarily governs the formulation, ingredients, manufacture and labeling of supplements while advertisements are governed by a “sister” agency, the Federal Trade Commission (“FTC”). In general, the two agencies have shared jurisdiction under a long-standing memorandum of understanding, and they work closely together as to the monitoring of dietary supplements. The FTC has primary responsibility for claims in advertising, including print ads, TV and radio ads, infomercials, catalogs, and other direct marketing materials—such as the Internet. The two agencies have issued joint open letters to the
industry, e.g., cautioning joint enforcement actions against marketers of
opportunistic products like Herbal Cipro and Stress Less supplements in
the wake of 9/11 and again after the Iraq war. Your web pages must also be
free of deceptive promotions, and include only claims for which there is
adequate substantiation. Indeed, the FTC conducts periodic “surf days”
when it examines the Internet for ads in violation. For the last 3 or 4
years, the FDA and FTC have also co-operated in a “Cyber Sting” strategy
called Operation Cure.all, which begins with the FTC’s close scrutiny of
Internet websites.
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