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• • • • • • • • • • • • • • • • • • Answers to Difficult Questions What is SierraSil What makes SierraSil unique How does SierraSil work How much SierraSil do I need to take daily What is your return policy When will I start feeling the benefits of SierraSil Is there any lead in SierraSill? Who may benefit most from SierraSil Is there any mercury in the product?...aluminum, iron, etc. What is the iron content in SierraSil What minerals are contained in SierraSil Why don’t you list the minerals comprised in SierraSil on the label Is it ethical? Why can’t you tell me about what’s in the product Are there any human clinical trials involving SierraSil Is SierraSil safe What mining Techniques do you use? Are there any contradiction? Is there any lead in SierraSil? • The lead in SierraSil is naturally occurring, which exempts SierraSil from Proposition 65. • LD 50 study. All animals were healthy, gained weight • Sub-acute toxicity study: 90 day rat study. o No incidence of treatment related mortality, no adverse effect on body weight or average daily food consumption, no alterations of blood plasma levels, no affect on urinanalysis parameters, and no related gross pathological or histopathological alterations as a result of treatment. • Bioaccessibility study: Of the .013 mg per serving, less than .0003 mg per serving is bio-accessible. Return to Top Is there any mercury in the product?...aluminum, iron, etc. • Same talking points as above • Refer to Bioaccessibility chart, section 1.2 of science notebook Return to Top What is the iron content in SierraSil? Frequently Asked Questions about SierraSil Page 2 SierraSil is comprised of numerous naturally-occurring minerals. The iron in SierraSil is naturally-occurring and shown to be safe for human consumption. While there are 120 mg of iron per serving, studies indicate that only 3.3 mg of iron per serving or 18% of RDI is bioaccessible. However, U.S. and Canadian regulations now require a warning on the label for iron-containing, orally ingested products. This warning was implemented to protect against young children (under the age of 6) from accidentally consuming an entire bottle of iron-containing supplements and experiencing harmful side effects from too much iron. Return to Top What minerals are contained in SierraSil? SierraSil consists of a unique and naturally-occurring blend of smectite, calcium sulfate, silicon dioxide, feldspar, potassium iron sulfate, kaolinite, and zeolite minerals, each containing individual elements such as calcium, magnesium, iron, manganese, copper, zinc, selenium, chromium, molybdenum, and phosphorous in a form that possesses unusual health promoting properties. Other naturally occurring and trace elements found in SierraSil, such as strontium, beryllium, boron, potassium and sodium may be beneficial for health, but recommended daily intake levels have not yet been established. Return to Top Why don’t you list the minerals comprised in SierraSil on the label? Space limitations on label. SierraSil is the ingredient for the Joint Formula product. Since SierraSil is a naturally-occurring mineral composite and is the only ingredient, we are not required to list of the individual elements in SierraSil. If we formulated and blended SierraSil out of constituent components then we would need to list all the minerals. The new label will show the amount of calcium and iron in SierraSil and will also have the required FDA warning regarding iron content. (FYI, the warning was instituted after some children sucked on Geritol iron supplements and suffered adverse reactions and even a fatality.) Return to Top * These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. Frequently Asked Questions about SierraSil Page 3 Is it ethical? Absolutely! The safety studies we completed are very thorough. Our clinical studies have been called the gold standard, by industry leaders. Return to Top Why can’t you tell me about what’s in the product? SierraSil is a proprietary mineral complex and as a proprietary Return to Top What mining techniques used? Sourced in desert area. Modern mining technologies are used. Return to Top Any contradiction? None. Osteoarthritis study: no adverse effects. Return to Top Does it help rebuild cartilage, joints, tendons? It might, we have studied for it. It can be used to glucosamine. Return to Top The Answers to Your Questions about SierraSil™ 1. What is SierraSil™? SierraSil is a distinct, fasting-acting and powerful naturally-occurring mineral composite found only in the high Sierra Mountains. Patent pending SierraSil supports joint mobility, flexibility and active lifestyles.* Unlike some joint support formulas that may take months to work, SierraSil can promote noticeable benefits in less than two weeks. SierraSil contains no glucosamine or chondroitin. Return to Top * These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. Frequently Asked Questions about SierraSil Page 4 2. What makes SierraSil unique? SierraSil is unique in its source, its combination of minerals, and in its benefits. The SierraSil mineral deposit is found only in the high Sierra Mountains. SierraSil contains a rich complex of minerals with unique properties unlike any other complex known. Dr. Haydn Murray, a renowned mineralogist, conducted an x-ray diffraction analysis of SierraSil; he reported: “In my more than 50 years of mineral research, I have never seen a combination of minerals like this before.” SierraSil is unique due to its mechanism of action, which supports cartilage integrity through gene suppression.* See question 4 for more details. SierraSil is also one of the only joint support formulas on the market that does not contain glucosamine or chondroitin. Return to Top . 4. How does SierraSil work? SierraSil was recently evaluated in a mechanism of action study. Study results showed that SierraSil supports cartilage integrity.* The findings are published in the peer-reviewed Journal of the American Nutraceutical Association 1 (JANA, Vol. 7, No 2:32-39). This in vitro tissue explant study, conducted in collaboration with researchers at Case Western Reserve University School of Medicine, utilized human cartilage tissue and cells obtained from patients at the time of knee surgery. Results show that SierraSil significantly reduced the breakdown of cartilage structural integrity, caused by the pro-inflammatory cytokine Interleukin 1β, by 68-73%. “These results indicate that SierraSil is likely to be an effective antiinflammatory agent and that these benefits are likely due to suppression of gene expression,” (italics added for emphasis) said Mark Miller, Ph.D., Professor of Cardiovascular Sciences and Pediatrics at Albany Medical College (NY). Miller, a current grant reviewer for research for the National 1 Miller, Mark J.S., Ahmed, S. et al. 2004. Suppression of Human Cartilage Degradation and Chondrocyte Activation by a Unique Mineral Supplement (SierraSil™) and a Cat’s Claw Extract, Vincaria®. Journal of the American Nutraceutical Association. Vol 7. No. 2:32-39. * These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. Frequently Asked Questions about SierraSil Page 5 Institutes of Health (NIH), was the lead researcher and reporter for this mechanism of action study. Return to Top 5. When will I start feeling the benefits of SierraSil? SierraSil often produces noticeable results in less than two weeks and may have long-term benefits as well. Many of the benefits, such as those described in the results of the mechanism of action study, require continued use of SierraSil. Return to Top 6. How much SierraSil do I need to take daily? SierraSil is a powerful macro and trace mineral supplement, which exhibits beneficial properties in small amounts. The recommended daily intake of SierraSil for joint mobility is 2 grams, or three capsules daily of the Sierra Mountain Minerals, Inc. Joint or Joint Plus Formulas. We recommend that you take the capsules on an empty stomach, at least one-half before or one hour after meals. Return to Top 7. Are there any human clinical trials involving SierraSil? Yes. SierraSil has been used in a number of clinical trials, both published and unpublished. SierraSil has shown excellent results in all such trials. SierraSil is being evaluated in a double-blind, randomized, multi center placebo-controlled study involving 120 patients, all 20 years of age or older, who are diagnosed with osteoarthritis of the knee. Results of this clinical study are expected in early 2005. The study was undertaken to further validate findings from an unpublished pilot study, which demonstrated the ability of SierraSil alone and in combination with Vincaria® to dramatically improve joint flexibility, mobility and activity.* As mentioned in question number 4, SierraSil was the focus of a recent mechanism of action study. Those results were published in the Journal of * These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. Frequently Asked Questions about SierraSil Page 6 the American Nutraceutical Association (JANA Vol. 7, No. 2: 32-39). Mark Miller, PhD, presented these findings at the International Inflammation Research Association conference held on October 4th in Lake George, New York. Return to Top 8. Is SierraSil safe? SierraSil has been clinically tested in both animal and human studies and was found to be completely safe. Safety testing included a 90-day sub-acute safety and toxicity study using pharmaceutical protocols. This study showed that SierraSil has no negative side effects even when taken up to and at levels of 1000 mg per kilogram of body weight. Additionally, an LD50 study found that SierraSil was unable to produce any toxic effect in 100% of the animals tested at approximately 80 times the recommended intake level. In fact, the animals used in the LD50 study experienced improved health and gained weight overall. We recommend that pregnant women consult with a physician before using SierraSil. Return to Top 10. Who may benefit most from SierraSil? SierraSil and the SierraSil formulas are excellent supplements for active men and women of all ages, including baby boomers, seniors and athletes. When enhanced with specific nutrients, SierraSil can contribute to promoting an even wider range of health benefits.* Join the many health conscious consumers who are choosing SierraSil to replenish needed minerals for natural, uncomplicated, fast-acting solutions to today’s health challenges.* Return to Top Return Policy If a customer is not happy they can return it to us at our offices for a full refund - within 90 days. They just send to * These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. Frequently Asked Questions about SierraSil Page 7 Sierra Mountain Minerals KMG International, Inc. 313 W Mendenhall, Suite A Bozeman, MT 59715 Return to Top If you have additional questions or would like more information about SierraSil, please call 1-888-888-1464 or visit www.sierrasil.com. * These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.