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Do you experience muscle pain and inflammation?   
Date:
April 25, 2007 03:30 PM
FlexAgility MAX Everyone experiences muscle pain and inflammation due to overuse and exertion. We’ve all had those softball games, weekend camping trips or chore-intensive days when our body lets us know we’ve overdone it. So, what can you do about it? Well, fortunately, there is a proprietary formula with clinically studied ingredients that provides a natural solution: FlexAgility MAX. FlexAgility MAX is designed to reduce pain and inflammation due to overuse. Its clinically studied ingredients have been shown to help balance the body’s own inflammatory response. Let’s take a look at FlexAgility MAX and answer a few questions you may have about it. Q. What is inflammation? Why does it happen? A. Inflammation is actually an essential part of your body’s natural healing process. When some form of physical stress affects the body, the immune system responds by supplying defensive compounds to the stressed site. This is what causes the fluid build-up, pain and redness we typically associate with inflammation. And until the situation is resolved those symptoms will stick around. So, why is that good? Because without these signals – pain and inflammation – we’d probably do even more damage. In a sense, pain and inflammation are very effective stop signs. The problem is, if our bodies are continuously bombarded by factors that trigger inflammation, these defenders (and their symptoms) are always around. This can mean unnecessary pain and inflammation following overuse and exertion. Q. What does FlexAgility MAX have to do with inflammation? A. FlexAgility MAX provides triple-action activity against occasional pain and inflammation, with powerful antioxidant free-radical scavengers, the enzyme bromelain, and a natural COX-2 inhibitor. Q. So what is COX-2 and why should I inhibit it? A. We’ve all been hearing a lot in the news about COX-2 inhibition and may have wondered about its connection to pain and inflammation. Let’s take a look: Cyclooxygenase is an enzyme that comes in two main types, abbreviated for convenience: COX-1 and COX-2. The COX enzymes regulate compounds involved with inflammation, including prostaglandins. COX-1 is found throughout the body, and maintains the integrity of the stomach lining, circulation and kidneys. COX-2 on the other hand, cruises along the central nervous system – it’s much more attuned to our brain’s sense of “what hurts.” Primarily activated by inflammatory stress, COX-2 generates prostaglandins – the hormone-like defensive compounds that cause the responses we associate with pain and inflammation due to overuse. You can understand why so much research has focused on COX-2 inhibition. Decreasing its activity means short-circuiting the “inflammation cascade” that follows occasional overuse. Because COX-1 is associated with a healthy stomach lining, it is not an enzyme you want to inhibit. Unfortunately, many products don’t know the difference between COX-1 and COX-2 – Filing both with one blast. Fortunately, there are ingredients in FlexAgility MAX that can tell them apart. One of them is IsoOxygene. IsoOxygene is a patented hops extract shown in scientific studies to significantly inhibit COX-2, while leaving COX-1 alone. And, it is a 20 times more potent COX-2 inhibitor than other tested popular botanic products, including curcumin and grape seed. Q. How do antioxidants support the body during times of inflammation due to overuse? A. Overall, the body ahs a pretty darn good repair system. However, oxidative stress due to free radical damage can take its toll, especially during times of occasional physical stress. Free radicals and reactive oxygen species can damage cells, because they are hungry, unstable molecules in search of electrons. To find them, they attack other cells. These pillaged cells then become free radicals themselves, setting off a chain reaction of oxidative stress. Free radicals are formed during the body’s normal functions, and can have benefits, such as neutralizing viruses and bacteria. However, in doing do, they erode the body’s own antioxidant defenses, too. And, free radicals typically become very active during times of inflammation due to overuse or other stressors. The good news is that the herbal and antioxidant elements in FlexAgility MAX help support the body’s own natural anti-inflammatory defenses. Take vitamin C, for instance. This extremely well-known antioxidant has been scientifically studied for its beneficial effects on muscle, collagen and connective tissue health. Collagen and connective tissue is what helps hold us together – literally. And famous antioxidant, green tea, has been well-studied for the benefits of a polyphenol called epigallocatechin-3-gallate, or simply EGCG. In scientific and clinical studies, EGCG from green tea works as an overall antioxidant, scavenging free radicals, and supporting healthy collagen. In fact, one study showed that green tea polyphenols supported collagen health by 50% versus only 16% in controls. The green tea extract in FlexAgility MAX is especially focused on these beneficial polyphenols. It’s standardized to contain 70% polyphenols – half from EGCG. The green tea acts in concert with elderberry and ginger in the formula to help prevent oxidative stress to the body due to occasional overuse. Anthocyanins are natural antioxidants found in berries and vegetables. Black elderberry extract, one of the herbal ingredients in FlexAgility MAX, was shown in scientific studies to be more bioavailable – that is, more readily used by the body – than the natural bioflavonoids of other plants. Again, antioxidants help keep the body in optimum health- especially during times of physical stress. Ginger, used for centuries in Ayurvedic medicine, provides strong, natural antioxidant activity. In fact, a recent scientific study found more than 50 separate antioxidants in ginger root. Of course, there are many components of plants that show strong antioxidant properties. A scientific study comparing flavonoid antioxidant activity and inflammation have shown that rutin was the most effective in reducing the inflammation cascade. Boswellia serrata is a tree found growing in the dry, hilly regions of Another antioxidant ingredient in FlexAgility MAX, N-acetylcysteine (NAC), even helps the body produce more of its own antioxidants, cysteine and glutathione. In a double-blind, placebo-controlled clinical study, N-acetylcysteine inhibited occasional pain and inflammation due to overuse and attenuated fatigue by 26% compared to controls! N-acetylcysteine has also been shown in scientific tests to act as an antioxidant, supporting healthy collagen and synovial fluid. The last ingredient, bromelain, provides the enzymatic pathway used by FlexAgility MAX. Bromelain is a proteolytic enzyme derived from pineapple. Clinical and scientific studies showed benefits from bromelain in reducing pain and inflammation from occasional overuse. So, there you have it- the triple action of FlexAgility MAX: COX-2 inhibition (and COX-1 sparing), antioxidant benefits, and enzyme support. Q. Is there another product you’d recommend that I use with FlexAgility MAX? A. One other product I recommend without hesitation is GS-500, a glucosamine sulfate supplement that has been shown to help build and support cartilage. The body’s connective tissue and cartilage include a natural compound called glucosamine. Supplemental glucosamine sulfate is up to 98% absorbable, so more glucosamine reaches the target structures. It has been clinically studied on its effect in building cartilage. About Enzymatic Therapy: Like Chris, Enzymatic Therapy is a trailblazer. Since our founding in 1981, we’ve been leading the industry with innovative natural products. After all, in 1993, Enzymatic Therapy introduced glucosamine sulfate, shown to help build and support cartilage, to the In the intervening years, Enzymatic Therapy has been at the frontline of innovation and invention. Many revolutionary precuts, including Saventaro, Cell Forte, Heartburn Free, Petadolex Patented Brain Support, Whole Body Cleanse, Earth’s Promise, Hot Plants for Him and Hot Plants for Her have been introduced by Enzymatic Therapy. One of the newest products, (and the reason you’re reading this) is FlexAgility MAX. FlexAgility MAX works with the body’s own natural anti-inflammatory pathways to relieve pain and reduce inflammation due to occasional overuse. Our proprietary FlexBend of ingredients, combined with antioxidants and the proteolytic enzyme, bromelain, is unique among natural products.
(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=1529) MSM - Natures Primary Sources of Organic Dietary Sulfur 
Date:
August 02, 2005 03:48 PM
(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=720) Federal Court Overturns FDA Ban on Ephedra at Low Doses 
Date:
June 09, 2005 08:41 AM
Federal Court Overturns FDA Ban on Ephedra at Low Doses by Rakesh M. Amin and Mark Blumenthal A Utah Federal District Court recently limited the scope of a year old Food and Drug Administration’s (FDA) Final Rule1 banning the sale of all ephedrine-alkaloid dietary supplements.2 The Court’s ruling has a limited affect on the ability of companies to sell ephedrine nationally, but is important regarding FDA procedure for creating rules and enforcement powers. Ephedrine alkaloids are found primarily in the controversial herb ephedra (Ephedra sincica Stapf., Ephedraceae). The District Court determined that the FDA’s use of a risk-benefit analysis was against the intent of Congress in passing the Food, Drug and Cosmetic Act,3 which presumes all foods are safe and requires the FDA to prove the existence of a significant or unreasonable risk. The court held that to require food producers to establish a benefit before selling their product places an improper burden on them and was inconsistent with Congress’s intent when it passed the Dietary Supplement Health and Education Act of 1994 (DSHEA) to clearly place the burden of proof of safety of a dietary ingredient on the FDA.4 Secondly, the court determined the FDA had to show by a preponderance of the evidence “a significant or unreasonable risk of illness or injury.”5 Therefore, in order to ban all sales of a given product, the FDA must first prove that the dosage amount in the product presents an unreasonable risk.6 Prior to this ruling, the FDA was not required to consider dosage size before banning a substance. This ruling has limited effects at the moment since the FDA may appeal this decision. Additionally, the ruling has no effect on the laws of several states (including California, Illinois and New York) which have banned all sales of ephedrine alkaloids in dietary supplements. The ruling also only applies to products containing 10 mg or less of ephedrine alkaloids per daily dosage. Any product exceeding that amount is still banned and will continue to be enforced under the FDA rule.7 The court, in its ruling, specifically precluded the FDA from taking any enforcement action against Nutraceutical Corporation, the company that filed the lawsuit, for its sale of products containing 10mg or less of ephedra and for the FDA to consider further rulemaking “consistent with this Order”.8 However, the court did not specifically instruct the FDA to refrain from taking enforcement action against other brands containing less than 10mg of ephedrine.9 As such, companies considering launching new products containing ephedrine alkaloids are advised to do so carefully. Nutraceutical Corporation president Bruce Hough was cited in The New York Times as saying that the company’s reason for Filing the suit was not based on ephedra and that his company had no plans to begin marketing ephedra supplements in the near future.10 Hough was quoted as saying, “We filed it [the lawsuit] because the FDA established rules that could cause problems to the rest of our business.” Hough was referring to the legal basis upon which the FDA banned the sale ephedra. He told the American Botanical Council that the FDA was applying a drug standard of risk vs. benefit to herbs and dietary supplements – technically foods under the law. [Hough B. Personal communication to M. Blumenthal, Apr. 27, 2005.] His company filed the lawsuit in an attempt to deter FDA’s new procedure for creating what he considered arbitrary rules which contradict the plain meaning of existing federal law (DSHEA). The American Herbal Products Association (AHPA) issued a statement on April 26 clarifying its policy on the sale of ephedra in dietary supplements.11 AHPA has notified all its members that at this time it is the organization’s policy that none of its members should be selling low doses (10 mg or less) of ephedra in dietary supplements until the FDA has clarified its position on the Court decision. At this time it is not clear whether FDA plans on appealing the decision or will implement the new policy set by the Court. The court decision does not affect the sale of the herb ephedra in traditional formulations intended for use that is consistent with traditional uses, e.g., pulmonary complaints, and are dispensed by licensed healthcare practitioners. As might be expected, court’s decision has stimulated a new round of media and congressional criticism of the relative safety of herbs and dietary supplements as well as DSHEA. For example, a highly critical article by Chris Mooney was posted on the website of the American Prospect on April 25.12 The Prospect is relatively influential in Democratic and progressive political circles in Washington. The article uses language such as the court decision is a “scandal” and a “disturbing ruling”, refers to DSHEA as “a terrible law” and a “peculiar and misguided law” and the “wrongheaded standards encoded in the DSHEA”, and repeats the often-cited media mantra about “unregulated herbal supplements” and that the “FDA has been hamstrung and effectively rendered impotent.” More information regarding the sale of ephedrine products or FDA regulations in general is available from the law offices of Rakesh M. Amin at (312) 327-3382 or rakesh@amin-law.com. References 1 21 C.F.R. Pt. 119, Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk (Published February 11, 2004) (Effective April 12, 2004) available at /dockets/98fr/1995n-0304-nfr0001.pdf 2 Nutraceutical Corporation and Solaray, Inc. v. Lester Crawford, D.V.M., Acting Commissioner, U.S. Food and Drug Administration, et al., Case No. 2:04CV409TC, U.S. District Court for the Central District of Utah; available at gov/reports/204cv409-28.pdf
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