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jaydpiii  Posts:0
 Newbie
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| 10/06/2004 4:53 PM |
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| YEAH!!!
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Recalls and Warnings
From time to time, ConsumerLab.com learns of recalls, warnings, or other alerts relating to vitamin, mineral, herbal, and other dietary supplements, as well as other nutrition products. Subscribers can access any of these reports, while non-subscribers can view the latest posting and the headlines of earlier reports. This new service began January 1, 2002. Latest Recall and Warning Past Recalls and Warnings
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False Claims Made by Marketer of Cortisol-related Weight-Loss Supplements According to FTC
(Date Posted: 10/6/2004)
On October 6, 2004, the Federal Trade Commission (FTC)charged marketers of two dietary supplements with claiming, falsely and without substantiation, that their products can cause weight loss and reduce the risk of, or prevent, serious health conditions. According to the FTC’s complaint, Los Angeles-area marketers Window Rock Enterprises, Inc. and Infinity Advertising, Inc., their principals, Stephen Cheng and Gregory Cynaumon, and business partner and product formulator Shawn Talbott have sold “CortiSlim” and “CortiStress” through a number of widely aired infomercials and short TV commercials, as well as radio and print advertisements and Internet Web sites.
“The Window Rock defendants’ weight-loss and disease-prevention claims fly in the face of reality,” said Lydia B. Parnes, Acting Director of the FTC’s Bureau of Consumer Protection. “No pill can replace a healthy program of diet and exercise.”
The FTC’s complaint alleges that the Window Rock defendants violated the FTC Act by making deceptive efficacy claims for CortiSlim and CortiStress. In addition, the complaint alleges that the defendants violated the FTC Act by using a deceptive format in at least two of their infomercials to suggest falsely that the infomercials were independent television programs, rather than paid commercial advertising. The complaint seeks permanent injunctive relief, including redress for consumers who purchased the products.
CortiSlim
According to the FTC, the defendants began marketing CortiSlim in August 2003, through nationally disseminated infomercials featuring Cynaumon and Talbott that aired on anumber of television channels, including Access Television, Travel Channel, and Discovery Channel. The FTC alleges that the defendants promoted cortisol control as “the answer” for anyone who wants to lose weight, especially abdominal weight. According to the FTC’s complaint, the defendants’ broadcast ads, print ads, and Web sites claimed that persistently elevated levels of cortisol, the “stress hormone,” are the underlying cause of weight gain and weight retention and also claimed that CortiSlim effectively reduces and controls cortisol levels and thereby causes substantial weight loss. The FTC alleges that the defendants claimed that CortiSlim: (1) causes weight loss of 10 to 50 pounds for virtually all users; (2) causes users to lose as much as 4 to 10 pounds per week over multiple weeks; (3) causes users to lose weight specifically from the abdomen, stomach, and thighs; (4) causes rapid and substantial weight loss; (5) causes long-term or permanent weight loss; and (6) causes weight loss. The FTC also alleges that the defendants claimed that the effectiveness of CortiSlim and its ingredients is demonstrated by over 15 years of scientific research. According to the FTC’s complaint, these claims are false or unsubstantiated.
CortiStress
According to the FTC, the defendants began marketing CortiStress in September 2003, through a nationally disseminated infomercial, also featuring Cynaumon and Talbott, that aired on a number of television channels, including TVN Direct. The FTC alleges that the defendants promoted cortisol control as “perhaps the most important aspect” of reducing health and disease risks. According to the FTC’s complaint, the defendants’ infomercial claimed that persistently elevated levels of cortisol are the underlying cause of “every modern lifestyle disease that is associated with this fast-paced 21st century lifestyle” and also claimed that CortiStress controls cortisol and thus should be taken “for as long as you want to have good health.” The FTC alleges that the defendants claimed that CortiStress reduces the risk of, or prevents, conditions such as osteoporosis, obesity, diabetes, Alzheimers’ disease, cancer, and cardiovascular disease. According to the FTC’s complaint, these claims are false or unsubstantiated.
Infomercial Format
The FTC’s complaint also alleges that the defendants produced their infomercials for CortiSlim and CortiStress to look like episodes of a talk show called “Breakthroughs” that features Cynaumon as the “host.” According to the complaint, the “Breakthroughs” logo appears in the lower right-hand corner of the screen throughout one of the CortiSlim infomercials. Cynaumon introduces Talbott as a “guest” he wanted on that particular “program” to tell the “audience” about Talbott’s scientific breakthrough regarding cortisol and his related product, either CortiSlim or CortiStress. The infomercials do not indicate or otherwise reveal that Cynaumon and Talbott are part of a joint venture to create, manufacture, and market CortiSlim and CortiStress. When a toll-free telephone number appears on-screen, Cynaumon presents the number for “more information” and states that callers who mention the “Breakthroughs” program will receive a special discount. According to the complaint, when the toll-free number appears on-screen, no oral or written disclaimer is provided to indicate that “Breakthroughs” is, in fact, a paid advertisement for CortiSlim or CortiStress; rather, the paid advertisement disclaimers appear only at the very beginning and very end of the infomercials.
The complaint against the Window Rock defendants signals the Commission’s continuing concern about the use of deceptive format in infomercials, and this is the second recent case to include an allegation that the format of the infomercial misleads consumers. In July 2004, the Commission filed charges, including a deceptive format charge, against the marketers of a product called “Supreme Greens with MSM.” In that case, the Commission won a preliminary injunction that prohibits efficacy claims for the product and requires clear “paid advertising” disclosures in any future infomercial advertising. (See press release dated July 1, 2004; www.ftc.gov/os/caselist/0233138/0233138.htm.
Stipulated Interim Agreement and Order
The Commission and the Window Rock defendants have also submitted a stipulated interim agreement that, with the court’s approval, will become an order. Under the agreement, advertising for CortiSlim and CortiStress cannot make any of the claims alleged in the FTC’s complaint. In addition, the defendants agree to limit their future advertising to claims that are supported by competent and reliable scientific evidence and agree not to misrepresent that their products are supported by scientific studies. Finally, the defendants agree not to use any advertisement that misrepresents itself as something other than a paid advertisement, and they also agree to include appropriate “paid advertisement” disclaimers in their advertising.
FTC Warning Letters
In a related development, the FTC has begun sending warning letters to more than 25 Web site operators and others who are marketing products with claims that the products will affect cortisol and thereby cause weight loss, reduce the risk of or prevent disease, or produce other health benefits. In its warning letters, the FTC states that it is not aware of any competent and reliable scientific evidence to support those claims and warns that unsupported claims are unlawful under the FTC Act. Accordingly, the FTC’s warning letters instruct the Web site operators and other marketers to discontinue any false or deceptive claims immediately.
FDA Warning Letter
The U.S. Food and Drug Administration (FDA) also has taken regulatory action against the marketers of CortiSlim. On August 19, 2004, the FDA sent a warning letter to Stephen Cheng and Window Rock Enterprises, Inc., stating that the dietary supplement CortiSlim is misbranded and violates the provisions of the Federal Food, Drug, and Cosmetic Act (the Act). According to the FDA’s letter, CortiSlim’s label and accompanying information make unsubstantiated claims that CortiSlim “eliminates cravings,” “controls appetite,” “burn[s] calories more efficiently and naturally through thermogenesis,” and “diminishe[s] hunger and stress eating.” The FDA also asserts that claims that CortiSlim “supports healthy cortisol levels” or “supports weight maintenance efforts” would be unsubstantiated. FDA further expressed to the firm that if prompt action to correct these violations was not taken, enforcement action may be initiated without further notice. The Act provides for seizure of illegal products and for an injunction against the manufacturer and/or distributor of illegal products. For additional information and a copy of the warning letter, please visit the FDA’s Web site, www.fda.gov.
“We will take appropriate enforcement action against firms that promote dietary supplement products with unsubstantiated claims about the benefits of the product,” said Dr. Lester M. Crawford, Acting FDA Commissioner. “Consumers rely on the claimed benefits of the product, and we owe it to them that such claims be supported by competent and reliable scientific evidence.”
http://www.ftc.gov/opa/2004/10/windowrock.htm
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~john |
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Scott  Posts:0
 Newbie
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| 10/06/2004 9:04 PM |
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| Yes----good has been done here! |
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kate419  Posts:0
 Newbie
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| 10/07/2004 1:10 AM |
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| I haven't posted in a long time--- been traveling outside the US. Was surprised to see the cortislim commercials when I got back and I had just logged in tonight to see what (if anything) Dr Sears thought about the whole control-of-cortisol idea for weight loss. Glad to hear the FDA is going after these guys, but I saw the commercial again yesterday so it hasn't been pulled yet.
Cheers,
Kate |
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ActiveForums 3.6
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Dr. Barry Sears is a leading authority on the dietary control of hormonal response. A former research scientist at the Boston University School of Medicine and the Massachusetts Institute of Technology, Dr. Sears has dedicated his research efforts over the past 30 years to the study of lipids. He holds 13 U.S. Patents in the areas of intravenous drug delivery systems and hormonal regulation for the treatment of cardiovascular disease.
A turning point in his research occurred in 1982. That year, the Nobel Prize in Medicine was awarded for discoveries of the role that specialized hormones, known as eicosanoids, play in the development of cardiovascular disease, diabetes, auto-immune diseases, and cancer. Since eicosanoids are only generated from dietary fat, Dr. Sears reasoned that one could apply intravenous drug delivery principles to nutrition in order to control these exceptionally powerful hormonal responses with laser-like precision. In essence, his approach treats food as if it were a drug.
This area of his research led to various patents in the area of hormonal control by essentially using food as an oral drug delivery system to modulate eicosanoids especially for cardiovascular, diabetic, and neurological patients.
The impact of Dr. Sears’ revolutionary work in the dietary control of hormonal response began with the publication of his landmark book, The Zone. Since its publication in June 1995, The Zone has sold more than 2,000,000 hardcover copies, and became a #1 best seller on the New York Times book list. In addition, The Zone has been translated into 22 languages indicating a worldwide response to Dr. Sears’ research. His second book, Mastering the Zone, published in 1997, also became a New York Times bestseller with hardcover sales in excess of 500,000 copies to date. His third book, Zone Perfect Meals in Minutes, published in 1997, quickly became one of the best-selling cookbooks of 1997 and an another New York Times bestseller. The Anti-Aging Zone was published in 1999 and provides the molecular insights into how the Zone Diet can reverse the aging process. The Omega Rx Zone, published in 2002, explores the molecular foundation of chronic disease and how high-dose fish oil can dramatically reverse it. His latest book The Anti-Inflammation Zone discusses how to combat silent inflammation in order to reduce the risk of cancer, heart disease, diabetes, dementia, and many other inflammatory conditions—and how to reverse these conditions if they are already present. To date more than 5 million hardcover copies of his Zone books have been sold in the United States.
His research has elevated food from more than simply a source of calories to being recognized as an exceptionally powerful drug. Because of his revolutionary research, Dr. Sears has been a frequent guest on many national programs such as 20/20, Today, Good Morning America, CBS Morning News, CNN, and MSNBC.
Dr. Sears continues his ongoing research as President of Zone Labs, a biotechnology company in Danvers, MA as well as the President of the non-profit Inflammation Research Foundation in Marblehead, MA. In addition to continuing research on the hormonal effects of food, Dr. Sears has expanded his research in developing innovative dietary approaches to treating cancer and neurological conditions, as well as his on-going work in treating cardiovascular diease and type 2 diabetes.
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I have been taking the Fish Oil for over 3 years now. I am 44 playing hockey and working out. The Fish oil helps with the pain that I get from playing hockey. It greatly enhances my performance on the ice and while working out. I have noticed a big difference in my energy, attentiveness and memory. If I miss a day for whatever reason, I notice a huge difference and it feels like something is missing. Anyway that is my short little story and it comes from the heart.
– Carter B.
I am a nutritionist and Ph.D. doctor of health and nutrition. For Dr. Sears to figure out balancing fat, carbs and protein, is really beyond brilliant. It is a milestone in diet history. I go over people's diet/emotional journals. Mostly all the time, we discover that the fatigue, irritability, unstable emotions were due to the imbalance in their diet. Using the Zone to balance them out, helps control weight, roller coaster emotions and gives them energy. Dr. Sears is so right when he says food is medicine. He has figured out the most powerful drug combination going, called The Zone.
Best and healthy wishes,
– Elaine W., Ph.D., N.C., M.A.
I have a very exhausting job as a flight attendant. I read the "Omega Rx Zone" about 4 years ago and started taking the fish oil. I am 47 and have been flying for 22 years. I am very active, I run and lift weights. But combining lack of regular sleep, a physically demanding job, and irregular eating patterns this job takes a toll on the body. Since taking the fish oil, I have noticed that I do not get exhausted. I get tired, but not exhausted. I stopped taking it for a couple of months and then started taking another company's fish oil. I started getting exhausted again. I came back to Zone Labs and will continue with the fish oil for the rest of my life. I believe in the product and it makes a huge difference in my life. It makes a difference with my running as well. I also bring the bars and shakes with me on the road. It is almost impossible to eat the way I should at work. I haven't found the right secret. At least I have my Zone fish oil, bars, and shakes.
– Kathryn S.
I have been in the Zone, for about 1 month now. I wanted to share with you how wonderful I think this program is. I have been a personal trainer for almost 10 years and actively compete in numerous athletic activities. The Zone program has helped me to achieve a better awareness of my nutritional needs and the results I have seen are amazing! I have lost nearly 13 lbs since I have been in the Zone. I feel more mentally alert, more focused at work, have greater intensity during my training, have made significant strength gains, and just feel better over all. With that said, I would like to thank you for helping me in my quest for "super-health"!
Thank you!
– Rob Y.
I read 'The Zone' and as exactly as I could followed the advice for diet. I noted weight loss progress. Over six months, I lost 33 pounds. One year has passed since then. I have maintained the new weight, guided always by Zone concepts. The Zone is powerful - I have found it fantastic and I am very grateful to Dr Sears.
– Lyn S.
Before I stumbled across the Zone I was weighing close to two hundred pounds and I was depressed. I used to be a gymnast as a young man. I would think, "look at me now," when I looked in a mirror. The day I found 'The Zone' book, I was intrigued and as I read it the science made sense and so, I began to follow the "treatment". I began to lose weight and I was feeling way more energetic. I am forty two years old, I am very active and my weight is down to 162 lbs, 38 pounds lost on the Zone. I cycle, walk, jog, swim and I can now perform some of the more simple gymnastic skills I did twenty years ago...I literally feel like I have turned back the clock.
Thank you!
– Jack J.
I have been on the Zone diet for 7 years. I did not go on the diet to lose weight necessarily; but fairly quickly I lost 25 pounds, going from 190 to 165; from a 36-inch waist to a 32-inch waist. I primarily did the Zone to live healthier. My health is excellent now. I just turned 62 years old. My Zone is my eating lifestyle now; I seldom stray; and I do not miss anything. It is The Good Life.
– Curtis Y.
My wife's doctor told her to read "Enter the Zone" and to do the diet, so I told her I would do it with her. After only one week on the plan we went on a strenuous hike (the first of the year), and when we stopped at our favorite coffee shop on the way home I was able to get out of the car and stand upright and walk into the place without pain or stiffness. The Zone had eliminated all the inflammation that had always forced me to stumble all humped over into the coffee shop any time we skied or hiked all day.
Thank you, Doctor Sears.
– Larry C.
I used to have a lot of knee pain when I walked or ran. I have been taking Omega Rx for almost a year now, and rarely have any pain. I believe it is the anti-inflammation action of the oil. I feel smarter as well. Thanks for developing such a superior oil!
– Joe W.
Prior to following the Zone Diet, my body fat was around 15% and my weight around 153 pounds. No matter what I did, my weight and body fat did not change much. I regularly cycled 20-30 hours per week logging well over 400 miles. That had little impact on body fat or weight. Diet also seemed to have little impact on body fat or weight. Within a couple of months of following the zone diet, my weight dropped rather quickly to 142 pounds and body fat to about 8%. I still regularly cycle up to 20 hours per week (during the summer). I have also started strength training. I eat about 16 blocks per day. I take 3.6 grams of fish oil per day, along with Vitamin E, Alpha Lipoic Acid, CoQ10, and B & C vitamins. I also take GLA, which in my opinion, has significantly reduced fatigue and improved recovery times after exercise.
– Jeremy S.
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All polyphenols have antioxidant properties than can be measured by their Oxygen Radical Absorption Capacity (ORAC), but not all polyphenols have anti-inflammatory properties. The polyphenols in Dr. Sears’ Zone Polyphenol Plus have been carefully chosen to have both.
Polyphenols are the phytochemicals that not only give fruits and vegetables their color, but also help regulate inflammation. In addition, polyphenols also activate the key enzyme (AMP kinase) that helps restore cellular ATP levels. Polyphenols also help regulate the activation of inducible inflammatory proteins (such as COX-2 and inflammatory cytokines).
There are more than 4,000 known polyphenols, and the richest sources are fruits and vegetables. In general, the more color a fruit or vegetable has, the richer the polyphenol content.
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Zone Labs’ Ultra Refined Omega-3 Concentrates are three times fresher and contain less than 1/10th the mercury than what is allowed by the Norwegian Medicinal Standard and European Pharmacopoeia Standard
Zone Labs adheres to the International Fish Oil Standard (IFOS), an independent third party validated laboratory quality standard that is more rigid than any other global standard for purity.
- No company in the worlds runs more tests with IFOS than Zone Labs
- Zone Labs receives a 5 out of 5 star IFOS rating for every batch it tests
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| Standard |
IFOS Standard for a 5-Star Ranking |
Council for Responsible Nutrition |
European Pharmacopeia |
Norwegian Medicinal Standards |
| Peroxide |
< 3.75 meg/kg |
5 meg/kg |
10 meg/kg |
10 meg/kg |
| Totox Levels |
< 20 meg/kg |
26 meg/kg |
NA |
NA |
| Lead |
< 10 ppb |
10 ppb |
100 ppb |
100 ppb |
| Mercury |
< 10 ppb |
10 ppb |
100 ppb |
100 ppb |
| Dioxans and Furans |
< 1 ppt |
2 ppt |
2 ppt |
2 ppt |
| PCBs |
< 45 ppb |
90 ppb |
NA |
NA |
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"IFOS – THE TOP GLOBAL PURITY STANDARD FOR OMEGA-3 FROM FISH"
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Zone Labs products show no detectable lead or mercury when tested down to 10ppb, which is 10 times below the Norwegian Medicinal Standard and European Pharmacopoeia Standard limits.
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Zone Labs products are three times fresher than the minimum allowed by the Norwegian Medicinal Standard and European Pharmacopoeia Standards (based on average peroxide values).
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Zone Labs starts with only wild, small fish from pristine Chilean waters and ends with proprietary validation and testing processes to achieve an IFOS certified 5 star rating.
8-Step Manufacturing Process - Quality Assured
Testing to specification all raw materials, bulk products, packaging material and finished products – always using stringent internal standards and in-process testing.
- Extraction of fish oil
- Winterization – remove limited amounts of saturated fats
- Absorption – remove heavy metals
- Preliminary Molecular Distillation – refining “touch up” to reduce contaminants
- Oil conversion to ethyl esters
- Ethyl ester thermal fractionation – remove additional saturated fats
- True Molecular Distillation – final refining to remove pcb’s and long-chain monoenes
- Rigid Processes – proprietary validation, inspection and encapsulation methods. Independent lab verification of IFOS requirements and certified 5 star rating
No farmed fish. No large fish. Pristine waters.
Zone Labs starts with wild sardines & anchovies fished from cold, pristine waters off of South America where there are less environmental impurities.
A recommended serving of Zone Labs Ultra-Refined Concentrates delivers 8 times more omega-3’s than a typical retail fish oil supplement.
Most fish oil supplements have 30% or less of the healthy omega-3s EPA and DHA, with the remaining 70% of the capsule containing unbeneficial, lesser refined fatty acids that contribute to their bad taste and gastric side effects.
Getting a clinically valid dose of omega-3’s is easy with Zone Labs’ Ultra-Refined Omega-3 Concentrates.
Typical Retail Dose = 300mg omega-3
Standard Zone Dose = 2400mg omega-3
A serving of canned tuna has 12 times less omega-3’s than
Zone Labs Ultra-Refined Omega-3 Concentrates
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Commonly consumed fish and shellfish in the United States
Mercury Source: Food and Drug Administration, FDA 1900-2004, “National Marine Fisheries Service Survey of Trace Elements in the Fishery Resource". Omega-3 Level Source: American Heart Association Website.
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Mercury level
in parts per million (ppm) |
Omega-3 fatty acids
(milligrams per 3-oz. serving) |
| Zone Omega-3 Products |
< 0.01 |
2400 (standard 4 capsule serving |
| Salmon (fresh, frozen) |
0.014 |
1200 |
| Flounder or sole |
0.050 |
480 |
| Pollock |
0.041 |
450 |
| Crab |
0.060 |
400 |
| Scallops |
0.050 |
290 |
| Shrimp |
ND* |
290 |
| Catfish |
0.050 |
270 |
| Clams |
ND* |
250 |
| Cod |
0.095 |
210 |
| Canned Tuna (light) |
0.120 |
200 |
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Zone Labs’ leading product. OmegaRx delivers all of the benefits of Zone Labs’ ultra-refined omega-3 concentrates.
Advantages
- Delivers clinically proven health benefits from the omega-3 fatty acids EPA and DHA*
- Promotes a healthy heart, healthy brain, healthy immune system, healthy circulatory system, healthy joints, healthy moods, healthy triglyceride levels and a healthy pregnancy*
- Combats silent inflammation
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