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XTEND-15sec-NEWSt
26th March 2003

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FDA proposes new dietary supplement regulations.n1

The FDA has announced that it proposes a system of "current good manufacturing practices (CGMPs)" in the manufacturing, packing, and holding of "dietary supplements." The proposed rule is intended to ensure that dietary supplements, herbs, and similar products are not adulterated with contaminants or impurities, and their labels accurately reflect their ingredients. The proposal covers designing and constructing physical plants; establishing quality control procedures; testing manufactured dietary ingredients and dietary supplements; maintaining records; and handling consumer complaints related to CGMPs. Manufacturers would be required to evaluate the identity, purity, quality, strength, and composition of their products, and products that are contaminated or lack any ingredient listed on the label would be considered adulterated. [FDA proposes labeling and manufacturing standards for all dietary supplements. FDA news release, March 7, 2003] http://www.fda.gov/bbs/topics/NEWS/2003/NEW00876.html.

Warren Matthews comments: This is good news even though they are talking about a three year phase in period. Hopefully this will result in an overall improvement of the quality of dietary supplements which will benefit the industry as a whole. It is well overdue. Currently many manufacturers claim that their product is FDA approved even though the FDA does not approve specific products….only ingredients. Also the claim that their manufacturing facilities are FDA 'approved' is meaningless. The current GMP structure in the US is also of questionable value as it is industry issued with minimal requirements. The new FDA proposal will go someway towards (but not all) the already stringent government requirements already in place in New Zealand for GMP facilities.

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Rexall/Cellasene cases may be settledn2

Rexall Sundown, Inc, has agreed to pay up to $12 million to resolve FTC charges that it falsely advertised that its product "Cellasene" could effectively remove "cellulite" without exercise or dieting. The agreement bars Rexall from claiming without substantiation that Cellasene or any other product eliminates or substantially reduces cellulite, body fat, or weight. The agreement will become final when state courts approve settlements pending in class-action suits in Florida and California, a process that may take several months. The FTC will then administer a redress fund of up to $12 million for dissatisfied consumers. Consumers seeking redress should call the FTC's settlement hotline at (202) 326-3793. [Rexall Sundown to pay up to $12 million to settle charges regarding cellulite treatment product: company allegedly made false and unsubstantiated claims for "Cellasene." FTC news release, March 11, 2003.] For details of the news release click here.

Warren Matthews comments: Cellulite is difficult to get rid…but it is possible. However, no one pill on its own will achieve its removal. To get rid of it requires effort on a number of different fronts. I will be covering this subject in the weight loss report I am working on.

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Food Companies take on Dr Atkinsn3

Lobbying is underway in Washington to try and counter proposed changes to the official 'food pyramid'. The wheat council which is comprised of various food manufacturing companies is part of the lobbying. It seems that Americans are beginning to realize that the food pyramid is wrong and has largely held its position through industry pressure, not through good nutrition.

It appears a major contributor for the change in public awareness is due to the popularity of Dr Atkins diet. There is an article written by Carey Gillam and published by Reuters that you may be interested in reading. For details of it please click here.

Warren Matthews comments: No surprises here. All my research indicates that the current official food pyramid is very unhealthy and a contributor to obesity. Whereas grains to a very limited extent are OK in their natural form, they can be deadly by the time they are processed and into 'foods' with all the additives. Also they are a major cause of food allergies.

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Important notice: All material provided within XTEND-15sec-NEWS is for informational and educational purposes only, and is not to be construed as medical advice or instruction. No action should be taken solely on the contents of this publication. Consult your physician or a qualified health professional on any matters regarding your health and wellbeing or on any opinions expressed within this newsletter. The information provided in this newsletter is believed to be accurate based on the best judgment of the editor but the reader is responsible for consulting with their own health professional on any matters raised within.





For Release: March 11, 2003f1

Rexall Sundown to Pay up to $12 Million to Settle Charges Regarding Cellulite Treatment Product

Company Allegedly Made False and Unsubstantiated Claims for "Cellasene"
(Full Article)

Rexall Sundown, Inc. (Rexall) will pay up to $12 million to resolve Federal Trade Commission charges regarding its marketing of the dietary supplement, "Cellasene," a purported cellulite treatment product. The settlement is contingent on approval by the federal district court in Miami and approval of related settlements in class action lawsuits currently pending against Rexall in California and Florida. If approved, the FTC and class action settlements together will provide up to $12 million in redress for consumers throughout the United States who purchased Cellasene.

"Hundreds of thousands of consumers were misled by the claims for this product," said Howard Beales, Director of the FTC's Bureau of Consumer Protection. "This case should alert advertisers to the fact that their chances of getting away with making unsubstantiated claims are slim to none."

Rexall is a Florida-based subsidiary of Royal Numico, N.V. that manufactures and markets a variety of nutritional supplements and consumer health products. In 1999, Rexall launched a national public relations campaign that heralded the introduction of Cellasene as a major news event, and hired an agency to distribute widely a "video news release" that described the Cellasene clinical studies as "impressive." News stories on Cellasene appeared throughout the country. Shortly thereafter, Rexall advertised Cellasene in major newspapers including The Washington Post and USA Today. The company also advertised Cellasene in magazines, on the Internet, on television and radio, and through free-standing inserts in newspapers. Sales of Cellasene exceeded $40 million in the United States. The eight-week Cellasene regimen cost consumers almost $200.

In July 2000, the FTC sued Rexall in the U.S. District Court for the Southern District of Florida, alleging that the company violated the FTC Act by making unsubstantiated claims about the ability of Cellasene to eliminate or substantially reduce cellulite and false claims that it had clinical evidence establishing Cellasene's efficacy. In its promotional materials, Rexall had stated that "clinically researched" Cellasene was "The One That Works," and that, "Unlike massages and creams, Cellasene works from within, nutritionally, to help eliminate cellulite at its source.

"In addition to its consumer redress provisions, the stipulated final order prohibits Rexall from making any unsubstantiated cellulite reduction or elimination claim for Cellasene. It also prohibits the defendant from making unsubstantiated claims regarding cellulite, body fat or weight loss for drugs or dietary supplements and from misrepresenting test or study results in connection with the sale of any dietary supplement or drug.

The settlement will become final when the class action settlements are approved in final form by the California and Florida State courts, a process that may take several months. After these approvals are obtained, the FTC will administer a redress fund of up to $12 million for consumers who were dissatisfied with Cellasene. Consumers who purchased Cellasene and want to participate in the redress program should call the Commission's settlement hotline at: 202-326-3793.

The Commission vote authorizing staff to file the stipulated final order was 5-0. It was filed in the U.S. District Court, Southern District of Florida, in Miami, on March 11, 2003.

NOTE: This stipulated final order for permanent injunction is for settlement purposes only and does not constitute an admission by the defendant of a law violation. Stipulated final orders have the force of law when signed by the judge.

Copies of the stipulated final order are available from the FTC's Web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. The FTC works for the consumer to prevent fraudulent, deceptive, and unfair business practices in the marketplace and to provide information to help consumers spot, stop, and avoid them. To file a complaint, or to get free information on any of 150 consumer topics, call toll-free, 1-877-FTC-HELP (1 877-382-4357), or use the complaint form at http://www.ftc.gov. The FTC enters Internet, telemarketing, identity theft, and other fraud-related complaints into Consumer Sentinel, a secure, online database available to hundreds of civil and criminal law enforcement agencies in the U.S. and abroad.

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Beef vs. bagels - Food companies take on Dr. Atkins (Full Article)f2

Sunday March 16, 11:23 am ET
By Carey Gillam

OVERLAND PARK, Kan., March 16 (Reuters) - It has been months since Tina Moore last bit into a bagel or a slice of toast.

"Protein is good. Carbs are bad," says 41-year-old Moore, who altered her diet five years ago in a bid to lose weight.

Moore, the owner of a hair salon, is one of the estimated 15 million-plus Americans seen as devoted followers of dieting guru, Dr. Robert Atkins, who recommends eating protein for those who want to rid themselves of unwanted weight and keep the pounds off.

"Carbs and sugar... they give you a quick high, then you get really low. You get tired and hungry," said Moore, who sees herself as a reformed "carbohydrate addict."

The hamburger patty is good, the hamburger bun bad, according to the teachings of Atkins, who has turned his philosophies into a dieting revolution, starting with his first book, "Dr. Atkins Diet Revolution," in 1972.

Atkins books -- his latest, "Atkins for Life," was published this year -- routinely top best-seller lists. Atkins companies have racked up millions of dollars in sales of specialty low-carb food products and carb-counting scales.

But the popularity of Atkins' eating advice, now appealing to another generation, is fraying the nerves of some food companies who rely on the consumer appetite for carbohydrate-laden foods such as pastas and pizzas, cakes, cookies and cereals, to add heft to their own bottom lines.

They claim Atkins is falsely disparaging food groups that serve as a foundation for American eating. And that by teaching people to severely limit the use of flour-based products, Atkins is eating into sales of some bread and cereal products in the United States.

"Our industry has to do something, and soon. It is starting to become a mainstream belief that carbohydrates are bad," said Judi Adams, director of the Wheat Foods Council, a consortium of industry players that includes ConAgra, General Mills and Kellogg Co.

"This Atkins diet -- or, I call it Fatkins diet -- is going out unchallenged. People are starting to believe it," Adams said.

Part of the consortium's push will be in Washington, where federal health officials are starting talks on revisions to the nation's 11-year-old Food Guide Pyramid.

Wheat Foods will be actively involved in defending the grains, Adams said.

Currently, the pyramid puts bread, cereals, rice and pasta as the foundation for healthy eating, recommending six to 11 servings a day. But some are pushing for changes that would move grains off the foundation, and cut back servings.

SLIM PICKINS

There is limited funding for the anti-Atkins campaign, as most food companies spend their advertising dollars on product specific programs to tout such things as new Berry-Burst Cheerios, recently released by General Mills.

So, with only a slender budget to try to counter the Atkins phenomenon, the Wheat Foods Council is aiming its "educational" campaign" at nutritionists and the medical community.

The strategy is a direct attack on Atkins: Americans who follow the Atkins diet increase their risk of health problems that include cardiovascular disease, high cholesterol, kidney damage and some cancers, the Wheat Foods Council says.

Adding insult to injury, it claims that Atkins followers can also suffer headaches, constipation and bad breath.

The council says obesity is not specifically tied to carbohydrates but is the simple result of lazy overeaters.

"Healthful grain-based foods have become the scapegoat for weight gain, when overeating and underexercising are at issue," said Carol Pratt, a Kellogg nutrition and regulatory affairs expert, and incoming chairwoman for Wheat Foods.

FEWER COOKIES AND CAKES

Consumer eating habits are hard to track, but the latest Consumer Expenditure Survey of the U.S. Department of Labor does indicate a possible shift away from grain-based foods.

According to the government survey, consumer spending in 2001 for ready-to-eat and cooked cereals, pasta, flour, flour mixes and bakery products dropped from the previous year even as consumer spending for meat, poultry, fish and eggs and other similar products increased for the third year in a row.

Moreover, the 0.2 percent decrease in spending came as the consumer price index for those foods grew 2.9 percent. As well, wheat consumption in the United States dropped 4 percent from 1997 to 2001, according to industry research.

"I'm very much concerned," said Mark Dirkes, spokesman for Interstate Bakeries, the nation's largest wholesale baker and the maker of Wonder Bread. "He (Atkins) has run a very effective campaign. That just can't be good for our industry."

CLEANING OUT THE CABINETS

Among Atkins preachings: the elimination of "white flour-laden junk food" from kitchen cabinets, and research that Atkins says shows carbohydrates work to slow the body's burning of fat and make people feel hungrier faster.

And after decades of rejecting Atkins' theories, some new scientific research studies, including work by Harvard University, have started lending credence to Atkins' ideas.

Colette Heimowitz, director of research at the Atkins Health and Medical Information Services says over-consumption of bread, cereal and baked products is partly to blame for overweight Americans. Products made with white flour, sugars and hydrogenated oils are the worst.

Still, she says, Atkins is not looking to go to war with the food companies, and that even Atkins die-hards allow for an occasional doughnut or cookie.

"We teach people how to respect it and, on rare occasions, have it in moderation," she said. "We know people can't stay away from it forever."

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