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XTEND-15sec-NEWSt
10th September 2004

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FDA recognizes benefits of Omega 3s...n1

Yesterday the US Food and Drug Administration (FDA) today announced the availability of a qualified health claim for reduced risk of coronary heart disease (CHD) on conventional foods that contain eiscosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 fatty acids.

Typically, EPA and DHA Omega-3 fatty acids are contained in oily fish, such as salmon, lake trout, tuna and herring. These fatty acids are not essential to the diet; however, scientific evidence indicates that these fatty acids may be beneficial in reducing CHD.

This follows a similar qualified health claim approved by the FDA back in 2000. To read a news release from NPI on this please click here.

Warren Matthews comments: The more people who know about the benefits of Omega 3's the better. Not only is it helpful for heart disease, but also is good for the brain! It makes me wonder though why it took so long for government authorities to officially recognize the benefits from fish oil when it has been widely known for decades.

Remember though that they are referring to the Omega 3's in fish oil, not plant Omega 3's as they do not contain DHA and EPA. Instead they contain ALA which has to be converted to DHA and EPA within the body. For many people this conversion does not take place and as such they do not get the benefits of DHA and EPA from plant based Omega 3's.

A word of warning! If you are taking Omega 3 fish oil supplements, only use those which have been through the process of molecular distillation. This is because ordinary fish oil is high in contaminants, such as PCB's and heavy metals (including mercury), particularly from Northern Hemisphere fish stocks.

Because of this problem we developed a pure fish oil soft gel using uncontaminated fish caught in New Zealand. We use the oil from this fish and put it through the molecular distillation process to produce the purest product possible. For more info click here.

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Bodyflex Marketers Settle FTC Charges of False and Unsubstantiated Inch and Fat Loss Claims...

FTC Settlement Requires $2.6 Million Consumer Refund Program.

Marketers of the BodyFlex+ System (BodyFlex) have agreed to settle Federal Trade Commission allegations that they deceptively advertised that BodyFlex causes users to lose from four to 14 inches in the first seven days. The proposed settlement, which requires court approval, establishes a $2.6 million consumer refund program, and requires the defendants to stop making the false claims about BodyFlex that were challenged in the FTC's complaint.

BodyFlex is an 18-minute routine involving stretching, deep breathing, and exercises with the BodyFlex Gym Bar - a plastic exercise bar with a resistance band. In 2003, the defendants promoted BodyFlex in a heavily-aired national infomercial and on the Internet at www.bodyflex.com. The ads claimed, "in just seven days you can lose from four to 14 inches guaranteed with BodyFlex Plus.

To read the FTC news release click here.

Warren Matthews comments: It is sad that consumers are still taken in by scams such as this. At the end of the day, it is what you put in your mouth that influences your weight. Exercise helps but without controlling what you eat all you will always be facing a losing battle with weight. You need to understand the cause of the weight gain. When you truly understand this it becomes much easier to deal with a weight problem. There is no miracle solution no matter what clever marketers may suggest.

If you haven't done so, you might find our weight loss report of benefit to you. Click here for a free copy.

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Doctors' body accuses drug firms of 'disease mongering'...n3

The Royal College of General Practitioners has accused drug companies of "disease-mongering" in order to boost sales.

The college, whose members include many of Britain's 37,000 GPs, says the pharmaceutical industry is taking the National Health Service to the brink of collapse by encouraging unnecessary prescribing of costly drugs.

To read this interesting article by Michael Day, Health Correspondent click here.

Warren Matthews comments: Hmm... nothing much for me to say here! Our long time readers know what I think about these types of practices!

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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.





FDA Announces Qualified Health Claims for Omega-3 Fatty Acids (Full Article)f1

The Food and Drug Administration (FDA) today announced the availability of a qualified health claim for reduced risk of coronary heart disease (CHD) on conventional foods that contain eiscosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 fatty acids.

Typically, EPA and DHA omega-3 fatty acids are contained in oily fish, such as salmon, lake trout, tuna and herring. These fatty acids are not essential to the diet; however, scientific evidence indicates that these fatty acids may be beneficial in reducing CHD.

"Coronary heart disease is a significant health problem that causes 500,000 deaths annually in the United States," said Dr. Lester M. Crawford, Acting FDA Commissioner. "This new qualified health claim for omega-3 fatty acids should help consumers as they work to improve their health by identifying foods that contain these important compounds."

A qualified health claim on a conventional food must be supported by credible scientific evidence. Based on a systematic evaluation of the available scientific data, as outlined in FDA's "Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements", FDA is announcing a qualified health claim for EPA and DHA omega-3 fatty acids. While this research is not conclusive, the FDA intends to exercise its enforcement discretion with respect to the following qualified health claim:

"Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of food] provides [x] grams of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat and cholesterol content.]

In 2000, FDA announced a similar qualified health claim for dietary supplements containing EPA and DHA omega-3 fatty acids and the reduced risk of CHD. FDA recommends that consumers not exceed more than a total of 3 grams per day of EPA and DHA omega-3 fatty acids, with no more than 2 grams per day from a dietary supplement.

The EPA and DHA omega-3 fatty acid qualified health claim is the second qualified health claim that FDA has announced for conventional foods.

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Bodyflex Marketers Settle FTC Charges of False and Unsubstantiated Inch and Fat Loss Claims
(Full Article)

FTC Settlement Requires $2.6 Million Consumer Refund Program

Marketers of the BodyFlex+ System (BodyFlex) have agreed to settle Federal Trade Commission allegations that they deceptively advertised that BodyFlex causes users to lose from four to 14 inches in the first seven days. The proposed settlement, which requires court approval, establishes a $2.6 million consumer refund program, and requires the defendants to stop making the false claims about BodyFlex challenged in the FTC's complaint.

BodyFlex is an 18-minute routine involving stretching, deep breathing, and exercises with the BodyFlex Gym Bar - a plastic exercise bar with a resistance band. In 2003, the defendants promoted BodyFlex in a heavily-aired national infomercial and on the Internet at www.bodyflex.com. The ads claimed, "in just seven days you can lose from four to 14 inches guaranteed with BodyFlex Plus."

The FTC's complaint, filed in federal district court in November 2003, and amended in January 2004, charges that the defendants made false and unsubstantiated claims that: 1) BodyFlex causes users to lose from four to 14 inches across six body areas in the first seven days without reducing calories; 2) BodyFlex causes users to burn enough body fat to achieve the claimed inch loss in the first seven days; and 3) a clinical study proves that BodyFlex causes significant fat loss and inch loss in the first seven days.

The FTC's amended complaint names Savvier, Inc. and Savvier, LP, California companies; their principals, Jeffrey Tuller and Jack Ching Chung Chang; BodyFlex, Inc., a Nevada corporation; and its principal and BodyFlex spokesperson Greer Childers. In a stipulated motion filed on August 31, 2004, the FTC asked the court to dismiss charges against defendant Jack Ching Chung Chang.

The proposed stipulated final judgment and order bans the remaining settling defendants from making the false claims challenged in the complaint. It also prohibits the defendants from making claims, for any product, service, or program that purports to provide weight-loss, inch- loss, fat-loss, exercise or fitness benefits, and for any dietary supplement, food or drug, without scientific substantiation. The order further prohibits the defendants from misrepresenting test or research results for any of these covered products, services, or programs.

The order requires Savvier LP to establish and administer a $2.6 million consumer refund program. Savvier LP also will pay the administrative costs of the refund program. Under the program, dissatisfied consumers will have an opportunity to receive either a full refund or a pro rata share, depending on the consumer response to the refund offer. Savvier LP will send notices to BodyFlex purchasers describing how they can receive a refund. After the refund program is completed, any unused funds will be disgorged to the U.S. Treasury. The FTC has established a consumer hotline number for BodyFlex: 202-326-2935.

The order also contains a $36 million "avalanche clause," which would make this entire amount immediately due if the court finds that the defendants misrepresented their financial condition.

Finally, the order contains various recordkeeping and reporting requirements to assist the FTC in monitoring the defendants' compliance.

The Commission vote authorizing staff to file the proposed Stipulated Final Judgment and Order was 5-0. The Order was filed in the U.S. District Court for the Central District of California, on August 31, 2004, and is subject to court approval.

Consumer Tips

The FTC has two consumer publications about exercise equipment,Avoiding the Muscle Hustle" and "Pump Fiction: When Marketers Overextend Their Fitness Claims." These publications, found at www.ftc.gov/dietfit, offer tips to consider and questions to ask before buying exercise equipment.

To lose weight and get in shape:

  • Commit to sensible eating and moderate exercise.
  • Remember: the benefits of exercise require exercise - not gizmos or gimmicks.
  • Be patient. Losing weight and inches takes time.

The FTC consumer hotline number for BodyFlex is 202-326-2935.

NOTE: This Stipulated Final Judgment and Order is for settlement purposes only and does not constitute an admission by the defendants of a law violation. Stipulated Final Judgments and Orders have the force of law when signed by the judge.

Copies of the Stipulated Final Judgment and 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 in English or Spanish (bilingual counselors are available to take complaints), 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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Doctors' body accuses drug firms of 'disease mongering' (Full Article)f3
By Michael Day, Health Correspondent
(Filed: 29/08/2004)

The Royal College of General Practitioners has accused drug companies of "disease-mongering" in order to boost sales.

The college, whose members include many of Britain's 37,000 GPs, says the pharmaceutical industry is taking the National Health Service to the brink of collapse by encouraging unnecessary prescribing of costly drugs.

In evidence to a parliamentary inquiry, the college accuses the companies of over-playing the dangers of conditions such as mild depression or slightly raised blood pressure.

Dr Maureen Baker, the college's honorary secretary, wants the Commons health inquiry to investigate the companies' practices.

"It would be fruitful to look into the increase in disease-mongering by them," she told The Sunday Telegraph.

"It is very much in the interest of the pharmaceutical industry to draw a line that includes as large a population as possible within the 'ill' category. The bigger this group is, the more drugs they can sell. If current trends continue, publicly funded health-care systems will be at risk of financial collapse with huge cost to society as a whole."

The college lists hypertension, high cholesterol, osteoporosis, anxiety and depression as examples of common conditions that, in mild forms, are often inappropriately treated with drugs.

Richard Ley, a spokesman for the Association of the British Pharmaceutical Industry, said: "It seems odd for this criticism to come from the Royal College of all organisations, because a decision on when and how to treat a patient is the doctor's."

Dr Baker, however, questioned the impartiality of treatment guidelines from bodies of specialist doctors that tell GPs when and what to prescribe, saying they were often overly influenced by and financially reliant on drug companies.

Earlier this month, it emerged that three senior members of the Joint Committee on Vaccination and Immunisation, which recommended the introduction of the new five-in-one jab for diphtheria, tetanus, whooping cough, polio and Hib had received "industrial support" from two pharmaceutical firms, Aventis Pasteur and Merck Sharp & Dome, which are supplying the vaccination.

Some observers are also worried about "hard-sell" methods applied to general practice. Last year, a survey of 1,000 GPs published in the British Medical Journal found that those who saw drugs-company representatives at least once a week were more likely to prescribe drugs that were not needed.

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