Last month the Federal Trade Commission launched "Operation Big Fat Lie," a nation-wide law enforcement sweep against six companies making false weight-loss claims in national advertisements. Operation Big Fat Lie is the latest in the Commission's efforts to: stop deceptive advertising and provide refunds to consumers harmed by unscrupulous weight-loss advertisers; encourage media outlets not to carry advertisements containing bogus weight-loss claims; and educate consumers to be on their guard against companies promising miraculous weight loss without diet or exercise.
"False and misleading advertisements are about as credible as a note from the Tooth Fairy," said Federal Trade Commission Chairman Deborah Platt Majoras. "As part of our 'no tolerance' policy, we are announcing six new cases against advertisers using bogus weight loss claims.
According to a report in the British Guardian, criminals in Britain are to be given vitamin supplements in an unusual attempt to reduce anti-social behaviour which will test the effect of diet on the brain.
The move is controversial, with many in the prison service sceptical that healthy food could make much difference to hardened criminals.
The proposals being drawn up within the Home Office reflect a growing interest in the potential link between junk diets laced with additives and disturbed or hyperactive behaviour. American research has shown a link between poor diet and aggressive or impulsive tendencies, including a recently published US study of young children from Mauritius which found they were significantly less likely to grow up to have criminal records if fed an enriched diet from a young age. More...
It has been proven that it can work in schools (pity more schools didn't do it). So, why not in prisons!!
A Food and Drug Administration official said Friday "we categorically reject" accusations the agency has failed to protect the public against dangerous drugs. "All the drugs that are on the market have risks," asserted Dr. Steven Galson, acting director of the FDA Center for Drug Evaluation and Research.
Appearing on morning television a day after an FDA critic renewed allegations the regulatory agency mishandled the arthritis drug Vioxx, Galson also said that a review is under way of five other medications whose safety was questioned.
This article follows on from an earlier article in Xtend-15sec-News in which the handling of VIOXX and other drugs by the FDA was criticized by one of their own. To read the balance of the article please click here.
TC Launches 'Big Fat Lie' Initiative Targeting Bogus Weight-loss Claimsf1
(Full Article)
2004-11-10 - Federal Trade Commission (FTC)
Today, the Federal Trade Commission is launching "Operation Big Fat Lie," a nation-wide law enforcement sweep against six companies making false weight-loss claims in national advertisements. Operation Big Fat Lie is the latest in the Commission's efforts to: stop deceptive advertising and provide refunds to consumers harmed by unscrupulous weight-loss advertisers; encourage media outlets not to carry advertisements containing bogus weight-loss claims; and educate consumers to be on their guard against companies promising miraculous weight loss without diet or exercise.
Complaints in each of the six cases announced today allege that defendants used at least one of the seven bogus weight-loss claims that are part of the FTC's "Red Flag" education campaign announced in December 2003. That ongoing Red Flag campaign provides guidance to assist media outlets in voluntarily screening out weight-loss ads that contain claims that are too good to be true.
"False and misleading advertisements are about as credible as a note from the Tooth Fairy," said Federal Trade Commission Chairman Deborah Platt Majoras. "As part of our 'no tolerance' policy, we are announcing six new cases against advertisers using bogus weight loss claims. By also working with media outlets to reject false ads and educating consumers to make informed choices, the FTC hopes to keep this national obesity epidemic from getting worse."
The cases announced today challenge ads containing false Red Flag claims for a variety of products, including pills, powders, green tea, topical gels, and diet patches. The FTC alleges in each case that the weight-loss claims are false and that the defendants did not have adequate substantiation for the claims they made. The challenged ads ran in nationally-known publications such as: Cosmopolitan; Woman's Own; Complete Woman; USA Weekend; Dallas Morning News; San Francisco Chronicle; Cleveland Plain Dealer; Albuquerque Journal; and in Spanish-language publications, such as TeleRevista Magazine. In each of these cases, the Commission is seeking to stop the bogus ads and to secure redress for consumers. In addition to the cases announced today, the Commission has filed lawsuits against seven other companies since April 2004 for making similarly false Red Flag weight-loss claims. (See attached list of cases.)
FTC's "Red Flag" Media Education Campaign
These cases follow up on the FTC's December 2003 announcement of its Red Flag initiative to encourage the media to adopt standards that would screen out weight-loss advertisements that contain false claims. Preliminary results of this effort are promising. "Through our monitoring, we have seen a decrease in the frequency of false weight loss claims in the media," said Chairman Majoras. "This tells us that many in the publishing and broadcasting industries are doing the right thing and stepping up their efforts to reject ads like the ones we targeted today. That is good for consumers, good for the media, and good for honest advertisers."
As part of the Red Flag initiative, the FTC staff has sent reminder letters to media outlets that ran advertisements challenged in the six law enforcement actions announced today. The purpose of these letters is to assist media in identifying and rejecting weight-loss ads that contain facially false claims. The media letters include: (1) a copy of the problem advertisement; (2) a copy of the Commission's Reference Guide for Media on Bogus Weight Loss Claim Detection; and (3) a description of each Red Flag Claim contained in the problem advertisement.
Consumer Education
The FTC is launching a campaign to help consumers spot claims that almost always signal a diet rip-off. Weighing the Evidence in Diet Ads warns consumers to steer clear of diet pills, patches, creams, or other products that offer quick weight loss without diet or exercise; that claim to block the absorption of fat, calories, or carbohydrates; or that promise that consumers can eat all they want of high-calorie foods and still lose weight. Consumers can find more tips on protecting themselves from questionable diet products at http://www.ftc.gov/dietfit.
The FTC has also launched a new "teaser" web site to reach consumers surfing online for weight-loss products. Teaser sites mimic real Web pages, using common buzz words and making the kind of exaggerated diet claims found on many web sites. At first glance, the teaser site appears to advertise a new pill promising to help consumers "Lose up to 10 pounds per week - with no sweat, no starvation!" Once the consumers try to order the product, they learn the ad is actually a consumer education piece posted by the FTC to warn consumers about diet rip-offs. The FTC's new teaser site can be found at: http://www.wemarket4u.net/fatfoe.
Law Enforcement Actions
Selfworx.com LLC
On November 4, 2004, the Commission filed a complaint in the U.S. District Court, District of Maine, against Selfworx.com LLC, Iworx LLC, and Jeffrey V. Kral. The Scarborough, Maine-based defendants advertised two weight-loss products: geloäothin - a topical gel, and Ultra LipoLean - a dietary supplement tablet described as a "fat blocker."
The complaint alleges that the defendants make false and unsubstantiated claims that geloäothin, when rubbed into the skin: (1) causes substantial weight loss, including as much as 21 pounds in six weeks; (2) dissolves fat deposits in days; and (3) dissolves and removes cellulite from the body. The complaint further alleges that defendants falsely claim that clinical studies demonstrate that geloäothin will reduce fat and cellulite deposits on contact.
The complaint further alleges that the defendants make false and unsubstantiated claims that LipoLean causes rapid and substantial weight loss, including as much as four pounds per week, without the need to diet; and that only two tablets of LipoLean absorb 20 to 30 grams of fat from a meal.
Femina, Inc.
On November 8, 2004, the FTC filed a complaint in the U.S. District Court, Southern District of Florida, against Femina, Inc., based in Pembroke Pines, Florida, and its owner, Husnain Mirza, challenging ads for three products - "1-2-3 Reduce Fat" (a three-part kit), "Siluette Patch" (a transdermal patch made from pure seaweed), and "Fat Seltzer Reduce" (a dietary supplement). The 1-2-3 Reduce Fat kit includes Xena RX, a diet pill; Reduce Gel Magic, a gel to put on the body; and a plaster corset to wrap around the body. The Xena RX pill purportedly contains green tea extract, and the Magic gel purportedly contains aloe vera and sea algae. The defendants primarily use Spanish-language ads.
The complaint alleges that the defendants make false and unsubstantiated claims: (1) that 1-2-3 Reduce Fat causes weight loss by blocking and eliminating fat; (2) that the green tea extract blocks up to 40 percent of the absorption of fat; and (3) that the aloe vera and seaweed gel eliminates inches of fat.
The complaint also alleges that the defendants make false and unsubstantiated claims that the Siluette Patch: (1) causes substantial weight loss when worn on the body; (2) causes rapid weight loss with no dietary changes; (3) eliminates cellulite and controls metabolism; and (4) eliminates accumulated fat.
The complaint also alleges that the defendants make false and unsubstantiated claims that Fat Seltzer Reduce: (1) causes rapid and permanent weight loss; (2) causes fat to be absorbed and eliminated fast and easily through the urine; and (3) causes weight loss without the need to diet or exercise.
On November 8, 2004, the court entered a temporary restraining order that prohibits the defendants from making false or misleading claims for any weight loss product. The TRO also includes provisions requiring the defendants to maintain records and other evidence, and requiring them to provide an accounting of their sales and other financial information.
CHK Trading Co., Inc.
On November 4, 2004, the FTC filed a complaint in the U.S. District Court, Southern District of New York, against two companies - CHK Trading Co., Inc., based in New Jersey, and CHK Trading Corp., based in New York City. The Commission alleged that the corporate defendants and their principal, Chong Kim, market and sell "Hanmeilin Cellulite Cream," a topical cream which contains Chinese herbs and other all-natural ingredients. Users are told to apply the cream on the buttocks, stomach, and thighs and massage until the cream is completely absorbed. The defendants advertise their product to Spanish-speaking consumers via national advertisements in TeleRevista magazine, as well as to English-speaking and Korean-speaking consumers via their Web sites.
The complaint alleges that the defendants make false and unsubstantiated claims that rubbing Hanmeilin Cellulite Cream into the body: (1) causes permanent weight loss; (2) causes substantial weight loss, including as much as 10 to 95 pounds; and (3) eliminates fat and cellulite.
Natural Products
On November 3, 2004, the FTC filed a complaint in the U.S. District Court, Central District of California, against Natural Products, LLC; All Natural 4 U, LLC; and Ana M. Solkamans. The Tustin, California-based defendants sell a dietary supplement called "Bio Trim," "Body-Trim/Bio-Trim" or "Body-Trim" in capsule and powder form. Users are told to take two capsules with eight ounces of water one half-hour before their two biggest meals, or, if using the powder, users are told to take one half-teaspoon of the powder mix in eight ounces of cold juice 15 minutes before two meals.
The complaint alleges that the defendants make false and unsubstantiated claims that Bio Trim: (1) causes users to lose substantial weight, while eating unlimited amounts of food; (2) causes substantial weight loss by blocking the absorption of fat or calories; (3) works for all overweight users; and (4) is clinically proven to cause rapid and substantial weight loss without reducing calories.
New England Diet Center
On November 4, 2004, the Commission filed a complaint in the U.S. District Court, District of Connecticut, against Bronson Partners, LLC, (doing business as New England Diet Center and Bronson Day Spa), and Martin Howard. The defendants, based in Westport, Connecticut, sold Chinese Diet Tea and the Bio-Slim Patch - purported weight loss products. Users of the Chinese Diet Tea are told to drink one cup of tea after each meal to neutralize the absorption of fattening foods.
The complaint alleges that the defendants make false and unsubstantiated claims that Chinese Diet Tea: (1) causes rapid and substantial weight loss without the need to diet or exercise; (2) enables users to lose as much as six pounds per week over multiple weeks and months without the need to diet or exercise; (3) enables users to lose substantial weight while enjoying their favorite foods; (4) blocks the absorption of fat and calories; and (5) causes substantial weight loss for all users. The complaint further alleges that defendants falsely claim that Chinese Diet Tea is clinically proven to cause rapid and substantial weight loss without exercising or dieting.
The complaint further alleges that the defendants make false and unsubstantiated claims that the Bio-Slim Patch: (1) causes rapid and substantial weight loss without the need to exercise or diet; and (2) causes substantial weight loss when worn on the body.
AVS Marketing, Inc.
On October 27, 2004, the FTC filed a complaint in U.S. District Court for the Northern District of Illinois, Eastern Division, against AVS Marketing, Inc., and William R. Heid. The defendants, based in Thomson, Illinois, sell "Himalayan Diet Breakthrough," a dietary supplement containing Nepalese Mineral Pitch - "a paste-like material" that "oozes out of the cliff face cracks in the summer season" in the Himalayas. Users are directed to take one tablet with water before lunch, dinner and bedtime.
The complaint alleges that the defendants make false and unsubstantiated claims that Himalayan Diet Breakthrough: (1) causes rapid and substantial weight loss, including as much as 37 pounds in 8 weeks, without the need to reduce caloric intake or increase exercise; (2) causes users to lose substantial weight, including as much as 37 pounds in 8 weeks, while still consuming unlimited amounts of food; (3) causes substantial weight loss, including as much as 37 pounds in 8 weeks, by preventing the formation of body fat; (4) causes substantial weight loss for all users; and (5) enables users to lose safely as much as 37 pounds in 8 weeks.
On October 28, 2004, the court entered a temporary restraining order that prohibits the defendants from making the above claims or any other false or unsubstantiated product claims, and prohibits further sales of Himalayan Diet Breakthrough pending determination of the FTC's motion for a preliminary injunction. The TRO also includes provisions freezing the defendants' assets, requiring the defendants to maintain records and other evidence, and requiring the defendants to provide an accounting of their sales and other financial information.
State Enforcement Action
The Commission was joined today by the Maine Attorney General's Office, which is filing an additional weight loss enforcement action in Maine state court against a diet patch seller from that state. The defendant in that case made false claims for two weight-loss products - Slim Patch and Bodylite Gel Patch. The ads appeared in advertising carried in newspapers across the United States.
The Commission vote authorizing staff to file the six complaints in the appropriate federal district court was 5-0.
NOTE: The Commission files a complaint when it has "reason to believe" that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. A complaint is not a finding or ruling that the defendant has actually violated the law. Each case will be decided by the court.
Copies of the complaints announced today 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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Criminals to be fed supplements to improve behaviour (Full Article)f2
Gaby Hinsliff, chief political correspondent
Sunday November 28, 2004
The Observer
Criminals are to be given vitamin supplements in an unusual attempt to reduce anti-social behaviour which will test the effect of diet on the brain.
The move is controversial, with many in the prison service sceptical that healthy food could make much difference to hardened criminals.
The proposals being drawn up within the Home Office reflect a growing interest in the potential link between junk diets laced with additives and disturbed or hyperactive behaviour. American research has shown a link between poor diet and aggressive or impulsive tendencies, including a recently published US study of young children from Mauritius which found they were significantly less likely to grow up to have criminal records if fed an enriched diet from a young age.
The Youth Justice Board is helping to organise the British trial, which would involve young offenders who are serving community sentences, or who have recently been released from jail, being given daily supplements of fatty acids, trace minerals and vitamins to see if it reduces anti-social behaviour.
'We have agreed to assist them by facilitating access to young people where necessary,' said a spokesman. 'We are interested in seeing the results of this.'
The project raises ethical questions. While only volunteers will take part, if dramatic results from changing offenders' diets can be shown, that will raise the question of whether prison diets should be altered to 'dose' prison inmates into better behaviour.
Conversely, the approach is likely to be attacked by right-wing critics as allowing offenders to escape responsibility for their own crimes by blaming their diets.
However, a small previous study of teenagers in a young offenders' institution carried out by the research charity Natural Justice, found that boosting offenders' diets with supplements reduced disciplinary incidents - such as attacks on fellow inmates and officers, or breaking prison rules - by a third. While prison menus did offer healthy options, the researchers realised that inmates avoided them in favour of a diet of junk food that left them deprived of nutrients.
The charity wants to try to replicate the findings using a much larger group of young offenders, and examine the effect on their reoffending rates.
Bernard Gesch, chair of the charity, said: 'We are very pleased that they are interested enough to look at this. The implications are fairly massive: the government is forced to pump millions into anti-social behaviour programmes, and surely given the scale of findings we demonstrated [in the young offenders' institution] the dots aren't too difficult to join up.'
Prisons Minister Paul Goggins disclosed recently in a parliamentary written answer to the senior Tory MP Alistair Burt that the Home Office is considering research on offenders' diet.
The Prison Service is currently awaiting the results of a similar study involving offenders in Holland.
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FDA Official 'Rejects' Safety Criticisms (Full Article)f3
WASHINGTON - A Food and Drug Administration official said Friday "we categorically reject" accusations the agency has failed to protect the public against dangerous drugs. "All the drugs that are on the market have risks," asserted Dr. Steven Galson, acting director of the FDA Center for Drug Evaluation and Research.
Appearing on morning television a day after an FDA critic renewed allegations the regulatory agency mishandled the arthritis drug Vioxx, Galson also said that a review is under way of five other medications whose safety was questioned.
For the second consecutive Friday, Merck & Co. placed full-page advertising in select newspapers. The ads highlight the company's commitment to transparency in research, commitment to patient safety and the health of its balance sheet. Economists estimate the Vioxx disaster could ultimately cost Merck up to $18 billion in lost profits and legal costs.
In one of a trio of full-page ads in Friday's Wall Street Journal, Merck proclaims a 100-year tradition of putting patients first, wording that echoes the company president's testimony before Congress one day earlier.
"When we obtain data from our clinical studies, we promptly disclose them," the ad states. "When questions arise about our medicines, we quickly analyze the available data, explore their meaning within the company and in scientific forums, and conduct further studies as warranted."
In revelatory testimony to the Senate Finance Committee Thursday, a senior FDA safety reviewer David Graham had cited Meridia, Crestor, Accutane, Bextra and Serevent as having problems. The manufacturers of these drugs immediately defended the use and safety of their products.
Graham argued that the country is "virtually defenseless" against a repeat of the Vioxx debacle. Galson immediately rejected that, saying it had "no basis in fact."
"What we're concerned about is the sort of hysterical charges that come out, that aren't based on reality," Galson said Friday on NBC's "Today" show.
"I think the drug industry would be astounded at the charges we're too cozy with them," he said. "I spend a lot of time dealing with complaints from the drug industry."
Dr. Sidney Wolfe, health research director for Ralph Nader 's watchdog group Public Citizen, said Friday he believes many more physicians and others at FDA should have the opportunity to air their concerns about drugs on the market.
"I think Dr. Graham is speaking, in a way, for many people in the FDA who know there are problems, but their superiors, supervisors, don't want them to talk," Wolfe told ABC's "Good Morning America."
"My faith in the FDA rests in the midlevel employees," Wolfe said, "the physicians, the epidemiologists, who know about problems and are frequently frustrated."
Wolfe said Public Citizen already had asked the FDA to take Crestor and Meridia off the market. He also said he believes Bextra should be removed.
Merck pulled Vioxx from the market on Sept. 30 after a study indicated the popular painkiller doubled the risk of heart attacks and stroke when taken for longer than 18 months.
The committee chairman, Sen. Charles Grassley told the hearing he believes an independent board of drug safety may be necessary to ensure the safety of medications after FDA approval.
An "awful lot of red flags" were raised before Vioxx was withdrawn, said Grassley, R-Iowa., and the agency disdained, rather than listened to, its own reviewers.
Graham contended that FDA has an inherent conflict of interest that triggers "denial, rejection and heat" when safety questions emerge about products it has approved.
In his view, the five most worrisome drugs that demand speedy action:
_Meridia, a weight-loss drug. He said the agency should consider whether its benefits outweigh the risks of higher blood pressure and stroke among people taking it.
_Crestor, an anti-cholesterol drug. He said the government should evaluate the occurrence of renal failure and other serious side effects among people taking Crestor.
_Accutane, an acne drug linked to birth defects. Graham said the drug represents a 20-year "regulatory failure" by the FDA and sales should be restricted immediately.
_Bextra, a painkiller. Graham said the drug poses the same heart attack and stroke risk as Vioxx. He recommended designing studies to look at the drug's cardiovascular risks.
_Serevent, an asthma treatment. He said the drug was shown, with 90 percent certainty in a long-term trial in England, to cause deaths due to asthma.
In his testimony, Graham said the FDA's Office of New Drugs unrealistically maintains a drug is safe unless reviewers establish with 95 percent certainty that it is not. That rule does not protect consumers, Graham told the Senate committee. "What it does is it protects the drug," he said.
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