 |
 |
 |
|
 |
 |
 |
|
 |
|
|
|
|
LinkBack | Thread Tools | Search this Thread | Display Modes |
12-22-2008, 11:58 PM
|
#1 (permalink) |
  
Location: Alabama
Start Weight: 175
Current Weight: 140
Goal Weight: 140
Posts: 8,839
 |
FDA Warns Consumers About Tainted Weight Loss Pills
Agency seeks recall of products that pose serious health risks The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers’ health at risk. The tainted weight loss products are: Fatloss Slimming 2 Day Diet 3x Slimming Power Japan Lingzhi 24 Hours Diet 5x Imelda Perfect Slimming 3 Day Diet 7 Day Herbal Slim 8 Factor Diet 7 Diet Day/Night Formula 999 Fitness Essence Extrim Plus GMP Imelda Perfect Slim Lida DaiDaihua Miaozi Slim Capsules Perfect Slim Perfect Slim 5x Phyto Shape ProSlim Plus Royal Slimming Formula Slim 3 in 1 Slim Express 360 Slimtech Somotrim Superslim TripleSlim Zhen de Shou Venom Hyperdrive 3.0 An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers' health at risk. These weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers. The FDA advises consumers who have used any of these products to stop taking them and consult their healthcare professional immediately. The FDA encourages consumers to seek guidance from a healthcare professional before purchasing weight loss products. “These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,” said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. “Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.” The FDA has inspected a number of companies associated with the sale of these illegal products, and is currently seeking product recalls. Based on the FDA’s inspections and the companies’ inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges. The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age. Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the United States. The drug, which is approved in Europe, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last two years. Health care professionals and consumers should report serious adverse events (side effects) or product quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products To learn more about FDA’s initiative against unapproved drugs read FDA’s Compliance Policy Guide here: Guidance for FDA Staff and Industry Marketed Unapproved Drugs- Compliance Policy Guide Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs. For drug safety information, read: FDA's Drug Safety Initiative # |
|
what would we do without you !!! 
Happy Holidays !!! 
|
01-13-2009, 05:13 PM
|
#3 (permalink) |
|
Location: Alabama
Start Weight: 175
Current Weight: 140
Goal Weight: 140
Posts: 8,839
|
FDA Expands Warning to Consumers About Tainted Weight Loss Pills
List increases from 28 to 69 products; Agency seeking recalls The U.S. Food and Drug Administration is expanding its nationwide alert to consumers about tainted weight loss pills that contain undeclared, active pharmaceutical ingredients. On December 22, 2008, FDA warned consumers not to purchase or consume 28 different products marketed for weight loss. Since that time, FDA analysis has identified 41 more tainted weight loss products that may put consumers’ health at risk. The tainted weight loss products are: Fatloss Slimming 2 Day Diet 3x Slimming Power Japan Lingzhi 24 Hours Diet 5x Imelda Perfect Slimming 3 Day Diet 7 Day Herbal Slim 8 Factor Diet 7 Diet Day/Night Formula 999 Fitness Essence Extrim Plus GMP Imelda Perfect Slim Lida DaiDaihua Miaozi Slim Capsules Perfect Slim Perfect Slim 5x Phyto Shape ProSlim Plus Royal Slimming Formula Slim 3 in 1 Slim Express 360 Slimtech Somotrim Superslim TripleSlim Zhen de Shou Venom Hyperdrive 3.0 Starcaps Slim Waistline Slim Waist Formula Slim Up Sliminate Slim Fast 2x Powerful Slimming Slim Express 4 in 1 Reduce Weihgt Super Fat Burner Super Slimming Sana Plus Trim 2 Plus Powerful Slim Waist Strength Formula Slimming Formula Perfect Slim Up Slim Burn Slim 3 in 1 Slim Formula Slim 3 in 1 M18 Royal Diet Slim 3 in 1 Extra Slim Waist Formula Slim 3 in 1 Extra Slim Formula Natural Model 2 Day Diet Slim Advance Miaozi MeiMiaoQianZiJiaoNang Meizitang Meili JM Fat Reducer Imelda Fat Reducer 7 Days Diet Extrim Plus 24 Hour Reburn Fasting Diet Cosmo Slim Body Slimming Body Shaping Body Creator BioEmagrecin 3 Days Fit 21 Double Slim Eight Factor Diet 7 Diet An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent) and bumetanide (a diuretic). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers' health at risk. These weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers. The FDA advises consumers who have used any of these products to stop taking them and consult their healthcare professional immediately. The FDA encourages consumers to seek guidance from a healthcare professional before purchasing weight loss products. “These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,” said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. “Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.” The FDA has inspected a number of companies associated with the sale of these illegal products, and is currently seeking product recalls. Based on the FDA’s inspections and the companies’ inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges. The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia (rapid heart beat), palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age. Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the United States. The drug, which is approved in Europe, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last two years. Health care professionals and consumers should report serious adverse events (side effects) or product quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products To learn more about FDA’s initiative against unapproved drugs read FDA’s Compliance Policy Guide here: Guidance for FDA Staff and Industry Marketed Unapproved Drugs- Compliance Policy Guide Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs. For drug safety information, read: FDA's Drug Safety Initiative # |
|
|
|
03-23-2009, 11:25 PM
|
#5 (permalink) |
|
Location: Alabama
Start Weight: 175
Current Weight: 140
Goal Weight: 140
Posts: 8,839
|
FDA News
FOR IMMEDIATE RELEASE March 20, 2009 Media Inquiries: Chris Kelly, 301-796-4676 Consumer Inquiries: 888-INFO-FDA FDA Uncovers Additional Tainted Weight Loss Products Agency alerts consumers to the finding of new undeclared drug ingredients The U.S. Food and Drug Administration is expanding, for the second time, its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients. The FDA has identified additional weight loss products (Herbal Xenicol, Slimbionic, and Xsvelten) and new undeclared active pharmaceutical ingredients (fenproporex, fluoxetine, furosemide, and cetilistat). The current list now includes the following 72 products: 2 Day Diet Fatloss Slimming Slim 3 in 1 M18 Royal Diet 2 Day Diet Slim Advance GMP Slim 3 in 1 Slim Formula 2x Powerful Slimming Herbal Xenicol Slim Burn 3 Day Diet Imelda Fat Reducer Slim Express 4 in 1 3 Days Fit Imelda Perfect Slim Slim Express 360 3x Slimming Power JM Fat Reducer Slim Fast* 5x Imelda Perfect Slimming Lida DaiDaihua Slim Tech 7 Day Herbal Slim Meili Slim Up 7 Days Diet Meizitang Slim Waist Formula 7 Diet Miaozi MeiMaoQianZiJiaoNang Slim Waistline 7 Diet Day/Night Formula Miaozi Slim Capsules Slimbionic 8 Factor Diet Natural Model Sliminate Eight Factor Diet Perfect Slim Slimming Formula 21 Double Slim Perfect Slim 5x Somotrim 24 Hours Diet Perfect Slim Up Starcaps 999 Fitness Essence Phyto Shape Super Fat Burner BioEmagrecim Powerful Slim Superslim Body Creator ProSlim Plus Super Slimming Body Shaping Reduce Weihgt Trim 2 Plus Body Slimming Royal Slimming Formula Triple Slim Cosmo Slim Sana Plus Venom Hyperdrive 3.0 Extrim Plus Slim 3 in 1 Waist Strength Formula Extrim Plus 24 Hour Reburn Slim 3 in 1 Extra Slim Formula Xsvelten Fasting Diet Slim 3 in 1 Extra Slim Waist Formula Zhen de Shou * This product should not be confused with the line of meal replacement and related products that are marketed as conventional foods under the brand name “Slim-Fast®”. The manufacturer of Slim-Fast®, Unilever United States, Inc., maintains that the Slim Fast product which appears on this list is not in any way associated with, sponsored or approved by, or otherwise related in any way to the Slim-Fast® brand of meal replacement and related products. “These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed maximum recommended dosages,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health.” On Dec. 22, 2008, the FDA warned consumers not to purchase or consume 28 different products marketed for weight loss. On Jan. 8, 2009, the FDA expanded the list of tainted weight loss products to include 41 additional tainted products. The FDA will continue to update this list as warranted. The products listed above, some of which are marketed as dietary supplements, are promoted and sold on various Web sites and in some retail stores and beauty salons. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the products' labels or in promotional advertisements. These products have not been approved by the FDA, are illegal, and include the following undeclared active pharmaceutical ingredients:
The FDA advises consumers who have used any products containing these ingredients to stop taking them and consult their health care professional immediately. The FDA also encourages consumers to seek guidance from a health care professional before purchasing weight loss products. The health risks posed by these products can be very serious and include high blood pressure, seizures, tachycardia (rapid heartbeat), palpitations, heart attack, and stroke. Sibutramine, a controlled substance, was found in many of these products at levels much higher than the maximum daily dosage for Meridia, the only FDA-approved drug product containing sibutramine. These higher levels of sibutramine can increase the incidence and severity of these health risks. Fenproporex, another controlled substance, can cause arrhythmia and possible sudden death. Health care professionals and consumers should report serious adverse events (side effects) or product quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
To learn more about the FDA’s initiative against unapproved drugs see the FDA’s Compliance Policy Guide at: Guidance for FDA Staff and Industry Marketed Unapproved Drugs- Compliance Policy Guide Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs. For drug safety information, see: FDA's Drug Safety Initiative. |
|
|
Linear Mode
Copyright © PhenForum.com 2004-2007
|
