FDA Research On Diet Pill

If you are into dietary supplements or even if you just watch the news you have probably seen the recall of Hydroxycut weight-loss supplements after the Food and Drug Administration urged consumers to immediately stop using the recalled products, which are made by Iovate Health Sciences Inc and marketed for weight loss, boosting energy and other uses.

I checked the supplement sites I go to all the time, like supplementstogo and found that they didn’t carry some of them anyway, but the ones they did have had already removed on the same day the FDA sent out their bulletin, so I am impressed with their responsiveness.

We may not be able to use the Iovate Health Sciences Hydroxycut for awhile but there are plenty of other outstanding products out there for achieving weight loss goals.

I also went to the FDA site and looked at the information they had listed. If you want to check it out I have added a link here. The recalled products included Hydroxycut Regular Rapid Release Caplets, Hydroxycut Carb Control and Hydroxycut Max Drink Packets.

"The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist," said Dr. Linda Katz, interim chief medical officer in the FDA's Center for Food Safety and Applied Nutrition.

The company agreed to voluntarily pull the 14 products even though the FDA has not seen reports of serious harm with all of them, Katz said. Agency officials are investigating which doses and ingredients may be harmful, she said.
Two products with different ingredients, Hydroxycut Cleanse and Hoodia, were not included in the recall.

Finally the FDA advises that if you had taken the recalled products see your doctor if you had symptoms of liver injury like nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach pain, itching or an unusual loss of appetite.

Hold Off Buying Pistachio's For A Bit

Remember last winter when we watched the national salmonella outbreak in peanuts unfold, when a Georgia Company shipped contaminated products, well the FDA is now warning people not to eat any food containing pistachios, which could carry contamination from the same bacteria.

Salmonella, the most common cause of food-borne illness, is a bacteria that causes diarrhea, fever and cramping. Most people recover, but the infection can be life-threatening for children, the elderly and people with weakened immune systems.

For nuts, roasting is supposed to kill the bacteria. But problems can occur if the roasting is not done correctly or if roasted nuts are re-contaminated. That can happen if mice, rats or birds get into the facility.

It seems that California-based Setton Pistachio of Terra Bella Inc., the second-largest pistachio processor, is voluntarily recalling more than 2 million pounds of its roasted nuts shipped since last fall.

The FDA learned about the problem last Tuesday, when Kraft Foods Inc. notified the agency that it had detected salmonella in roasted pistachios through routine product testing. Kraft and the Georgia Nut Co. recalled their Back to Nature Nantucket Blend trail mix the next day.

The recalled nuts represent a small fraction of the 55 million pounds of pistachios that the company's plant processed last year and an even smaller portion of the 278 million pounds produced in the state in the 2008 season, according to the Fresno-based Administrative Committee for Pistachios.

California alone is the second-largest producer of pistachios in the world.
According to the company's Web site, Setton Pistachio is in the corporate family of Commack, N.Y.-based Setton International Foods Inc. The company sells nuts, dried fruit, edible seeds, chocolate and yogurt-coated candies.

By Friday, grocery operator Kroger Co. recalled one of its lines of bagged pistachios because of possible salmonella contamination, saying the California plant also supplied its nuts. Those nuts were sold in 31 states.

Fabia D'Arienzo, a spokeswoman for Tulare County-based Setton Pistachio, said the company was only recalling certain bulk roasted in-shell and roasted shelled pistachios that were shipped on or after September 1.

Because Setton Pistachio shipped tote bags of nuts weighing up to 2,000 pounds to 36 wholesalers across the country, it will take weeks to figure out how many products could be affected, said Jeff Farrar, chief of the Food and Drug Branch of the California Department of Public Health.

"It will be safe to assume based on the volume that this will be an ingredient in a lot of different products, and that may possibly include things like ice cream and cake mixes," Farrar said. "The firm is already turning around trucks in transit to bring those back to the facility."

The outbreak is still ongoing. More than 690 people in 46 states have gotten sick. Nearly 3,900 products made with peanut ingredients from Peanut Corp. of America have been recalled.

California public health authorities have taken hundreds of samples at Setton's processing facility, but lab results have not yet determined whether salmonella was found at the plant. The food companies' own tests of the contaminated products isolated four different types of salmonella, but none were the same strain as the one found in the peanuts, Acheson said.

Safe Weight-Loss Supplements

Recently there have been news items that the FDA is investigating dozens of weight loss supplements, most of them imported from China, that contain hidden and potentially harmful drugs like bumetanide.

The best known brand was a pill called StarCaps, a papaya-infused weight loss capsule. It had some celebrity endorsements and magazine ads.

A full list of the tainted pills of which there are 69, is available on the F.D.A.’s Web site, www.fda.gov. An agency spokeswoman said people who want to report problems with the pills could call 1-800-FDA-1088.

Steven M. Mister, the president of the Council for Responsible Nutrition, a trade group whose members include ingredient suppliers and makers of dietary supplements, said that the majority of weight-loss supplements were safe. The F.D.A., he said, is mainly citing obscure imported brands.

Last year, the F.D.A. adopted new “good manufacturing practices” rules that require makers of dietary supplements to test the purity of each ingredient and the final product. Another new statute, which went into effect in December 2007, requires manufacturers to notify the F.D.A. of any reports of serious health problems caused by the pills.

“The law adequately protects consumer health because it does have the monitoring system in place,” said Mr. Mister, of the industry trade group.

After seeing these reports late last fall I searched a number of popular online sites like supplementstogo and worldclassnutrition, and found that they DID NOT contain any of the tainted weight loss supplements.

It restored my confidence that there are ethical merchants online that indeed check to ensure the safety of supplements before listing them on their sites.

So my advice for today is to choose a reliable merchant who conforms to the good manufacturing practices if you are in the market for weight loss or supplements in general.

It is tough to know everything about the thousands of products available these days, but quality conscious retailers are monitoring their sites to ensure the safety of the ingredients in the products they buy and sell also.

Caught Doing It Right

There was another article in Mens Health News that the FDA added 41 products to a diet pill warning because they contain undeclared, active pharmaceutical ingredients that may put consumers’ health at risk.

In reviewing multiple sites I found at least three websites hat DO NOT offer any of the harmful products or ingredients. I am encouraged that I can trust that the supplements and products on these sites are the highest quality, along with low prices.

I feel safe ordering from these sites: World Class Nutrition, Supplements To Go, A-Z-Nutrition

Everyone should read what the FDA has to say, check what you are taking and verify the ingredients. It would also be prudent when searching for quality supplements and finding a site that sells these pills that may cause a health risk, to keep on clicking. It’s better to be safe than sorry.

Here are some links and important information about the Diet Pills to stay away from.

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.
· Online: www.fda.gov/MedWatch/report.htm
· Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
· Fax: (800) FDA-0178
· Phone: (800) FDA-1088
Information for consumers can be found at:http://www.fda.gov/cder/consumerinfo/weight_loss_products.htm
To learn more about FDA’s initiative against unapproved drugs read FDA’s Compliance Policy Guide here: http://www.fda.gov/cder/Guidance/6911fnl.htm.
For drug safety information, read: FDA's Drug Safety Initiative
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.

FDA Warns Consumers About Tainted Weight Loss Pills

There have been some news articles recently that the FDA recalled more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers’ health at risk.

I just finished looking through the sites that I regularly go to and am happy to report that they DO NOT offer any of the harmful ingredients. I am glad that I can trust that the supplements and products on these sites are the highest quality, along with low prices.

I feel safe ordering from these sites: World Class Nutrition, Supplements To Go, A-Z-Nutrition

Here is the information about the Diet Pills to stay away from. I suggest that everyone read what the FDA has to say, check what you are taking and verify the ingredients. It’s better to be safe than sorry.

The FDA recalled 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.

Online: www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088
Information for consumers can be found at:
http://www.fda.gov/cder/consumerinfo/weight_loss_products.htm

Information for consumers can be found at:http://www.fda.gov/cder/consumerinfo/weight_loss_products.htm
To learn more about FDA’s initiative against unapproved drugs read FDA’s Compliance Policy Guide here: http://www.fda.gov/cder/Guidance/6911fnl.htm.
For drug safety information, read: FDA's Drug Safety Initiative