[My] Life in Wisconsin

FDA Warns Consumers About Tainted Weight Loss Pills

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html
FDA News

FOR IMMEDIATE RELEASE
December 22, 2008


Media Inquiries:
Rita Chappelle, 240-753-8603
Consumer Inquiries:
888-INFO-FDA

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.

* 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

Consumer Directed Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products

FDA has developed these questions and answers (Q & A’s) to help consumers, health care practitioners, and the general public understand FDA’s actions regarding weight loss products contaminated with various prescription drugs and chemicals. Many of these products are marketed as dietary supplements. Unfortunately, FDA cannot test and identify all weight loss products on the market that have potentially harmful contaminants in order to assure their safety. Enforcement actions and consumer advisories for unapproved products only cover a small fraction of the potentially hazardous weight loss products marketed to consumers on the internet and at some retail establishments.

1. What undeclared drugs and/or chemicals are contained in the weight loss products associated with this action?

Laboratory tests revealed the presence of sibutramine, rimonabant, phenytoin, and phenolphthalein. A summary of our findings are below:

Undeclared Drug Product(s) Name>

Sibutramine


2 Day Diet
3 Day Diet
3x Slimming Power
5x Imelda Perfect Slimming
7 Diet Day/Night Formula
7 Day Herbal Slim
8 Factor Diet
24 Hours Diet
999 Fitness Essence
Extrim Plus
Fatloss Slimming
GMP
Imelda Perfect Slim
Lida DaiDaihua
Miaozi Slim Capsules
Perfect Slim
Perfect Slim 5x
ProSlim Plus
Royal Slimming Formula
Slim 3 in 1
Slim Express 360
Slim Tech
Somotrim
Superslim
Triple Slim
Venom Hyperdrive 3.0
Zhen de Shou

Rimonabant


Phyto Shape

Phenytoin (trace)


3x Slimming Power
Extrim Plus

Phenolphthalein


8 Factor Diet
24 Hours Diet
Fatloss Slimming
Imelda Perfect Slim
Perfect Slim 5x
Royal Slimming Formula
Superslim
Zhen de Shou



2. What action is FDA taking regarding these tainted weight loss products?

FDA is taking action to help ensure that these products and other products containing undeclared prescription ingredients are removed from the marketplace. FDA has inspected a number of firms associated with the sale of these products and is currently seeking recalls of the products. Based on these inspections and the firms’ responses to recall requests, FDA may take additional enforcement steps to include warning letters, seizure, injunction, or criminal charges.

3. What is sibutramine and what are the associated risks?

Sibutramine is a Schedule IV controlled substance and the active pharmaceutical ingredient in Meridia, an approved prescription drug to treat obesity.

Some of the identified products recommend taking more than 3 times the recommended daily dosage of sibutramine. Because of this, even consumers without a history of health problems that take these high doses of sibutramine may suffer serious adverse effects if they take these products, such as increased blood pressure, tachycardia, palpitations, and seizure.

Populations who would be at increased risk of serious adverse health effects from consuming a standard dose of sibutramine include:

* Patients with a history of hypertension, especially those with uncontrolled or poorly controlled hypertension.
* Patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
* Patients with narrow angle glaucoma.
* Patients with a history of seizure.
* Patients predisposed to bleeding events and those taking concomitant medications known to affect hemostasis or platelet function.
* Patients with severe hepatic dysfunction.
* Patients concurrently taking the following medications:
o Sumatriptan
o Dihydroergotamine
o Dextromethorphan
o Meperidine,
o Pentazocine
o Fentanyl
o Lithium
o Tryptophan
o MAO inhibitors

4. What is rimonabant and what are the associated risks?

Rimonabant is the active pharmaceutical ingredient in Zimulti which has not been approved in the United States. In Europe the drug is known as Acomplia.

In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects—seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients. In June of 2008, the Medicines and Healthcare Products Regulatory Agency of the United Kingdom linked rimonabant to 5 deaths and 720 adverse reactions over the past two years. In October, the European Medicines Agency recommended that marketing and sales of Accomplia be suspended due to safety concerns.

5. What is phenolphthalein and what are the associated risks?

Phenolphthalein was an ingredient in some Over-the-Counter laxative products until 1999 when the FDA reclassified the drug as “not generally recognized as safe and effective” after studies indicated that phenolphthalein presented a potential carcinogenic risk. Phenolphthalein has also been found to be genotoxic in that it can damage or cause mutations to DNA.

6. What is phenytoin and what are the associated risks?

Phenytoin is the active pharmaceutical ingredient in Dilantin, an approved anti-seizure medication. Because there were trace amounts of this drug in some of these products, the risk was not assessed. However, these products could pose a risk to consumers who are allergic or hypersensitive to phenytoin.

7. Who are the manufacturers of these products?

Many of these products do not list the manufacturer on the label or in the advertisements. However, most of the products appear to have been manufactured in China.

8. Does FDA regulate these products?

Although some of the identified products are marketed as “dietary supplements”, all of these products should have been submitted to the FDA for approval prior to marketing. Regulatory requirements for dietary supplements differ from those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that its products are safe before they are marketed. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.

Manufacturers must make sure that product label information is truthful and not misleading. However, products which contain an ingredient that has been approved as a new drug such as sibutramine or an ingredient that does not supplement the diet are not considered to be dietary supplements. Consequently these products should also have been submitted to FDA for approval prior to their marketing.

9. Will there be recalls?

It is anticipated that several of these products will be recalled. Recalls and instructions for returns can be found at: http://www.fda.gov/opacom/7alerts.html.

10. Are there more contaminated products like these on the market?

More and more products tainted with prescription drugs, including drugs for erectile dysfunction, diabetes, and obesity, are finding their way into the U.S. marketplace. Many are labeled as dietary supplements or supplements. FDA takes this escalating issue very seriously, and is committed to doing all that it can to identify and remove these dangerous products from the market. However, unfortunately, it is not possible for FDA to test and identify all tainted products.

11. What can consumers do to help protect themselves from harm?

Consult with your health care professional before taking dietary supplements to treat obesity or other diseases. All consumers should be familiar with the following signs of health fraud:

* Promises of an "easy" fix for problems like excess weight, hair loss, or impotency.
* Claims such as "scientific breakthrough," "miraculous cure," "secret ingredient," and "ancient remedy."
* Impressive-sounding terms, such as "hunger stimulation point" and "thermogenesis" for a weight loss product.
* Claims that the product is safe because it is "natural."
* Undocumented case histories or personal testimonials by consumers or doctors claiming amazing results.
* Promises of no-risk, money-back guarantees.


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

#
MEDICAL RECALLS:

http://www.fda.gov/cber/recalls.htm

Melamine and CYANURIC ACID Contamination ~ China

http://www.fda.gov/oc/opacom/hottopics/melamine.html
Melamine Contamination in China
(Updated: December 22, 2008)

BUYER BEWARE!

Would someone tell me WHY we are dumb enough to continue buying crap from China in the first place???

DontFeed-the-dragon-1

The FDA is advising consumers not to consume the following products because of possible melamine contamination:

* G&J Hot Cocoa Stuffer Item 120144
* G&J His and Hers Hot Cocoa Set Item 120129
* G&J Cocoa item 120126, sold in 2 flavors: French Vanilla Cocoa and Double Chocolate Cocoa
* Wonderfarm "Successful" Assorted Biscuits New!
* Wonderfarm "Royal Flavour" Assorted Biscuits
* Wonderfarm "Lovely Melody" Assorted Biscuits
* Wonderfarm "Daily Life" Assorted Biscuits

Hazelnut Wafer Rolls

* Topaz Hazelnut Wafer Rolls with Hazelnut Chocolate Flavored Creme Filling (photo page)

* Sweet Time Christmas Dressy Bear with Chocolate Bar
* Fresh and Crispy Jacobina Biscuits
* Koala’s March Crème filled Cookies
* YILI Brand Sour Milk Drink
* YILI Brand Pure Milk Drink
* Blue Cat Flavored Drinks
* White Rabbit Candies
* Mr. Brown Mandehling Blend Instant Coffee (3-in-1)
* Mr. Brown Arabica Instant Coffee (3-in-1)
* Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1)
* Mr. Brown Caramel Macchiato Instant Coffee (3-in-1)
* Mr. Brown French Vanilla Instant Coffee (3-in-1)
* Mr. Brown Mandheling Blend instant Coffee (2-in-1)
* Mr. Brown Milk Tea (3-in-1)
* Infant formula manufactured in China


Topics on this Page
* Introduction
* Update on FDA’s Investigation
* FDA's Warnings/Advisories
* News Updates
* List of Company Recalls
* Information for Consumers
* Information for Industry
* FDA's Testing Methods
* Other Resources

Introduction

On September 12, 2008, in light of reports from China of infant formula contaminated with melamine, the FDA issued a Health Information Advisory to proactively reassure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Asian communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants.

**** No Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States.

The FDA contacted the companies that manufacture infant formula for distribution in the United States and received information from the companies that they are not importing formula and do not source milk-based ingredients from China.

In addition, the FDA -– in conjunction with state and local officials – continues to check Asian markets for food items that are imported from China and that could contain a significant amount of milk or milk proteins.

The FDA has broadened its domestic and import sampling and testing of milk-derived ingredients and finished food products containing milk or milk-derived ingredients from Chinese sources. FDA has recommended that consumers not consume certain products because of possible contamination with melamine. A list of those products is below.
Update on FDA’s Investigation



November 28, 2008: FDA’s ongoing investigation continues to show that the domestic supply of infant formula is safe and that consumers can continue using U.S. manufactured infant formulas. FDA has concluded that levels of melamine alone or cyanuric acid alone, at or below 1 part per million (ppm) in infant formula do not raise public health concerns. FDA has updated its interim risk assessment, issued in early October, with this information:

http://www.cfsan.fda.gov/~dms/melamra4.html.

The FDA has been collecting and analyzing samples of domestically manufactured infant formula for the presence of melamine and melamine-related compounds. To date, FDA tests have found extremely low levels of melamine in one infant formula sample and extremely low levels of cyanuric acid in another. The levels were so low (well below 1 ppm) that they do not pose a health risk to infants:

http://www.fda.gov/oc/opacom/hottopics/melamine/testresults.html.

Melamine is not naturally occurring and is not approved to be directly added to food in the United States. However, melamine is approved for use as part of certain food contact substances. Low levels of melamine are present in the environment and trace amounts may occur in certain food commodities as a result of approved uses.
Parents using infant formula should continue using U.S. manufactured infant formula. Switching away from using one of these infant formulas to alternate diets or home-made formulas could result in infants not receiving the complete nutrition required for proper growth and development.

Transcript for FDA’s Media Briefing: FDA’s Updated Interim Safety and Risk Assessment of Melamine and its Analogues in Food for Humans
November 28, 2008
FDA’s Warnings/Advisories

News Updates

November 13, 2008: As part of its ongoing strategy to address the present problem with melamine contamination of consumer products exported from the People’s Republic of China, FDA has expanded its import controls on Chinese dairy products, and food and feed products manufactured in China that contain dairy ingredients. Since Oct. 10, 2008, FDA has had an import alert in place for specific products found contaminated with melamine and melamine-related compounds. FDA has collected additional information on the scope of the melamine contamination problem in China, and determined a countrywide import alert is warranted.

This action will help ensure that only Chinese dairy products and food and feed products manufactured in China that contain dairy ingredients are not contaminated with melamine and melamine-related compounds reach U.S. consumers. No adverse health effects have been reported in the United States from contamination with melamine of dairy products or dairy containing products. But melamine is not approved for direct addition to human or animal foods and no manufacturer is allowed to deliberately add it to any food for U.S. consumers.

As part of ongoing activities, FDA will also examine a range of protein-containing products beyond just dairy and dairy-containing products for contamination with melamine and melamine-related compounds. FDA will continue to take appropriate regulatory action if these efforts uncover additional contamination.

* FDA Detects Melamine Contamination in Flavored Drink (October 6, 2008)
* FDA Updates Health Information Advisory on Melamine Contamination (Sept 26, 2008)
* FDA Updates Health Information Advisory on Melamine Contamination (Sept 23, 2008)
* FDA Updates Health Information Advisory on Melamine Contamination (Sept.20, 2008)
* FDA Issues Health Information Advisory on Infant Formula (Sept. 12, 2008)

Company Recalls

* Dorsey Marketing Inc. Voluntarily Recalls Three G&J Gourmet Market Cocoa Products: 120126, 120129, 120144 (Dec. 19, 2008) New!
* Interfood Shareholding Company Issues a Nationwide recall of Wonderfarm Brand Biscuits Because of Possible Health Risk (Dec. 9, 2008)
* Walgreens Recalls 173 Teddy Bears With Chocolate Bars Sold Since Late September 2008 (Dec. 5, 2008)
* Everlasting Distributors Inc. Issues a Nationwide Recall of Fresh and Crispy Jacobina Biscuits Because of Possible Health Risks (Oct. 29, 2008)
* Lotte USA, Inc. Initiates Nationwide Recall of Koala's March Crème filled Cookies (Oct. 17, 2008)
* HUA XIA Food Trade USA, Inc. Recalls YILI Brand Sour Milk Drink and YILI Brand Pure Milk Drink, Because of Possible Health Risk (Oct. 10, 2008)
* Tristar Food Wholesale, Inc. Issues a Nationwide Recall of Blue Cat Flavored Drink Because of Possible Health Risk (Oct. 3, 2008)
* Mr. Brown 3-In-1 & and 2-In-1 Powdered Packets in Bag Coffee Mixes Due To Health Risk (Oct. 1, 2008)
* QFCO, Inc. Recalls White Rabbit Candy Because of Possible Health Risk (Sept. 26, 2008)

Information for Consumers

* Frequently Asked Questions and Answers on Melamine and Melamine Contamination

Information for Industry

* Letter to the United States Food Manufacturing Industry Regarding Melamine

FDA's Testing Methods

The FDA Field laboratories are using LC-MS/MS methods that are capable of determining melamine and cyanuric acid at levels of 0.25 ppm in powdered infant formula and other dairy-containing food products or ingredients. These and a GC/MS method for melamine and its analogues are:

* Melamine Methodology

o Determination of Melamine and Cyanuric Acid Residues in Infant Formula using LC-MS/MS
o Interim Method for Determination of Melamine and Cyanuric Acid Residues in Foods using LC-MS/MS
o GC/MS method for melamine and analogues

Other Resources

* WHO web site on melamine

http://www.who.int/foodsafety/fs_management/infosan_events/en/index.html


* CDC web site on melamine

http://emergency.cdc.gov/agent/melamine/chinafood.asp

Christmas Eve Travel Woes ~(The Whole Country).

http://www.weather.com/newscenter/nationalforecast/index.html?from=sixten_headline
For everyone staying at home, I wish you little snow to shovel, a full tummy and all the joys that Christmas may bring.

But this story is about and for those of you who may find yourselves traveling today...
~and especially by car....

Vaya con Dios.
Be safe and be prepared for anything.
You mean the world to me!

XOXO
Anne

_______


National Weather Forecast - weather.com

Tom Moore, Lead Meteorologist, The Weather Channel
Dec. 23, 2008 8:23 pm ET
Midwest | View Regional Video

A storm system will be moving up through the Great Lakes.

As it does, a mixed bag of precipitation will continue into Wednesday.

It appears that a swath of significant snow will fall from central Iowa northeast through southern Wisconsin to northern Michigan.

Most locations in those areas will see at least 6 inches of snow while parts of northern Michigan could see up to a foot.

A messy combination of snow, sleet and rain will continue through Tuesday morning across southern Michigan, northern Indiana, northern Illinois and northern Missouri.

As slightly colder air moves in behind the storm, mixed precipitation will likely change to snow possibly accumulating 1 to 3 inches before ending Tuesday.

Elsewhere, look for some rain and thunderstorms from the Ohio Valley to the lower Mississippi Valley with one to two inches of rain possible through Wednesday.

The weather will be mainly quiet on Christmas day with chilly, but not bitterly cold, temperatures.

Thursday night and Friday will feature another storm system with rain and mixed precipitation.
Northeast | View Regional Video

Snow will move rapidly across interior sections of the northeast overnight.

By Tuesday morning, snow will mix with or change to sleet and freezing rain over many locations.

The ice may linger into the late morning hours, but should change to all rain by early afternoon.

The most vulnerable areas will be across the Mohawk Valley, the upper Hudson Valley and the upper Connecticut Valley.

Much of northern New York and New England will see snow mixing with sleet or freezing rain.

Most other areas will see mainly rain from Wednesday into Wednesday night.

The mountains and northern Maine may hold on to all snow with 4 to 8 inches possible.

Low clouds accompanying the rain should cause delays at the airports from Boston to Washington, D.C. adding to the travel woes nationwide.

Christmas Day should be much quieter with most locations having a sunny, cool and blustery day.

A few snow showers are possible in western New York and northwest Pennsylvania primarily during the morning.
West | View Regional Video

A couple of weather systems will produce more wintry weather conditions across the Northwest on Wednesday.

The more potent system will sweep into northern California.

This system will feature heavy rain and mountain snow over California.

A few thunderstorms are possible along coastal sections during the afternoon and evening hours.

Low cloudiness associated with the rain could hamper air travel from San Francisco south to Los Angeles.

The rain in the Los Angeles and San Diego areas could produce some mudslides especially in the burn zones.

Snowfall in the mountains could measure one to two feet, especially in the Sierra-Nevada south of the Tahoe area.

Moisture from this storm spreads inland to Nevada, Utah, western Colorado and northern Arizona by early evening.

Rain should fall in the deserts with snow expected everywhere else.

Meanwhile low pressure, and an associated front, will slide down from the Gulf of Alaska to the Pacific Northwest where more snow is expected.

The snow should change to rain along the Oregon coast and in southwest Oregon during the afternoon.

In Portland and the Willamette Valley the snow may mix with or briefly change to rain during the mid to late afternoon, but should go back to all snow at night.

Portland needs slightly more than 1 inch to record its snowiest December on record.

The snow should linger into Christmas Day before tapering off Thursday evening in the Northwest.

Christmas Day should be a snowy and windy one across the Intermountain West as the California storm moves inland.
South | View Regional Video

Compared to the other regions of the country, the South will have the least problems, but the picture is not all rosy.

A line of showers and thunderstorms will be moving eastward across Kentucky, Tennessee, Alabama, Mississippi, Louisiana and southeast Texas.

A few storms may turn severe with small hail and gusty winds.

This activity will move into the western Carolinas, Georgia and the Florida Panhandle Wednesday night and early Thursday.

Christmas Day could feature a few showers from the coastal Carolinas to the Gulf Coast.

The rest of the region will be dry and mild.

Florida will be balmy temperatures well into the 70s and lower 80s Christmas Eve and Christmas Day.

A more serious severe weather threat will exist from the southern plains to the Mississippi valley from late Friday to Saturday as a new storm gathers strength.