Lida DaiDaihua. Ingredients. FDA Warning.

FOR IMMEDIATE RELEASE
(Free-Press-Release.com) December 30, 2008 -- FDA is warning customers about 25 weight loss products. The pills contain undeclared ingredient sibutramine, a controlled substance can be sold only with a medical prescription and used under health care professional. Products that have been labeled as herbal supplements violate FDA regulations.

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

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

“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 manufactures or distributors should stop selling and promoting these weight loss products voluntarily. If the firm does not recall the product, then FDA can seek legal action under the FD&C Act. These include seizure of available product, and/or injunction of the firm, including a court request for recall of the product. It is in the interest of FDA, as well as industry, to get unsafe and defective products out of consumer hands as soon as possible.

What is sibutramine?

Sibutramine is manufactured and distributed by Knoll

Pharmaceutical Company, Mount Olive, NJ, under the brand name
Meridia.

FDA has approved sibutramine (Meridia) for the management of
obesity, a widespread, chronic disease that, combined with other
risk factors contributes to the deaths of an estimated 300,000
Americans each year. Marketing is pending scheduling by the U.S.
Drug Enforcement Administration. The following can be used to
answer questions:

Sibutramine helps reduce food intake and is indicated for
weight loss and maintenance of weight loss when used in
conjunction with a reduced calorie diet. It is indicated for

people whose initial body mass index (BMI) is at least 30 -- that
is, someone who is 5'6" and weighs 185 lbs. or more. Patients
with other risk factors, such as hypertension or diabetes, can be
treated with the drug if their BMI is 27 or higher, for example
someone who is 5'6" and weighs 167 lbs. or more.

Sibutramine works to suppress the appetite primarily by
inhibiting the reuptake of the neurotransmitters norepinephrine
and serotonin. The anti-obesity drug dexfenfluramine also
inhibits the reuptake of serotonin. However, dexfenfluramine,

unlike sibutramine, also causes an increase in release of
serotonin from the nerve cell.

In clinical trials, patients treated with sibutramine while
on a reduced-calorie diet, showed a significant weight loss
during the first six months of treatment, and significant weight
loss was maintained for one year. In one 12-month study, the
average weight loss in patients taking sibutramine, 10 mg daily,
was about 10 lbs., and in those taking 15 mg daily was about 14
lbs. The average weight loss in persons on only a reduced
calorie diet was 3.5 lbs.

The most common side effects associated with sibutramine
include dry mouth, headache, constipation and insomnia. The drug
causes a small increase in average blood pressure, and causes a
higher increase in some patients. FDA recommends patients taking
sibutramine have regular blood pressure evaluations. People with
uncontrolled high blood pressure should not take sibutramine.
No cases of pulmonary hypertension, a rare but serious side
effect associated with the anti-obesity drugs fenfluramine and
dexfenfluramine, have been reported in clinical trials of

sibutramine. Echocardiograms on patients taking sibutramine did
not show more valvular disease than those on placebo.

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.

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.

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.

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.

lida daidaihua warning  lida     Lida DaiDaiHua     lida daidaihua fda     lida fakes     lida recall     lida warning