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
Supplements To Go
does NOT
carry any of these diet pills!!
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
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
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