FDA Public Notice

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Product to AVOID

Public Notification: " Slim Xtreme Herbal Slimming Capsule " Contains

Undeclared Drug Ingredient

[5/10/2011] The Food and Drug Administration (FDA) is advising consumers

not to purchase or use " Slim Xtreme Herbal Slimming Capsule, " a product

for weight loss sold on various websites and distributed by Globe All

Wellness. The company falsely claims on the label that the product is

" 100% natural. "

FDA laboratory analysis confirmed that " Slim Xtreme Herbal Slimming

Capsule " contains sibutramine. Sibutramine is a controlled substance

that was withdrawn from the U.S. market in October 2010 for safety

reasons. The product poses a threat to consumers because sibutramine is

known to substantially increase blood pressure and/or pulse rate in some

patients and may present a significant risk for patients with a history

of coronary artery disease, congestive heart failure, arrhythmias, and

stroke. This product may also interact in life threatening ways with

other medications a consumer may be taking.

Consumers should stop using this product immediately and throw it away.

Consumers who have experienced any negative side effects should consult

a health care professional as soon as possible.

Healthcare professionals and patients are encouraged to report adverse

events or side effects related to the use of this product to the FDA's

MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report Online:

www.fda.gov/MedWatch/report.htm1

* Download form

<http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.ht

m> 2 or call 1- to request a reporting form, then complete

and return to the address on the pre-addressed form, or submit by fax to

1-800-FDA-0178

Note: This notification is to inform the public of a growing trend of

products marketed as dietary supplements or conventional foods with

hidden drugs and chemicals. These products are typically promoted for

sexual enhancement, weight loss, and body building, and are often

represented as being " all natural. " FDA is unable to test and identify

all products marketed as dietary supplements that have potentially

harmful hidden ingredients. Consumers should exercise caution before

purchasing any product in the above categories.

Please refer to the links below for more information:

* Tainted Weight Loss Products

<http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineS

afely/MedicationHealthFraud/ucm234592.htm> 3

* Subscribe to the RSS feed

<http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/TDS/rss.xm

l> 4

* Tainted Supplement Consumer Article

<http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM236998.pdf

> 5

Contact Us

* Human Drug Information

*

*

* druginfo@...

Division of Drug Information (CDER)

Office of Communications

Feedback Form

<http://www.accessdata.fda.gov/scripts/email/cder/comment.cfm> 6

10001 New Hampshire Avenue

Hillandale Building, 4th Floor

Silver Spring, MD 20993

S. Kalman PhD, RD, FACN

Director, BD - Nutrition & Applied Clinical Trials

Miami Research Associates

6141 Sunset Drive

Suite 301

Miami, FL. 33143

Direct -

Office ext. 5109

Fax

Email: dkalman@...

Web: www.miamiresearch.com