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Public Notification: “Acai Berry Soft Gel ABC” Contains Undeclared Drug Ingredient
[October 18, 2011]
The Food and Drug Administration (FDA) is advising consumers not to
purchase or use “Acai Berry Soft Gel ABC,” a product for weight loss
sold on various websites and in some retail stores.FDA laboratory analysis confirmed that “Acai Berry Soft Gel ABC” contains sibutramine. Sibutramine is a controlled substance that was removed 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, or 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.htm
- Download form or call 1-800-332-1088 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:
Contact FDA
Toll Free
(855) 543-3784, or
(301) 796-3400
Human Drug Information
Division of Drug Information (CDER)
Office of Communications
Feedback Form
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993
Office of Communications
Feedback Form
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993
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