Weight Loss Products: Public Notification - Undeclared Drug Ingredients

Including:

Mix Fruit Slimming
Lingzhi Cleansed Slim Tea
24 Ince
Lipo 8 Burn Slim Capsules
Sliming (sic) Diet By Pretty White
Trim-Fast Slimming Softgel

[Posted 07/09/2014]

AUDIENCE: Consumer

ISSUE: The FDA is advising consumers not to purchase or use Mix Fruit Slimming, Lingzhi Cleansed Slim Tea, 24 Ince, Lipo 8 Burn Slim Capsules, Sliming (sic) Diet By Pretty White, and Trim-Fast Slimming Softgel products promoted and sold for weight loss on various websites and possibly in some retail stores. FDA laboratory analysis confirmed that these products contains sibutramine. Laboratory analysis also confirmed that Mix Fruit Slimming contains phenolphthalein.

These products pose 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. These products may also interact, in life-threatening ways, with other medications a consumer may be taking. Studies have that indicated that phenolphthalein presents a cancer-causing risk.

BACKGROUND: Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States.

RECOMMENDATION: The FDA is advising consumers not to purchase or use these products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products 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

[07/08/2014 - Public Notification - FDA]