FDA MedWatch - Skinny Bee Diet by Love My Tru Body: Recall - Undeclared Drug Ingredients

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Skinny Bee Diet by Love My Tru Body: Recall - Undeclared Drug Ingredients

AUDIENCE: Consumer

ISSUE: Love My Tru Body is voluntarily recalling all of Skinny Bee Diet 500 mg to the consumer level after FDA laboratory testing found Skinny Bee Diet to contain sibutramine, desmethylsibutramine, and/phenolphthalein.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Desmethylsibutramine is an active metabolite of sibutramine. Sibutramine and its active metabolites 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. Phenolpthalein was previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is no longer marketed in the U.S. These undeclared ingredients make this product an unapproved new drug for which safety and efficacy have not been established.

BACKGROUND: The product is used as a weight loss dietary supplement and is packaged in white silver bottle with red capsules. The affected Skinny Bee Diet product includes bottles MFD: 03.07.2016, EXP: 03.06.2018. Love My Tru Body distributed Skinny Bee Diet capsules nationwide March 23 – April 28, 2016 to consumers via the internet at www.lovemytrubody.com

RECOMMENDATION: Love My Tru Body notified its customers by US Mail. Consumers who are currently in possession of recalled Skinny Bee Diet capsules should stop using the product and discard.

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
• 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

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm528505.htm