November 20, 2014
REFA Enterprises, LLC Recalls Forever Beautiful Bee Pollen Due to Undeclared Sibutramine and Phenolphthalein
The Missouri Department of Health and Senior Services received information regarding a recall of one lot of Forever Beautiful Bee Pollen (UPC #6333090804632) and Forever Beautiful Infinity (UPC #633090804649). The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established.
Products containing sibutramine pose a threat to consumers because Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat and cancer with long-term use.
All affected products are marketed as dietary supplements for weight loss and were packaged and distributed as follows:
- Forever Beautiful Bee Pollen is packaged in bottles of 60 capsules, Forever Beautiful Bee pollen was distributed via internet to consumers nationwide from July 7, 2014 - November 3, 2014.
- Forever Beautiful Infinity is packaged in bottles of 60 capsules. Forever Beautiful Infinity was distributed via internet to consumers nationwide from July 7, 2014 - November 3, 2014.
The full recall can be found at: www.fda.gov/Safety/Recalls/ucm423908.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.