Weight Loss Products Recalled Due to Undeclared Ingredient
On July 19, 2013, dietary supplement company, Herbal Give Care LLC, issued a voluntary total recall of its products: Esbelin siloutte te and Esbelin siloutte Herbal Blend with L-Carnitine (30 Capsules). According to the manufacturer, Esbelin siloutte te is a fat burner that removes stored fat, achieving elimination through the urine and preventing fat accumulation. Additionally, the product is intended to promote healthy digestive functioning. The Esbelin siloutte Herbal Blend with L-Carnitine (30 capsules) product is used to help normalize nervous appetite, preventing fat accumulation and fluid retention in tissues, per the manufacturer.
The reason for the recall is that the products contain undeclared Sibutramine, N-Desmethylsibutramine, and N-di-Desmethylsibutramine. The Sibutramine may pose a health threat because it is known to substantially increase blood pressure and/or pulse rate in some users. To review the FDA safety alert, click here. For a copy of the company’s press release, click here.
Sibutramine was withdrawn from the U.S. market in 2010 due to the health concerns. Manufacturers and distributors alike must be aware of regulatory developments that impact the sale of their products. Similarly companies must stay on top of scientific developments that impact the safety of their products. Importers are at times in a particularly precarious position because they are often relying upon third parties to properly identify all ingredients and provide the information necessary for Safety Data Sheets. Developing regulatory and science monitoring programs is essential to staying on top of the information needed before putting a product into the stream of commerce.