Shaping Beauty: We are cooperating with the FDA
In a letter dated July 14, the FDA claimed that several Shaping Beauty dietary supplements were making unauthorized drug claims by claiming to cure, mitigate, treat or prevent disease.
It also noted that the Pennsylvania-based firm had sold slimming capsules and tea under the Celerite brand that contained sibutramine, an active pharmaceutical ingredient in a drug (Meridia) that had been withdrawn from the US market last year amid safety concerns, although it acknowledged that bosses had now recalled these products.
“We acknowledge that you state that you have discontinued the receipt and distribution of Celerite Slimming Capsules and Celerite Slimming Tea, and that your firm is cooperating with FDA by conducting a voluntary recall of these products.”
Celerite products discontinued
In a statement to NutraIngredients-USA, attorney Masha K. Bach said: “The FDA clearly acknowledged in its July 14 letter that Celerite products were discontinued, and that Shaping Beauty is cooperating with the FDA.”
She added: “Shaping Beauty and the FDA cooperated on the recall and continue to cooperate to address any other concerns the FDA expressed. We are in the process of addressing any remaining issues. Shaping Beauty and the FDA are working this out effectively and directly.”
The recall was instigated in January after FDA lab analyses found the Celerite supplements contained undeclared Sibutramine used as an appetite suppressant for weight loss.
