iSlim, LLC

Warning LetterOpen

United StatesIssued May 3, 2023Division of Pharmaceutical Quality Operations II

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Letter Details

Firm: iSlim, LLC
Location: United States
FEI Number: N/A
Country: United States
Issue Date: May 03, 2023
Issuing Office: Division of Pharmaceutical Quality Operations II
Product Type: Drugs
Status: Open

Summary

iSlim, LLC was warned for selling "Alfia Weight Loss Capsules," an unapproved new drug containing undeclared sibutramine (a withdrawn prescription ingredient linked to heart attack and stroke risk) in violation of sections 505(a) and 301(d) of the FD&C Act. The product was also misbranded under section 502, with marketing claims on the company's website asserting the capsules would curb appetite, increase energy, burn fat, and improve digestion—establishing drug intent without FDA approval. Laboratory analysis confirmed the presence of sibutramine, a pharmaceutical ingredient that had been removed from the U.S. market in 2010 due to safety concerns.