# FDA WARNING_LETTER - iSlim, LLC - May 16, 2023

Source: https://www.keypedia.com/records/warning_letter/islim-llc/3a746a5d-a7ec-43da-bfe5-70aaf59ccacd

> FDA WARNING_LETTER for iSlim, LLC on May 16, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: iSlim, LLC
- Inspection Date: 2023-05-16
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations II
- Summary: The FDA issued a Warning Letter to Mr. Shans on May 3, 2023, following a December 2022 review of www.alfia.com, where "Alfia Weight Loss Capsules" were sold. Laboratory analysis confirmed the product contains undeclared sibutramine, a drug withdrawn from the U.S. market in 2010 due to increased risks of heart attack and stroke.

The product is deemed an unapproved new drug under sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)) because it is intended to affect body structure/function and is not generally recognized as safe and effective. No FDA-approved application exists for it.

Furthermore, "Alfia Weight Loss Capsules" is a misbranded drug under section 502 of the FD&C Act (21 U.S.C. 352) and violates section 301(a) (21 U.S.C. 331(a)). Specific misbranding violations include:
- Failure to bear adequate directions for use (502(f)(1)), as sibutramine requires professional supervision and was withdrawn due to safety risks.
- False or misleading labeling (502(a)) due to the undeclared

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/monica-r-maxwell/e1b3373a-80b0-4023-9aea-b4ac7170c964)

Company: https://www.keypedia.com/companies/islim-llc/6d1bf6bd-b7f0-4379-8461-888f170520f8

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-ii/930d696b-0ac7-4de4-8268-e3db00525bc6