# FDA WARNING_LETTER - Xcel Research LLC - December 10, 2024

Source: https://www.keypedia.com/records/warning_letter/xcel-research-llc/1f465794-dfc5-4548-b224-4b609d8b23df

> FDA WARNING_LETTER for Xcel Research LLC on December 10, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Xcel Research LLC
- Inspection Date: 2024-12-10
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On December 10, 2024, the FDA issued a Warning Letter to Andrew Pierce of Xcelpeptides.com following an October 2024 review of their website. The FDA observed that Xcelpeptides.com offers various products for sale in the U.S., including “RETA” (Retatrutide), “CagriLean” (Cagrilintide and Semaglutide), “CAGRILINTIDE,” “MAZDUTIDE,” “SEMA” (Semaglutide), “SURVODUTIDE,” and “SERMORELIN.”

The FDA determined these products are unapproved new drugs, introduced or delivered for introduction into interstate commerce, violating sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Despite labeling stating "FOR RESEARCH USE ONLY" and "NOT INTENDED FOR HUMAN USE," the FDA found evidence on the website establishing the products' intended use as drugs for human use. These products are considered drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), as they are intended to prevent, treat, or cure disease conditions and/or affect

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Company: https://www.keypedia.com/companies/xcel-research-llc/e0cf30bb-f361-4467-9948-ac2201569851

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c