Philadelphia 7, Inc d/b/a Passional Boutique

Warning LetterOpen

Dumesh Kankanamalage Chief Executive Officer Philadelphia 7, Inc d/b/a Passional Boutique 317 South St Philadelphia , PA 19147 United States manager@passionalboutique.comIssued Dec 16, 2025Center for Devices and Radiological Health

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

Violations2

Issue DateDec 16, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Philadelphia 7, Inc d/b/a Passional Boutique
Location: Dumesh Kankanamalage Chief Executive Officer Philadelphia 7, Inc d/b/a Passional Boutique 317 South St Philadelphia , PA 19147 United States manager@passionalboutique.com
FEI Number: N/A
Country: United States
Issue Date: December 16, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Drugs
Status: Open

Summary

Philadelphia 7, Inc d/b/a Passional Boutique was cited for distributing breast binders, including the UNTAG line marketed for reducing gender dysphoria, which the FDA classified as medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act. The company failed to register its manufacturing establishments and list its devices as required by section 510 of the Act, resulting in the products being misbranded under section 502(o). The FDA determined that the firm violated section 301(a) of the Act by introducing misbranded devices into interstate commerce through its website and warned that failure to promptly correct these violations could result in further regulatory action.

Philadelphia 7, Inc d/b/a Passional Boutique FDA Warning Letter, December 16, 2025