# FDA WARNING_LETTER - old tiles wallpaper, llc  - January 31, 2023

Source: https://www.keypedia.com/records/warning_letter/old-tiles-wallpaper-llc/54f825c7-7215-427f-8d98-2de7416d902c

> FDA WARNING_LETTER for old tiles wallpaper, llc  on January 31, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: old tiles wallpaper, llc 
- Inspection Date: 2023-01-31
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On January 30, 2023, the FDA issued a Warning Letter to Rozan Kitchen regarding products sold on www.oldtilesdecor.com. An FDA review on October 11, 2022, found "Wind River Skin Comfort Blend," "Wind River Cayenne Tincture," and "Wind River Elderberry Tincture" offered for sale.

These products are deemed unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and their introduction into interstate commerce violates section 301(d), 21 U.S.C. 331(d). The "Wind River Skin Comfort Blend" and "Wind River Cayenne Tincture" are also misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), violating section 301(a), 21 U.S.C. 331(a).

The FDA is particularly concerned due to a nationwide public health emergency involving mpox, and the company's products claim to mitigate, prevent, treat, diagnose, or cure mpox. Examples of drug claims include "This skin remedy boosts skin health with a powerful antibiotic, antimicrobial, anti-fungal, anti-itch essential

## Related Officers

- [Director](https://www.keypedia.com/people/jill-p-furman/984bfbfc-3f4e-46bc-8d3b-3d82e56c6ac9)

Company: https://www.keypedia.com/companies/old-tiles-wallpaper-llc/35f7ebee-c150-453e-9b9b-cdb0fbdff0e0

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