old tiles wallpaper, llc – FDA Warning Letter, Jan 31, 2023
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
ID · 54f825c7-7215-427f-8d98-2de7416d902c
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