Old Tiles Wallpaper, LLC DBA Old Tiles Decor
FDA issued a warning letter to Old Tiles Wallpaper, LLC DBA Old Tiles Decor (Payson, UT) for selling three products — 'Wind River Skin Comfort Blend,' 'Wind River Cayenne Tincture,' and 'Wind River Elderberry Tincture' — as unapproved new drugs in violation of the FD&C Act, with particular concern over mpox-related claims and marketing to children and infants. The products were found to make drug-intended-use claims (treating monkeypox sores, heart conditions, cold and flu) without FDA approval or authorization. Two of the products were also found to be misbranded for lacking adequate directions for use. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (7)
IWind River Cayenne Pepper Tincture for boosting heart health. Cayenne Pepper is a fantastic source of antioxidants and other plant compounds that protect our cells and promote health. f you are worried about heart issues, high blood pressure, blood clots, myocarditis, etc, having this, or simply cayenne pepper in your cupboard can save a life. Administer under the tongue, while calling 911.
Recommended to help prevent and ease cold and flu symptoms.
This skin remedy boosts skin health with a powerful antibiotic, antimicrobial, anti-fungal, anti-itch essential oil remedy.
It is a remedy to tame inflammation, lessen stress, and help protect your heart, too.
Wind River Elderberry Syrup Tincture is packed with antioxidants and vitamins that boost your immune system.
Child: Half adult dose. Infant/Toddler: Ask your doctor. Or 1 tsp every 4 hours.
Sarracenia Purpurea was used by the Native Americans for generations, for Smallpox. May help with Monkeypox sores.
Required actions (3)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address these matters.
We request that you cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of mpox.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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