What happened
Original notice title
Old Tiles Wallpaper, LLC DBA Old Tiles Decor MARCS-CMS 643920, January 30, 2023
From the archived source record
Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your “Wind River Skin Comfort Blend” and “Wind River Cayenne Tincture” products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). We request that you cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of mpox. Unapproved New Human Drugs Based on a review of your website, your “Wind River Skin Comfort Blend,” “Wind River Cayenne Tincture,” and “Wind River Elderberry Tincture” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Administer under the tongue, while calling 911.” On the product webpage for “Wind River Elderberry Tincture,” on [see original source] • “Wind River Elderberry Syrup Tincture is packed with antioxidants and vitamins that boost your immune system.” • “It is a remedy to tame inflammation, lessen stress, and help protect your heart, too.” • “Recommended to help prevent and ease cold and flu symptoms.” In addition, FDA is particularly concerned that you market your “Wind River Elderberry Tincture” for use in preventing cold and flu symptoms in children and infants. The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations such as children and infants who may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 3639ec6b30d8
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →