Old Tiles Wallpaper, LLC DBA Old Tiles Decor

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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.

Passage 2

your “Wind River Skin Comfort Blend,” “Wind River Cayenne Tincture,” and “Wind River Elderberry Tincture” products are not generally recognized as safe and effective for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).

Passage 3

Your “Wind River Skin Comfort Blend” and “Wind River Cayenne Tincture” products are misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for their intended uses.