- Delivery Method:
- Via Email
Recipient NameRozan Kitchen
- Old Tiles Wallpaper, LLC DBA Old Tiles Decor
175 S 400 E
Payson, UT 84651
- Issuing Office:
- Center for Drug Evaluation and Research | CDER
January 30, 2023
Dear Rozan Kitchen:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address, www.oldtilesdecor.com, on October 11, 2022, and observed that your website offers “Wind River Skin Comfort Blend,” “Wind River Cayenne Tincture,” and “Wind River Elderberry Tincture” for sale in the United States. 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). As explained further below, introducing or delivering these products for introduction into interstate commerce violates section 301(a) and (d) of the FD&C Act, 21 U.S.C. 331(a) and (d).
The Department of Health and Human Services (HHS) has determined that a public health emergency exists nationwide involving mpox.1,2 Therefore, FDA is taking measures to protect customers from products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure mpox. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure mpox in people. 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.
Examples of claims from your website, www.oldtilesdecor.com, that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:
On the product webpage for “Wind River Skin Comfort Blend,” https://oldtilesdecor.com/products/wind-river-skin-comfort-monkeypox-colloidal-silver-blend-4-oz-peppermint-essential-spikenard-oil-sarracenia-purpurea-homeopathic-relief:
• “This skin remedy boosts skin health with a powerful antibiotic, antimicrobial, anti-fungal, anti-itch essential oil remedy.”
• “Sarracenia Purpurea was used by the Native Americans for generations, for Smallpox. May help with Monkeypox sores.”
On the product webpage for “Wind River Cayenne Tincture,” https://oldtilesdecor.com/products/wind-river-cayenne-tincture-non-alcoholic-homeopathic-relief:
• “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.”
On the product webpage for “Wind River Elderberry Tincture,” on https://oldtilesdecor.com/products/wind-river-elderberry-syrup-non-alcoholic-homeopathic-relief:
• “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. For example, the label of this product states in part, “Child: Half adult dose. Infant/Toddler: Ask your doctor. Or 1 tsp every 4 hours.” Your products have not been evaluated by FDA for safety, effectiveness, and quality. 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.
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). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 355(a).
Misbranded Human Drugs
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. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5.) Prescription drugs, as defined in section 503(b)(1)(A) of the Act, 21 U.S.C. 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner. Your “Wind River Skin Comfort Blend” and “Wind River Cayenne Tincture” products are offered for conditions that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Accordingly, the listed products are misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). The introduction or delivery for introduction into interstate commerce of misbranded drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Please direct any inquiries to FDA at FDAAdvisory@fda.hhs.gov.
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
1 Secretary of Health and Human Services, Renewal of Determination that a Public Health Emergency Exists (issued Nov. 2, 2022), available at https://aspr.hhs.gov/legal/PHE/Pages/mpx-renewal-2Nov2022.aspx.
2 HHS has adopted the World Health Organization’s renaming of monkey pox to “mpox” to reduce stigma. Department of Health and Human Services, Biden Harris Administration Supports the World Health Organization Renaming of Monkeypox to mpox (issued Nov. 28, 2022), available at https://www.hhs.gov/about/news/2022/11/28/biden-harris-administration-supports-the-world-health-organization-renaming-of-monkeypox-to-mpox.html.