U.S. Food & Drug Administration
Center for Food Safety and Applied Nutrition
College Park, MD 20740
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUEST
Date: June 15, 2017
Ms. Rachel Winard, Founder
232 Third Street, Suite B303
Brooklyn, NY 11215
Dear Ms. Rachel Winard:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://soapwallakitchen.com in June 2017 and has determined that you take orders there for the products Cardamom Ginger Soap Bar, Lavender & French Clay Soap Bar, Restorative Face Serum, Rosewood, Cedar & Clay Soap Bar, Shea Butter, Tangerine & Clay Soap Bar, and The Balm-Concentrated Repair Balm. The claims on your website establish that the products are drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and/or § 321(g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or function of the human body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Restorative Face Serum
• “This Face Serum is a custom combination of…Evening Primrose oil…(a wonderful source of gamma linoleic acid-with powerful anti-inflammatory…properties…and”
• “sea buckthorn oils…(which…alleviate eczema, rosacea and sensitive skin rashes.)”
Shea Butter, Tangerine & Clay Soap Bar and Lavender & French Clay Soap Bar
• “French green clay [(an ingredient in this product)] gently stimulates blood flow…”
Rosewood, Cedar and Clay Soap Bar
• “Rosewood and cedarwood essential oils … helping prevent break-outs and balancing oil/combination skin while alleviating acne, scars, eczema, psoriasis and wrinkles.”
• Combined with kaolin clay [(an ingredient in this product)], which gently stimulates blood flow…”
Cardamom Ginger Soap Bar
• “[G]round green cardamom [(an ingredient in this product)] provide a … effective antiviral and antimicrobial barrier.”
The Balm - Concentrated Repair Balm
• “Moringa and prickly pear seed oils [(ingredients in this product)] repair tissue damage…”
• “Arnica [(an ingredient in this product)] reduces swelling, inflammation and bruising.”
• “Horse chestnut [(an ingredient in this product)] minimizes varicose veins and leads to improved circulation.”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. 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 Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
This letter is not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Please send your reply to the Food and Drug Administration, Attention: Scott R. Izyk, Compliance Officer, One Winners Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contact Scott R. Izyk at 518-453-2314 x1012 or email@example.com.
Program Division Director
Office of Human and Animal Food Operations East – Division 1
This page was posted on April 30, 2019.