06.28.17
The US Food and Drug Administration (FDA) issued a warning letter earlier this month to Soapwalla Inc. after a review of the company's website (soapwallakitchen.com) determined that product claims on the 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.
Soapwalla's products include 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. According to FDA, some of Soapwalla's website claims provide evidence that its products are intended for use as drugs. Such claims 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.”
In its Warning Letter, FDA noted that the missive was not an all-inclusive statement of violations associated with Soapwalla's products or their labeling, and FDA did not attempt to list all of the products that are promoted on the website for intended uses that cause them to be drugs. FDA requested that Soapwalla take prompt action to correct all violations associated with its 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.
Soapwalla's products include 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. According to FDA, some of Soapwalla's website claims provide evidence that its products are intended for use as drugs. Such claims 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.”
In its Warning Letter, FDA noted that the missive was not an all-inclusive statement of violations associated with Soapwalla's products or their labeling, and FDA did not attempt to list all of the products that are promoted on the website for intended uses that cause them to be drugs. FDA requested that Soapwalla take prompt action to correct all violations associated with its 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.
