FDA Warning Letters

Soapwalla Warned For Medical Claims

Boutique soap maker Rachel Winard has been formally ordered by the U.S. Food and Drug Administration, or FDA, to remove non-allowed healing claims she makes while hawking her vegan facial soaps and other skincare products.

From the FDA’s official warning letter to Soapwalla, which is now public, we learn that the agency recently took a close look at Winard’s website, SoapWallaKitchen.com, and found Winard marketing her toiletries with claims that investigators say go beyond what such products are allowed to make under the current Federal Food, Drug, and Cosmetic Act. One of Soapwalla’s face serums, a healing balm and 3 of its soaps were specifically called out.

Soapwalla FDA-Warned Soaps

Three of Winard’s Soapwalla soaps got the agency in a lather. A bar made with French clay is hawked for its supposed stimulating affect on blood flow while a soap made with cardamom promises to kill germs. The Rosewood, Cedar and Clay Soap Bar was called out for claiming to prevent breakouts and “alleviate” scars, wrinkles and skin conditions like eczema and psoriasis.

Soapwalla's Rosewood, Cedar and Clay Soap Bar is warned for illegal healing claims.

Screenshot of Soapwalla’s Rosewood, Cedar and Clay Soap Bar product page taken June 28, 2017 with FDA-warned claims clearly visible.

Soapwalla Restorative Face Serum

About her Restorative Face Serum product Winard made claims about 2 ingredients in particular. The serum’s evening primrose is attached to claims like “anti-inflammatory”; the sea buckthorn oil promises to “alleviate” a number of skin conditions, including eczema and rosacea.

FDA says Rachel Winard and Soawalla cannot promise people that her Restorative Face Serum product will treat their rashes, rosacea or eczema.

Screenshot of Soapwalla’s Restorative Face Serum product page taken June 28, 2017 with FDA-warned claims clearly visible.

Soapwalla’s The Balm – Concentrated Repair Balm

Several ingredients in Winard’s The Balm product got the agency’s attention. Of the moringa oil and prickly pear seed oil, Winard promises “repair” of tissue damage while the arnica ingredient is supposed to reduce “swelling, inflammation and bruising”. An additional ingredient–horsechestnut–is touted as a varicose vein reducer and a way to improve circulation.

FDA says medicinal claims made for Soapwalla's Concentrated Repair Balm arre unproven and unallowed.

Screenshot of Soapwalla’s The Balm product page taken June 28, 2017 with FDA-warned claims clearly visible.

Of course, the FDA fired back at Soapwalla’s marketing spiel, saying that none of the cited products have ever been proven safe or effective for any of those conditions. And claiming that they are effective makes them unapproved drugs.

As always, the agency also added that the alleged marketing violations listed in the letter were not intended to be a full list of all of Soapwalla’s potential problems. Winard, like all business owners who are sent such a notice from the FDA, is responsible for going through her marketing material and removing claims that violate the Act.

As is typical in cases like this, Soapwalla and Rachel Winard were given 15 working days to address the FDA’s concerns and either address or dispute them. The warning letter was dated June 15, 2017; as of my visit to Soapwalla’s website this morning I found the cited claims still clearly visible, as evidenced by the accompanying screengrabs.


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Categories: FDA Warning Letters

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