Is Soapwalla Inc. Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

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

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

• “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…”

Potential Health Risks

Consumers should be aware of potential risks associated with products from Soapwalla Inc..

Regulatory Context

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.

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.