FDA WARNING_LETTER - Solace International, Inc.

On July 3, 2014, the FDA issued a Warning Letter to Solace International, Inc. regarding their products "Derma Tend Original Mole, Wart, Skin Tag Remover" and "Derma Tend Ultra Mole, Wart, Skin Tag Remover," marketed on www.dermatend.com.

The FDA determined that these products are unapproved new drugs and are misbranded under the Federal Food, Drug, and Cosmetic Act. Violations include marketing products as drugs intended for diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect body structure/function, without FDA approval. Specific claims cited include "Removes moles and skin tags" and "Safely remove unwanted moles, imperfections, and skin tags at home."

As new drugs, Derma Tend products require an FDA-approved application, which they lack, violating sections 301(d) and 505(a) of the Act. Furthermore, the products are misbranded under section 502(f)(1) because they are intended for conditions not amenable to self-diagnosis and treatment, meaning adequate directions for laypersons cannot be provided. The products do not conform to the Final Monograph for OTC Wart Remover Products (21 C.F.R § 358 Subpart B), as they address mole and skin tag removal and do not contain the permitted active ingredient, salicylic acid.

Solace International, Inc. must take prompt action