FDA WARNING_LETTER - WallCann - Cura-Care.com

The FDA reviewed WallCann - Cura-Care.com's website, www.cura-care.com, and determined that Curaderm-BEC5 is promoted and sold to mitigate, prevent, treat, or cure disease in humans, or to affect the structure or function of the body. Statements on the website claim Curaderm-BEC5 is a "clinically proven, cost effective treatment for both primary and secondary skin cancer care," can treat various skin cancers and sunspots, and allows users to "avoid painful Surgery, Radiotherapy, Chemotherapy or other conventional treatments."

The FDA classified Curaderm-BEC5 as a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) due to its intended uses. Furthermore, it is deemed a new drug under section 201(p) of the Act because it is not generally recognized as safe and effective for its advertised uses. The sale of this product without an FDA-approved application violates sections 301(d) and 505(a) of the Act.

Additionally, the product is considered misbranded under section 502(f)(1) of the Act because it is offered for conditions (e.g., cancer) not amenable to self-diagnosis and treatment by laypersons, meaning adequate directions for safe use cannot be provided.

WallCann is advised to review all websites, product labels,