Episciences Inc – FDA Warning Letter, Dec 31, 2015

The FDA reviewed Epionce's website (www.epionce.com) in December 2015 and determined that products like "Lytic Gel Cleanser," "Milky Lotion Cleanser," and "Extreme Barrier Cream" are marketed with claims that classify them as unapproved new drugs. The website, product catalog, and Facebook page contain claims indicating the products are intended for the cure, mitigation, treatment, or prevention of diseases, or to affect the structure/function of the human body, making them drugs under sections 201(g)(1)(B) and 201(g)(1)(C) of the FD&C Act.

Examples of drug claims include recommendations for regimens for conditions such as acne, dermatitis/eczema, diabetes-related conditions, hyperpigmentation, keratosis pilaris, psoriasis, radiation dermatitis, rosacea, and skin aging. Clinical trial summaries on the website also claim effectiveness for reducing actinic keratoses and comparable efficacy to prescription drugs for hyperpigmentation.

These products are considered "new drugs" under section 201(p) because they are not generally recognized as safe and effective for their intended uses. Marketing them without an approved New Drug Application (NDA) violates section 301(d) of the Act. Furthermore, products offered for conditions not amenable to self-diagnosis and treatment (e.g., psoriasis, rosacea, radiation dermatitis) lack adequate directions for