FDA WARNING_LETTER - Galyna / Ivan Podornikova

The FDA issued a Warning Letter after reviewing the company's websites, which offer unapproved and misbranded new drugs for sale to U.S. consumers, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The violations include: 1. **Unapproved New Drugs**: Products like "Viagra Professional," "Cialis Super Active," and "Female Viagra" are considered drugs under section 201(g) of the FD&C Act due to their intended use for disease treatment or affecting body structure/function. They are also new drugs under section 201(p) as they are not generally recognized as safe and effective. No approved applications under section 505 of the FD&C Act are in effect for these products, violating sections 505(a) and 301(d). 2. **Misbranded Drugs**: * The websites offer prescription drugs, including controlled substances, without requiring a prescription from a licensed practitioner, thus misbranding them under section 503(b)(1). * These drugs are intended for conditions not amenable to self-diagnosis, and their labeling lacks adequate directions for safe use by a layman, misbranding them under section 502(f)(1). They are not exempt from this requirement under 21 C.F.R. § 201.115. *