Arkadiy Kisin/White Forest Solutions – FDA Warning Letter, Sep 18, 2012

The FDA issued a Warning Letter to Arkadiy Kisin/White Forest Solutions on September 18, 2012, for marketing unapproved and misbranded drugs through numerous websites. The FDA's Internet Pharmacy Task Force determined that the websites offered products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The violations include offering "new drugs" such as "Viagra Professional," "Cialis Super Active," "Female Viagra," "Cialis Professional," and "Viagra Soft," as well as "Norplant" and "Accutane" (isotretinoin), without FDA approval. These products are considered unapproved new drugs under sections 201(g), 201(p), 301(d), and 505(a) of the FD&C Act. Norplant and Accutane had previously approved applications that were withdrawn.

Furthermore, the websites offered prescription drugs, including controlled substances, without requiring a prescription from a licensed practitioner, rendering them misbranded under section 503(b)(1) of the FD&C Act. The drugs also lacked adequate directions for use by a layman, violating section 502(f)(1). The sale of isotretinoin without required safety controls (like the iPLEDGE program) was cited as false and misleading, and lacking adequate warnings, violating sections 502(a) and