FDA WARNING_LETTER - Medsnoscript

The FDA issued a Warning Letter to Medsnoscript.com for offering unapproved and misbranded new drugs for sale, specifically "Generic Tamiflu," in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The "Generic Tamiflu" is deemed an unapproved new drug under sections 201(p) and 505(a) of the FD&C Act because it is not generally recognized as safe and effective, and no approved applications exist for it. Its introduction into interstate commerce is prohibited under section 301(d).

Furthermore, the product is misbranded under several sections: - Section 503(b)(1): Offered for sale without requiring a prescription from a licensed practitioner. - Section 502(a): Labeling is false or misleading, implying it is an FDA-approved drug. - Section 502(f)(1): Lacks adequate directions for use by a layman, as it treats conditions not amenable to self-diagnosis and treatment, and is not exempt from this requirement due to its unapproved status.

The FDA emphasizes the inherent risk of unapproved and misbranded drugs, citing potential contamination, counterfeiting, and inconsistent active ingredient levels. The letter requires Medsnoscript.com to immediately cease marketing violative drug products to U.S. consumers and to notify the FDA within 15 working days of corrective actions taken or planned