FDA WARNING_LETTER - Eassybuyonline

The FDA issued a Warning Letter to Eassybuyonline for offering unapproved and misbranded opioid products, specifically "Citra" (tramadol), 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 "Citra" are considered new drugs under section 201(p) of the FD&C Act because they are not generally recognized as safe and effective for their labeled uses. They lack FDA approval, violating sections 301(d) and 505(a). FDA-approved tramadol carries a "black box warning" due to risks like addiction, respiratory depression, and neonatal opioid withdrawal syndrome. 2. **Misbranded Drugs:** The products are misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson, as they are prescription drugs requiring professional supervision. Since they are unapproved, they are not exempt from this requirement, violating section 301(a).

The FDA emphasizes the inherent risk to consumers from unapproved drugs, which may be contaminated, counterfeit, or have inconsistent active ingredients, especially given the U.S. opioid epidemic. Eassybuyonline is required to immediately cease offering violative drugs for sale and respond in writing within 10 working days, detailing corrective actions and prevention measures. Failure to