FDA WARNING_LETTER - www.rxeasymeds.com - September 10, 2020

The FDA issued a Warning Letter to www.rxeasymeds.com for offering unapproved and misbranded opioid products for sale to U.S. consumers, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). The website introduces opioids, such as "Nalbin" (nalbuphine) by Global Pharma, into interstate commerce without FDA approval, contravening sections 301(d) and 505(a) of the FD&C Act. These are considered new drugs as they are not generally recognized as safe and effective for their labeled uses and lack approved applications.

Furthermore, the products are misbranded under section 502(f)(1) of the FD&C Act because they lack adequate directions for use by a layperson. As prescription drugs, they require professional supervision for safe use, and their labeling does not provide sufficient information for self-treatment, violating section 301(a).

The FDA emphasizes the significant public health risks posed by unapproved and misbranded opioids, including potential contamination, varying active ingredient amounts, and the absence of safety and effectiveness assurances. The agency requires www.rxeasymeds.com to immediately cease offering violative drugs for sale and to notify the FDA within 15 working days of corrective actions taken or planned to address these violations and prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction.