FDA WARNING_LETTER - citypharma.us - May 30, 2023

The FDA issued a Warning Letter to www.citypharma.us on May 22, 2023, for introducing unapproved new drugs and misbranded drugs into interstate commerce, violating sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act. The website offers unapproved and misbranded opioid drug products (e.g., "Citra 100 mg" tramadol), benzodiazepines (e.g., "Rivotril 2mg" clonazepam), and Schedule II stimulants (e.g., "Adderall 10mg").

These products are considered unapproved new drugs because they lack FDA approval under section 505(a) of the FD&C Act, despite FDA-approved versions existing for some. They are misbranded under section 502(f)(1) as they lack adequate directions for layperson use, and under section 503(b)(1) for being prescription drugs sold without a prescription. The FDA highlights significant public health risks due to the potential for abuse, addiction, severe adverse effects, and co-use with other substances, especially given the opioid epidemic.

Citypharma.us is required to cease offering these drugs for sale to U.S. consumers and respond in writing within 15 working days, detailing