FDA WARNING_LETTER - pharmahealthonline.com - January 10, 2023

On January 6, 2023, the FDA issued a Warning Letter to www.pharmahealthonline.com for introducing unapproved and misbranded new drugs into interstate commerce, violating sections 301(a), 301(d), and 505(a) of the FD&C Act. The website was observed selling unapproved and misbranded opioid and benzodiazepine drug products, which pose significant public health risks due to the opioid epidemic and the potential for abuse and co-use with other substances.

Specific violations include offering "JPDOL-100" (tramadol), "Ksalol 1mg" (alprazolam), and "Rivotril 2mg" (clonazepam). These products are new drugs lacking FDA approval under section 505(a) of the FD&C Act, making their introduction into interstate commerce illegal. Although FDA-approved versions of these drugs exist, they are prescription-only and carry boxed warnings regarding serious risks like addiction, respiratory depression, and death.

Furthermore, these drugs are misbranded under section 502(f)(1) of the FD&C Act because their labeling lacks adequate directions for use by a layperson. As prescription drugs, they require professional supervision and cannot be safely used without it.

The FDA requires www.pharmahealthonline.com to cease offering all unapproved and misbranded drugs for sale to U.