PowerAll Pharma – FDA Warning Letter, Sep 3, 2021

The FDA issued a Warning Letter to PowerAll Pharma on August 31, 2021, for introducing unapproved and misbranded new drugs, specifically opioids and benzodiazepines, into interstate commerce via their websites (e.g., Powerallpharma.com). The FDA observed violations of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act.

The identified violations include selling unapproved new drugs like "Tramadol LP Zentiva 50 mg," "Tramadol Arrow LP 100 mg," "Opana ER (Oxymorphone)," and "Valium Pills (Diazepam)." These products lack FDA approval under section 505(a) of the FD&C Act, making their introduction into interstate commerce illegal. The letter highlights the significant public health risks associated with unapproved opioids and benzodiazepines, including addiction, abuse, respiratory depression, and the dangers of co-use with other substances.

Furthermore, these drugs are misbranded under section 502(f)(1) because they lack adequate directions for layperson use, as they are prescription drugs requiring professional supervision. They are also misbranded under section 503(b)(1) and violate section 301(k) because PowerAll Pharma offers them without requiring a prescription, jeopardizing patient