FDA WARNING_LETTER - Sorcerz.com - May 16, 2023

The FDA issued a Warning Letter to www.sorcerz.com on April 19, 2023, for introducing unapproved and misbranded new drugs, specifically opioids and benzodiazepines, into interstate commerce, violating sections 301(a), 301(d), and 505(a) of the FD&C Act. The FDA's review of the website revealed the sale of products like "Ol-Tram Tablets 100mg" (tramadol) and "Farmapram 2mg" (alprazolam) without FDA approval.

These products are considered "new drugs" under section 201(p) because they lack general recognition of safety and effectiveness for their labeled uses and have no approved applications under section 505(a). Furthermore, they are misbranded under section 502(f)(1) because their labeling lacks adequate directions for use, as they are prescription drugs requiring professional supervision and are not exempt from this requirement.

The FDA emphasized the significant public health risks associated with the easy online availability of unapproved opioids and benzodiazepines, citing the opioid epidemic and the dangers of polysubstance use with benzodiazepines. The letter requires www.sorcerz.com to cease offering these products for sale to U.S. consumers and to respond within 15 working days, detailing corrective actions and prevention measures. Failure to comply may result in legal action, including