FDA WARNING_LETTER - PIL - April 08, 2025

The FDA issued a Warning Letter to www.thesafepills.org on March 27, 2025, for unlawfully selling unapproved and misbranded drugs, specifically opioid products, to U.S. consumers over the internet. The website introduces into interstate commerce unapproved new drugs and misbranded drugs, violating sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FDA observed the sale of tapentadol products, marketed as "Aspadol 100mg (Tapentadol)," "Typendol 100mg (Tapentadol)," and "Generic Nucynta," among others. These products are considered unapproved new drugs under sections 201(g) and 201(p) of the FD&C Act because they are intended for human use but lack FDA approval for safety and effectiveness. While FDA-approved tapentadol products exist, those offered by www.thesafepills.org do not have approved applications, violating sections 301(d) and 505(a). FDA-approved tapentadol products are prescription-only and carry a boxed warning due to risks like addiction, abuse, and respiratory depression.

Furthermore, the drugs are misbranded under