FDA WARNING_LETTER - www.portmeds.com - July 29, 2025

The FDA issued a warning letter to Portmeds.com on July 16, 2025, following a review of their website, which revealed the sale of unapproved and misbranded drugs, including opioids, benzodiazepines, and Schedule II stimulants. These actions violate 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 highlighted the significant public health risks posed by the easy availability of these substances online, particularly amidst the ongoing opioid epidemic and rising mortality from psychostimulant-involved overdoses.

Portmeds.com was found to be selling unapproved versions of drugs such as tapentadol, hydrocodone, oxycodone, and tramadol, which are intended for pain relief but lack FDA-approved applications. The sale of these drugs without FDA approval circumvents regulatory safeguards, potentially exposing consumers to contaminated or counterfeit products.

The FDA has requested that Portmeds.com immediately cease offering these unapproved and misbranded drugs to U.S. consumers to protect public health. The company must ensure compliance with FDA regulations, which require that new drugs cannot be legally marketed without prior approval, ensuring their safety and effectiveness. Failure to comply could result in further regulatory action.