FDA WARNING_LETTER - yourtramadol.com - November 22, 2022

The FDA issued a Warning Letter to www.yourtramadol.com on November 14, 2022, for unlawfully selling unapproved and misbranded drugs, specifically opioid products, to U.S. consumers over the internet. The FDA's review of the website revealed violations of sections 301(a), 301(d), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The website offers "Ol-Tram Tablets 50mg" under the "Pain Relief" heading, which is an unapproved new drug. While FDA-approved tramadol exists, it requires a prescription and carries a "black box warning" due to risks like addiction, abuse, respiratory depression, and neonatal opioid withdrawal syndrome. The "Ol-Tram Tablets 50mg" lack FDA approval, violating sections 301(d) and 505(a) of the FD&C Act.

Furthermore, the drug is misbranded under section 502(f)(1) of the FD&C Act because its labeling lacks adequate directions for use by a layperson. As a prescription drug, it requires supervision by a licensed practitioner and cannot be safely self-administered. This constitutes a violation of section 301(a) of the FD&C Act.

The FDA demands that www.yourtramadol.com cease offering all un