FDA WARNING_LETTER - V10Suppliers.com - July 23, 2024

On July 22, 2024, the FDA issued a Warning Letter to V10Suppliers.com 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), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The website offers unapproved new drugs, including "OL-TRAM TABLETS 100mg" and "Tramadol 100mg," and "Oxylan 40mg" and "Oxycodone 40mg GL Pharma UK," under the "Pain Killers" heading. These products are considered new drugs under section 201(p) of the FD&C Act because they lack FDA approval for safety and effectiveness, violating sections 301(d) and 505(a).

Furthermore, these drugs are misbranded under section 502(f)(1) of the FD&C Act because their labeling lacks adequate directions for use by a layperson. As prescription drugs, they require professional supervision and cannot be safely used without it. The website also offers these prescription drugs without requiring a prescription, violating section 503(b