FDA WARNING_LETTER - 247Med

The FDA issued a Warning Letter to 247Med for offering unapproved new drugs and misbranded drugs for sale on multiple websites, including eupainrelief.com and painaz.com. The FDA determined these products violate sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act.

Specifically, products like "Tramadol retard," marketed as an analgesic for moderate to severe pain, are considered unapproved new drugs under sections 201(g) and 201(p) of the FD&C Act because they lack FDA approval and are not generally recognized as safe and effective for their labeled uses. While FDA-approved tramadol exists, the "Tramadol retard" product sold by 247Med is not approved and lacks the required boxed warning regarding serious risks like addiction, respiratory depression, and neonatal opioid withdrawal syndrome.

Furthermore, "Tramadol retard" is a misbranded drug under section 502(f)(1) of the FD&C Act because it fails to bear adequate directions for use. As a prescription drug, it requires professional supervision and cannot be safely used by a layperson, thus lacking adequate directions. The FDA emphasizes the significant public health risk due to the potential for abuse and dependency, especially amid the opioid epidemic.

The FDA demands immediate cessation of marketing violative drug products to U.S