FDA WARNING_LETTER - lekapharma.com - September 10, 2020

The FDA issued a Warning Letter to www.lekapharma.com on August 31, 2020, for offering unapproved new drugs and misbranded drugs for sale to U.S. consumers, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA highlighted the severe public health crisis of opioid addiction and abuse, noting the significant risks posed by internet availability of such drugs.

Specifically, www.lekapharma.com introduced "Tramapar" (a combination of tramadol and paracetamol) into interstate commerce. This product is an unapproved new drug under sections 201(g) and 201(p) of the FD&C Act, as no FDA-approved applications exist for this specific combination or manufacturer. The FDA emphasized that approved tramadol carries a "black box warning" due to risks like addiction, abuse, respiratory depression, and neonatal opioid withdrawal syndrome.

Furthermore, "Tramapar" is misbranded under section 502(f)(1) of the FD&C Act because it lacks adequate directions for use by a layperson. As a prescription drug, it requires professional supervision for safe use, and adequate directions cannot be provided for self-treatment.

The FDA requires www.lekapharma.com to immediately cease offering violative drugs for sale and take prompt action to correct all violations, including those involving other similarly misbranded and/or unapproved new drugs.