FDA WARNING_LETTER - www.buydrugsmedsonline.com - September 10, 2020

The FDA issued a Warning Letter to www.buydrugsmedsonline.com for offering unapproved and misbranded opioid products, specifically "Tramal" (tramadol), for sale to U.S. consumers, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The website introduces into interstate commerce unapproved new drugs, violating sections 301(d) and 505(a) of the FD&C Act, as no approved applications exist for "Tramal." These drugs are not generally recognized as safe and effective, lacking FDA oversight and potentially being contaminated, counterfeit, or containing incorrect active ingredients.

Furthermore, the products are misbranded under section 502(f)(1) of the FD&C Act because they lack adequate directions for use by a layperson. As prescription drugs, they require professional supervision for safe use, and their labeling fails to provide sufficient information, violating section 301(a).

The FDA emphasizes the severe public health risks posed by the easy availability of unapproved and misbranded opioids, especially given the ongoing opioid epidemic. The letter requires immediate cessation of violative drug sales and a written response within 15 working days detailing corrective actions and a timeline for completion. Failure to comply may result in regulatory actions like seizure or injunction.