FDA WARNING_LETTER - RemedyMart

The FDA issued a Warning Letter to RemedyMart for offering unapproved and misbranded opioid products, specifically "OL-Tram" (tramadol), for sale to U.S. consumers, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is particularly concerning due to the opioid epidemic.

The products are deemed "new drugs" under section 201(p) of the FD&C Act because they are not generally recognized as safe and effective for their labeled uses and lack FDA approval, violating sections 301(d) and 505(a). While FDA-approved tramadol exists, RemedyMart's "OL-Tram" is unapproved and lacks the required boxed warning for risks like addiction, respiratory depression, and neonatal opioid withdrawal syndrome.

Furthermore, the products are "misbranded" under section 502(f)(1) because they lack adequate directions for layperson use, as tramadol is a prescription drug requiring professional supervision. RemedyMart's sale of tramadol without a prescription also violates section 503(b)(1) and results in misbranding under section 301(k).

RemedyMart must immediately cease offering violative drugs for sale. Failure to correct these violations may lead to FDA regulatory actions like seizure or injunction. RemedyMart must respond in writing within 10 working days, detailing corrective actions or explaining delays. The letter identifies generixstore.