IceNetworks Ltd./www.mega-pillspharmacy.com – FDA Warning Letter, Sep 10, 2020

The FDA issued a Warning Letter to www.mega-pillspharmacy.com on August 31, 2020, for offering unapproved and misbranded opioid products for sale to U.S. consumers, specifically citing tramadol. The website's activities violate sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act.

The FDA determined that products like "Tramadol (Ultram)" from "Pharma Chemie co." are unapproved new drugs under sections 201(g) and 201(p) because they lack FDA approval for safety and effectiveness, violating sections 301(d) and 505(a). The letter highlights that FDA-approved tramadol carries a black box warning for serious risks, including addiction and respiratory depression, which the unapproved version lacks.

Furthermore, the products are misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson, as they are prescription drugs requiring professional supervision. Since the drug is unapproved, it is not exempt from this requirement under 21 CFR 201.115, violating section 301(a).

The FDA emphasized the inherent risk to consumers from unapproved and misbranded drugs, given the opioid crisis. The company must immediately cease