FDA WARNING_LETTER - Thomas Meds - September 10, 2020

The FDA issued a Warning Letter to Thomas Meds for offering unapproved and misbranded opioid products for sale to U.S. consumers, violating sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act. This action addresses the significant public health risks posed by the online availability of opioids, especially unapproved drugs lacking safety and effectiveness assurances. Specifically, Thomas Meds introduced unapproved new drugs like "OxyNorm" (oxycodone) and "Tramal" (tramadol) into interstate commerce, for which no FDA-approved applications exist. These products, despite having FDA-approved counterparts with serious boxed warnings, circumvent regulatory safeguards, potentially being contaminated, counterfeit, or containing incorrect active ingredients. Furthermore, these prescription opioids are misbranded under section 502(f)(1) of the FD&C Act because their labeling fails to bear adequate directions for use by a layperson, as they require supervision by a licensed practitioner. Thomas Meds is required to immediately cease selling these violative drugs and respond within 15 working days detailing corrective actions to prevent recurrence. Failure to comply may result in FDA regulatory actions such as seizure or injunction.