# FDA WARNING_LETTER - Thomas Meds - September 10, 2020

Source: https://www.keypedia.com/records/warning_letter/thomas-meds/557a85c9-e75e-4902-b2d0-97983389fcf8

> FDA WARNING_LETTER for Thomas Meds on September 10, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Thomas Meds
- Inspection Date: 2020-09-10
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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.

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)

Company: https://www.keypedia.com/companies/thomas-meds/f60e10f0-0682-418a-ba96-83eed8cca0b1

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c