# FDA WARNING_LETTER - Roidsmall.net - April 17, 2020

Source: https://www.globalkeysolutions.net/records/warning_letter/roidsmallnet/6bf889e8-e70e-4725-a6e5-70ee5ebf25b5

> FDA WARNING_LETTER for Roidsmall.net on April 17, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Roidsmall.net
- Inspection Date: 2020-04-17
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On April 22, 2020, the FDA issued a Warning Letter to www.roidsmall.net following a website review on April 17, 2020. The FDA observed the website offering drug products for sale in the U.S. that claim to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are deemed unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FDA emphasized the public health emergency declared for COVID-19 and the inherent risks of unapproved drugs, which lack safety and effectiveness assurances.

Specific violations include the sale of oseltamivir (marketed as "Antiflu" and "Fluvir"), lopinavir + ritonavir ("Lopimune"), and ritonavir ("Ritomune") under the heading "Buy Medicines for Treating and Preventing Coronavirus." While FDA-approved versions of these active ingredients exist, the specific products offered by www.roidsmall.net lack FDA approval for any use

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/roidsmallnet/6e326b75-a9a6-42d2-97e1-12604aa48e3d

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