Federal Register #FDA-2025-N-6692

FDA Debarment Order for Drug Import Violations Involving Counterfeit Viagra and Cialis

This notice announces a final debarment order issued by the Food and Drug Administration (FDA), part of the Department of Health and Human Services, against Jeffrey Thies for drug import violations. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs Involved: - Pfizer, Inc./Viatris, Inc. (Viagra) - Eli Lilly & Company (Cialis) - Key Details: - Jeffrey Thies is debarred for 10 years from importing or offering for import any drug into the United States - Debarment is based on felony convictions for trafficking in counterfeit goods and aiding and abetting - Counterfeit prescription drugs involved include Viagra and Cialis - Counterfeit marks and trade names were identical or substantially indistinguishable from those owned by the OEMs - Thies operated websites selling counterfeit sex pills, smuggled counterfeit drugs and packaging from China and India, and manufactured pills in a non-sterile environment - Notable Requirements: - The order prohibits Thies from importing or offering for import any drug during the debarment period - No products or services are being procured or awarded in this notice

Description

The Food and Drug Administration (FDA) is issuing a final debarment order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jeffrey Thies for 10 years from importing or offering for import any drug into the United States. This action follows Mr. Thies's conviction on two felony counts for trafficking in counterfeit goods and aiding and abetting, related to the importation of counterfeit prescription drugs. Mr. Thies was notified of the proposed debarment and waived his right to a hearing by not responding within the allotted time. The order is effective as of September 25, 2026.

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