Health Law Daily Wrap Up, CONTROLLED SUBSTANCES—NOTICES: Importer debarred for selling non-FDA approved drugs, (May 30, 2025)

By WK Editorial Staff

The FDA has debarred an individual for importing non-FDA approved drugs and controlled substances and offering them for sale on a website.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring an individual for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that the individual was convicted of one felony count under Federal law. The factual basis supporting the individual’s conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. The individual was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of May 16, 2024 (30 days after receipt of the notice), the individual had not responded. The individual’s failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter (Notice, 90 Fed. Reg. 22732 (May. 29, 2025)).

Dates. This order is applicable May 29, 2025.

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