Health Law Daily Wrap Up, MISBRANDING (FOOD, DRUGS & MEDICAL DEVICES)—NOTICES: Importer debarred for offering for sale misbranded male enhancement drugs, (May 30, 2025)

By WK Editorial Staff

The FDA has debarred an individual for importing and offering for sale misbranded male enhancement drugs.

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 10 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 for introduction into interstate commerce a misbranded drug, with the intent to defraud and mislead, and one felony count of illegal importation of merchandise. The factual bases supporting the individual’s convictions, as described below, are for 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 February 23, 2025 (30 days after receipt of the notice), he had not responded. The failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter (Notice, 90 Fed. Reg. 22736 (May. 29, 2025)).

Dates. This order is applicable May 29, 2025.

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