Federal Register #2026-07864

FDA Debarment Order for Drug Importation Offenses Involving Counterfeit Botox and Restylane

This notice announces a final debarment order issued by the Food and Drug Administration (FDA) against Kimberly Schaff Kiehl for drug importation offenses: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors Mentioned: - AbbVie Inc. (manufacturer of Botox) - Products/Services Referenced: - Counterfeit Botox (originally manufactured by AbbVie Inc.) - Counterfeit Restylane and other injectable drugs - Key Details: - Kimberly Schaff Kiehl is debarred for 10 years from importing or offering for import any drug into the United States - Debarment is based on convictions for mail fraud and importation/sale of counterfeit drugs - The order is enforced by the FDA's Division of Field Enforcement, Office of Field Regulatory Operations, and Office of Inspections and Investigations - No procurement of products or services is requested in this notice

Description

The Food and Drug Administration (FDA) is issuing a final debarment order under the Federal Food, Drug, and Cosmetic Act debarring Kimberly Schaff Kiehl for 10 years from importing or offering for import any drug into the United States. This action follows Ms. Kiehl's conviction of two federal felonies related to the importation of drugs or controlled substances. Ms. Kiehl was notified of the proposed debarment and waived her right to a hearing by not responding within the allotted time. The order is effective April 23, 2026, and prohibits Ms. Kiehl from importing drugs into the U.S. during the debarment period.

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