# 2025-21075: Woman Gets 5-Year Drug Import Ban, Ghosts Her Own Hearing

2025-21075, Nicole Shelby Randall: Final Debarment Order, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-11-25, effective 2025-11-25 (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-21075
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-21075
- Title: Nicole Shelby Randall: Final Debarment Order
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 53327
- Published: 2025-11-25
- Effective: 2025-11-25
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

Woman Gets 5-Year Drug Import Ban, Ghosts Her Own Hearing

## Summary

Nicole Shelby Randall is officially banned for 5 years from importing any drugs into the U.S. because she was convicted of bringing in a bad drug that broke federal law. She didn’t respond to the FDA’s notice or ask for a hearing, so the ban started on November 25, 2025. She can apply to end the ban anytime, but must follow special rules to keep her info private.

## Abstract

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Nicole Shelby Randall 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 Ms. Randall was convicted of one felony count under Federal law for introduction of an adulterated drug into interstate commerce. The factual basis supporting Ms. Randall's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Ms. Randall was given notice of the proposed debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of July 30, 2025 (30 days after receipt of the notice), Ms. Randall had not responded. Ms. Randall's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.

## Effects PRIA read

- Five‑Year Import Ban for Nicole Randall: cost, high. Nicole Shelby Randall is debarred for 5 years from importing or offering for import any drug into the United States, effective November 25, 2025. The debarment follows her January 22, 2025 felony conviction for introducing an adulterated drug into interstate commerce, and FDA states that importing…
- Right to Apply and Public Filing Rules: mixed, low. Ms. Randall (or anyone seeking termination of debarment) may apply to end the debarment at any time under section 306(d)(1). Applications submitted electronically to https://www.regulations.gov will be posted publicly unchanged; to keep information confidential you must submit a written/paper appli…

## Related documents

- [2026-20848](https://policyrisk.com/federal-register/2026-20848): Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods, 2026-10-13
- [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11
- [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13
- [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29
- [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25
- [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27

## Sources
- [2025-21075 on federalregister.gov](https://www.federalregister.gov/documents/2025/11/25/2025-21075/nicole-shelby-randall-final-debarment-order)
- [2025-21075 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-11-25/pdf/2025-21075.pdf)

## Related
- [Previous: 2025-21074, Center for Scientific Review; Notice of Closed Meetings](https://policyrisk.com/federal-register/2025-21074)
- [Next: 2025-21076, Center for Scientific Review; Notice of Closed Meetings](https://policyrisk.com/federal-register/2025-21076)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-21075 (as of 2026-06-08).