Notice2026-07864
Kimberly Schaff Kiehl: Final Debarment Order
Primary source
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Published
April 23, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
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 Kimberly Schaff Kiehl 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 Ms. Kiehl was convicted of two felonies under federal law. The factual basis supporting Ms. Kiehl's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Ms. Kiehl 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 March 9, 2026 (30 days after receipt of the notice), Ms. Kiehl had not responded. Ms. Kiehl's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 91 Issue 78 (Thursday, April 23, 2026)</title>
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[Federal Register Volume 91, Number 78 (Thursday, April 23, 2026)]
[Notices]
[Pages 21823-21824]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07864]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-7055]
Kimberly Schaff Kiehl: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: 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 Kimberly Schaff Kiehl 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 Ms. Kiehl was convicted of two
felonies under federal law. The factual basis supporting Ms. Kiehl's
conviction, as described below, is conduct relating to the importation
into the United States of a drug or controlled substance. Ms. Kiehl 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 March
9, 2026 (30 days after receipt of the notice), Ms. Kiehl had not
responded. Ms. Kiehl's failure to respond and request a hearing
constitutes a waiver of her right to a hearing concerning this matter.
DATES: This order is applicable April 23, 2026.
ADDRESSES: Any application by Ms. Kiehl for termination of debarment
under section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) may be
submitted at any time as follows:
Electronic Submissions
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application does not include any confidential
information that you or a third party may not wish to be posted, such
as medical information, your or anyone else's Social Security number,
or confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your application,
that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All applications must include the Docket No. FDA-
2025-N-7055. Received applications will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of your application. The second copy,
which will have the claimed confidential information redacted/blacked
out, will be available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both copies to the Dockets Management
Staff. Any information marked as ``confidential'' will not be disclosed
except in accordance with 21 CFR 10.20 and other applicable disclosure
law. For more information about FDA's posting of comments to public
dockets, see 80 FR 56469, September 18, 2015, or access the information
at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852 between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Field
Enforcement, Office of Field Regulatory Operations, Office of
Inspections and Investigations, Food and Drug Administration, at 240-
402-8743, or <a href="/cdn-cgi/l/email-protection#0c68696e6d7e616962787f4c6a686d2264647f226b637a"><span class="__cf_email__" data-cfemail="f195949390839c949f8582b1979590df999982df969e87">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(D) of the FD&C Act permits debarment of an
individual from importing or offering for import any drug into the
United States if FDA finds, as required by section 306(b)(3)(C) of the
FD&C Act, that the individual has been convicted of a felony for
conduct relating to the importation into the United States of any drug
or controlled substance.
On July 3, 2025, Ms. Kiehl was convicted as defined in section
306(l)(1) of the FD&C Act, in the U.S. District Court for the Middle
District of Florida, Tampa Division, when the court accepted her plea
of guilty and entered judgment against her for the felony offenses of
mail fraud in violation of 18 U.S.C. 1341 and causing counterfeit drugs
to be made, sold, or held for sale in violation of 21 U.S.C. 331(i)(3)
and 333(a)(2) (sections 301(i)(3) and 303(a)(2) of the FD&C Act). The
underlying facts supporting the conviction are as follows:
As contained in the Superseding Information and in the Plea
Agreement from her case, Ms. Kiehl was the registered agent and
authorized member for Focus Beauty, LLC (Focus Beauty) and she operated
Focus Beauty's website to market and offer for sale drugs and other
products. Between January 2020 and September 2021, several packages
destined for Ms. Kiehl's address were seized by the Department of
Homeland Security (DHS). Additionally, Ms. Kiehl received notices from
the FDA and/or Customs and Border Protection about the violative nature
of the products she was importing from China and other foreign
countries.
On or about April 1, 2020, a DHL package shipped from China and
destined for Ms. Kiehl's residence was intercepted. The package was
addressed to the fake name of ``Cathy Ryan'' and the shipping documents
identified the contents as engraving pen kits and glass bottles.
Special Agents from DHS Homeland Security Investigations (HSI)
conducted a border search of the package and determined that it
contained 15 boxes marked ``Restylane Injectable 1 x 1 ML;'' eight
boxes
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marked ``Galderma Restylane Injectable Lyft Lidocaine 1 ML, The Perlane
Collection, Injectable Gel with Lidocaine;'' and, seven boxes marked
``Galderma Restylane Injectable Lidocaine 1 ML, Injectable Gel with
Lidocaine.''
Following this seizure, and others, on September 2, 2021, a Special
Agent from FDA's Office of Criminal Investigations acting in an
undercover capacity purchased items through the website
<a href="http://www.focusisbeauty.com">www.focusisbeauty.com</a>. The agent ordered, (1) Intense Repair Serum,
which bore the image of Botox, and was found in the section of the
website titled: ``Botox, Anesthetics, & Diluents;'' and, (2) Intense
Repair Serum, which bore the image of a product titled Daewoong
Boulinum Toxin Type A Nabota and was found in the section of the
website titled: ``Botox, Anesthetics, & Diluents.''
On or about September 17, 2021, agents retrieved the box shipped by
Ms. Kiehl. The box contained five products marked as ``Botox'' with
writing in the Turkish language. The products were determined to be
counterfeit versions of the Botox product manufactured for and only
distributed in Turkey. Botox is the brand name, owned by AbbVie Inc.
(AbbVie), of a drug derived from botulinum toxin type A. Botulinum
toxin type A is a highly potent toxin which can cause the disease
botulism when present in human beings in a sufficient amount. The FDA
has approved a biological products license for Botox and a supplement
to the license application for the treatment of what is commonly
referred to as wrinkles. Both FDA approved licenses for Botox products
limits them to use pursuant to a prescription from a licensed
practitioner. While Botox products may be purchased through
intermediary sources, all purchases are shipped from an AbbVie
warehouse facility in Houston, Texas. This occurs to meet the strict
temperature controls required for botulinum toxin-containing products.
On October 14, 2021, a search warrant was executed at Ms. Kiehl's
residence. During the execution of the warrant, agents discovered
hundreds of counterfeit products violative of the FD&C Act that were
imported into the United States from foreign countries. These products
were discovered throughout the residence, including in a freezer among
frozen food items, in a pantry among dry goods, and hidden behind a
false wall. Ms. Kiehl was present during the execution of the search
warrant and agreed to speak with agents. Ms. Kiehl acknowledged
ordering and receiving drugs and other products from foreign countries.
She admitted to using fake recipient names on packages shipped to her
from China, in an effort to avoid the seizure of the products, which
were violative products. When using fake names did not stop the
packages from being seized, Ms. Kiehl began using her son's address to
receive the products, which were violative products. Ms. Kiehl
acknowledged selling unapproved and counterfeit drugs and other
products on the website, <a href="http://www.focusisbeauty.com">www.focusisbeauty.com</a>, and shipping those
products in interstate commerce to customers.
Shipping records obtained by DHS/HSI revealed approximately 176
foreign based packages were imported by Ms. Kiehl and shipped to her
residence between January 9, 2019, and September 19, 2021.
Additionally, between approximately July 2017, and October 2021, Ms.
Kiehl received approximately $341,218 for the sale of misbranded and
counterfeit drugs and other products that lacked the required FDA
approval.
FDA sent Ms. Kiehl, by certified mail, on February 3, 2026, a
notice proposing to debar her for a 10-year period from importing or
offering for import any drug into the United States. The proposal was
based on a finding under section 306(b)(3)(C) of the FD&C Act that Ms.
Kiehl's felony conviction under Federal law for mail fraud in violation
of 18 U.S.C. 1341 and causing counterfeit drugs to be made, sold, or
held for sale in violation of 21 U.S.C. 331(i)(3) and 333(a)(2) was for
conduct relating to the importation of any drug or controlled substance
into the United States because she illegally imported and introduced
misbranded prescription drug products into interstate commerce.
In proposing a debarment period, FDA weighed the considerations set
forth in section 306(c)(3) of the FD&C Act that the Agency considered
applicable to Ms. Kiehl's offense and concluded that the offense
warranted the imposition of a 10-year period of debarment.
The proposal informed Ms. Kiehl of the proposed debarment and
offered her an opportunity to request a hearing, providing her 30 days
from the date of receipt of the letter in which to file the request,
and advised her that failure to request a hearing constituted a waiver
of the opportunity for a hearing and of any contentions concerning this
action. Ms. Kiehl received the proposal and notice of opportunity for a
hearing on February 7, 2026. Ms. Kiehl failed to request a hearing
within the timeframe prescribed by regulation and has, therefore,
waived her opportunity for a hearing and waived any contentions
concerning her debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Division of Field Enforcement Director, Office of
Inspections and Investigations, under section 306(b)(3)(C) of the FD&C
Act, under authority delegated to the Director, Division of
Enforcement, finds that Ms. Kimberly Schaff Kiehl has been convicted of
a felony under Federal law for conduct relating to the importation into
the United States of any drug or controlled substance. FDA finds that
the offense should be accorded a debarment period of 10 years as
provided by section 306(c)(2)(A)(iii) of the FD&C Act.
As a result of the foregoing finding, Ms. Kiehl is debarred for a
period of 10 years from importing or offering for import any drug into
the United States, effective (see DATES). Pursuant to section 301(cc)
of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for
import into the United States of any drug by, with the assistance of,
or at the direction of Ms. Kiehl is a prohibited act.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-07864 Filed 4-22-26; 8:45 am]
BILLING CODE 4164-01-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.