Notice2024-12974
Richard B. Smith III: Final Debarment Order
Primary source
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Published
June 13, 2024
Effective
June 13, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Richard B. Smith III 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 Mr. Smith was convicted of two felony counts under Federal law, only one of which serves as the basis of this debarment: receiving misbranded drugs in interstate commerce and delivering for pay. The factual basis supporting Mr. Smith's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Smith 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 November 29, 2023 (30 days after receipt of the notice), Mr. Smith had not responded. Mr. Smith's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 89 Issue 115 (Thursday, June 13, 2024)</title>
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[Federal Register Volume 89, Number 115 (Thursday, June 13, 2024)]
[Notices]
[Pages 50344-50346]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-12974]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3081]
Richard B. Smith III: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring
Richard B. Smith III 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 Mr. Smith was convicted of two felony counts under Federal
law, only one of which serves as the basis of this debarment: receiving
misbranded drugs in interstate commerce and delivering for pay. The
factual basis supporting Mr. Smith's conviction, as described below, is
conduct relating to the importation into the United States of a drug or
controlled substance. Mr. Smith 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 November 29, 2023 (30 days after
receipt of the notice), Mr. Smith had not responded. Mr. Smith's
failure to respond and request a hearing constitutes a waiver of his
right to a hearing concerning this matter.
[[Page 50345]]
DATES: This order is effective June 13, 2024.
ADDRESSES: Any application by Mr. Smith for termination of debarment
under section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) may be
submitted 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-
2023-N-3081. 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. Publicly
available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Compliance
and Enforcement, Office of Policy, Compliance, and Enforcement, Office
of Regulatory Affairs, Food and Drug Administration, at 240-402-8743,
or <a href="/cdn-cgi/l/email-protection#2c48494e4d5e414942585f6c4a484d0244445f024b435a"><span class="__cf_email__" data-cfemail="ed89888f8c9f808883999ead8b898cc385859ec38a829b">[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 13, 2023, Mr. Smith was convicted, as defined in section
306(l)(1) of the FD&C Act, in the U.S. District Court for the Western
District of Missouri-Kansas City Division, when the court entered
judgment against him for two offenses, only one of which served as the
basis for Mr. Smith's debarment, receiving misbranded drugs in
interstate commerce and delivering for pay in violation of sections
301(c) and 303(a)(2) of the FD&C Act (21 U.S.C. 331(c) and 333(a)(2)).
FDA's finding that debarment is appropriate is based on the felony
conviction referenced herein. The factual basis for this conviction is
as follows:
As contained in the Information, filed on July 27, 2022, and in the
Plea Agreement from Mr. Smith's case, filed on July 27, 2022, Mr. Smith
operated Tap and Blade, a medical spa, located in Kansas City, MO. Tap
and Blade was engaged in medical practices such as injections of
prescription drugs to enhance facial features, and aesthetics such as
microblading and permanent makeup tattooing, among other services.
FDA's Office of Criminal Investigations (OCI) began investigating Tap
and Blade in December 2020 based on information that multiple patients
of Tap and Blade suffered injuries after receiving treatment. On April
7, 2021, OCI agents executed a search warrant at Tap and Blade and
interviewed Mr. Smith. During that interview, he admitted that he
purchased BOTOX from the website <a href="http://Alibaba.com">Alibaba.com</a>, which is based in China.
Mr. Smith told agents that he had the products mailed to his mother's
home and then later had them delivered to his business in Kansas City,
MO. The products were shipped from outside Missouri. Mr. Smith admitted
during his interview that he knew the products were illegal because
``they require a prescription or have to come from Allergan
themselves.'' Mr. Smith admitted that he purchased the products from
<a href="http://Alibaba.com">Alibaba.com</a> because those products were cheaper, allowing him to lower
his cost compared to his competitors which also gained him more
customers. Mr. Smith admitted to agents that the products he
administered to his customers were ``all Chinese,'' and that no legal
prescriptions were obtained for these products. In his plea agreement,
Mr. Smith admitted that he purchased foreign, unapproved, and
misbranded BOTOX on or about January 1, 2018, through on or about April
30, 2021, and that all the BOTOX his patients received were foreign and
unapproved. The foreign and unapproved BOTOX was misbranded because it
did not bear adequate directions for use. Mr. Smith also admitted in
his plea agreement that he never told his patients that he was using
illegal prescription drugs. Mr. Smith also stated that because he knew
what he was doing was not right that he only treated individuals that
wouldn't turn him in. Mr. Smith also admitted in his plea agreement
that he never had a doctor or medical director associated with Tap and
Blade and that he knew his patients should have seen a doctor
[[Page 50346]]
prior to being treated with prescription drugs.
As a result of this conviction, FDA sent Mr. Smith, by certified
mail, on October 25, 2023, a notice proposing to debar him for a 5-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 Mr. Smith's felony conviction under Federal law
for Receiving Misbranded Drugs in Interstate Commerce and Delivering
for Pay in violation of 21 U.S.C. 331(c) and 333(a)(2), was for conduct
relating to the importation into the United States of any drug or
controlled substance because he imported misbranded drugs and
introduced those misbranded drugs into interstate.
In proposing a debarment period, FDA weighed the considerations set
forth in section 306(c)(3) of the FD&C Act that it considered
applicable to Mr. Smith's offense and concluded that the offense
warranted the imposition of a 5-year period of debarment.
The proposal informed Mr. Smith of the proposed debarment and
offered him an opportunity to request a hearing, providing him 30 days
from the date of receipt of the letter in which to file the request,
and advised him that failure to request a hearing constituted a waiver
of the opportunity for a hearing and of any contentions concerning this
action. Mr. Smith received the proposal and notice of opportunity for a
hearing at his residence on October 30, 2023. Mr. Smith failed to
request a hearing within the timeframe prescribed by regulation and
has, therefore, waived his opportunity for a hearing and waived any
contentions concerning his debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Richard
B. Smith III 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 5 years as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
As a result of the foregoing finding, Mr. Smith is debarred for a
period of 5 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, the importing or offering for import into the United
States of any drug by, with the assistance of, or at the direction of
Mr. Smith is a prohibited act.
Dated: June 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12974 Filed 6-12-24; 8:45 am]
BILLING CODE 4164-01-P
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