[Federal Register Volume 89, Number 115 (Thursday, June 13, 2024)]
[Notices]
[Pages 50344-50346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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

     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. An application 
submitted electronically, including attachments, to https://www.regulations.gov 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 https://www.regulations.gov.
     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

     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.
     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 https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket, go to https://www.regulations.gov 
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 [email protected].

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 Alibaba.com, 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 
Alibaba.com 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