89 FR 115 pgs. 50344-50346 - Richard B. Smith III: Final Debarment Order
Type: NOTICEVolume: 89Number: 115Pages: 50344 - 50346
Pages: 50344, 50345, 50346Docket number: [Docket No. FDA-2023-N-3081]
FR document: [FR Doc. 2024-12974 Filed 6-12-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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 debarments@fda.hhs.gov.
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:
[top] 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
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]
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