[Federal Register Volume 90, Number 48 (Thursday, March 13, 2025)]
[Notices]
[Pages 11984-11985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-04030]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3779]
Jonathan Corbett Cosie: 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 (FD&C Act) debarring
Jonathan Corbett Cosie 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 Mr. Cosie was convicted of two felony counts
under Federal law for introducing misbranded drugs into interstate
commerce with the intent to defraud and mislead. The factual basis
supporting Mr. Cosie's conviction, as described below, is conduct
relating to the importation into the United States of a drug or
controlled substance. Mr. Cosie 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 January 6, 2025 (30 days after receipt
of the notice), Mr. Cosie had not responded. Mr. Cosie's failure to
respond and request a hearing constitutes a waiver of his right to a
hearing concerning this matter.
DATES: This order is applicable March 13, 2025.
ADDRESSES: Any application by Mr. Cosie 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
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-
2024-N-3779. 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, 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, 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 30, 2024, Mr. Cosie 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-Jacksonville Division when the court accepted his
plea of guilty and entered judgment against him for two counts of
introducing misbranded drugs into interstate commerce with the intent
to
[[Page 11985]]
defraud and mislead in violation of sections 301(a) and 303(a)(2) of
the FD&C Act (21 U.S.C. 331(a) and 21 U.S.C. 333(a)(2)). The underlying
facts supporting the conviction are as follows: As contained in the
Information and Plea Agreement from Mr. Cosie's case, from
approximately 2016 through 2020, he owned and operated several
businesses including HCGRK LLC a/k/a Health Conscious Group Rx LLC
(HCGRX). According to its website, HCGRX advertised itself as a
national distributor of competition quality weight loss, body building
and sports supplements. The website also advertised products for the
treatment of erectile dysfunction, which were described as generic
versions of the prescription drugs VIAGRA (sildenafil) and CIALIS
(tadalafil). Among other supplements, Mr. Cosie sold a number of
products containing Human Chorionic Gonadotropin (``HCG''). HCG is a
hormone produced by the placenta during pregnancy. FDA has approved
several prescription drugs containing HCG for the treatment of female
infertility and for other medical conditions. FDA has not approved any
HCG-containing products for weight loss, nor for any purpose without a
prescription. Mr. Cosie falsely claimed on his website that his company
was cooperating with international pharmacies to ship orders out. In
fact, Mr. Cosie obtained unapproved prescription drugs containing HCG
from foreign manufacturers and other sources. Then, after importing
those drugs, Mr. Cosie would apply to the vials his own counterfeit
labels which he created and printed and which contained false and
misleading information. Mr. Cosie then knowingly and intentionally sold
the drugs to consumers without a prescription or the supervision of a
licensed medical practitioner. From October 28, 2017, through December
24, 2020, Mr. Cosie received approximately $626,202.77 in proceeds from
distribution of misbranded prescription drugs, and $20,000 for the sale
of HCGRX.
FDA sent Mr. Cosie, by certified mail, on December 3, 2024, a
notice proposing to debar him 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 Mr.
Cosie's felony convictions under Federal law for introducing misbranded
drugs into interstate commerce with the intent to defraud and mislead
in violation of sections 301(a) and 303(a)(2) of the FD&C Act, was for
conduct relating to the importation of any drug or controlled substance
into the United States because Mr. Cosie 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 it
considered applicable to Mr. Cosie's offense and concluded that the
offense warranted the imposition of a 10-year period of debarment.
The proposal informed Mr. Cosie 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. Cosie received the proposal and notice of opportunity for a
hearing on December 7, 2024. Mr. Cosie 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 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 Mr. Jonathan Corbett Cosie has been convicted
of felonies under Federal law for conduct relating to the importation
into the United States of any drug or controlled substance. FDA finds
that the offenses 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, Mr. Cosie 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, the importing or offering for import into the United
States of any drug by, with the assistance of, or at the direction of
Mr. Cosie is a prohibited act.
Dated: March 7, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-04030 Filed 3-12-25; 8:45 am]
BILLING CODE 4164-01-P