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 Francis Esteban Matos for a period o...
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 Francis Esteban Matos 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. Matos was convicted of a felony under Federal law. The factual basis supporting Mr. Matos's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Matos 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 May 18, 2026 (more than 30 days after receipt of the notice), Mr. Matos had not responded. Mr. Matos'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 July 24, 2026.
ADDRESSES:
Any application by Mr. Matos 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”).
For a written/paper application submitted to the Dockets Management
( printed page 46790)
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-2026-N-1199. 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 onhttps://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” 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
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 October 14, 2025, Mr. Matos was convicted as defined in section 306(l)(1) of the FD&C Act, in the U.S. District Court for the Eastern District of Pennsylvania, when the court accepted his plea of guilty and entered judgment against him for the felony offense of conspiracy to introduce misbranded drugs into interstate commerce in violation of 18 U.S.C. 371. The underlying facts supporting the conviction are as follows:
As contained in the Information from his case, to which he pleaded guilty, Mr. Matos operated a business called Suplidora America that, among other things, obtained and distributed pharmaceutical drugs even though neither Mr. Matos nor Suplidora America had a license to obtain, hold, or dispense pharmaceutical drugs.
Beginning in or about May 2022, Mr. Matos arranged to have others purchase pharmaceutical drugs in the Dominican Republic and mail them to him and his associates. On various occasions between in or about May 2022 and in or about January 2023, law enforcement seized parcels containing pharmaceutical drugs sent from the Dominican Republic to Mr. Matos and his associates. Some of these parcels contained tablets containing sildenafil. At times, Mr. Matos received notification from law enforcement that parcels sent to him containing pharmaceutical drugs had been seized by law enforcement. Mr. Matos and his associates would then sell the pharmaceutical drugs to customers, typically convenience stores. Mr. Matos did not require his customers to provide a prescription to obtain pharmaceutical drugs from him or Suplidora America even though many of the pharmaceutical drugs dispensed by him and his associates required such a prescription. The drugs Mr. Matos introduced into interstate commerce were misbranded because (1) the drugs' labeling failed to bear adequate directions for use as required by section 502(f) of the FD&C Act (21 U.S.C. 352(f)); (2) the drugs' labeling was in a foreign language (Spanish), in violation of section 502(c) of the FD&C Act; and (3) the drugs were dispensed without the prescription of a practitioner licensed by law to administer such drugs in violation of sections 503(b), 301(a), and 303(a)(2) of the FD&C Act (21 U.S.C. 353(b), 331(a), and 333(a)(2)).
FDA sent Mr. Matos, by certified mail, on April 13, 2026, 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. Matos's felony conviction under Federal law for conspiracy to introduce misbranded drugs into interstate commerce in violation of 18 U.S.C. 371 was for conduct relating to the importation of any drug or controlled substance into the United States because Mr. Matos conspired to illegally import and introduce 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 Mr. Matos's offense and concluded that the offense warranted the imposition of a 5-year period of debarment.
The proposal informed Mr. Matos 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 a waiver of any contentions concerning this action. Mr. Matos received the proposal and notice of opportunity for a hearing on April 16, 2026. Mr. Matos 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. Francis Esteban Matos 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. Matos is debarred for a period of 5
( printed page 46791)
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. Matos during his period of debarment is a prohibited act.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.