Andrew Jonathan Morgan: Final Debarment Order

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AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: 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 Andrew Jonathan Morgan 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. Morgan was convicted of a felony under federal law. The factual basis supporting Mr. Morgan's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Morgan 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 April 29, 2026 (30 days after receipt of the notice), Mr. Morgan had not responded. Mr. Morgan'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 June 17, 2026. ADDRESSES: Any application by Mr. Morgan 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 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-1123. 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. ( printed page 36604) On October 2, 2025, Mr. Morgan 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 Pennsylvania, when the court accepted his plea of guilty and entered judgment against him for the felony offense of misbranding drugs in interstate commerce with intent to defraud in violation of 21 U.S.C. 331(k) and 333(a)(2) (sections 301(k) and 303(a)(2) of the FD&C Act). The underlying facts supporting the conviction are as follows: As contained in the Indictment from Mr. Morgan's case, to which he pled guilty in relevant part, Mr. Morgan sold what he purported to be “Prop Xanax” pills to the general public through the website he operated, corneliusrxprops.com, and several associated websites. However, despite labeling these pills as “prop” in an attempt to claim that these were not drugs subject to regulation by FDA, Mr. Morgan knew that the pills he sold would be consumed by his customers. Also, although Mr. Morgan purported to sell “Xanax,” some of the customers who purchased the drugs through his websites actually received bromazolam. Mr. Morgan obtained the bromazolam he sold in interstate commerce, including by importing it from China. The bromazolam was misbranded because it was manufactured, prepared, and processed in a facility not registered with the Secretary of Health and Human Services, was disbursed without adequate directions for use, and had labeling that was misleading. FDA sent Mr. Morgan, by certified mail, on March 18, 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. Morgan's felony conviction under federal law for misbranding drugs in interstate commerce with intent to defraud in violation of 21 U.S.C. 331(k) and 333(a)(2) was for conduct relating to the importation of any drug or controlled substance into the United States because Mr. Morgan imported and introduced misbranded drugs in interstate commerce with intent to defraud. 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. Morgan's offense and concluded that the offense warranted the imposition of a 5-year period of debarment. The proposal informed Mr. Morgan 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. Morgan received the proposal and notice of opportunity for a hearing on March 30, 2026. Mr. Morgan 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. Andrew Jonathan Morgan 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. Morgan 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 (21 U.S.C. 331(cc)), the importing or offering for import into the United States of any drug by, with the assistance of, or at the direction of Mr. Morgan during his period of debarment is a prohibited act. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.