2024-18268. Ryan Stabile: Final Debarment Order

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Department of Health and Human Services

Food and Drug Administration

1. [Docket No. FDA-2024-N-1090]

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 Ryan Stabile for a period of 15 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Stabile was convicted of three felony counts under Federal law: one count of conspiracy and two counts of introduction of misbranded drugs with intent to defraud/mislead. The factual basis supporting Mr. Stabile's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Stabile 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 June 7, 2024 (30 days after receipt of the notice), Mr. Stabile had not responded. Mr. Stabile'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 August 15, 2024.

ADDRESSES:

Any application by Mr. Stabile 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 ( print page 66414) 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-1090. 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. 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 Compliance and Enforcement, Office of Policy, Compliance, and Enforcement, Office of Regulatory Affairs, Food and Drug Administration, 240-402-8743, or [e-mail].

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 February 14, 2024, Mr. Stabile was convicted as defined in section 306(l)(1) of the FD&C Act in the U.S. District Court for the District of Massachusetts when the court accepted his plea of guilty and entered judgment against him for the offenses of conspiracy in violation of 18 U.S.C. 371, and two counts of introduction of misbranded drugs with intent to defraud/mislead in violation of 21 U.S.C 331(a) and 333(a)(2) (sections 301(a) and 303(a)(2) of the FD&C Act). The underlying facts supporting the conviction are as follows: As contained in the indictment and plea agreement, Mr. Stabile owned the companies Ultra Vulgar Media, LLC and Supplements for Work (S4W). S4W sold nootropics, a class of drugs and supplements claiming to enhance mood and cognitive functioning. Tianeptine, when sold as a mood enhancer or as a nootropic, or when otherwise intended to treat or mitigate a disease or to affect the structure or any function of the human body, is a drug within the meaning of section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)), and a prescription drug within the meaning of section 503(b)(1) of the FD&C Act (21 U.S.C. 353(b)(1)). A drug is misbranded under section 503(b)(1) of the FD&C Act if it is a prescription drug dispensed without the prescription of a practitioner licensed by law to administer such drugs. A drug is also misbranded under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) if its labeling does not bear adequate directions for use.

Mr. Stabile and S4W operated several websites where Mr. Stabile knowingly sold various forms of tianeptine, which were not approved by the FDA. Although Mr. Stabile's websites displayed statements that the tianeptine being sold was for research purposes only, and not intended for human consumption, Mr. Stabile sold it to customers for those customers' personal use. Mr. Stabile sold tianeptine without requiring the prescription of a practitioner licensed by law to administer prescription drugs. In addition, the tianeptine Mr. Stabile sold was not labeled with adequate directions for use. Mr. Stabile and his coconspirators smuggled the tianeptine into the United States from a supplier in China and had the supplier send shipments to Mr. Stabile or his coconspirators at several post office boxes Mr. Stabile controlled. Mr. Stabile and his coconspirators gave his supplier in China instructions on steps they could take to mislabel packages of tianeptine in order to evade U.S. Customs and Border Protection (CBP) detection. Through Mr. Stabile's illegal smuggling and distribution of tianeptine, he earned at least $1,833,922.13.

Beginning in December 2017, some of the packages of tianeptine Mr. Stabile and his coconspirators imported were intercepted and seized by CBP. In an effort to have CBP release the packages, Mr. Stabile and his coconspirators filed a petition to have a package of tianeptine released, which falsely represented that the package was mislabeled and that the tianeptine was for research and development only.

FDA sent Mr. Stabile, by certified mail, on May 3, 2024, a notice proposing to debar him for a 15-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. Stabile's felony convictions under Federal law for conspiracy in violation of 18 U.S.C. 371, and two counts of introduction of misbranded drugs with intent to defraud/mislead in violation of sections 301(a) and 303(a)(2) of the FD&C Act, were for conduct relating to the importation of any drug or controlled substance into the United States because Mr. Stabile illegally imported tianeptine from China and then distributed tianeptine in ( print page 66415) 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. Stabile's offense and concluded that the offense warranted the imposition of a 15-year period of debarment.

The proposal informed Mr. Stabile 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. Stabile received the proposal and notice of opportunity for a hearing on May 8, 2024. Mr. Stabile 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 Mr. Ryan Stabile 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 15 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act.

As a result of the foregoing finding, Mr. Stabile is debarred for a period of 15 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. Stabile is a prohibited act.

Dated: August 12, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.