Julia Fees: Final Debarment Order

CourtFood And Drug Administration,Health And Human Services Department
Citation86 FR 71271
Record Number2021-27056
Publication Date15 December 2021
Federal Register, Volume 86 Issue 238 (Wednesday, December 15, 2021)
[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
                [Notices]
                [Page 71271]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2021-27056]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Food and Drug Administration
                [Docket No. FDA-2021-N-0505]
                Julia Fees: 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 (FD&C Act) debarring
                Julia Fees 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 Ms. Fees was convicted of one felony count under Federal
                law for conspiracy to commit offenses against the United States. The
                factual basis supporting Ms. Fees' conviction, as described below, is
                conduct relating to the importation into the United States of a drug or
                controlled substance. Ms. Fees was given notice of the proposed
                debarment and was given an opportunity to request a hearing to show why
                she should not be debarred. As of September 12, 2021 (30 days after
                receipt of the notice), Ms. Fees had not responded. Ms. Fees' failure
                to respond and request a hearing constitutes a waiver of her right to a
                hearing concerning this matter.
                DATES: This order is applicable December 15, 2021.
                ADDRESSES: Submit applications for termination of debarment to the
                Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
                Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at
                https://www.regulations.gov.
                FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
                Enforcement (ELEM-4029), Office of Strategic Planning and Operational
                Policy, Office of Regulatory Affairs, Food and Drug Administration,
                12420 Parklawn Dr., Rockville, MD 20857, 240-402-8743, or at
                [email protected].
                SUPPLEMENTARY INFORMATION:
                I. Background
                 Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D))
                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 May 5, 2021, Ms. Fees was convicted, as defined in section
                306(l)(1) of FD&C Act, in the U.S. District Court for the Western
                District of Pennsylvania, when the court entered judgment against her
                for the offense of conspiracy to commit offenses against the United
                States, in violation of 18 U.S.C. 2 and 371. FDA's finding that
                debarment is appropriate is based on the felony conviction referenced
                herein.
                 The factual basis for this conviction is as follows: As contained
                in the indictment in Ms. Fees' case, filed August 22, 2017, to which
                she plead guilty, from on or about April 2015 and continuing until May
                2017, Ms. Fees was involved in the operation of a website,
                www.etizy.com, through which she sold and distributed a drug known as
                etizolam to consumers throughout the United States. Etizolam is a drug
                known as thienodiazepine, which is chemically similar to
                benzodiazepines and carries risks of dependency, toxicity, and the
                possibility of fatal overdose. Etizolam is not FDA-approved in the
                United States. Ms. Fees and her co-conspirator illegally bought
                etizolam from an overseas supplier in India, which she then arranged to
                have smuggled into the United States through the use of multiple post
                office boxes controlled by her and her co-conspirator. To avoid Federal
                regulators, she used false and misleading labeling and generally
                misrepresented the nature of the products sold on the website she
                operated. Ms. Fees reshipped the misbranded etizolam to customers
                located in the United States.
                 As a result of this conviction, FDA sent Ms. Fees, by certified
                mail, on August 3, 2021, a notice proposing to debar her 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 Ms. Fees' felony conviction under Federal law for
                conspiracy to commit offenses against the United States, in violation
                of 18 U.S.C. 371, was for conduct relating to the importation into the
                United States of any drug or controlled substance because she illegally
                imported, relabeled, and then introduced unapproved etizolam 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 Ms. Fees' offense and concluded that the
                offense warranted the imposition of a 5-year period of debarment.
                 The proposal informed Ms. Fees of the proposed debarment and
                offered her an opportunity to request a hearing, providing her 30 days
                from the date of receipt of the letter in which to file the request,
                and advised her that failure to request a hearing constituted a waiver
                of the opportunity for a hearing and of any contentions concerning this
                action. Ms. Fees received the proposal and notice of opportunity for a
                hearing on August 13, 2021. Ms. Fees failed to request a hearing within
                the timeframe prescribed by regulation and has, therefore, waived her
                opportunity for a hearing and waived any contentions concerning her
                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 Ms. Julia
                Fees 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, Ms. Fees 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 or controlled substance by,
                with the assistance of, or at the direction of Ms. Fees is a prohibited
                act.
                 Any application by Ms. Fees for termination of debarment under
                section 306(d)(1) of the FD&C Act should be identified with Docket No.
                FDA-2021-N-0505 and sent to the Dockets Management Staff (see
                ADDRESSES). The public availability of information in these submissions
                is governed by 21 CFR 10.20(j).
                 Publicly available submissions will be placed in the docket and
                will be viewable at https://www.regulations.gov or at the Dockets
                Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
                through Friday, 240-402-7500.
                 Dated: December 9, 2021.
                Lauren K. Roth,
                Associate Commissioner for Policy.
                [FR Doc. 2021-27056 Filed 12-14-21; 8:45 am]
                BILLING CODE 4164-01-P
                

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