[Federal Register Volume 76, Number 103 (Friday, May 27, 2011)]
[Notices]
[Pages 30947-30948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13198]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0629]


Stephen Lee Seldon: 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 (the FD&C Act) 
permanently debarring Stephen Lee Seldon, M.D. from providing services 
in any capacity to a person that has an approved or pending drug 
product application. We base this order on a finding that Dr. Seldon 
was convicted of felonies under Federal law for conduct relating to the 
regulation of a drug product under the FD&C Act. Dr. Seldon was given 
notice of the proposed permanent debarment and an opportunity to 
request a hearing within the timeframe prescribed by regulation. Dr. 
Seldon failed to respond. Dr. Seldon's failure to respond constitutes a 
waiver of his right to a hearing concerning this action.

DATES: This order is effective May 27, 2011.

ADDRESSES: Submit applications for special termination of debarment to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Office of Regulatory 
Affairs (HFC-230), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) 
requires debarment of an individual if FDA finds that the individual 
has been convicted of a felony under Federal law for conduct relating 
to the regulation of any drug product under the FD&C Act.
    On March 27, 2009, the U.S. District Court for the District of 
Nevada entered judgment against Dr. Seldon for mail fraud in violation 
of 18 U.S.C. 1341, aiding and abetting, in violation of 18 U.S.C. 2, 
and misbranded a drug while held for sale in violation of 21 U.S.C. 
331(k) and 333(a)(2).
    FDA's finding that debarment is appropriate is based on the felony 
convictions referenced herein for conduct relating to the regulation of 
a drug product. The factual basis for those convictions is as follows: 
Dr. Seldon was a physician licensed by the State of Nevada to practice 
medicine. He owned and operated a practice called A New You Medical 
Aesthetics (A New You) in Las Vegas, Nevada. From on or about October 
15, 2003, until on or about September 16, 2005, in the State and 
Federal District of Nevada, and elsewhere Dr. Seldon and his wife, 
aided and abetted by each other, devised a scheme and artifice to 
fraudulently obtain money from patients by substituting cheaper, non-
FDA approved product marketed by Toxin Research International, Inc. 
(TRI-toxin) in treatments provided to patients at A New You, while 
falsely and fraudulently representing to the patients that they were 
receiving injections of the more expensive, FDA-approved BOTOX product 
manufactured by Allergan, Inc.
    As part of the scheme, Dr. Seldon ordered and caused to be ordered 
38 vials of TRI-toxin between October 2003 and September 2004 while at 
the same time his practice stopped purchasing the approved BOTOX.
    As part of his scheme, Dr. Seldon spoke at a seminar in Scottsdale, 
Arizona, in September 2004, sponsored by Toxin Research International, 
Inc. and claimed that he used it on patients in his practice, 
notwithstanding a warning on each vial that TRI-toxin was for research 
purposes only and not for human use.
    Dr. Seldon defrauded his patients by misleading them to believe 
that they were receiving the FDA-approved drug BOTOX, when in fact, the 
patients were receiving TRI-toxin, which was not FDA-approved, thereby 
exposing the patients to severe health risk. Dr. Seldon also caused 
advertisements to be placed in local magazines offering BOTOX 
injections, creating the false impression that he was using the FDA-
approved BOTOX. Dr. Seldon additionally caused patients to sign consent 
forms that fraudulently represented that he would be injecting approved 
BOTOX when he knew he would be injecting the patients with TRI-toxin.
    As a result of his convictions, on February 22, 2011, FDA sent Dr. 
Seldon a notice by certified mail proposing to permanently debar him 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal was based on 
a finding, under section 306(a)(2)(B) of the FD&C Act, that Dr. Seldon 
was convicted of felonies under Federal law for conduct relating to the 
regulation of a drug product under the FD&C Act. The proposal also 
offered Dr. Seldon 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. The proposal was received on February 25, 2011. 
Dr. Seldon failed to respond within the timeframe prescribed by 
regulation and has, therefore, waived his opportunity for a hearing and 
has waived any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(a)(2)(B) of the FD&C Act, under 
authority delegated to the Director (Staff Manual Guide 1410.35), finds 
that Stephen Lee Seldon has been convicted of a felony under Federal 
law for conduct relating to the regulation of a drug product under the 
FD&C Act.
    As a result of the foregoing finding, Dr. Seldon is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application under sections 505, 512, 
or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 
351 of the Public Health Service Act (42 U.S.C. 262), effective (see 
DATES) (see sections 306(c)(1)(B), (c)(2)(A)(ii), and 201(dd) of the 
FD&C Act (21 U.S.C. 321(dd))). Any person with an approved or pending 
drug product application who knowingly employs or retains as a 
consultant or contractor, or otherwise uses the services of Dr. Seldon, 
in any capacity during Dr. Seldon's debarment, will be subject to civil 
money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 
335b(a)(6))). If Dr. Seldon provides services in any capacity to a 
person with an approved or pending drug product application during his 
period of debarment he will be subject to civil money penalties 
(section 307(a)(7) of the FD&C Act (21 U.S.C. 335b(a)(7)). In addition, 
FDA will not accept or review any abbreviated new drug applications 
submitted by or with the assistance of Dr. Seldon during his period of 
debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Seldon for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2010-N-0629 and sent to the Division of Dockets 
Management (see ADDRESSES). All such submissions are to be filed in 
four copies. The public availability of information in these

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submissions is governed by 21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 16, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-13198 Filed 5-26-11; 8:45 am]
BILLING CODE 4160-01-P