Notice2023-00791
Gabriel J. Letizia, Jr.: Final Debarment Order
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 18, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Gabriel J. Letizia, Jr. from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Letizia was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Letizia was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why he should not be debarred within the timeframe prescribed by regulation. Mr. Letizia has not responded to the notice. Mr. Letizia's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.
Full Text
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<title>Federal Register, Volume 88 Issue 11 (Wednesday, January 18, 2023)</title>
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[Federal Register Volume 88, Number 11 (Wednesday, January 18, 2023)]
[Notices]
[Pages 2935-2937]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00791]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1600]
Gabriel J. Letizia, Jr.: Final 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 (FD&C Act) permanently
debarring Gabriel J. Letizia, Jr. from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Mr. Letizia was
convicted of a felony under Federal law for conduct that relates to the
regulation of a drug product under the FD&C Act. Mr. Letizia was given
notice of the proposed permanent debarment and was given an opportunity
to request a hearing to show why he should not be debarred within the
timeframe prescribed by regulation. Mr. Letizia has not responded to
the notice. Mr. Letizia's failure to respond and request a hearing
within the prescribed timeframe constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is applicable January 18, 2023.
ADDRESSES: Submit applications for special termination of debarment to
the Dockets Management Staff, Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
at <a href="/cdn-cgi/l/email-protection#5632333437243b3338222516303237783e3e2578313920"><span class="__cf_email__" data-cfemail="a4c0c1c6c5d6c9c1cad0d7e4c2c0c58accccd78ac3cbd2">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires
[[Page 2936]]
debarment of an individual from providing services in any capacity to a
person that has an approved or pending drug product application 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 May 18, 2022, Mr. Letizia was convicted in the U.S.
District Court for the Southern District of New York, of one felony
count of conspiracy to commit wire fraud in violation of 18 U.S.C. 371,
and two misdemeanor counts of misbranding in violation of 21 U.S.C.
331(a) and 333(a)(1). 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 Superseding Information in Mr. Letizia's case, filed May 4,
2021, and from the transcript of his guilty plea hearing, filed on May
26, 2021, Mr. Letizia was the owner and executive director of AMA
Laboratories (AMA), a consumer product testing company in Rockland
County, New York. Mr. Letizia began operating AMA in the early 1980s
and became its sole owner in approximately 2003. Mr. Letizia falsely
used the title ``Dr.'' in correspondence, falsely representing to
customers that he held a Ph.D. AMA purported to test the safety and
efficacy of cosmetics, sunscreens, and other products on specified
numbers of volunteer panelists for consumer products companies. AMA's
customers would use the test results to support their claims that their
products were safe, effective, hypoallergenic, or provided a certain
sun protection factor (SPF), including after exposure to water. AMA
customers that manufactured sunscreens used the test results to comply
with FDA regulations requiring sunscreen manufacturers to have their
products tested and to maintain the test results for possible review by
the FDA.
From 1987 to April 2017, Mr. Letizia and AMA personnel operating at
Mr. Letizia's direction, defrauded AMA's customers of more than $46
million by testing products on materially lower numbers of panelists
than the numbers specified and paid for by AMA's customers. At Mr.
Letizia's direction, AMA personnel rarely tested products on the number
of panelists requested by AMA's customers and for which they had paid.
AMA's fees for tests were based, in part, on the number of panelists
that were to participate in the study. However, at Mr. Letizia's
direction AMA sent its customers fraudulent test results, via
interstate email and facsimile communications, in which AMA personnel
included fictitious data for ``phantom'' panelists who had not actually
participated in the tests. At Mr. Letizia's direction, AMA employees
had panelists who agreed to partake in studies at AMA fill out consent
forms and other paperwork as if they would be participating in all of
the studies that were being performed at AMA at that time. These
panelists were then used as ``phantom'' panelists in other studies, and
their consent forms for those studies would falsely make it appear to
those who might audit AMA's files, including FDA investigators and
AMA's customers, that the panelists had participated in studies when,
in fact, they had not. In addition, AMA customers who paid for AMA to
test their sunscreen products relied on the reliability of AMA's test
results for purposes of accurately and lawfully labeling the SPF level
of the sunscreen products those customers intended to sell. Mr. Letizia
knowingly caused AMA employees to send false reports to AMA's customers
in that testing had not been performed on the whole panel as requested
and paid for by AMA's customers. In so doing, Mr. Letizia knowingly
caused AMA's customers to market and sell to consumers in the United
States and elsewhere, sunscreen, with labels that failed to reveal
material facts in that the labels on these products stated that the SPF
level of the sunscreen was 50 with no indication on that label that the
laboratory testing of the panel paid for by AMA customers had not been
performed.
In addition, at Mr. Letizia's direction, AMA personnel routinely
falsified test results relating to AMA's customers' products, which
included suppressing reports of adverse reactions and deviating from
testing protocols. AMA personnel reported adverse reactions to
customers only in extreme cases and often offered to retest the product
and, in some cases, change the test procedure with the hope of reducing
the number of reported negative reactions. AMA personnel also falsified
data to accord with prior results from smaller ``screener'' study
results or customer expectations.
Based on this conviction, FDA sent Mr. Letizia by certified mail on
September 12, 2022, a notice 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 Mr. Letizia was
convicted, as set forth in section 306(l)(1) of the FD&C Act, of a
felony under Federal law for conduct relating to the regulation of a
drug product under the FD&C Act. The proposal also offered Mr. Letizia
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 file a timely request for a hearing would
constitute an election not to use the opportunity for a hearing and a
waiver of any contentions concerning this action. Mr. Letizia received
the proposal on September 16, 2022. He did not request a hearing within
the timeframe prescribed by regulation and has, therefore, waived his
opportunity for a hearing and 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(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Letizia 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, Mr. Letizia is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see sections 306(a)(2)(B) and (c)(2)(A)(ii) of the FD&C Act). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses in any capacity the services of Mr. Letizia during his
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 Mr. Letizia 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). In
addition, FDA will not accept or review any abbreviated new drug
application from Mr. Letizia during his period of debarment, other than
in connection with an audit under section 306 of the FD&C Act (section
306(c)(1)(B) of the FD&C Act). Note that, for purposes of sections 306
and 307 of the FD&C Act, a ``drug product'' is defined as a ``drug
subject to regulation under section 505, 512, or 802 of this Act [(21
U.S.C. 355, 360b, 382)] or under section 351 of the Public Health
Service Act [(42 U.S.C. 262)]'' (section 201(dd) of the FD&C Act (21
U.S.C. 321(dd))).
Any application by Mr. Letizia for special termination of debarment
under section 306(d)(4) of the FD&C Act) should be identified with
Docket No. FDA-2022-N-1600 and sent to the Dockets Management Staff
(see
[[Page 2937]]
ADDRESSES). The public availability of information in these submissions
is governed by 21 CFR 10.20.
Publicly available submissions will be placed in the docket and
will be viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday, 240-402-7500.
Dated: January 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00791 Filed 1-17-23; 8:45 am]
BILLING CODE 4164-01-P
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