[Federal Register Volume 88, Number 11 (Wednesday, January 18, 2023)]
[Notices]
[Pages 2935-2937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
https://www.regulations.gov.

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 [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) 
requires

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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

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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 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: 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


