Damian Williams, the United States Attorney for the Southern District of New York, Catherine Hermsen, Assistant Commissioner, United States Food and Drug Administration Office of Criminal Investigations (“FDA-OIC”), Michael J. Driscoll, Assistant Director-in-Charge of the New York Field Division of the Federal Bureau of Investigation (“FBI”), and Thomas Walsh, Rockland County District Attorney, announced that GABRIEL LETIZIA, Jr., was sentenced in White Plains federal court to 60 months in prison for defrauding customers of his consumer products testing company and causing misbranded drugs to be introduced into interstate commerce. United States District Judge Kenneth M. Karas imposed today’s sentence. LETIZIA previously pled guilty before United States Magistrate Judge Paul E. Davison.
U.S. Attorney Damian Williams said: “For three decades, Gabriel Letizia defrauded AMA’s customers and jeopardized the safety of millions of consumers, all in the name of greed. Thanks to our partners at FDA-OIC, the FBI, and the Rockland County District Attorney’s Office, he has now been sentenced to prison.”
According to the allegations in the Indictment, the Superseding Information to which LETIZIA pled guilty, court filings, and statements made in court:
LETIZIA was the owner and executive director of AMA Laboratories, Inc. (“AMA”), a consumer product testing company in Rockland County, New York. LETIZIA began operating AMA in the early 1980s, and became its sole owner in approximately 2003.
AMA purported to test the safety and efficacy of cosmetics, sunscreens, and other products on specified numbers of volunteer panelists for consumer products companies. Clients of AMA used 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 clients 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 through April 2017, LETIZIA and AMA personnel operating at his 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. According to AMA employees, the majority of AMA’s tests contained fraudulent results, for two reasons. First, at LETIZIA’s instruction, AMA personnel rarely tested products on the number of panelists requested by AMA’s clients. Instead, AMA tested products on a far lower number of panelists, typically 20 or less, rather than the 50 for which the clients had paid. AMA’s fees for tests were based, in part, on the number of panelists that were to participate in the study. At LETIZIA’s direction, AMA sent its clients fraudulent test results in which AMA personnel included fictitious data for “phantom” panelists who had not actually participated in the tests.
Second, at LETIZIA’s direction, AMA personnel routinely falsified test results relating to its clients’ products, which included suppressing adverse reactions and deviating from testing protocols. From 2012 through April 2017, AMA received $46.2 million in revenue from the fraudulent reports.
In addition to his prison term, LETIZIA, 72, of New City, New York, was sentenced to three years of supervised release, restitution in the amount of $1,440,238, and forfeiture in the amount of $46,200,000.
Mr. Williams praised the outstanding investigative work of the U.S. Food and Drug Administration, Office of Criminal Investigations, the Federal Bureau of Investigation, and the Rockland County District Attorney’s Office.
