FOR IMMEDIATE RELEASE
Petition challenges decades-long misuse of Psychemedics Corporation’s unvalidated drug testing on law enforcement officers and applicants, exposing regulatory gaps, racial disparities, and due-process violations.
New York, NY — October 24, 2025 — New York Civil-rights attorney Eric Sanders of The Sanders Firm, P.C. announced the filing of a landmark Food and Drug Administration (FDA) Citizen Petition by former New York City Police Officer Frankie F. Palaguachi, challenging the unauthorized use of hair testing for drugs of abuse by law enforcement agencies and public employers.
The petition, filed pursuant to 21 C.F.R. § 10.30, calls on the United States Food and Drug Administration (FDA) to take regulatory and enforcement action against the decades-long misuse of an immunoassay device (510(k) K111929) manufactured by Psychemedics Corporation. Although cleared under 21 C.F.R. § 862.3870 for serum, plasma, saliva, and urine, the device has never been cleared or approved for use on hair — a fact long obscured by employers’ reliance on the company’s marketing and institutional practice rather than regulatory authorization or scientific validation.
Decades of Unauthorized Use
For nearly three decades, the New York City Police Department has used Psychemedics’ hair testing as a determinative employment tool in recruitment, disciplinary, and retention decisions. From approximately 1996 to 2012, the Department employed Psychemedics’ Radioimmunoassay of Hair (RIAH) testing. Beginning in 2012, it transitioned to Enzyme Immunoassay (EIA) testing under the same 510(k) clearance, despite the fact that the FDA’s classification explicitly excludes hair matrices.
This unregulated expansion has resulted in thousands of applicants and officers being subjected to an unvalidated testing regime that cannot reliably distinguish ingestion from environmental contamination, lacks independent scientific consensus, and fails to comply with federal employment testing standards.
“The FDA never cleared this device for hair testing. What’s been happening for almost thirty years is the institutionalization of an unvalidated methodology, weaponized in employment decisions, disproportionately harming Black and Latino officers and applicants,” said Eric Sanders.
Frankie Palaguachi: A Case That Exposes the System
EEOC Charge — April 18, 2025
Palaguachi filed an EEOC Charge of Discrimination against the City of New York and Psychemedics Corporation, challenging the City’s reliance on Psychemedics’ hair immunoassay methodology in employment actions. As of the filing of this Citizen Petition, neither respondent has submitted a position statement.Motion to Strike & Dismiss — August 26, 2025
Palaguachi moved to (i) strike the testimony of Dr. Ryan B. Paulsen (Psychemedics Laboratory Director) and Sergeant Danny Tse, (ii) preclude the anticipated testimony of Deputy Chief Surgeon/MRO Dr. Joseph J. Ciuffo, and (iii) exclude Exhibits 1–4 (collection questionnaire; Paulsen CV; “positive” EIA result; MRO documents), and to dismiss the charges. The motion argued that Psychemedics’ EIA hair methodology is inadmissible under Frye, unvalidated under UGESP, and that 510(k) clearance does not establish either scientific or employment validation.Reply in Further Support — August 30, 2025
The Reply emphasized:
a. The absence of SAMHSA hair-testing standards or independent professional endorsement;
b. The lack of UGESP-compliant validation or disparate-impact analysis by the employer;
c. Vendor-employee conflict and lack of independence in Dr. Paulsen’s testimony;
d. The direct applicability of Jones v. City of Boston and the Massachusetts Civil Service Commission decision rejecting Psychemedics’ hair immunoassay as proof of ingestion; and
e. The persistent conflation of 510(k) “substantial equivalence” with scientific or UGESP validation.Motion Denied — September 2, 2025
The Department denied Palaguachi’s Motion to Strike & Dismiss, permitting reliance on Psychemedics’ hair testing and associated testimony despite the lack of FDA clearance for hair matrices or UGESP validation.Fogel Draft Report — September 23, 2025
The Department circulated a Fogel notice attaching a Draft Report and Recommendation proposing termination based on Psychemedics’ hair EIA results.Fogel Response/Comments — September 24, 2025
Counsel submitted formal comments asserting that the Draft was ultra vires:
a. It substituted accreditation, licensure, and 510(k) clearance for Frye, Rule 7.01, and UGESP;
b. Ignored Jones, the Massachusetts CSC ruling, and Lohr/Riegel/Buckman;
c. Misallocated UGESP’s burden of validation to the employee;
d. Overlooked collection defects, including improper body-hair site selection; and
e. Treated the MRO process as a rubber stamp rather than an independent safeguard.
The response invoked Fogel v. Board of Education to require the agency to address record-based legal objections before issuing a final determination.HARMS Citizen Petition — October 16, 2025
A related FDA Citizen Petition was filed by the public health advocacy group HARMS, challenging employer misuse of Psychemedics’ hair immunoassays and seeking labeling revisions, public advisory notices, and regulatory enforcement.Termination — October 17, 2025
The Police Commissioner terminated Palaguachi the day after the HARMS filing, while the EEOC Charge remained unanswered and FDA review was pending. The termination was based solely on Psychemedics’ hair EIA results, despite the absence of FDA clearance for hair matrices, the lack of UGESP validation, and the known scientific unreliability of the methodology.
“This isn’t just a legal problem — it’s a civil-rights crisis,” Sanders said. “An entire generation of applicants and officers has been judged and disqualified based on junk science masquerading as regulatory clearance.”
Scientific Admissions Undercut NYPD’s Own Case
The petition cites key scientific evidence, including a 2022 peer-reviewed article in the Journal of Analytical Toxicology authored by Virginia A. Hill, Michael I. Schaffer, Ryan B. Paulsen, and G. Neil Stowe of Psychemedics Corporation. Dr. Paulsen — the same witness relied on by NYPD in Palaguachi’s disciplinary proceeding — explicitly acknowledged in that publication that:
“Not all THC from external contamination may be removed,” and THC–THC-COOH ratios “vary widely.”
This admission directly undermines the reliability of Psychemedics’ methodology as a determinative indicator of ingestion and contradicts NYPD’s reliance on Dr. Paulsen’s testimony to assert scientific validity. The article confirms what multiple independent experts, litigators, and appellate courts have already recognized: Psychemedics’ methodology is unfit for forensic employment determinations.
Legal Framework and Regulatory Violations
The petition outlines how the misuse of Psychemedics’ device violates multiple legal and regulatory standards:
FDA Regulations (21 C.F.R. § 862.3870) — Hair matrices are not included in the cleared device classification.
Frye and Rule 7.01 — The methodology lacks general scientific acceptance and independent validation.
UGESP (29 C.F.R. Part 1607) — NYPD and other employers have failed to conduct required validation studies, disparate impact analyses, or consider less discriminatory alternatives.
Civil Rights Law — Federal courts have already held that Psychemedics’ testing produced racially disparate impacts, most notably in Jones v. City of Boston (2014, 2016), which led to a $2.6 million settlement.
National and International Implications
Psychemedics’ misuse is not limited to New York. Law enforcement and public employers across the United States have adopted the same flawed testing, often under the false assumption that it carries FDA clearance. Internationally, Psychemedics’ hair testing has been used in Brazil for driver licensing and employment screening, further amplifying the consequences of FDA inaction.
“The FDA’s silence has allowed this misuse to spread nationally and globally,” Sanders said. “By issuing a clear determination and taking enforcement action, FDA can correct the record, protect public employees, and restore scientific integrity.”
Requested FDA Actions
The petition asks FDA to:
Determine that use of 510(k) K111929 and predecessor Psychemedics immunoassay methodologies for hair testing lies outside the device’s cleared classification under 21 C.F.R. § 862.3870;
Initiate enforcement action against Psychemedics for misbranding and unauthorized marketing;
Revise labeling and issue a public communication to employers and law enforcement agencies; and
Coordinate with civil-rights enforcement agencies to address the documented harms.
A Turning Point
“This is bigger than one case,” Sanders concluded. “Frankie Palaguachi’s story is the legal and human face of an institutional failure. If FDA acts, it can help stop decades of discriminatory, scientifically unsound employment practices and bring long-overdue accountability to both public agencies and private vendors.”
About The Sanders Firm, P.C.
Founded by civil-rights attorney Eric Sanders, The Sanders Firm, P.C. is a New York-based law firm concentrating on civil-rights, employment, and police misconduct litigation. The firm has represented thousands of clients in complex legal matters involving racial discrimination, due-process violations, and systemic institutional misconduct.
###
Read Citizen Petition
Read Exhibit 2 Boston Police Drug Testing Appeal
Read Exhibit 3 EEOC Charge of Discrimination
Read Exhibit 4 Motion to Strike and Motion to Dismiss
Read Exhibit 5 Reply in Further Support of Motion
Read Exhibit 7 Trial Transcript Day One
Read Exhibit 8 Draft Report and Recommendation