B. The HARMS Citizen Petition: Exposing Systemic Regulatory Failure and Demanding Public Transparency

Eight days before the Palaguachi filing, on October 16, 2025, the nonprofit organization Harmed Americans for Reform in Medical-Device Safety (HARMS) submitted its own Citizen Petition to the Food and Drug Administration through the Center for Devices and Radiological Health. This petition represents a broader public-interest initiative that seeks to hold the agency accountable for its past 510(k) clearance of Psychemedics’ cannabinoid hair-testing device (K111929) and its predecessor radioimmunoassay (RIA) device (K011426).

The HARMS petition calls for three principal actions by the FDA: (1) to revise the labeling of Psychemedics’ devices to make clear that they do not determine actual drug use and cannot differentiate ingestion from passive exposure; (2) to issue a public communication to employers and law-enforcement agencies clarifying that the device does not establish marijuana use and should not be used for disciplinary or employment purposes; and (3) to publish the underlying data and investigation findings for transparency and public accountability.

The petition explains that the FDA cleared Psychemedics’ enzyme immunoassay device on May 1, 2012, under 21 C.F.R. section 862.3870—a classification that covers testing for cannabinoids in blood serum, plasma, saliva, and urine, but explicitly excludes hair. By using this classification for a hair-based device, the FDA unknowingly created a “daisy-chain effect,” where each subsequent device was cleared based on an improper predicate device that did not share the same intended use or test matrix. This regulatory misalignment enabled Psychemedics to market hair testing for employment and law-enforcement purposes without any scientific validation.

The HARMS filing provides detailed scientific evidence from peer-reviewed sources showing that hair testing for cannabinoids cannot distinguish between use and exposure, is subject to environmental contamination, and lacks standardized cutoff levels for tetrahydrocannabinol metabolites. It contrasts these deficiencies with validated standards for urine and blood testing developed by the Substance Abuse and Mental Health Services Administration, which require confirmatory testing using gas chromatography or liquid chromatography to eliminate false positives. No equivalent standards exist for hair.

The petition also underscores that the FDA’s own classification language was never meant to include hair, and that the device’s labeling and marketing materials mislead employers into believing they can determine marijuana use when the test merely detects the presence of metabolites that may result from environmental contact. HARMS therefore requests that the FDA issue a public advisory to state and federal employers clarifying that the device cannot reliably determine intentional drug use.

Both petitions highlight the same core problem: for nearly three decades, Psychemedics has promoted hair-based testing as scientifically and federally validated when it has never been approved for that use. This misrepresentation has enabled public employers—including the New York City Police Department—to use invalid scientific methods to decide who is fit to serve.

C. Combined Significance of the Petitions

The Palaguachi and Harmed Americans for Reform in Medical-Device Safety (HARMS) Citizen Petitions operate in tandem. The Palaguachi Petition provides the human and institutional dimension, documenting how Psychemedics Corporation’s unapproved hair-based drug testing was used by the New York City Police Department to disqualify and terminate officers—most notably, former Officer Frankie F. Palaguachi, whose career was destroyed based on scientifically invalid results. The HARMS Petition complements this record by establishing the scientific and regulatory foundation: it demonstrates how Psychemedics manipulated the Food and Drug Administration’s classification system to market and profit from an uncleared medical device for hair testing, misleading public employers into believing the method was federally authorized. Together, the two petitions expose the full arc of misconduct—from regulatory manipulation to human harm—and form the evidentiary backbone of this investigation and forthcoming litigation.

Together, these filings establish both the legal and scientific foundation for civil litigation against Psychemedics Corporation and the City of New York. They reveal that the misuse of hair-based immunoassay testing was not a technical oversight but a systemic pattern of regulatory evasion and civil-rights violations—a process through which unvalidated science was transformed into an instrument of employment control and racial disparity. The Food and Drug Administration’s failure to clarify the scope of its 510(k) clearances allowed this misuse to persist for decades, enabling institutional harm that is now fully documented in the public record through these two petitions.

II. The Testing Methods: Hair Analysis and Enzyme Immunoassay

A. Hair Analysis Using Radioimmunoassay Techniques

Hair analysis, often referred to as radioimmunoassay of hair, was first introduced in the 1980s as a means of detecting long-term drug exposure. The process involves dissolving or digesting a small sample of hair and applying radiolabeled antibodies designed to bind to drug molecules or their metabolites. Psychemedics Corporation popularized this technique commercially under its radioimmunoassay (RIA) platform, which the Food and Drug Administration later identified as predicate device K011426.

Unlike urine or blood testing, which measures the active presence of a drug or metabolite within the body at a given point in time, hair testing attempts to infer a pattern of use extending months into the past. However, because hair is an external biological material exposed constantly to the environment, it is highly susceptible to contamination—including secondhand smoke, surface contact, airborne particles, and even the use of certain hair products.

In addition, hair’s keratin structure and melanin content vary among individuals, leading to uneven absorption of drug compounds. Darker, coarser hair tends to bind lipophilic molecules such as tetrahydrocannabinol (THC) and cocaine more strongly than lighter or chemically treated hair. These variations create systematic racial bias in testing outcomes, a pattern confirmed in Jones v. City of Boston (752 F.3d 38 [1st Cir. 2014]), where hair testing by Psychemedics was found to produce racially disparate results.

Two authoritative scientific reviews—the National Research Council’s 2009 report on forensic science and the President’s Council of Advisors on Science and Technology’s 2016 report—each concluded that hair testing lacks validated protocols, reproducibility, and standardized cut-off thresholds capable of distinguishing ingestion from passive exposure. Subsequent peer-reviewed studies (Moosmann et al., 2015; Taylor et al., 2017) confirmed that identical metabolite concentrations can result from mere environmental exposure.

Because of these unresolved scientific problems, radioimmunoassay hair testing has never achieved general acceptance within the toxicological community and fails every element of the Frye, Daubert, and UGESP standards for reliability, relevance, and job-related validity. No federal agency—including the Substance Abuse and Mental Health Services Administration—recognizes hair testing for cannabinoids as a validated or approved matrix for workplace drug detection.

B. Enzyme Immunoassay Testing and Psychemedics’ Misuse

Enzyme immunoassay is a biochemical technique that uses enzyme-linked antibodies to screen biological specimens for drugs or metabolites. When used on blood, saliva, or urine, enzyme immunoassay serves as an initial screening tool only. Federal guidelines require that any presumptive positive be confirmed by gas chromatography–mass spectrometry (GC/MS) or liquid chromatography–mass spectrometry (LC/MS) to ensure specificity and eliminate false positives.

In May 2012, Psychemedics obtained Food and Drug Administration clearance for its Microplate Enzyme Immunoassay for Cannabinoids (510(k) K111929), referencing the earlier radioimmunoassay device (K011426) as its predicate. However, both devices were cleared under 21 C.F.R. section 862.3870, which applies solely to testing of blood serum, plasma, saliva, and urine. Hair was never included in the classification.

Despite this, Psychemedics expanded the method to hair samples, asserting without validation that antibody binding could function equivalently in keratinized tissue. In reality, the chemical environment of hair fundamentally alters antibody-antigen interactions, leading to cross-reactivity, inconsistent recovery, and elevated false-positive rates. Psychemedics’ own cutoff levels for tetrahydrocannabinol metabolites are internally generated, unpublished, and unverified.

By promoting enzyme immunoassay for hair testing, Psychemedics effectively converted a federally cleared medical device to an unapproved use, circumventing the Food and Drug Administration’s regulatory safeguards. The company’s marketing materials—used by municipal and law-enforcement employers including the New York City Police Department—misled decision-makers into believing the test was “Food and Drug Administration–cleared” and “forensically proven,” when in fact it was neither.

In scientific terms, enzyme immunoassay applied to hair is not a validated analytical method; in legal terms, it is inadmissible evidence under Frye and Daubert; and in regulatory terms, it constitutes off-label promotion of a medical device in violation of the Federal Food, Drug, and Cosmetic Act.

The continued reliance on this unapproved methodology by the New York City Police Department—both in applicant screening and disciplinary contexts—represents a systemic failure of oversight. It has exposed employees and candidates to arbitrary testing outcomes unsupported by any legitimate scientific, regulatory, or civil-service standard.

Summary

Hair analysis and enzyme immunoassay, when applied to hair, do not meet the scientific, regulatory, or legal thresholds required for valid employment testing. They are inherently unreliable, racially biased, and unauthorized under federal law. Their use by Psychemedics Corporation and the New York City Police Department thus represents not merely administrative error but institutional misconduct grounded in scientific misrepresentation.

III. Institutional Misconduct: How Unvalidated Science Became Policy

The New York City Police Department’s adoption of Psychemedics Corporation’s hair-based drug testing was not the result of scientific review or regulatory approval—it was a quiet administrative expansion of a private vendor’s marketing claims.

Beginning in the mid-1990s, the NYPD incorporated Psychemedics’ radioimmunoassay hair testing into its applicant and employee screening, later shifting to the enzyme-based version after 2012. At no point did the department conduct its own validation study under the Uniform Guidelines on Employee Selection Procedures, seek independent toxicological review, or obtain a ruling from the Food and Drug Administration authorizing hair testing.

Instead, the department accepted the company’s promotional language—asserting that its method was “FDA-cleared” and “forensically proven”—and embedded those claims in internal policy. This turned unapproved science into official procedure. Over time, that practice hardened into policy through silence: procurement offices, counsel, and oversight agencies treated the testing as routine laboratory work, even though it relied on an uncleared medical device.

The result is an institutional system built on scientific misrepresentation and administrative inertia. Officers and applicants have faced termination, disqualification, or discipline based on results that cannot distinguish ingestion from environmental contact, a violation of both scientific reliability standards (Frye and Daubert) and employment-law validity standards (UGESP).

This long-term misuse of unvalidated testing constitutes institutional misconduct, not administrative oversight. It reflects a pattern in which regulatory silence became permission, and permission became policy—leaving thousands of employees exposed to unjust outcomes rooted in bad science.

IV. Legal Violations and Implications

Federal Regulatory Violations:
Unauthorized marketing, distribution, and off-label use of radioimmunoassay hair (RIAH), enzyme immunoassay (EIA), and related hair-analysis devices for purposes never cleared or approved by the Food and Drug Administration. These devices were marketed as “FDA-cleared” despite the absence of any clearance for hair as a biological matrix.

Employment Law Violations:
Failure to comply with the Uniform Guidelines on Employee Selection Procedures, Title VII of the Civil Rights Act of 1964, and the New York State and New York City Human Rights Laws, all of which require that employment testing be valid, job-related, and nondiscriminatory.

Constitutional Violations:
Deprivation of due process and equal protection where disciplinary or hiring decisions were based on scientifically invalid or unreliable results generated by RIAH, EIA, or successor immunoassay methods.

Civil-Rights Violations:
Disparate impact on racial and ethnic minority groups resulting from the uncorrected effects of melanin binding in hair, which produces disproportionately higher detection rates in darker or coarser hair types when tested through RIAH, EIA, or similar immunochemical methods.

V. Categories of Affected Individuals

To organize the litigation efficiently, The Sanders Firm, P.C. is identifying potential class participants in four primary categories involving RIAH, EIA, and all successor or derivative hair-testing variants used by the New York City Police Department and its contractors:

Group One — Individuals (Applicants and Employees) with “Failed” Test Results
Those who tested “positive” under any Psychemedics hair-based method—including RIAH, EIA, or related immunoassay technologies—and subsequently faced disqualification, termination, suspension, or other disciplinary action. These individuals will form the lead cohort in the forthcoming litigation.

Group Two — Individuals (Applicants and Employees) with “Passed” Test Results
Those who received “negative” or “passing” results on RIAH, EIA, or comparable tests yet were still subjected to retesting, monitoring, or adverse treatment, demonstrating institutional misuse of unvalidated science.

Group Three — Individuals (Employees) Selected for “Random” Testing
Those chosen for purportedly random drug testing through undisclosed algorithms or selection procedures that incorporated RIAH or EIA hair testing. Early evidence indicates these programs were not truly random and may have disproportionately targeted certain employees or demographic groups.

Group Four — Individuals (Employees) Subjected to “For Cause” Testing
Those ordered to undergo RIAH, EIA, or related testing following alleged misconduct, anonymous complaints, or retaliatory actions. Many of these “for cause” tests appear to have been pretextual and imposed without legitimate basis, violating principles of due process and fair employment.

VI. Objectives of the Litigation

The Sanders Firm, P.C. seeks to:

• Obtain a court injunction prohibiting the continued use of unapproved or scientifically unvalidated RIAH, EIA, or derivative hair-testing methodologies in any City of New York employment context;

• Recover monetary and equitable relief for affected officers, applicants, and employees whose careers or reputations were damaged;

• Expose the institutional misconduct of Psychemedics Corporation and the City of New York in adopting and perpetuating these unapproved methods; and

• Establish enduring oversight, accountability, and scientific transparency to ensure that all future employment testing complies with federal scientific, regulatory, and civil-rights standards.

VII. Call for Participants

If you are or were an applicant, officer, or civilian employee of the New York City Police Department who:

• Was subjected to radioimmunoassay hair (RIAH), enzyme immunoassay (EIA), or any related hair-analysis testing since 1996;

• Received a “positive” or “negative” result and experienced disqualification, discipline, or other adverse employment consequences; or

• Was included in a so-called “random” or “for cause” testing program that relied on any form of RIAH or EIA analysis,

you may be eligible to participate in this investigation.

The Sanders Firm, P.C. is currently accepting an initial group of approximately one hundred participants for confidential intake interviews, documentation review, and classification within the developing litigation framework.

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.

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