I. Introduction: What’s at Stake
For nearly three decades, hair drug testing has quietly operated as a shadow policy tool across public and private employment sectors. Law enforcement agencies, hospitals, security contractors, transportation authorities, and private employers have used these tests as if they carry the weight of law.
But here’s the reality: hair testing using immunoassay methods — including Enzyme immunoassay (EIA) and Radioimmunoassay (RIAH) — has never been authorized by the United States Food and Drug Administration (FDA) for employment use.
These tests exist in a legal vacuum. Employers rely on regulatory silence, not legal authority. Applicants and employees pay the price — often without understanding that they have powerful legal tools to fight back.
This blog lays out a comprehensive, step-by-step strategy for challenging adverse employment decisions based on unapproved hair testing. It is intended for potential applicants, probationary employees, public safety workers, union members, and attorneys who need a clear legal and procedural roadmap.
II. Understanding the Legal Defect: No FDA Authorization
Most hair testing devices in employment rely on the same core regulatory fiction: “FDA approved.”
In truth, the FDA cleared certain immunoassay devices under 21 C.F.R. § 862.3870 for serum, plasma, saliva, or urine. Hair is not included in this intended use. That means:
✅ There is no FDA approval or clearance for hair testing.
🚫 There is no recognized federal standard for hair testing under Substance Abuse and Mental Health Services Administration (SAMHSA).
⚠️ There are no standardized cutoff levels, no required validation studies, and no federal chain-of-custody protocols for hair.
This gap matters because employers cannot lawfully treat an unapproved, scientifically contested test as dispositive evidence in employment decisions. Yet many do.
Regulatory silence is not a license. It’s a vulnerability.
III. The Scientific Problem: Why Hair Testing Is Unreliable
The scientific limitations of hair testing are not theoretical — they are well documented:
Environmental contamination: Hair absorbs drugs from external environments, especially in urban areas.
No ingestion distinction: Hair tests cannot reliably differentiate between exposure and use.
Melanin bias: Melanin-rich hair binds metabolites more readily, disproportionately affecting Black and Brown individuals.
No standardization: Without federal cutoffs or calibration, test results vary between labs.
Lack of regulatory oversight: SAMHSA has repeatedly declined to adopt hair testing for precisely these reasons.
These flaws translate directly into legal vulnerability. If the test cannot meet minimal scientific standards, it cannot satisfy Title VII’s “job related and consistent with business necessity” defense.
IV. The Legal Framework: How the Law Protects You
A. FDA Regulatory Authority
The FDA’s device clearance process is governed by the 510(k) pathway. Under 21 C.F.R. § 862.3870, devices cleared for immunoassay testing are limited to serum, plasma, saliva, and urine. Using the device for hair testing is an off-label use with no federal authorization.
B. UGESP Validation Requirements
The Uniform Guidelines on Employee Selection Procedures (UGESP), codified at 29 C.F.R. § 1607, require employers to produce technical validation studies if a selection procedure has an adverse impact. Sections 1607.3 and 1607.5 are explicit: the burden rests on the employer.
Hair testing has well-documented racial disparities, triggering the validation requirement. Most employers cannot meet it.
C. Title VII and Disparate Impact
Under Title VII of the Civil Rights Act of 1964, a facially neutral employment practice that has a disparate impact on a protected group is unlawful unless the employer can show business necessity. This principle comes from Griggs v. Duke Power Co. and Albemarle Paper Co. v. Moody.
Racial bias in hair testing is not incidental — it is structural. Once you show disparate impact, the burden shifts to the employer to defend the test. Without FDA approval or validation, they usually cannot.
D. Due Process and Administrative Law (Public Employees)
For public employees — especially law enforcement applicants — reliance on unapproved testing also raises due process issues. An adverse action based on an unauthorized, unreliable test may be challenged as arbitrary and capricious under state administrative law, such as an Article 78 proceeding in New York.
V. Step-by-Step Strategy to Challenge the Decision
Step 1: Preserve All Documentation
Obtain your test result, chain of custody, and all communications.
Request the lab’s methodology, cutoff levels, and calibration procedures.
Demand the FDA clearance letter authorizing hair testing (they won’t have one).
Keep copies of job postings, policies, and internal guidance.
This builds your evidentiary foundation.
Step 2: Demand Employer Validation
Formally request in writing:
Any validation studies under UGESP § 1607.5.
Evidence of FDA authorization.
Chain-of-custody compliance.
Laboratory quality assurance protocols.
If they cannot produce this, their reliance on the test is legally indefensible.
Step 3: Frame the Legal Theory Early
Challenging an adverse employment decision tied to unapproved hair testing requires a clear legal theory from the outset. Depending on your status (applicant, employee, public sector, union member) and the facts of your case, your claim may rest on one or more of the following legal grounds — this is not an exhaustive list:
Disparate Impact under Title VII of the Civil Rights Act of 1964
— Particularly where hair testing has a racially disparate effect on Black and Brown applicants due to melanin bias and environmental contamination.Disparate Treatment or Retaliation Claims
— Where the employer applies testing selectively or uses results as a pretext for discriminatory action.Due Process Violations (Public Sector)
— Especially for law enforcement, civil service, or other government applicants or employees subject to constitutional or statutory procedural protections.Arbitrary and Capricious Administrative Action (State Administrative Law)
— For example, under an Article 78 proceeding in New York challenging unlawful reliance on unauthorized testing methods.Violations of Collective Bargaining Agreements or Civil Service Protections
— Including improper disciplinary procedures, lack of just cause, or failure to follow agreed-upon testing protocols.Failure to Validate Selection Procedures under Uniform Guidelines on Employee Selection Procedures (UGESP)
— Where the employer fails to produce technical validation studies for a test with known adverse impact.Negligence, Negligent Misrepresentation, or Product Liability Claims (Against Vendors and/or Employers)
— Where a testing vendor or employer represents a test as “FDA approved” or “scientifically valid” when it is not.Breach of Contract or Promissory Estoppel
— In cases involving conditional employment offers or testing agreements that were not properly or lawfully administered.State or Local Human Rights Statutes
— Such as New York State Human Rights Law or New York City Human Rights Law, which often provide broader protections than federal law.Common Law Defamation or Stigma-Plus Claims
— Where an employer’s reliance on a false positive or unauthorized test harms professional reputation or employability.
📝 Note: The specific legal theory — or combination of theories — should be tailored to the facts of the case. For example, a probationary police officer might combine a Title VII disparate impact claim with an Article 78 challenge, while a private sector employee may focus on state human rights statutes and negligence against the vendor.
Having a clear theory from the outset focuses your challenge.
Step 4: File the Appropriate Legal or Administrative Action
A. EEOC Charge
File a charge with the U.S. Equal Employment Opportunity Commission (EEOC) alleging disparate impact under Title VII.
Hair testing’s racial bias supports the claim.
UGESP requires employer validation.
The lack of FDA authorization undermines any “business necessity” defense.
B. State or City Human Rights Agencies
In New York, this could mean filing with the New York State Division of Human Rights or New York City Commission on Human Rights. State and local laws can be even more protective than federal law.
C. Citizen Petition under 21 C.F.R. § 10.30
A Citizen Petition forces the FDA to respond in writing and place the issue on the public record. Once the FDA states that hair testing was never authorized, employers lose their shield.
D. Article 78 Proceeding (New York)
For public employment, an Article 78 challenge allows applicants to contest arbitrary and capricious agency decisions — including reliance on unapproved tests.
E. Union Grievance or Arbitration
If your employment is covered by a collective bargaining agreement, file a grievance. Many CBAs contain due process protections against the use of unlawful testing methods.
VI. Leveraging the Science in Legal Arguments
A powerful challenge integrates legal and scientific evidence. The key scientific vulnerabilities:
Melanin bias = built-in racial disparity.
Environmental contamination = false positives.
Lack of SAMHSA standards = no federal reliability benchmark.
Lack of FDA approval = no intended use authorization.
No UGESP validation = employer burden failure.
The more you push these weaknesses into the legal record, the harder it becomes for the employer to defend.
VII. For Law Enforcement and Public Safety Applicants
Law enforcement agencies, including New York City Police Department, were among the earliest adopters of hair testing — and among the most legally vulnerable.
Agencies frequently misrepresent tests as “FDA approved.”
Psychological “holds” or disqualifications based on hair testing often lack procedural safeguards.
Article 78 challenges can expose the absence of lawful standards and require reinstatement or reconsideration.
This is especially critical for probationary officers and applicants: the earlier you assert your rights, the stronger your position.
VIII. The Citizen Petition Strategy: Forcing the Government to Speak
One of the most effective levers is the Citizen Petition under 21 C.F.R. § 10.30.
Here’s why:
It forces the FDA to answer in writing whether hair testing is authorized.
It creates a public administrative record.
It strips employers of their “regulatory silence” defense.
It strengthens EEOC, arbitration, and Article 78 claims by establishing official agency inaction.
This strategy was used effectively in the recent Palaguachi Petition, which brought the issue squarely before the FDA.
IX. Litigation as Leverage
If administrative processes fail or stall, litigation can:
Compel discovery of employer testing practices.
Expose lack of validation.
Trigger judicial review of arbitrary and capricious agency action.
Support class or systemic claims where patterns emerge.
Litigation doesn’t just vindicate individual rights. It forces structural change.
X. Building a Strong Evidentiary Record
A good legal claim is built long before a lawsuit is filed.
Key evidence to collect:
Lab results, methodology, and internal policies.
Employer statements about FDA “approval.”
Data showing racial or demographic disparities.
FOIL/FOIA records of agency testing practices.
Expert testimony on contamination and reliability.
Even if the employer reverses course, this record can support broader enforcement action.
XI. Common Employer Defenses — and How to Counter Them
When employers are confronted with challenges to their use of unapproved hair testing, they often rely on a handful of predictable defenses. Understanding these arguments — and how to dismantle them — is critical to an effective legal strategy.
One of the most common claims is that “the test is FDA approved.” This is false. While immunoassay devices were cleared under 21 C.F.R. § 862.3870, that clearance applies only to serum, plasma, saliva, and urine — not hair. Hair testing remains an unapproved, off-label use. No amount of internal policy or vendor marketing can change that legal reality.
Another frequent line is “everyone uses it.” This defense tries to equate longevity or widespread practice with legality. But regulatory silence is not approval. The fact that agencies or employers have relied on the test for years does not give it legal authority. If anything, longstanding misuse underscores systemic failure — not legitimacy.
Employers also assert that “the test is reliable.” But this claim collapses under scrutiny. There is no Substance Abuse and Mental Health Services Administration standard governing hair testing, no federally recognized cutoff levels, and significant evidence of contamination and racial bias. Without federal oversight or validation, “reliability” is merely an assertion — not a legal defense.
Another common argument is “it’s job-related.” Under Title VII of the Civil Rights Act of 1964, this claim carries a specific burden. Once a plaintiff shows disparate impact, the employer must prove the test is job-related and consistent with business necessity. Unsupported assurances won’t satisfy this burden, particularly when the test lacks FDA authorization and scientific reliability.
Finally, employers often fall back on “it’s in our policy.” Internal policies cannot override federal law, civil rights protections, or constitutional standards. An employer’s unilateral decision to adopt an unapproved testing method does not make that method lawful.
Each of these defenses is rooted in institutional habit, not legal authority. By systematically exposing the gap between what employers say and what the law requires, applicants and employees can strip these arguments of their persuasive power and bring the issue back to its legal core: the test is unauthorized, unreliable, and discriminatory.
XII. Conclusion: Silence Is Not Law
For decades, hair testing has functioned in the shadows — propped up not by statutory authority or scientific rigor, but by regulatory silence. That silence is not neutral. It has allowed employers to exclude thousands of applicants and employees, disproportionately affecting communities of color and working-class individuals.
But silence can be broken. With the right strategy — combining UGESP, Title VII, FDA regulatory procedures, administrative law, and litigation — you can challenge the use of unapproved hair testing and expose its lack of legal foundation.
The law is not on the side of unauthorized testing. It is on the side of those willing to challenge it.