For more than three decades, both public agencies and private employers have relied on hair drug tests the federal government never actually authorized. These unapproved methods have determined who gets hired, who keeps their job, and who is cast out of their profession.

The United States Food and Drug Administration (FDA) had — and still has — clear statutory authority to regulate these devices. Yet it failed to act. In that silence, private actors filled the void, building a multibillion-dollar industry on the illusion of federal legitimacy.

This was not a misunderstanding. It was a structural failure — a calculated inaction that allowed vendors and employers to turn unapproved technology into a mechanism of control.

I. A Brief History of Employment Drug Testing — and the FDA’s Retreat

Drug testing entered the employment context during the late 1980s, spurred by President Reagan’s Executive Order 12564, which mandated drug-free federal workplaces. The Substance Abuse and Mental Health Services Administration (SAMHSA) later issued the Mandatory Guidelines for Federal Workplace Drug Testing Programs, setting standards for urine testing.

Crucially, those standards never included hair. SAMHSA repeatedly rejected proposals to add hair testing due to unresolved concerns about contamination, racial bias, and scientific validity.

The FDA, meanwhile, maintained responsibility for regulating the devices themselves under the Federal Food, Drug, and Cosmetic Act (FD&C Act). That meant ensuring that testing equipment was used only for its approved or cleared intended use.

But as hair testing migrated from forensic experiments into mainstream employment screening, the FDA declined to intervene. It neither approved the practice nor prohibited it. That silence would become the foundation for three decades of misuse.

II. The FDA’s Legal Authority — and Its Abdication

Under the FD&C Act, the FDA regulates medical devices used for diagnostic or forensic purposes. These include in-vitro diagnostic tests used to detect the presence of drugs or metabolites in biological samples.

Devices can only be marketed if they receive Premarket Approval (PMA) or 510(k) clearance, the latter requiring proof of “substantial equivalence” to an existing legally marketed device for the same intended use.

The EIA immunoassay testing device manufactured by Psychemedics Corporation received 510(k) clearance under 21 C.F.R. § 862.3870, which covers testing in serum, plasma, saliva, and urine. Hair was not included.

This distinction matters because intended use is not a suggestion — it is a legally enforceable restriction. Using a device for an unapproved purpose constitutes misbranding under 21 U.S.C. § 352. The FDA could have acted under its enforcement powers to stop or restrict such misuse. It chose not to.

The agency’s inaction reflects a deeper failure of administrative will — what legal scholars call “regulatory abdication”. When the FDA prioritizes commercial convenience over statutory compliance, it cedes control of public safety to the marketplace.

And once vendors and employers discovered that silence would not be punished, it became a business model.

III. How Silence Became Institutional Policy

In administrative law, silence can be as powerful as action. The FDA’s decision not to enforce its own regulatory boundaries allowed vendors to market their products as though approval extended to hair samples.

Employers, especially in law enforcement and safety-sensitive sectors, seized the opportunity. They framed hair testing as more “comprehensive” and “forward-looking” — language that appealed to bureaucracies obsessed with control.

By the early 1990s, large departments such as the New York City Police Department had adopted hair testing as part of their candidate assessment and disciplinary systems. Over time, this unapproved method became codified in policies, administrative procedures, and even collective bargaining agreements.

From there, the practice spread to healthcare systems, educational institutions, transportation authorities, and private security firms. The absence of regulation had been replaced by institutional custom, creating a de facto regulatory regime where employers made the rules and workers paid the price.

IV. The False Promise of Science

Hair testing’s appeal rests on its promise of long-term detection — the idea that drugs remain traceable in hair for up to 90 days. That claim, however, ignores a fundamental scientific problem: hair testing cannot reliably distinguish ingestion from environmental exposure.

In forensic literature, contamination has been recognized for decades as an unavoidable limitation. Drugs or smoke in the environment can adhere to hair strands, particularly in urban environments or among individuals exposed to drug users. No laboratory washing protocol has ever been proven to eliminate this risk completely.

Further, hair testing lacks federal cut-off levels comparable to those used in SAMHSA-regulated urine testing. Each private lab sets its own standards, meaning that two individuals tested by different labs could receive conflicting results from the same exposure.

The FDA never required validation studies or uniform performance criteria. That omission transformed unverified science into legal evidence — evidence that could cost someone their career.

V. Racial Bias and Structural Discrimination

The racial bias inherent in hair testing compounds the scientific unreliability. Melanin-rich hair binds drug metabolites more readily than lighter hair. As a result, Black and Brown individuals are more likely to produce positive results, even at equal or lower exposure levels than white individuals.

This disparity has been documented in multiple studies, including those published in the Journal of Analytical Toxicology and cited in federal court cases. The issue was significant enough that SAMHSA cited it as a principal reason for excluding hair testing from its federal standards.

By ignoring these known disparities, employers and agencies perpetuated a testing regime that functionally discriminates by race, even if not by intent. That alone is sufficient to support Title VII disparate impact claims.

The FDA’s silence on these issues isn’t bureaucratic restraint — it’s complicity in a racially biased system that masquerades as objective science.

VI. The Legal Consequences of Misuse

When employers use unapproved devices to make employment decisions, they expose themselves to significant legal risk.

• Title VII: Disparate impact claims based on racially disproportionate outcomes.

• Due Process: Public employees terminated based on scientifically unreliable testing may challenge the action as arbitrary and capricious.

• Tort and Contract Claims: Private employees can assert wrongful termination or breach of implied covenant claims when employers rely on unauthorized testing.

• Fraud and Misrepresentation: Vendors that market devices as “FDA approved” for hair testing may be liable under state consumer protection laws.

Each of these potential liabilities arises from one core fact: the test was never approved for hair. Every employment decision that relied on it rests on a legally defective foundation.

VII. The Palaguachi Petition: Forcing the FDA to Speak

That is precisely why the Palaguachi Citizen Petition matters. Filed under 21 C.F.R. § 10.30, it compels the FDA to take a public position — something it has avoided for over three decades.

Once a Citizen Petition is filed, the FDA must respond in writing. Its response becomes part of the public administrative record, usable in court, in policy hearings, and in legislative oversight.

The petition asks a simple but far-reaching question:
Why has the FDA allowed hair testing to be used in employment when it never approved that use?

A formal acknowledgment from the agency that hair testing was never authorized would have profound implications. It would expose decades of unlawful practice, open the door to litigation, and force policymakers to confront a long-ignored problem.

VIII. A Tale of Two Standards: Urine vs. Hair

The contrast with SAMHSA’s urine testing standards is instructive. Urine testing under 49 C.F.R. Part 40 includes detailed procedures: specimen collection, chain of custody, lab certification, and Medical Review Officer oversight.

Hair testing, by contrast, has none of these safeguards. There are no federal performance standards, no chain-of-custody mandates, and no oversight mechanism. Yet employers treat hair test results as final, often denying appeals or secondary testing.

The result is a bifurcated system: one regulated, standardized, and scientifically validated — and another entirely unregulated, racialized, and punitive.

By refusing to close that gap, the FDA enabled employers to choose the less accountable option.

IX. Institutional Consequences and Civil Rights Exposure

If the FDA publicly acknowledges that hair testing was never authorized, the consequences will be immediate. Employers and agencies may face:

• Class action litigation by applicants and employees denied jobs or terminated based on unapproved testing.

• Regulatory reform efforts demanding that Congress or the Department of Health and Human Services impose explicit prohibitions.

• Civil rights investigations into racial disparities in enforcement outcomes.

• Financial liability for wrongful termination, loss of income, and reputational harm.

These outcomes are not hypothetical. They are foreseeable and long overdue.

X. The Broader Problem: Regulatory Silence as a Civil Rights Issue

What makes this case extraordinary is what it reveals about the nature of regulatory silence. In theory, the FDA’s neutrality protects scientific objectivity. In practice, its silence has created a structural inequity.

By abdicating oversight, the FDA ceded power to private laboratories and employer agencies — entities with financial and institutional interests in maintaining the status quo. The agency’s refusal to act effectively legalized discrimination and pseudoscience under the color of federal authority.

This is not administrative restraint. It is institutional complicity.

XI. What Accountability Requires

Accountability begins with transparency. The FDA must publicly acknowledge that hair testing was never authorized under 21 C.F.R. § 862.3870. It must issue clear guidance to employers, vendors, and federal contractors that such use violates intended-use restrictions.

Congress should go further:

• Require the FDA to publish enforcement actions related to unapproved employment testing.

• Mandate performance standards for all biological sample testing used in employment contexts.

• Strengthen whistleblower protections for employees disciplined under unauthorized testing regimes.

Agencies that used hair testing — particularly in law enforcement — must review prior employment actions and correct the record where necessary. The integrity of public employment demands no less.

XII. The Reckoning Ahead

For too long, the FDA’s silence has masqueraded as neutrality. It is not neutral to ignore racial bias. It is not neutral to allow unapproved testing to decide who can work.

The Palaguachi Citizen Petition is more than an administrative filing. It is a challenge to a system that has treated silence as law and inaction as policy. Once the FDA speaks, decades of institutional misconduct will be exposed for what it is: an unlawful practice that operated with the quiet consent of federal regulators.

When law fails to act, silence becomes a form of power. The Citizen Petition forces that silence to break — and in doing so, begins to restore accountability to a system that has long forgotten what that word means.