For years, both public agencies and private companies have quietly relied on drug testing methods the federal government never actually authorized. These unapproved practices have shut people out of jobs, cost workers their livelihoods, and evaded regulatory oversight.
At the center of this problem is a simple fact: The United States Food and Drug Administration (FDA) never authorized hair testing under the regulatory pathway employers claim. Yet these tests have been used in hiring and disciplinary decisions for decades.
That silence has consequences. And the FDA Citizen Petition is one of the few legal tools capable of forcing the agency to answer for it.
The Legal Foundation of a Citizen Petition
The Citizen Petition is rooted in 21 C.F.R. § 10.30, which gives any person—not just corporations or government agencies—the power to petition the FDA to act. A petitioner may request that the agency:
Take or refrain from an administrative action,
Reconsider or withdraw a prior clearance, or
Enforce existing federal regulations.
The critical distinction is that the FDA must respond in writing and place that response in the public administrative record. This creates a transparent, legally usable record for litigation, legislative oversight, or policy reform.
This is not a PR exercise. It is a binding administrative process. Once the petition is filed, the FDA cannot simply ignore it. The agency must take a position.
FDA Regulation, 510(k) Clearance, and Hair Testing
Many employers rely on the misperception that hair testing is “FDA approved.” It is not.
The EIA hair testing device from Psychemedics Corporation received 510(k) clearance under 21 C.F.R. § 862.3870, which applies to immunoassay devices used on serum, plasma, saliva, and urine. Hair was not included in that clearance.
510(k) clearance is itself a narrow regulatory pathway. It does not evaluate a device for safety and effectiveness in the same way as premarket approval (PMA). It merely allows marketing if the device is substantially equivalent to an existing, legally marketed device for a specific intended use. Expanding that use—such as applying a device cleared for urine testing to hair samples—violates the scope of the clearance.
Despite this, hair testing quietly crept into employment settings beginning in the 1990s. Agencies and employers accepted it as valid because the FDA never explicitly said “no.” That silence, however, does not equal authorization. And legally, using a device outside its intended use undermines the legitimacy of any employment decision based on its results.
How Employers Circumvent Oversight
A particularly egregious example is the use of this unapproved testing method by the New York City Police Department and other law enforcement agencies. But the problem is not limited to policing.
Private employers in healthcare, education, transportation, security, and construction have adopted these same unapproved methods to screen applicants and discipline employees.
The legal architecture allows this to happen because:
The FDA has not explicitly enforced the intended-use limitation.
Employers treat silence as approval.
Workers lack practical mechanisms to challenge the use of these tests outside of litigation.
The result is a regulatory end-run—a situation where employment decisions rest on a testing method never evaluated or authorized by the FDA for hair analysis.
What’s at Stake for Applicants and Employees
This practice has deep and far-reaching consequences.
First, it affects job applicants who are denied employment opportunities before they ever set foot on the job. Employers often claim they are relying on “FDA approved” tests. In reality, they are relying on tests used in a way the FDA never authorized.
Second, it affects current employees, who may face suspension, discipline, or termination based on a positive hair test. Because hair testing is scientifically different from urine or blood testing, it introduces a heightened risk of external contamination—particularly from environmental exposure to drugs rather than ingestion.
Third, hair testing has documented racial disparities. Because melanin-rich hair more readily binds drug metabolites, Black and Brown workers are more likely to test “positive” despite not using the substance in question. This amplifies systemic discrimination in hiring and retention.
Fourth, workers are often denied meaningful due process. Employers frame the test as authoritative and final, discouraging legal challenges. But when the underlying test was never authorized for that purpose, the entire employment action rests on shaky legal ground.
The Power of the Palaguachi Petition
The Palaguachi Citizen Petition seeks to break this cycle. It forces the FDA to confront the core legal issue:
Why have employers been allowed to use a testing device on hair when the FDA never approved it for that purpose?
This petition is not about one officer. It’s about decades of federal inaction that allowed unapproved testing to shape hiring, promotion, and termination decisions nationwide.
By filing a Citizen Petition, affected workers—through counsel—can:
Create a binding administrative record that cannot be ignored,
Compel the agency to take a position,
And build a foundation for broader litigation and policy reform.
Once the FDA is on record, employers will no longer be able to rely on silence as a shield.
Legal and Policy Implications
If the FDA ultimately confirms that hair testing was never authorized, it could expose employers and agencies to:
Civil rights litigation, including claims under Title VII, state and local anti-discrimination laws,
Due process challenges in disciplinary actions,
Liability for wrongful termination or failure to hire based on invalid testing methods,
And regulatory pressure to abandon unlawful testing practices.
In short, a single administrative petition could reverberate through entire industries.
What Every Applicant and Employee Should Know
“FDA approved” does not apply to hair testing under 21 C.F.R. § 862.3870.
Both applicants and employees have the right to question the legality of the testing method used against them.
A Citizen Petition is not symbolic. It is a legal mechanism that creates a record and compels an agency response.
This is fundamentally a civil rights and due process issue, not a technicality.
Breaking Regulatory Silence
The FDA has a statutory responsibility to regulate the devices employers rely on. Its silence has allowed a scientifically unreliable and racially biased testing method to shape careers and lives. The Citizen Petition is how that silence is broken.
Workers deserve to know that the test being used against them is legally authorized. If it isn’t, the integrity of every hiring or disciplinary decision built on that test is open to challenge.