FDA Paves Way for Oral Fluid Drug Testing Following ATA Advocacy

Agency action also opens the door to acceptance of hair testing

Washington - Today, the American Trucking Associations applauded the Trump Administration for taking a critical step towards unlocking advanced drug testing methodologies in safety sensitive industries.

A proposed rule by the U.S. Food and Drug Administration would eliminate the 510(k) clearance requirement, which served as the primary obstacle for labs seeking certification to perform oral fluid testing despite its approval for regulated use over three years ago. The proposal also paves the way for a wider modernization of federal drug testing, from incorporating additional methods like hair testing to strengthening the nation's capacity to react quickly to emerging drug threats, such as fentanyl and synthetic cannabinoids.

This breakthrough came after six Members of Congress sent a letter at ATA's request to the U.S. Department of Health and Human Services. Reps. Andy Harris (R-MD), Ben Cline (R-VA), Pete Sessions (R-TX), Mike Bost (R-IL), Mike Collins (R-GA), and Claudia Tenney (R-NY) urged HHS Secretary Robert F. Kennedy Jr. to reform the nation's drug testing programs.

"Trucking relies on a strong federal drug testing program to protect public safety and ensure that impaired individuals are not operating commercial motor vehicles," said ATA President & CEO Chris Spear. "Following years of advocacy focused on cutting red tape, ATA is pleased that FDA has finally created a pathway to implement oral fluid testing. This major development also lays the groundwork for the eventual adoption of hair testing. Empowering employers with these tools will make drug testing more accurate, more cheat-resistant, and less invasive. The end result will be a stronger trucking workforce and safer roads for everyone."

For well over a decade, ATA has warned that the federal government's overreliance on urine testing has created dangerous gaps in the system-including widespread drug test "cheating." According to an analysis of Quest Diagnostics data, substituted and invalid urine specimens increased by more than 370% and 36%, respectively, between 2022 and 2023 among federally regulated, safety-sensitive employees-a troubling trend that underscores how vulnerable the current system has become.

As directly observed methods, oral fluid and hair testing are less susceptible to substitutions or tampering. Additionally, hair testing offers a longer detection window, providing a more complete picture of past drug use. Access to these testing methods ensures motor carriers have the most effective, robust toolboxes when it comes to understanding potential patterns of drug and alcohol use and safety hazards, yet for years, their adoption has been stalled by needless bureaucratic delays.

Oral fluid testing was approved for regulated use in 2023, yet no U.S. laboratory has been able to obtain certification due to the 510(k) clearance process. The 510(k) requirement also risked further delaying the adoption of hair testing once HHS issues its guidance.

The comment window for FDA's proposed rule is open for the next 60 days. ATA plans to submit comments in support of removing the 510(k) requirement and is encouraging other safety stakeholders to do the same via regulations.gov.