FDA Finalizes 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 in taking a major step towards unlocking advanced drug testing methodologies in safety-sensitive industries. ATA helped spearhead the coalition dedicated to expanding and enhancing the nation's drug testing protocols and tools to help keep America's roadways safe.

A newly finalized rule by the U.S. Food and Drug Administration exempts regulated drug testing from the 510(k) Clearance requirement, which served as the primary obstacle for labs seeking certification to perform oral fluid testing despite this method's 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 novel drug threats, such as fentanyl and synthetic cannabinoids.

FDA initiated its rulemaking process earlier this year shortly after six Members of Congress sent a letter at ATA's request to the U.S. Department of Health and Human Services. ATA submitted comments on FDA's proposed rule in June.

"A modern drug testing program is essential to keeping impaired drivers off the road and protecting the motoring public," said ATA Chief Advocacy & Public Affairs Officer Henry Hanscom. "After years of ATA advocacy, FDA has finally removed a major regulatory roadblock that prevented oral fluid testing from moving forward. This long-overdue action creates a pathway for labs to develop and employers to access more accurate, less invasive, and harder-to-defeat testing methods, while making federal programs nimbler in responding to emerging drug threats. It is an important victory for highway safety and a critical step toward a stronger trucking workforce."

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 delays.

Oral fluid testing was approved for regulated use in 2023, yet the 510(k) clearance process prevented U.S. laboratories from obtaining certification. The 510(k) requirement also risked further delaying the adoption of hair testing once HHS issues its guidance.

FDA's final rule removing the 510(k) requirement is a victory long sought by ATA, the National Drug & Alcohol Screening Association, and other key partners, who worked together to press federal officials to eliminate this major bureaucratic barrier.