WASHINGTON, D.C. — The FDA has removed a major regulatory obstacle that has blocked the rollout of oral fluid drug testing for commercial truck drivers since the method was approved for regulated use in 2023 — but motor carriers still cannot use the new testing method yet, and won’t be able to until at least two laboratories obtain federal certification.
On October 6, the FDA finalized an order exempting certain clinical toxicology test systems used in federal drug testing programs from the agency’s 510(k) premarket notification requirements. The change took effect immediately and applies to 14 categories of test systems including those used to detect amphetamines, cocaine, methamphetamine, cannabinoids, and opiates.
The American Trucking Associations, which helped spearhead a coalition pushing for the change, called it a long-overdue victory. “After years of ATA advocacy, FDA has finally removed a major regulatory roadblock that prevented oral fluid testing from moving forward,” said ATA Chief Advocacy and Public Affairs Officer Henry Hanscom. “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.”
Why Urine Testing Remains the Only Option for Now
DOT regulations under 49 CFR Part 40 require at least two HHS-certified laboratories capable of testing oral fluid specimens before any DOT-regulated employer can begin using the method — one to test the primary specimen and one for the split specimen. The FDA action removes the 510(k) barrier that was blocking laboratories from pursuing that HHS certification, but the certification process itself still must be completed.
Scott Taillie, chairman of the National Drug and Alcohol Screening Association, said the FDA order marks a turning point. “This marks the day that oral fluid testing can proceed to market. For years the science was proven, and the industry was ready, but a regulatory carve-out stood in the way.”
Once HHS certifies a second oral fluid laboratory, DOT regulations provide for an 18-month transition period. DOT will publish a Federal Register notice announcing when that period begins.
Why the Change Matters
ATA has argued for more than a decade that the federal government’s reliance on urine testing has created serious safety vulnerabilities. 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.
Oral fluid and hair testing are directly observed methods, making them significantly harder to cheat. Hair testing also offers a longer detection window than urine, providing a more complete picture of a driver’s drug use history. ATA said the FDA action also paves the way for future modernization including hair testing and faster regulatory responses to emerging drug threats like fentanyl and synthetic cannabinoids.
The next milestone for motor carriers to watch is HHS certification of the two laboratories needed to move oral fluid testing from regulation to actual practice.
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