The Trump Administration is moving ahead with its push to unlock advanced drug testing methodologies such as hair and oral testing, which are widely considered more reliable and less prone to “cheating.”
The move is being applauded by leaders of safety-sensitive industries like trucking.
The proposed rule by the U.S. Food and Drug Administration (FDA) 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.
Members of Congress sent a letter at the industry’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.
The ruling is significant because the trucking industry, particularly led by the American Trucking Associations, has warned that the federal government’s overreliance on urine testing has created dangerous gaps in the system—including widespread drug test adulteration “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.
Directly observed methods such as 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 risks 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.
