Promising Movement on Oral Fluid Testing

HHS urged to move on oral fluid drug testing

A group of lawmakers urged the U.S. Department of Health and Human Services to take action to allow oral fluid drug testing for federally-regulated workplace drug testing programs.

Oral fluid testing was approved for use in 2023, yet no laboratory has been able to achieve certification because of regulatory barriers at the Food and Drug Administration, the lawmakers wrote in a letter to HHS Secretary Robert F. Kennedy Jr. The group said that "structural misalignment" at the FDA is preventing employers from using modern methods to combat a what they called a massive surge in test cheating.

“Regulated employers therefore cannot utilize this reliable, flexible, and directly observed testing method, which allows detection of recent drug use and a more effective response to today's rapidly evolving drug threats,” they added. “In fact, absent regulatory action, it is possible that U.S. employers will only be able to access federally authorized oral fluid testing by sending specimens to Canada -- only a Canadian laboratory has applied National Laboratory Certification Program (NLCP) oral fluid certification.”

Led by Rep. Andy Harris (R-Maryland), the lawmakers contended that current rules incorrectly treat workplace safety programs as clinical diagnostic tools -- a distinction that subjects new testing technologies to the FDA’s 510(k) medical device clearance process, a pathway the letter describes as a "regulatory barrier" ill-suited for forensic occupational standards.

Clearing regulatory hurdles, the lawmakers said, would “provide employers with reliable alternatives to address the ongoing and alarming rise in urine testing subversion -- an issue that has generated a niche industry of sophisticated products designed to defeat drug tests.”

The Congressmembers asked HHS to take the following four actions:

• Affirm that laboratory-based workplace drug testing is non-clinical and falls outside FDA medical device authority.

• Recognize the Substance Abuse and Mental Health Services Administration (SAMHSA) as the sole governing oversight body for these programs.

• Designate SAMHSA’s Division of Workplace Programs as the authority for updating drug panels and testing technologies.

• Finalize hair testing guidelines originally mandated by Congress in 2015.