DOT Oral Fluid Drug Testing Clears an FDA Hurdle

What happened

DOT oral fluid drug testing got one step closer this week. Oral fluid means a saliva swab instead of a urine cup. The Trucker reported the news on Oct. 7.

On Oct. 6, the FDA (the agency that oversees medical devices) finalized an order. It lets certain drug test systems skip a review step called 510(k) when they are used for federal drug testing programs. The change took effect right away.

Before this order, those test systems got that break only for job and insurance testing. Federal programs were left out. The FDA first proposed the change in May. It got about 70 comments, and most supported it. The agency made it final with no changes.

The order covers 14 kinds of test systems. They check for drugs like amphetamines, cocaine, methamphetamine, marijuana (cannabinoids) and opiates.

Scott Taillie, chairman of the National Drug and Alcohol Screening Association (NDASA), called it "the day that oral fluid testing can proceed to market."

What it means for owner-operators

Here is the key point: nothing changes for your next test yet. Urine is still the only DOT drug test method allowed for trucking.

DOT approved saliva testing back in 2023. It never started because there were not enough labs. Before any carrier can use it, at least two labs must be certified by HHS (the Department of Health and Human Services). One lab tests the main sample. The second tests the split sample. There also must be trained collectors and approved collection kits.

Once HHS certifies a second lab, DOT rules give an 18-month transition for some directly observed collections.

When it does start, a saliva test can be done in front of the collector. Many drivers may find that easier than a urine test.

What to do next

• Keep doing urine tests for now. Do not skip or change any DOT test.
• Ask your testing provider. If you run your own authority, ask your consortium when they expect to offer oral fluid.
• Keep your drug and alcohol program in order. Pre-employment and random tests are part of every safety audit. Our guide to the new entrant safety audit shows what auditors check.
• Watch for the HHS lab news. That is the real start signal.

We will share it when the first labs are certified.