NOTA questions FDA's attempted regulation of on-site tests

The National On-site Testing Associates, Inc. (NOTA) has been revived in response to an attempt by the federal Food and Drug Administration (FDA) to regulate on-site, or point of collection, oral fluids drug and alcohol tests used by many small employers for non-medical purposes. NOTA is an association of manufacturers, users, and distributors of on-site drugs of abuse tests. These tests are sold throughout the world for use in workplace, sports, school, insurance, and criminal justice settings and numerous other non-medical applications. These tests are safe, accurate, cost effective, and easy to use.

“The FDA's unneeded regulation will restrain the advance of this valuable technology, unduly expend taxpayer dollars, and divert valuable FDA resources from critical concerns such as expediting drug approvals, monitoring food quality, and fighting terrorism's threat to our food supply”

“The FDA's unneeded regulation will restrain the advance of this valuable technology, unduly expend taxpayer dollars, and divert valuable FDA resources from critical concerns such as expediting drug approvals, monitoring food quality, and fighting terrorism's threat to our food supply,” noted David Evans, the Executive Director of NOTA. “In the past, serious questions about the FDAs jurisdiction to regulate on-site tests have been raised by Congress and other federal agencies.”

“The FDA claims jurisdiction over on-site drug tests because they now define on-site oral fluids drug tests as “medical” or "diagnostic” devices, however, the FDA has no jurisdiction over drug testing unless the testing is intended to be used for the diagnosis of disease to treat a disease. On-site testing in the workplace is not "medical" or "diagnostic" testing. The employer, or school administrator, or probation officer who uses on-site drug tests is often the first line of defense in the deterrence of drug use. They are not used for a medical diagnosis but to prevent drug use,” stated Evans.

Employers use these tests for non-medical purposes such as:

1. To promote an orderly work environment and deter drug use.

2. To provide a cost effective method to reduce employer costs associated with drug abuse.

3. To discourage illegal or immoral conduct by employees.

4. To promote workplace safety.

“The FDA regulatory costs will be passed on to the thousands of small businesses who use these tests,” noted Evans. “This money could be better spent to hire new employees.”