Worldwide Medical Corp. is selling its First Check Home Drug Test without required clearance from the U.S. Food and Drug Administration, the agency said in a warning letter.
The product, which screens people for traces of marijuana, cocaine, opiates and methamphetamines, fits the definition of a "medical device" that requires FDA approval, the agency said.
The July 7 letter, released Tuesday through the Freedom of Information Act, said the company never submitted information to the agency showing the product to be safe or effective.
Worldwide Medical, an Irvine-based developer of various diagnostic drugs, could not be reached for comment.
Companies must apply for FDA clearance of medical devices under the Federal Food, Drug, and Cosmetic Act. Although the product had a label saying that it was "not to be used for medical purposes," the FDA letter said the disclaimers didn't free the company from regulation.
Shares in Worldwide Medical fell 13 cents Tuesday to close at $3.06 in over-the-counter trading.
The FDA sends hundreds of warning letters to companies each year, and only a small number result in any significant agency action. Still, the letters can be the last notice before the FDA takes steps such as seizing inventory or pursuing civil fines.