FDA SAYS HOME DRUG TEST UNCERTIFIED

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.