FDA Says Home Drug Test Uncertified!

FDA Says Home Drug Test Uncertified!
Posted by FoM on July 21, 1999 at 12:46:51 PT
From Bloomberg News
Source: LA Times
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.Pubdate: July 21, 1999Copyright 1999 Los Angeles Times. All Rights Reserved 
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Comment #1 posted by frank cowsert jr. on July 21, 19119 at 19:37:22 PT:
de guvmint duz't agin........
another infringement on people's freedom and right to privacy...they make us pee in a bottle...but won't let us check ourselves...HELLO BIG BROTHER! they seem to think they are did Marie Antoinette...we'll see....
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