FDA approves over-the-counter drug test
January 21, 1997
Web posted at: 8:50 p.m. EST
WASHINGTON (CNN) -- The Food and Drug Administration cleared
an over-the-counter drug test kit Tuesday, the first such
test to win federal approval.
The urine test can detect illegal drugs such as marijuana,
PCP, amphetamines, cocaine and heroin, and is expected to be
popular with parents and families of drug-rehabilitation
Dr. Brown's Home Drug Testing System, made by Personal Health
and Hygiene Inc., has equipment for urine collection, storage
and mailing, and instructions for getting results and
Test creator J. Theodore Brown Jr., a Silver Spring,
Maryland, psychologist, said his kits will reach drugstores
within six weeks and will cost less than $30.
Consumers will mail a urine sample in a tamper-proof package
to a government-certified laboratory which uses FDA-approved
drug tests, including confirmatory retests to minimize false
results. Consumers anonymously telephone a toll-free number
All drug tests can give false-positive as well as
false-negative results. For example, they can miss abuse when
the urine is sampled too late, and can falsely signal abuse
if the person ate foods that mimic the metabolites drug tests
Last year, the FDA allowed some similar products to be
marketed without its approval under a so-called interim
The agency did so after being criticized in September for
cracking down on an Atlanta woman who sold 1,000 home
drug-test kits without the FDA's knowledge. The FDA said it
did not know if her test was accurate, but congressional
critics argued the agency was preventing parents from getting
tests employers can use.
The FDA relented, letting home drug tests to be sold
temporarily while it reevaluated how strictly such kits
should be regulated.
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