Wednesday, April 27, 2005

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It consisted of an audio cassette and eyeglasses that emitted sounds
and flashing lights. It caused epileptic seizures in some users. As a
result of a court order requested by FDA, 78 cartons of the devices,
valued at $200,000, were seized by U.S. marshals and destroyed in
June 1993.

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Unproven products cause direct health hazards when their use results
in injuries or adverse reactions. For example, a medical device called
the InnerQuest Brain Wave Synchronizer was promoted to alter brain
waves and relieve stress.

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Regulatory actions may be necessary in many cases because products
that have not been shown to be safe and effective pose potential
hazards for consumers both directly and indirectly. The agency's
priorities for regulatory action depend on the situation; direct risks to
health come first.

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To combat health fraud, FDA established its National Health Fraud
Unit in 1988. The unit works with the National Association of
Attorneys General and the Association of Food and Drug Officials to
coordinate federal, state and local regulatory actions against specific
health frauds.