Sunday, May 15, 2005

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Indirectly harmful products are those that do not themselves cause
injury, but may lead people to delay or reject proven remedies,
possibly worsening their condition. For example, if cancer patients
reject proven drug therapies in favor of unproven ones and the
unproven ones turn out not to work, their disease may advance
beyond the point where proven therapies can help.

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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.