Sunday, June 19, 2005

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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.

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Health fraud costs Americans an estimated $30 billion a year.
However, the costs are not just economic, according to John Renner,
M.D., a Kansas City-based champion of quality health care for the
elderly. "The hidden costs--death, disability--are unbelievable," he
says.

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Avoiding Fraud
FDA defines health fraud as the promotion, advertisement,
distribution, or sale of articles, intended for human or animal use, that
are represented as being effective to diagnose, prevent, cure, treat, or
mitigate disease (or other conditions), or provide a beneficial effect on
health, but which have not been scientifically proven safe and effective
for such purposes. Such practices may be deliberately deceptive, or
done without adequate knowledge or understanding of the article.