FDA Seeks to Regulate Complementary and Alternative Medicine; Products Such as Vegetable Juice Could Be Restricted for M...( Changes Would Cost Medicare Syste...),Health

Changes Would Cost Medicare System Billions

As Seniors Seek Conventional Treatments Instead

WASHINGTON, Sept. 5 /PRNewswire-USNewswire/ -- The Food and Drug Administration (FDA) is preparing new guidelines that threaten new, costly regulation of complementary and alternative medicines (CAM), used by 74.6 percent of adults at some point in their lives. The FDA guidance would define a product based on its "intended use." If vegetable juice were sold to satisfy thirst, for example, it would not be regulated, while if it were used to treat a medical condition (e.g. dehydration), it would be.

Under the guidelines, all items used for medicinal purposes -- including juices, lotions, vitamins and minerals -- could become more expensive and less available. As a result, millions of seniors may be forced to choose conventional treatments within the Medicare system instead of CAM paid for at their own expense, costing taxpayers unnecessary billions.

The FDA proposal, titled, "Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration," will represent the FDA's official thinking on this topic when finalized, but will not become regulatory policy. However, Congressional investigations frequently have found these types of guidance documents to be "intended to bypass the rulemaking process."

Complementary therapies might include aromatherapy to lessen a patient's discomfort during surgery; alternative therapies might include a special diet to treat cancer instead of chemotherapy. According to the National Institutes of Health, 74.6 percent of adults have used CAM at some point; a 2006 survey finds that close to two-thirds of adults over the age of 50 have used some form of CAM. The Centers for Disease Control estimated that the U.S. public spent between $36 billion and $47 billion on CAM therapies in 1997 alone.

"These changes mean that consumers will be less
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