The FDA guidance would define a product based on its "intended use." For example based on new the measures if vegetable juice were sold to satisfy thirst, 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.
If the new measures are approved millions of Americans- close to 75 percent of U.S. citizens will be affected. As a result, millions of seniors may be forced to choose between conventional treatments within the Medicare system instead of CAM paid for at their own expense, costing taxpayers unnecessary billions.
"These changes mean that consumers will be less likely to be able to treat themselves without excessive government interference," said Shannon Benton, executive director of The Senior Citizens League.
"Seniors who previously saved money by treating themselves with vitamins, lotions, or protein shakes may now need a prescription -- forcing them to bill Medicare for conventional medical treatments, costing the American taxpayer billions of dollars."
The FDA proposal, titled, "Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration," is slated to simply be a representation of the FDA's official standing on this topic, but many inside the federal government say it won't become regulatory policy. However according to critics of the plan, Congressional investigations frequently have found these types of guidance documents to be "intended to bypass the rulemaking process."
What's shocking to health practioners and proponents of alternative medicines is the categories that would be affected.
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.
Medicare's trustees forecast that the Medicare trust fund will be exhausted by 2019. The FDA's new proposal risks bankrupting Medicare's trust funds even sooner.
