FDA Should Regulate Complementary, Alternative Medicine

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The FDA proposal, titled, "Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration," will represent the FDA's official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 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 Senior Citizens League (TSCL) filed comments with the FDA in May protesting the impending guidance. In its comments, TSCL wrote, "Currently, few CAM approaches are reimbursed by Medicare and are therefore paid out of pocket by the consumer. On the other hand, if vitamins and minerals were regulated as 'drugs,' Medicare might be required to pay for those same vitamins and minerals. Such a simple change in status for CAM theoretically could cost the Federal Government billions of dollars annually."

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.

"On behalf of its 1.2 million supporters, The Senior Citizens League is advocating for ways to ensure the long-term stability of Medicare," said Ralph McCutchen, chairman of The Senior Citizens League. "Not only does this secret plan threaten to bankrupt Medicare even sooner, but it takes choices away from seniors when they need them most."