FDA Seeks Stricter Regulations for Alternative Medicines

The FDA is proposing stricter regulations for herbs, vitamins, vegetable juices and even “devices” such as massage oils, massage rocks, and acupuncture needles under a new guidance document up for review.

Complementary and Alternative Medicines are defined by NCCAM (the National Center for Complimentary and Alternative Medicine, a branch of the National Institutes of Health) as any medical practices that are distinctly different from those used in “conventional” or “allopathic” medicine generally practiced in the United States. It’s a very broad definition, encompassing such practices as acupuncture, massage therapy, herbal supplementation, and aromatherapy.

According to the document produced by the FDA, use of CAM therapies has risen substantially over the last few years, with one third of adults reporting using some form of CAM in the last year. Interestingly, the docket also reports that visits to CAM practitioners outnumber visits to primary care physicians each year.

The FDA claims that their regulations are simply a “guidance” as to what constitutes regulated CAM items. The CAM community disagrees. They see the defining of regulated items as an attempt to control the use of CAM within the United States—and possibly incorporate CAM devices and medicines into what some refer to as “Big Pharma,” the pharmaceutical industry.

The guidance document essentially defines any item used to treat, mitigate, cure or prevent a disease as regulated by the FDA. This means that if someone claims their vegetable juice helps cure cancer, the FDA then has the right to regulate that vegetable juice as a drug. It also means that if someone is using massage rocks as part of their therapy for a disease or disorder, those massage rocks are regulated as medical devices.

What impact does that have on the CAM practitioner and consumer? If something is regulated by the FDA as a drug or medical device, its use is restricted. People will no longer be able to legally grow or distribute herbs in their garden if those herbs are used for medicinal purposes or administer juice if that juice is said to have health benefits.

This might seem rather inconsequential, but rising drug costs cause alarm within the CAM community. FDA regulations of prescription medication have served a beneficial purpose—but they’ve also given control of prescription medications to the multi-national pharmaceutical companies, downgrading competition and sending drug costs soaring. The fear is that, if the FDA declares massage rocks, herbs, vitamins, juices, and acupuncture needles as “drugs” or “medical devices,” the same thing will happen for CAMs, and consumers will lose their access.

People have until April 30, 2007 to make comments on the docket available at the FDA:

Docket: 2006D-0480 - Draft Guidance [pdf document]

Docket Management Comment Form

Anyone who is interested in getting more involved should contact their representatives in congress.

© Copyright 2007 Insight Journal Online Magazine.

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