FDA Upgrades Acupuncture Needles’ Status

The Food and Drug Administration on Friday classified acupuncture needles as medical devices for “general use” by trained professionals.

The agency did not go so far as to state that acupuncture is effective for any particular condition, an outcome many acupuncturists had hoped for.

But by designating instruments of a 2,000-year-old Chinese healing art in the same category with such standard Western medical tools as scalpels and syringes, the FDA removed a major barrier to insurance coverage for acupuncture treatments.

“It’s a very wise and logical decision,” said Wayne B. Jonas, director of the Office of Alternative Medicine at the National Institutes of Health in Bethesda, Md., which sponsors research on acupuncture.

More than two dozen states and the District of Columbia have legalized acupuncture, and an estimated 15 million Americans have tried it for a variety of conditions. Practitioners insert flexible needles into the skin at specific points, then twist them to enhance the flow of a hypothetical “energy” in the body.

*

Until now, however, acupuncture needles have been classified as Class III medical devices, meaning their safety and usefulness was so uncertain that they could only be used in approved research projects. Because of that “experimental” status, many insurance companies, as well as Medicare and Medicaid, have refused to cover acupuncture.

Although FDA officials are aware that most acupuncture treatments in this country are not part of any formal experimental protocol, they have for years turned a blind eye to such infractions. But in December 1994, a team of lawyers and acupuncturists formally asked the FDA to approve the needles for the treatment of a number of conditions: pain, nausea and vomiting, substance abuse, asthma and other respiratory conditions, and stroke and paralysis.

Scores of scientific studies were submitted with the application to bolster claims that acupuncture is a safe and effective treatment for those ailments.

Needle manufacturers will have to submit documentation detailing the materials used and other specifications. The needles must be labeled as “single use only.” They also must bear a prescription labeling statement that restricts their use to qualified practitioners.

Dan DiFonzo of the Health Insurance Assn. of America said it was too soon to say whether the ruling would open the door to wide coverage for acupuncture.