Is acupuncture FDA approved?
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Nope. Only acupuncture needles themselves are approved as a Class II medical device (since 1996), not the practice of acupuncture itself. The FDA just requires needles to be sterile, non-toxic, labelled as single-use, and “used appropriately by licensed practitioners.”
In other words, they want acupuncture needles to be sharp, clean, and used with legitimate medical intent by trained people — as opposed to dull, dirty, and inserted under your fingernails by baristas. It’s a low bar.
Naturally, acupuncture practitioners often claim (or strongly imply) that FDA approval means that acupuncture works, that it is “endorsed” as effective (like here or here). This is ignorant and deceptive.
So what does “FDA approved” actually mean?
The FDA actually only requires evidence of efficacy for drugs (not proof). For everything else they regulate, they are focused on safety. For instance, FDA approval of food additives and medical devices mainly just means “probably safe as long as you don’t do something stupid with it.”
For medical devices, which includes everything from lasers to acupuncture needles, the FDA officially requires “valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses” (FD&C Act Chapter V: Drugs and Devices, section §360d, “Performance standards”). What they mean by “effective” is not medically beneficial (“efficacious”), but just that it does what it says on the tin.
For example, FDA approval of a laser therapy device means that it does in fact emit lasers •pew pew!• and it won’t hurt people when used appropriately… not that doing so is known to solve any medical problem.
In the case of acupuncture needles, FDA approval as “safe and effective” means that the needles will, in fact, safely puncture the skin when used appropriately. It does not mean that doing so is therapeutic.
Real world safety of acupuncture
The FDA screws up, and their approval is hardly a guarantee of anything in any case. Just because they have certified something as safe and effective doesn’t mean it actually is. There’s a long history of embarrassing examples of things the FDA should never have approved!
Acupuncture needles may be FDA approved as safe “when used as intended by licensed practitioners,” but the words as intended are doing a lot of heavy lifting there, and licensing doesn’t guarantee competence, wisdom, or even common sense.
Obviously acupuncture education isn’t exactly known for its devotion to science and physiology. Most acupuncturists sincerely believe we have magic energy fields, after all. They are on the record (in droves) claiming that acupuncture can treat COVID.
But even when used properly by practitioners who aren’t dangerously ignorant, acupuncture still isn’t completely innocuous — nothing that breaks the skin ever is (infection). If this was done for the sake of proven medical benefit, the trivial risks would be worth it. But there are no proven medical benefits and never have been, despite constant claims to the contrary.
This post is an excerpt from an update to my full report on acupuncture:Does Acupuncture Work for Pain? A review of modern acupuncture evidence and myths, focused on treatment of back pain & other common chronic pains