FDA regulates electric toothbrushes as medical devices

You might be surprised to learn that electric toothbrushes are regulated as medical devices.

That's because they are intended to prevent tooth decay.  The FDA provides a succinct definition of a medical device as follows:

Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to premarketing and postmarketing regulatory controls. A device is:

  • "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
     
    • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
    • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
This definition provides a clear distinction between a medical device and other FDA regulated products such as drugs. If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug.

Recently the FDA issued this consumer alert:

When using your electric toothbrush, you don’t expect parts of the device to pop off and chip your tooth, fly into your eyes or get stuck in your throat.

But that’s exactly what has happened to some users of the battery-powered Arm & Hammer Spinbrush—or the Crest Spinbrush, as it was called before 2009.

“It’s important that consumers know how to avoid the risks associated with using the Spinbrush,” says Shumaya Ali, M.P.H., a consumer safety officer at the Food and Drug Administration. “We’ve had reports in which parts of the toothbrush broke off during use and were released into the mouth with great speed, causing broken teeth and presenting a choking hazard.”

FDA regulates toothbrushes—whether manual or electric—as medical devices that are intended to help prevent tooth decay. Safety precautions should be taken with all kinds of electric toothbrushes.

“Electric toothbrushes can be very effective in removing dental plaque, and so they can help prevent dental decay and gum disease,” says Susan Runner, D.D.S., chief of FDA’s dental devices branch. “At the same time, it’s important to supervise children when they use these brushes, and to look out for any malfunctions of the toothbrush that might cause an injury.”

Injuries reported from using the Spinbrush powered toothbrush include

  • chipped or broken teeth
  • cuts to the mouth and gums
  • swallowing and choking on broken pieces
  • injury to the face and eyes

FDA is alerting the public about the potential for injury while using the following models of Spinbrush:

  • Spinbrush ProClean
  • Spinbrush ProClean Recharge
  • Spinbrush Pro Whitening
  • Spinbrush SONIC
  • Spinbrush SONIC Recharge
  • Spinbrush Swirl
  • Spinbrush Classic Clean
  • Spinbrush For Kids
  • Spinbrush Replacement Heads

The Spinbrush handle contains batteries and a motor that operates the brushes, which are attached to a brush head. In the models of Spinbrush made for adults, the brush head is removable and can be replaced.

But the brush head should not pop off during normal use, says Ali. “In some cases, the brush head popped off to expose metal pieces underneath that can—and have—poked individuals in the cheek and areas near the eyes, causing  injuries.”

The “Spinbrush for Kids” models, which have different handle designs, such as Spiderman and Thomas & Friends, do not have removable brush heads.  Nonetheless, problems with the Spinbrush for Kids have also been reported, such as cut lips, burns from the batteries, and bristles falling off and lodging in a child’s tonsils.

“FDA’s concern is that the unexpected release of any part of this battery-powered toothbrush during use poses a risk of injury,” says Steven Silverman, director of the Office of Compliance in FDA’s Center for Devices and Radiological Health. “And the risk is higher in children or adults who may need assistance but are not supervised while using the toothbrush.”

If you have a product intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, then you may have a medical device or a drug regulated by the FDA.

Even if you think you a dietary supplement, once you make a claim about treating, preventing or curing a disease, you may fall into the drug category. 

If you have a product, consult a skilled lawyer who understands FDA law relating to foods, drugs, cosmetics, dietary supplements, and medical devices.