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FDA Issues Warning on Power Toothbrushes

Cites issues with Arm & Hammer Spinbrush.

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By: TOM BRANNA

Editor

The US FDA yesterday sent out a consumer update about power toothbrushes, citing incidents with the 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,” said Shumaya Ali, M.P.H., a consumer safety officer at the Food and Drug Administration in the release from the agency. “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.”


According to the FDA post, 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 and Spinbrush Replacement Heads.


According to the FDA, 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, according to 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, causinginjuries.”


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,” noted 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.”


FDA’s inspection last year of Church & Dwight Co. Inc., which manufactures the Spinbrush, uncovered evidence that there had been numerous consumer complaints that had not been reported to the agency. On May 16, 2011, FDA reportedly warned the of its violations of the Federal Food, Drug, and Cosmetic Act, including failure to report—within a reasonable time frame—serious injuries.


After further discussions with Church & Dwight about the risks of the battery-powered Spinbrush, the company has taken some actions—improved the labeling to caution consumers to change the brush head every three months or sooner if the brush is worn or parts are loose, added bristles that change color with wear to give consumers a visual reminder of when to replace the brush head, and issued a safety notice about Spinbrush in television and print ads. The safety notice also appears on the Spinbrush website and the interactive voice response to consumers who call the company’s toll-free telephone numbers.

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