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ADA on OTC oral health care

This article was originally published in The Rose Sheet

Executive Summary

When an antiplaque claim is made for an OTC oral healthcare product, that product "should also be required to show that it is effective in reducing gingivitis," the American Dental Association asserts in comments to FDA Nov. 25. ADA supports FDA's recommendations in its advance notice of proposed rulemaking, but runs counter to industry's suggestion that antiplaque claims should stand on their own (1"The Rose Sheet" Dec. 1, 2003, p. 3). ADA also says it is "rational" to combine an anticaries or desensitizing agent with a Category I antigingivitis/antiplaque agent. However, supporting data "should be submitted demonstrating that specific combination products are safe and effective for all indications," trade group adds. ADA further points out that while chlorhexidine digluconate has not been marketed for a material time and to a material extent for OTC use in the U.S., it has been used in prescription products with significant published data supporting its safety and efficacy...
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