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Oral care labeling

This article was originally published in The Rose Sheet

Executive Summary

FDA exempts OTC dentifrices, mouthwash and mouth rinse products that contain sodium, calcium, magnesium or potassium from final rule requiring cautionary labeling for products intended for oral ingestion, agency states in the March 24 Federal Register in one 1notice for sodium and another 2notice for the remaining ingredients. FDA says it concurs with industry, which argued in comments that oral products do not pose the same risks as those ingested orally because the amount absorbed or accidentally ingested would be too small to pose a health threat. Industry also maintained that cautionary labeling could falsely suggest the products are intended for oral ingestion. FDA had proposed including the product categories in an amendment to a proposed final rule in1996. Final rule is effective April 23...
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