Author: Connett M.

Source: N/A

Year: 2016

Comment:

Abstract / Excerpt:

Pursuant to 21 C.F.R. § 10.25(a)(2) and 21 C.F.R. § 10.30, the Fluoride Action Network and International Academy of Oral Medicine & Toxicology (collectively, “Petitioners”), respectfully submit this Petition to request that the Commissioner of the U.S. Food & Drug Administration (FDA) exercise its authority under the Food, Drug & Cosmetic Act to take action to ensure an expedited removal from the market of unapproved, unsafe, unnecessary, and ineffective sodium fluoride-containing drops, tablets, and lozenges sold for the intended purpose of caries prevention (i.e., “fluoride supplements”).

Citation: Connett M. Citizen petition to FDA re: fluoride drops, tables, & lozenges. May 16, 2016. To the United States Food and Drug Administration (FDA) from the Fluoride Action Network (FAN) and the International Academy of Oral Medicine and Toxicology (IAOMT).