FDA Approves Claim for Fluoridated Water

On Oct 14, FDA released a notification regarding a label health claim for bottled water. The agency notes that on June 16, 2006, it received a notification from a law firm regarding a health claim for the relationship between fluoridated water and a reduced risk of dental caries. After waiting a 120-day period from the date of submission, FDA notes that manufacturers may now use the claim specified in the notification, as modified by the notifier in a letter to FDA dated Oct. 13, on the label and/or other labeling of any food product that meets the eligibility criteria, unless or until FDA or a court acts to prohibit the claim.

According to the June 16 notification and the letter to FDA dated Oct. 13, the food eligible to bear the claim is bottled water meeting the standards of identity and quality set forth in 21 CFR 165.110 (see http://www.cfsan.fda.gov/~lrd/FCF165.html), containing greater than 0.6 mg and up to 1.0 mg per liter total fluoride, and meeting all general requirements for health claims (see 21 CFR 101.14; http://www.gpo.gov/nara/cfr/waisidx_02/21cfr101_02.html) with the exception of minimum nutrient contribution (21 CFR 101.14 (e)(6)). The claim language is:

"Drinking fluoridated water may reduce the risk of [dental caries or tooth decay]."

The health claim is not intended for use on bottled water products specifically marketed for use by infants.

The notification and materials regarding the claim are publicly available from the FDA Division of Dockets Management (Docket No.2006Q-0418). Persons interested in these documents may view them at the Division of Dockets Management from 9 A.M. to 4 P.M., Monday through Friday at 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The Division of Dockets Management may be contacted at 301/827-6860. FDA also intends to make the documents available on the Dockets website at http://www.fda.gov/ohrms/dockets/dockets/dockets.htm under Docket No. 2006Q-0418.

To read the complete FDA statement on this subject, see http://www.cfsan.fda.gov/~dms/flfluoro.html.