FDA Seeking Comments on Labeling Proposal

FDA Seeking Comments on Labeling Proposal

WASHINGTON--The Food and Drug Administration (FDA) is reopening the commentperiod on a 1995 food labeling proposal. The agency is publishing the proposedrule in the May 4 Federal Register and will take comments for 60 days.Among the topics of interest are whether to allow unqualified health claims onfoods that do not contain 10 percent or more of certain required nutrients; andwhether the use of synonyms and/or abbreviated health claims are appropriate.

The original proposal, published in December 1995, proposed to amend theNutrition Labeling and Education Act (NLEA) to permit flexibility in the use ofnutrient content claims and health claims on food products and dietarysupplements. Among the proposals were allowing the use of unlisted synonyms fornutrient content claims; permitting claims on foods that do not contain 10percent of one or more certain required nutrients; allowing abbreviated healthclaims; and, providing criteria for FDA to consider in allowing unqualifiedhealth claims on foods containing high levels of one or more nutrients. Whilethe agency extended the comment period several times, it never published a finalrule on the proposal.

After FDA's task force from the Consumer Health Information for Better HealthInitiative in 2002 recommended the agency seek comment on unqualified healthclaims and other health topics, FDA published an advance notice of proposedrulemaking (ANPR). Notably, the ANPR did not cover the topics addressed in the1995 proposal, as FDA decided to seek comments to finalize that earlier proposedrule. As such, the agency reopened the comment period; the complete document isavailable online (www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm).

Written or electronic comments must be submitted by July 2 and referenceDocket Nos. 1994P-0390 and 1995P-0241. Comments may be submitted online (www.regulations.gov),via e-mail ([email protected]) orby mail (Division of Dockets Management, 5630 Fishers Lane, Room 1061,Rockville, MD 20852).