FDA Reopens Comment Period for 1995 Proposed Rule on Health Claims in Food Labeling
The Food and Drug Administration (FDA) has issued a notice announcing that it is reopening until July 6, 2004 the comment period for a 1995 proposed rule which proposed, among other things, to amend the FDA's existing health claims regulations to provide additional flexibility in the use of these claims on food products.
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According to FDA, the comment period is being reopened because of the length of time that has elapsed since publication of the 1995 proposed rule, and the recent availability of a report by the Task Force for the Consumer Health Information for Better Nutrition Initiative, FDA is interested in updating the administrative record for the 1995 proposed rule by seeking comments before issuing a final rule.
Although the FDA's notice requesting comments states that only certain components of the 1995 proposed rule are open for comment, FDA sources have stated by phone that FDA is actually seeking comments on the entire 1995 proposed rule, which concerned the use of unqualified health claims in food labeling, as well as specified topics from the Task Force's report that relate to unqualified health claims. (FDA sources explain that the term "unqualified health claim" means there is significant scientific agreement about a health claim appearing on a food label and, as such, it requires no disclaimer.)
The FDA states that comments previously submitted do not need to be resubmitted because all comments submitted to the previously listed docket numbers will be considered in any final rule to the 1995 proposal.
(See ITT's Online Archives or (Ref:95122175A), for BP summary of the 1995 proposed rule.)
-written or electronic comments must be submitted by July 6, 2004.
FDA Contact - Ritu Nalubola (301) 436-2371
Task Force Final Report & related documents available at http://www.fda.gov/oc/mcclellan/chbn.html
FDA notice (D/Ns 1994P-0390 and 1995P-0241, FR Pub 05/04/04) available athttp://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/pdf/04-10126.pdf