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HHS/FDA

RIN: 0910-AF99

Publication ID: Fall 2008

Title: Food Labeling; Serving Sizes and Nutrition Labeling (Section 610 Review)
Abstract: Section 101.9 (21 CFR part 101.9) describes the nutrition labeling requirements for foods. Section 101.12 (21 CFR part 101.2) specifies the reference amount customarily consumed per eating occasion for each food category. The reference amount customarily consumed of a food is the basis for the serving size that is declared in the food's nutrition labeling. Under section 101.9, the serving size must be expressed in a common household measure that is appropriate to the food. The most recent change to sections 101.9 and 101.12 was in 1999, when FDA amended these regulations to reduce the reference amount customarily consumed for baking powder, baking soda, and pectin, and to include 1/8 teaspoon as an allowable unit of household measure for nutrition labeling purposes. FDA is undertaking a review of sections 101.9 and 101.12 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in sections 101.9 and 101.12 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities. FDA will consider, and is soliciting comments on the following: (1) The continued need for the regulations in sections 101.9 and 101.12; (2) the nature of complaints or comments received concerning the regulations in sections 101.9 and 101.12; (3) the complexity of the regulations; (4) the extent to which the regulations in sections 101.9 and 101.12 overlap, duplicate, or conflict with other Federal rules, and to the extent feasible, with State or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulations in sections 101.9 and 101.12.
Agency: Department of Health and Human Services(HHS)	Priority: Routine and Frequent
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Prerule Stage
Major: No	Unfunded Mandates: No
RFA Section 610 Review: Section 610 Review
CFR Citation: 21 CFR 101
Legal Authority: 15 USC 1453 to 1455 21 USC 321 21 USC 331 21 USC 342 and 343 21 USC 348 21 USC 371

Legal Deadline:

Action	Source	Description	Date
Other	Statutory	Planned section 610 review	03/16/2009

Timetable:

Action	Date	FR Cite
Begin Review	12/00/2008
End Review	03/00/2009

Regulatory Flexibility Analysis Required: Undetermined	Government Levels Affected: Undetermined
Federalism: Undetermined
Included in the Regulatory Plan: No
RIN Data Printed in the FR: Yes
Agency Contact: Mary Brandt Statistician Department of Health and Human Services Food and Drug Administration Center for Food Safey and Applied Nutrition, 5100 Paint Branch Parkway, ONLDS (HFS-820), College Park, MD 20740 Phone:301 436-1788 Fax:301 436-1191 Email: mary.brandt@fda.hhs.gov