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HHS/FDA RIN: 0910-AF23 Publication ID: Fall 2004 
Title: Food Labeling; Serving Sizes of Products That Can Reasonably Be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes 
Abstract: In response to the Report of the Working Group on Obesity (OWG) that FDA issued on March 12, 2004, the agency will issue an advance notice of proposed rulemaking (ANPRM) in its efforts to combat the Nation’s obesity problem. The ANPRM will request comments on changes to the agency’s nutrition labeling regulations on serving size and comments on allowance of truthful, nonmisleading, and useful approaches for promoting consumption of smaller portion sizes. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 101.9(b)    21 CFR 101.12   
Legal Authority: 21 USC 321    21 USC 343    21 USC 371   
Legal Deadline:  None

Statement of Need: The Nation is currently facing a major long-term public health crisis. This trend toward overweight and obesity has accelerated during the past decade and is well documented by numerous scientific analyses. In 1999-2000, 64 percent of U.S. adults were overweight, increased from 56 percent when surveyed in 1988-1994; 30 percent of adults were obese, increased from 23 percent in the earlier survey. Among children age 6 through 19 years, 15 percent were overweight, compared with 10 percent to 11 percent in the earlier survey. Overweight and obesity are associated with increased morbidity and mortality. It is estimated that about 400,000 deaths per year may be attributed to obesity, and overweight and obesity increase the risk for coronary heart disease, type 2 diabetes, and certain cancers. The total economic cost of obesity in the United States is up to $117 billion per year, including more than $50 billion in avoidable medical costs, more than 5 percent of total annual health care expenditures. Fundamentally, overweight and obesity represents an imbalance between energy intake (e.g., calorie intake) and energy output (expended both as physical activity and metabolic activity).

Summary of the Legal Basis: Section 403(q)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (21 USC 343 (q)(1)(A)(i)) provides that certain foods under FDA’s jurisdiction bear nutrition information based on a serving size that reflects the amount of food customarily consumed and is expressed in a common household measure appropriate to the food. This ANPRM is soliciting recommendations on ways to amend certain provisions of its nutrition labeling regulations concerning serving size

Alternatives: Possible alternatives to this advance notice of proposed rulemaking are: (1) do not amend certain serving size provisions of the nutrition labeling regulations, particularly on packaged products that can be readily consumed at one eating occasion, but that indicate they represent more than one serving; or (2) rely on industry to voluntarily revise their labels to clarify that, particularly for packaged products that can be readily consumed at one eating occasion, that there is more than one serving in the package.

Anticipated Costs and Benefits: If rulemaking results from this ANPRM, the rule would generate costs because it would require firms to relabel some food products, in addition to potential reformulation and testing costs. Benefits of any rulemaking resulting from this ANPRM, depends on how consumers and producers respond to any changes in labeling serving sizes or portion sizes.

Risks: Attention to serving size is a key element of weight control since weight loss and weight management are dependent on the amount of food consumed at one eating occasion. Clarifying how serving size is presented on food labels is one way to provide consumers with information about their caloric intake.

Action Date FR Cite
ANPRM  12/00/2004    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
Agency Contact:
Lori LeGault
Department of Health and Human Services
Food and Drug Administration
HFS-840, 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:301 436-1791
Fax:301 436-2635

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