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HHS/FDA RIN: 0910-AF22 Publication ID: Fall 2004 
Title: Food Labeling; Prominence of Calories 
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 ways to give more prominence to “calories” on the food label. 
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: Undetermined 
CFR Citation: 21 CFR 101.9   
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)(C) of the Federal Food, Drug, and Cosmetic Act (21 USC 343) provides that certain foods under FDA’s jurisdiction bear nutrition information that provides for, among other things, the total calories served from any source and the total number of calories derived from total fat in each serving size or other unit of measure. This ANPRM is soliciting recommendations on ways to give more prominence to caloric information on the food label.

Alternatives: Possible alternatives to this advance notice of proposed rulemaking are: 1) do not amend certain provisions of the nutrition labeling regulations to give more prominence to calories on the food label; or 2) rely on industry to voluntarily give more prominence to “calories” on the food label.

Anticipated Costs and Benefits: If rulemaking results from this ANPRM, the rule would generate costs because it would require firms to reformulate food labels. Benefits of any rulemaking resulting from this ANPRM, depends on how consumers and producers respond to any changes in calorie labeling.

Risks: Attention to caloric intake is a key element of weight control since weight loss and weight management are dependent on caloric balance. Increasing the prominence of caloric information 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:
Jill Kevala
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition (HFS-830), 5100 Paint Branch Parkway,
College Park, MD 20740
Phone:301 436-1450
Fax:301 436-1191

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