PROPOSAL CHANGES IN THE NUTRITIONAL LABELING PROPOSAL CHANGES IN THE NUTRITIONAL LABELING
U..S. FOOD AND DRUG ADMINISTRATION

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Proposed Changes to the Nutrition Facts Label

The FDA is proposing to update the Nutrition Facts label found on most food packages in the United States. The Nutrition Facts label, introduced 20 years ago, helps consumers make informed food choices and maintain healthy dietary practices. If adopted, the proposed changes would include the following.

Greater Understanding of Nutrition Science Updated Serving Size Requirements and New Labeling Requirements for Certain Package Sizes Refreshed Design How to Comment on the Proposed Nutrition Label

FDA issuedtwo proposed rules on the nutrition facts label. The rules arepublished in the Federal Register (FR) so that members of the public can reviewthem and send their comments to us. The public is given a period of time to submit their comments.

The comment period closed August 1, 2014.

You may view submitted comments in the docket folder ofeach rule.

Food Labeling: Revision of the Nutrition and Supplement Facts Label

Docket Folder: FDA-2012-N-1210

Serving Sizes of Foods that can Reasonably be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily

Docket Folder: FDA-2004-N-0258

Explaining the Proposed Changes Highlights of the Proposed Changes Label Formats: Original vs. Proposed Serving Size Changes Questions & Answers Full Factsheet on the New Proposed Nutrition Facts Label Food Serving Sizes Get A Reality Check (Info-graphic)(PDF – 543KB) Proposed Nutrition Facts Label: What’s the Difference (Info-graphic) (PDF – 574KB) Audio Bites from FDA Commissioner Margaret A. Hamburg, M.D. Preliminary Regulatory Impact Analysis of the Proposed Rules (PDF: 397KB) Public Meeting Information Consumer Updates Proposed Nutrition Facts Label At-A-Glance

The FDA is proposing to update the Nutrition Facts label found on most food packages in the United States. The Nutrition Facts label, introduced 20 years ago, helps consumers make informed food choices and maintain healthy dietary practices. If adopted, the proposed changes would include the following.

1. Greater Understanding of Nutrition Science

Require information about “added sugars.” Many experts recommend consuming fewer calories from added sugar because they can decrease the intake of nutrient-rich foods while increasing calorie intake. Update daily values for nutrients like sodium, dietary fiber and Vitamin D. Daily values are used to calculate the Percent Daily Value listed on the label, which help consumers understand the nutrition information in the context of a total daily diet. Require manufacturers to declare the amount of potassium and Vitamin D on the label, because they are new “nutrients of public health significance.” Calcium and iron would continue to be required, and Vitamins A and C could be included on a voluntary basis. While continuing to require “Total Fat,” “Saturated Fat,” and “Trans Fat” on the label, “Calories from Fat” would be removed because research shows the type of fat is more important than the amount.

2. Updated Serving Size Requirements and New Labeling Requirements for Certain Package Sizes

Change the serving size requirements to reflect how people eat and drink today, which has changed since serving sizes were first established 20 years ago. By law, the label information on serving sizes must be based on what people actually eat, not on what they “should” be eating. Require that packaged foods, including drinks, that are typically eaten in one sitting be labeled as a single serving and that calorie and nutrient information be declared for the entire package. For example, a 20-ounce bottle of soda, typically consumed in a single sitting, would be labeled as one serving rather than as more than one serving. For certain packages that are larger and could be consumed in one sitting or multiple sittings, manufacturers would have to provide “dual column” labels to indicate both “per serving” and “per package” calories and nutrient information. Examples would be a 24-ounce bottle of soda or a pint of ice cream. This way, people would be able to easily understand how many calories and nutrients they are getting if they eat or drink the entire package at one time.

3. Refreshed Design

Make calories and serving sizes more prominent to emphasize parts of the label that are important in addressing current public health concerns such as obesity, diabetes, and cardiovascular disease. Shift the Percent Daily Value to the left of the label, so it would come first. This is important because the Percent Daily Value tells you how much of certain nutrients you are getting from a particular food in the context of a total daily diet. Change the footnote to more clearly explain the meaning of the Percent Daily Value.

Read more in the Factsheet on the New Proposed Nutrition Facts Label.

Label Formats

Original vs. Proposed

Proposed Serving Size Changes

What’s considered a single serving has changed in the decades since the original nutrition label was created. So now serving sizes will be more realistic to reflect how much people typically eat at one time.

Click to enlarge the serving sizeinfo-graphic (PDF: 85 K)

Questions & Answers

General

1. What changes are you planning to make on the label and how did you decide to make them?
The FDA’s proposed new Nutrition Facts label will make it easier for consumers to make informed decisions about the food they eat. The label reflects the latest scientific thinking about nutrition and the links between what people eat and chronic diseases like obesity and cardiovascular disease. FDA is proposing changes to the label based on new nutrition and public health research, the most recent dietary recommendations from expert groups, and input from four Advance Notices of Proposed Rule Making and various citizens’ petitions.Among the changes being considered for the proposed rules are: modifications to the required nutrients, based on the latest nutrition science; updated serving size requirements and labeling requirements for certain package sizes; and a refreshed design.

2. Will you be asking for comment on the proposed changes?
Yes, the two proposed rules are available for public comment for 90 days, and the agency looks forward to receiving comments.

3. Has the Nutrition Facts label changed since 1993?
While the Nutrition Facts label has been an important tool to help people make better food choices over the past 20 years, the only major change has been the requirement, effective in 2006, that trans fat be declared.

4. Are consumers using the label?Do we know what parts of the label they use most often?
Data from FDA’s Health and Diet Surveys in 2002 and 2008 show that more and more consumers are using the Nutrition Facts label.For example, the percentage of respondents reporting that they “often” read a food label the first time they purchase a food product rose from 44 percent in 2002 to 54 percent in 2008, and, among these consumers, two-thirds reported using the label to see how high or low the food was in components such as calories, sodium, vitamins or fat.More than half said they used labels to get a general idea of the nutritional content of the product.

5. How has the label influenced people’s eating habits, especially given the obesity epidemic?
The Nutrition Facts label provides information that addresses a number of nutritional concerns, including obesity. However, obesity is not the only important nutritional problem among the U.S. population.While concerns in recent years have largely shifted away from nutritional deficiencies, some population subgroups may still consume inadequate amounts of certain nutrients such as calcium and iron.Also, many nutrients are associated with chronic disease risk such as heart disease.The Nutrition Facts label can help address these nutritional concerns by providing information that consumers can use to make healthy choices.

As for the obesity epidemic, there are many contributing factors, such as exercise and eating behaviors, which are not addressed by the nutrition label.The Nutrition Facts label is one tool to help consumers make informed food choices and maintain healthy dietary practices, but these other factors must be addressed as well.

Also, the label may encourage manufacturers to reformulate existing products and offer new products with a healthier nutrition profile. The food industry has introduced thousands of new product choices with fewer calories, reduced fat, sodium and sugar, and more whole grains since the Nutrition Facts Label requirement was implemented.Following the requirement that trans fat be declared on the label, manufacturers worked to significantly decrease the trans fat content of food products.

Restaurant Foods

6. Because consumers are eating outside the home more and more, shouldn’t this nutrition information be found not just on food packages in stores but in restaurants?
Section 4205 of the Affordable Care Act, signed into law on March 23, 2010, directs the FDA to establish labeling requirements for restaurants, similar retail food establishments and vending machines.The FDA issued proposed regulations on April 6, 2011, but they have not yet been finalized.

Sodium

7. Why are you proposing a daily value of 2,300 mg for sodium but asking for comment on a much lower daily value of 1,500 mg?
Although sodium is an essential nutrient in the diet, increases in sodium can increase blood pressure.The FDA is proposing to set a daily value of 2,300 mg for sodium, which is based on the tolerable upper intake level for sodium established in 2005 by the Institute of Medicine (IOM) and current sodium recommendations from other consensus reports.The Daily Value on the current label is 2,400 mg, so the proposed change would not be significant.A Daily Value of 2,300 mg, however, is much lower than the average daily consumption in the U.S. of about 3,400 mg/day.

Some evidence, however, points to the need for a lower daily value.For example, the 2010 Dietary Guidelines for Americans recommended a reduction in sodium intake to less than 2,300 mg/day and a further reduction to 1,500 mg/day among groups that are at increased risk of the blood pressure-raising effects of sodium (individuals ages 51 or older, African Americans, and individuals with high blood pressure, chronic kidney disease or diabetes).These groups account for about half the U.S. population. But a recent IOM report on sodium issued in 2013 concluded that evidence from studies on direct health outcomes is inconsistent and insufficient to conclude that lowering sodium intakes below 2,300 mg/day will increase or decrease the risk of cardiovascular disease outcomes or mortality in the general U.S. population or in identified subgroups.Thus, FDA is proposing a daily value of 2,300 mg but is asking for comment on whether a daily value of 1,500 mg would be more appropriate and alternative approaches for selecting a dietary value for sodium.

Meanwhile, because approximately 75 percent of the sodium consumed by the U.S. population is from sodium added to food during processing, FDA is separately developing a long-term strategy to reduce the sodium content of the food supply to make it easier for people to consume less sodium.

Added Sugars

8. Why are you proposing to require declaration of “added sugars?”
The current label requires declaration of “Sugars.” The proposed rule would require declaration of “Added sugars” as well, indented under “Sugars,” to help consumers understand how much sugar is naturally occurring and how much has been added to the product. This proposal takes into account new data and information, including recommendations from federal agencies and information from other expert groups, citizen petitions, and public comments.For example, the Dietary Guidelines for Americans recommend reducing caloric intake from added sugars and solid fats because eating these can cause people to eat less of nutrient-rich foods and can also increase how many calories they take in overall. Added sugars provide no additional nutrient value, and are often referred to as “empty calories.” Expert groups such as the American Heart Association, the American Academy of Pediatrics, the Institute of Medicine and the World Health Organization also recommend decreasing intake of added sugars.

9. How much added sugars do Americans consume?
On average, Americans get 16 percent of their total calories from added sugars.The major sources of added sugars in the diet (with the highest sources listed first) are soda, energy and sports drinks, grain based desserts, sugar-sweetened fruit drinks, dairy-based desserts and candy.

10. To what level should consumers limit their intake of added sugars?
The government has no specific recommendation for added sugars.Including added sugars on the new Nutrition Facts label would allow consumers who want to limit their added sugar intake to compare various brands of similar products.

Nutrients of Public Health Significance

11. What are nutrients of public health significance?
These are nutrients that, when lacking, are associated with the risk of chronic disease. Essentially, they are nutrients Americans don’t eat enough of. The FDA believes these should be declared on the label so that people can see how much of these important nutrients are in the products.The FDA examined data from the National Health and Nutrition Examination Survey to determine which essential vitamins and minerals should be included as nutrients of public health significance.The FDA has proposed that the nutrients of public health significance should include calcium, vitamin D, potassium and iron.Calcium and iron already are required; vitamin D and potassium are being proposed to be added to the list of mandatory nutrients.

12. Why are Vitamin D and potassium being proposed to be added to the Nutrition Facts label?
Vitamin D is important for its role in bone health, and some population groups are not getting enough of it.Adequate potassium intake is beneficial in lowering blood pressure and intakes of this nutrient also are low among some population groups.

13. Why are you proposing to no longer require vitamins A and C?
Current data indicate that Vitamin A and C deficiencies in the general population are not common.These vitamins would still be allowed to be declared on labels on a voluntary basis.

Format changes

14. What changes are you proposing to make to the design of the Nutrition Facts label and why?
We are not proposing to change the “iconic” look of the label but are proposing several changes to improve the format. These proposed changes include:

Highlighting the caloric content of foods by increasing the type size and placing in bold type the number of calories and servings per container. Shifting information on Percent Daily Value to the left of the label. The Percent Daily Value is intended to help consumers place nutrient information in the context of a total daily diet. Declaring the actual amount, in addition to Percent Daily Value, of mandatory vitamins and minerals and, when declared, voluntary vitamins and minerals. Changing “Amount Per Serving” to “Amount per ___”, with the blank filled in with the serving size in common household measures (e.g. Amount per 2/3 cup) Replacing the listing of “Total Carbohydrate” with “Total Carbs” and indenting “Added Sugars” directly beneath the listing for “Sugars.” Right-justifying the actual amounts of the serving size information. Removing the existing footnote and using that area to better explain the Percent Daily Value.This part of the nutrition label is often misunderstood by consumers. We will be conducting an experimental study to help determine information that should be in the footnote to increase consumers’ understanding of the Percent Daily Value.

Serving Sizes

15. Would serving sizes on the label be smaller because of the obesity epidemic?
Not necessarily. Some serving sizes would potentially increase and others would potentially decrease. The Nutrition Labeling and Education Act requires the serving sizes to be based on amounts of food and drink that people typically eat, not on how much they should eat. FDA established the current serving size requirements in 1993 based primarily on data from food consumption surveys.More recent food consumption data show that 27 out of 158 (17 percent) of the reference amounts customarily consumed (RACCs) used to calculate serving sizes should be changed.This would mean that manufacturers would potentially have to change the serving sizes listed on their labels.

16. How much time would manufacturers have to make these proposed changes?

We are proposing that manufacturers have just over two years (two years after the effective date) to comply with any final requirements

Imports

17. Would the proposed new requirements apply to imported food?
Yes, foods imported to the United States would need to meet any final requirements.


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