UPDATE: FDA Issues Supplemental Proposed Rule for Updating the Nutrition Facts Label
FDA issues a supplemental proposed rule that would, among other things: (1) require declaration of the percent daily value (%DV) for added sugars; and (2) change the current footnote on the Nutrition Facts label.
Added sugars: FDA is proposing including the percent daily value (%DV) for added sugars on the Nutrition Facts label of packaged foods, giving consumers additional information for added sugars similar to information they have seen for decades with respect to nutrients such as sodium and certain fats. The percent daily value indicates how much a nutrient in a serving of food contributes to a daily diet and would help consumers make informed choices for themselves and their families. The percent daily value would be based on the recommendation that the daily intake of calories from added sugars not exceed 10 percent of total calories.
Footnote: FDA is also proposing to change the current footnote on the Nutrition Facts label to help consumers understand the percent daily value concept. The proposed statement on the label would be shorter than the current footnote to allow for more space on the label, stating: *The percent daily value (%DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.
Commenting on the supplemental proposed rule begins July 27, 2015.
For additional information, see
- Federal Register Notice: Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Supplemental Proposed Rule to Solicit Comment on Limited Additional Provisions
- Federal Register Notice: Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Reopening of the Comment Period as to Specific Documents
FDA is proposing to update the Nutrition Facts label on food packages to reflect new public health and scientific information, including evidence on nutrition, obesity and chronic disease. As part of the proposed updates, serving size requirements would be updated to reflect the amounts of food people are actually eating and drinking now as opposed to 20 years ago when the Nutrition Facts label was first introduced. In addition, the format of the label would be refreshed, with key parts of the label such as calories, serving sizes, and percent daily value more prominent.
The proposed changes reflect new dietary recommendations, consensus reports and national survey data and reflect input obtained through four advance notices of proposed rulemaking and numerous citizens’ petitions.
The proposed rules, which are published in the Federal Register, are open for comment for 90 days. FDA is proposing a compliance date of two years after the effective date for any final rule resulting from these proposed rules.
FDA is also proposing some corresponding updates to the Supplement Facts label on dietary supplements, including changes to daily values and units of measure.
The Nutrition Labeling and Education Act (NLEA) of 1990 gave FDA the authority to require nutrition labeling on foods. The objectives of the NLEA were to reduce consumer confusion about labels, help consumers make better food choices and encourage innovation by giving manufacturers an incentive to improve the nutrition profiles of foods. FDA issued final regulations for the Nutrition Facts label on January 6, 1993. The rule was effective on May 8, 1994. FDA was required by the Dietary Supplement Health and Education Act of 1994 to also establish nutrition labeling requirements for dietary supplements. These were published in 1997 and became effective in 1999.
The Nutrition Facts label has not changed significantly since it was first introduced except for the addition of trans fat to the list of required nutrients, effective in 2006. Between 2003 and 2007, FDA published four advance notices of proposed rulemaking, seeking public comment on the following issues: trans fat, prominence of calories, revision of reference values and mandatory nutrients and serving sizes. FDA has also received a number of citizens’ petitions requesting changes to the Nutrition Facts and Supplement Facts labels.
Highlights of the Proposed Rules
FDA is issuing two proposed rules. The first, Food Labeling: Revision of the Nutrition and Supplement Facts Label, addresses new scientific information and design changes. The second, which addresses revised serving size requirements, criteria for labeling based on package size, and other issues, is titled Serving Sizes of Foods that can Reasonably be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments.
Major proposed changes can be grouped into three categories: (1) Changes based on new nutrition science, (2) Updated serving size requirements and labeling for certain packages and (3) Refreshed design.
Original vs. Proposed
Changes based on new nutrition science
FDA is proposing to update the Nutrition Facts label to improve public health, incorporating the new nutrition recommendations to reduce the risk of chronic diseases such as cardiovascular disease, obesity, high blood pressure and stroke, and to encourage an adequate intake of essential nutrients. The proposed rules reflect new dietary recommendations, consensus reports and national survey data. Examples include the 2010 Dietary Guidelines for Americans, nutrient intake recommendations from the Institute of Medicine and nutrient intake and other data from the National Health and Nutrition Examination Survey (NHANES). The proposed changes would include:
- Requiring the declaration of “Added Sugars” on the label. “Sugars” include both “added sugars” and sugars that are naturally occurring in food. Americans on average eat 16% of their total calories from added sugars, the major sources being soda, energy and sports drinks, grain based desserts, sugar-sweetened fruit drinks, dairy-based desserts and candy. Currently, “Sugars” are required to be labeled on packages, and we are proposing to require the declaration of “Added Sugars” indented under “Sugars” so that both would be listed. We are proposing this after taking into account new data and information, including U.S. consensus reports and recommendations, a citizen’s petition, and public comments. For example, the Dietary Guidelines for Americans recommend reducing the intake of calories from added sugars; a high intake can decrease the intake of nutrient-rich foods in the diet. An IOM report on macronutrients stated that “although added sugars are not chemically different from naturally occurring sugars, many foods and beverages that are major sources of added sugars have lower micronutrient densities compared to foods and beverages that are major sources of naturally occurring sugars.” Other expert groups such as the American Heart Association, the American Academy of Pediatrics and the World Health Organization also recommend decreasing added sugars.
- Removing the requirement for declaring “Calories from fat.” Current research shows that the total fat in the diet is less important than the type of fat. In addition, FDA consumer research shows that removal of the declaration of “calories from fat” has no effect on consumers’ ability to judge the healthfulness of a product. FDA would continue to require “Total Fat,” “Saturated Fat,” and “Trans Fat” on the label.
- Revising the nutrients of public health significance that must be declared on the label. These are nutrients for which the U.S. population is consuming inadequate amounts and are associated with the risk of chronic disease. FDA analyzed data from the National Health and Nutrition Examination Survey (NHANES) and determined that calcium, vitamin D, potassium, and iron should be mandatory. Calcium and iron are already required; vitamin D and potassium would be newly required. Vitamin D is important for its role in bone development and general health, and intakes among some population groups are inadequate. Adequate potassium intake is beneficial in lowering blood pressure and intakes of this nutrient are also low among some population groups. FDA will propose that mandatory labeling no longer be required for vitamin C or vitamin A because current data indicate that deficiencies are not common; these vitamins would still be allowed to be declared on labels voluntarily.
- Revised Daily Values for certain nutrients that are either mandatory or voluntary on the label. Examples include calcium, sodium, dietary fiber and vitamin D. Some Daily Values are intended to guide consumers about maximum intake—saturated fat, for example—while others are intended to help consumer meet a nutrient requirement—iron, for example. Daily Values are used to calculate the percent daily value (%DV) on the label, which helps consumers to understand the nutrient information on the product label in the context of the total diet. The revisions in Daily Values are based on recommendations published by the Institute of Medicine and other reports such as the Dietary Guidelines for Americans. In addition to changing some Daily Values, FDA is also changing the units used to declare vitamins A, E and D from “international units,” or “I.U.” to a metric measure—milligrams or micrograms. FDA is also proposing to include the absolute amounts in milligrams or micrograms of vitamins and minerals, in addition to the %DV, on the label.
Updated serving size requirements and labeling for certain packages
By law, serving sizes must be based on amounts of food and drink that people customarily consume, not on what people should be eating. People are generally eating more today than 20 years ago, so some of the current serving sizes, and the amount of calories and nutrients that go with them, are out of date. Therefore, FDA is updating the reference values used by manufacturers to set serving sizes to make them more realistic, reflecting what people really eat and drink.
FDA set the current reference values (Reference Amounts Customarily Consumed, or RACCs), in 1994, based primarily on Nationwide Food Consumption Surveys conducted in 1977-1978 and 1987-1988. More recent food consumption data show that about 27 of the 158 (about 17%) of the current RACCs should be changed for different food categories. That would mean that manufacturers would potentially have to adjust serving sizes based on these proposed changes to the RACCs. FDA is also proposing to add 25 new RACCS, many at the request of various industry groups.
Additionally, FDA is proposing to require that some food products previously labeled as more than one serving be labeled as a single serving, because people typically eat or drink them in one sitting. All packages containing between 150% and 200% of the RACCs could no longer be labeled as more than one serving. Examples would be a 20-ounce can of soda or a 15-ounce can of soup. Certain larger packages that could be consumed in one sitting or in multiple sittings would be required to be labeled per serving and per package. This dual column labeling would be required if a package contained at least 200% of the RACC and less than or equal to 400% of the RACC. Examples would be a 24-ounce can of soda, a 10.5 ounce frozen entrée, a 19 ounce can of soup, and a pint of ice cream. For packages containing more than 400% of the RACC, dual column labeling would not be required.
The “iconic” look of the label would remain, but FDA is proposing several changes to highlight key parts of the label that are important in addressing current public health problems like obesity. Some of the proposed changes that would affect the look of the label 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 to the left of the label % Daily Value (DV). The %DV is intended to help consumers place nutrient information in the context of a total daily diet.
- Declaring the actual amount, in addition to %DV, for all vitamins and minerals when they are declared.
- Changing “Amount Per Serving” to “Amount per ___”, with the blank filled in with the serving size in common household measures, such as “Amount per 1 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.
- Reversing the order of “Serving Size” and “Servings Per Container” declarations.
- Removing the existing footnote that describes the Daily Values for 2,000 and 2,500 calories to provide more space to better explain the percent dietary value. This part of the nutrition label is often misunderstood by consumers, and FDA is conducting an experimental study to help determine how the footnote can help consumers to better understand the %DV.
Supplement Facts Label
Some, but not all, of the changes being proposed for the Nutrition Facts label also apply to the Supplement Facts label. The following would apply to both labels:
- proposed changes to the Daily Values
- nutrients of public health significance
- removal of the mandatory declaration of “Calories from fat”
- mandatory declaration of added sugars, when present
- changes to the units of measure
We are proposing that any final rules resulting from the proposed rules become effective 60 days after the date of the final rule’s publication in the Federal Register with a compliance date two years after the effective date. We recognize that it may take industry time to analyze products for which there may be new mandatory nutrient declarations, make any required changes to the labels, review and update their records of product labels, and print new labels. A compliance date that is two years after the effective date is intended to provide industry time to revise labeling to comply with any new labeling requirements while balancing the need for consumers to have the information in a timely manner.
Rulemaking Process and How to Submit Comments
FDA issues proposed rules in the Federal Register so that the public can review them and submit comments. FDA will consider comments received during the comment period on the proposed rules and then consider revising the rules based on its review of the comments before issuing any final rules. The proposed rules and supporting documents are filed in FDA’s official docket on http://www.regulations.gov
Economic Impact of the Proposed Rules
The benefits far outweigh the costs. The one-time cost to industry of labeling, reformulation, and initial recordkeeping is $2.3 billion, with a small annual cost associated with recurring recordkeeping. The cumulative benefits over 20 years range, on average, from $21.1 billion to $31.4 billion, depending on the inflation scenario used.