and Alyson L. Wooten, PharmD
Today, Friday, May 27, 2016, is the day that the new final regulations on Nutrition and Supplement Facts labeling will officially publish in the Federal Register. The availability of advanced copies of the final regulations was announced last week by the Food and Drug Administration (FDA or agency). The new regulations make changes to the content of the “iconic” Nutrition Facts panel found on packaged food labels today, as well as to the serving sizes of certain foods. Both final regulations were initially published in a prepublication format with the final regulation regarding Nutritional Facts and Supplements Facts labeling totaling 943 pages (the formatted version is now a more manageable 259 pages), and the Serving Sizes final regulation totaling 170 pages (the now formatted version is a manageable 48 pages).
The final regulations have an effective date of July 26, 2016
, a compliance date of July 26, 2018
(for manufacturers with more than $10 million in annual food sales), and of July 26, 2019
(for manufacturers with less than $10 million in annual food sales). The new regulations apply to virtually every packaged food that is manufactured in the United States, as well as those that are imported. Revisions of the Nutrition and Supplement Facts Labels
The final regulations addressing Nutritional and Supplement Facts labels represent the most significant changes to the food labeling regulations since they were initially adopted by FDA in 1993.
In finalizing the regulations the FDA received over “300,000 comments.”
In the preamble, the agency specifically addressed a total of 540 comments, with a fairly large number of the comments being related to the controversial requirement for the disclosure of “added sugars” and the new definition of dietary fibers.
The final regulation makes changes to both the format and the content of the Nutrition Facts panel. Below are highlights
of some of the major changes: Added Sugars
Despite a number of objections by stakeholders, FDA adopted the requirement that food labels disclose the amount of “Added Sugars.”
While food labels already require a declaration of the total amount of sugar (i.e., Total Sugars) in a product, FDA believes that an “added sugars” declaration is “necessary to provide consumers with a measure to assess the relative contribution of the added sugars from a serving of food as part of a healthy dietary pattern and enable consumers to avoid a dietary pattern containing excess calories from added sugars.”
FDA further noted that providing an “added sugars” declaration would promote the public health by ensuring [that consumers] have information to assist them in meeting nutrient needs within caloric limits and to assist them in constructing a healthy dietary pattern that is limited in added sugars to reduce the risk of [cardiovascular disease].”
According to the agency, there is scientific data to show that it is more difficult for consumers to meet their nutrient needs and stay within caloric limits if they consume more than 10 percent of their daily calories from added sugars.
FDA defines “added sugars” as those that are: either added during the processing of foods, or are packaged as such, and include sugars (free, mono, and disaccharides), sugars from syrups and honey, and sugars from concentrated fruit or vegetable juices that are in excess
of what would be expected from the same value of 100 percent fruit of the same type . . . . 21 C.F.R. §101.9(6)(iii).
The following are not considered
to be “added sugars” for the purpose of the new regulations: (1) fruit or vegetable juice concentrates used towards the total juice percentage label declaration or for Bix Standardization, (2) fruit juice concentrates which are used to formulate the fruit component of jellies, jams, or preserves in accordance with applicable standards of identity, or (3) the fruit component of fruit spreads. The “added sugars” declaration must be indented under “Total Sugars” and prefaced with the words “Includes” followed by the amount in grams: Added Sugars (Includes ‘X’ g Added Sugars) Dietary Fiber
The final regulation also provides a definition of dietary fiber for the first time since their implementation over 20 years ago. FDA defined dietary fiber as: Non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and in plants; isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.
21 C.F.R. §101.9(6)(i). (Emphasis added). The Agency concluded that “[b]y defining the term dietary fiber, based on beneficial physiological effects in human health rather than by chemical definition, we will ensure that the dietary fiber declared amount will assist consumers to maintain healthy dietary practices. . . .”
The FDA has found the following isolated or synthetic non-digestible carbohydrate(s) to have physiological effects that are beneficial to human health, and, as such, must be included in the calculation of the amount of dietary fiber:
- [beta]-glucan soluble fiber
- Psyllium husk
- Guar gum
- Locust bean gum, and
If a dietary fiber declaration is not required for a product, then the statement “Not a significant source of dietary fiber”
must be placed at the bottom of the table of nutrient values. The FDA’s definition of dietary fiber has been the source of concern, particularly with regard to the process of adding other “isolated or synthetic non-digestible carbohydrate(s)” that have a physiological effect that is beneficial to human health to the definition. In the preamble, the FDA notes that anyone can seek to amend the definition of dietary fibers to add new fibers through the Citizen Petition process in 21 C.F.R. §10.30.
While there has been some concern about the efficiency of this process, the agency noted that it did not have any data to support the number of possible fibers currently in existence to address this particular concern. In order to assist manufacturers interested in submitting citizen petitions, the FDA intends to issue a guidance document outlining the agency’s recommendation for demonstrating the beneficial physiological effect of any isolated and synthetic fibers that are not part of the regulation.
The Agency also plans to published a separate notice seeking comments on the available scientific data on other isolated or synthetic non-digestible carbohydrates (e.g., bamboo, inulin, soy fiber, wheat fiber, cotton seed, sugar beet fiber, pea fiber)
to assist the agency in the review of the scientific evidence. Vitamin and Minerals
The final regulation incorporates FDA’s proposal to update the vitamins and minerals “of public health significance,” based on the agency’s analysis of nutrient inadequacy. Under the final regulation, manufacturers will be required to declare the absolute amount (e.g., mg, mcg) and percent daily values (DVs) of vitamin D, calcium, iron, and potassium
. In the past, labels only had the percent DVs for vitamin D and potassium. Declarations of vitamin A and C will become voluntary, since deficiencies of these vitamins are rare nowadays. If vitamin A is declared, the unit of measurement is required to be mcg Retinol Activity Equivalents (RAE). FDA also revised the DVs for certain nutrients, including calcium, sodium, dietary fiber, and vitamin D. With regard to the order of nutrients declared on the label, the regulation makes the following changes:
- Adds choline to the list of nutrients in 21 C.F.R. § 101.36(b)(2)(i)(B) and requires it to appear after pantothenic acid on the label (because choline is a vitamin and pantothenic acid is the last vitamin on the list of nutrients provided in § 101.36(b)(2)(i)(B)).
- Specifies that calcium and iron shall be declared after choline on the label (because choline will now be declared after pantothenic acid on the label).
- Adds fluoride to the end of the list of nutrients in § 101.36(b)(2)(i)(B) such that, when it is declared (which is voluntary), it should be placed below potassium on the label.
FDA also clarified that “folic acid” should be used to declare the folic acid content in dietary supplements. “Folate” and “folacin” are no longer acceptable synonyms for declaring folic acid on the Supplemental Facts label. Daily Reference Values for Infants and Children
The final regulation also establishes daily reference values for infants aged 7-12 months, and children aged 1-3 years.
- The regulation changes the percent daily reference value categories from infants and children less than 4 years of age to “infants 7 through 12 months of age” and “children 1 through 3 years of age.”
- No daily reference values have been established for polyunsaturated fat, monounsaturated fat, insoluble fiber, soluble fiber, added sugars, sugar alcohols, and fluoride.
- With respect to sodium, a daily reference value of 1,500 mg has been established for children 1 through 3 years of age. No daily reference value for sodium was established for infants 7-12 months of age.
- When a product that is represented or purported to be for children 1 through 3 years of age contains a percent DV declaration for total fat, total carbohydrate, dietary fiber, or protein, the Rule requires that a symbol be placed next to the percent daily value declaration that refers the consumer to a statement at the bottom of the label that says “Percent Daily Values are based on a 1,000 calorie diet.”
The FDA is also making significant changes to the look of the “iconic” Nutrition Facts panel that consumers are familiar with. For example, the agency is making, among other things, the number of calories and the serving size more prominent. Below is an illustration of what is new and/or different from the last version of the label: Recordkeeping Requirements
The final regulations also require manufacturers to maintain written records “(e.g., analysis of databases, recipes, formulations, information from recipes or formulations or batch records) to verify the declared amount of that nutrient . . . .” Manufacturers will be required to maintain records for verification of the declaration of dietary fiber, added sugars, vitamin E, folic acid, and folate.
21 C.F.R. §101.9(10). While FDA provides some examples of the types of records that may be kept to verify these nutrient declarations, the agency did not specifically state which type of record must be kept in order to provide manufactures with “flexibility” regarding the type of information available to FDA for review. However, “whether determined analytically or through calculations documented in appropriate records, manufacturers are obligated to provide nutrient information that is not false or misleading.”
All records must be kept for a period of 2 years
after the introduction or delivery for introduction of a food into interstate commerce. 21 C.F.R. §101.9(11). Revisions to the Serving Sizes of Certain Foods
In the companion regulation, the agency is also revising the “serving sizes” for certain food packages to reflect what people are “actually eating, not what they should be eating.”
In the final regulation, FDA is updating, modifying and establishing several reference amounts customarily consumed (RACCs) based on new consumption data showing that the amount of food consumed by Americans has changed since 1993.
Moreover, data collected over the last 20 years has shown that container and unit sizes can influence the amount of food consumed.
To that end, the FDA is changing how serving sizes are determined for certain foods.
Below are some of the highlights that will have the most direct impact on the way consumers evaluate serving sizes:
- For food packages that are between one and two servings (e.g., 20 ounce bottle of soda), the calories and nutrients will be required to be listed as one serving.
- After considering many comments, FDA is increasing the RACC for ice-cream (including bulk products and novelties) from ½ cup to ⅔ cups.
- For packages that can be consumed in one sitting, or multiple sittings, the food packages will have to include a “dual column” label to indicate the amount of calories and nutrients in “one serving” and “per package/per unit” basis (e.g., 24 ounce bottle of soda or a pint of ice cream).
Below is an example of the new “dual column” nutritional facts panel: Download Copy 
The citations found in this blog post are from the advanced copy versions of the final regulations. See
Advanced copy of Final Rule, Food Labeling, Revision of the Nutrition and supplement Facts Labels available at https://www.federalregister.gov/articles/2016/05/27/2016-11867/food-labeling-revision-of-the-nutrition-and-supplement-facts-labels
; see also
Advanced copy of Final Rule, Food Labeling: Serving Sizes of Foods that Can Reasonably Be Consumed At One Eating Occasion; Dual-Colum Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath mints; and Technical Amendments, available at https://www.federalregister.gov/articles/2016/05/27/2016-11865/food-labeling-serving-sizes-of-foods-that-can-reasonably-be-consumed-at-one-eating-occasion
FDA amended the labeling regulations in 1995 to establish new and to update some daily values (DVs) and in 2003 to address the changes to the regulation of trans
Advanced copy of Final Rule, Food Labeling, Revision of the Nutrition and supplement Facts Labels at 23, available at https://www.federalregister.gov/articles/2016/05/27/2016-11867/food-labeling-revision-of-the-nutrition-and-supplement-facts-labels
.  Id
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Why the sugar industry hates the FDA’s new Nutrition Facts label, available at https://www.washingtonpost.com/news/wonk/wp/2016/05/20/why-the-sugar-industry-hates-the-fdas-new-nutrition-facts-label/  Id
. at 275.  Id.
at 71.  See
At a Glance: Highlights of the Final Nutrition Facts Label, available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm#images  See
Advanced copy of Final Rule, Food Labeling, Revision of the Nutrition and supplement Facts Labels at 896.  Id
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. at 428.  Id
. at 429-430.  Id
. at 438-439, 442.  Id
. at  See
Changes to the Nutrition Facts Label, available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm  Id
. at 5.  Id.  See
Changes to the Nutrition Facts Label, available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm