Over a decade in the making, the U.S. Food and Drug Administration (“FDA” or the “Agency”) recently issued two final rules revising its nutrition labeling regulations, most notably, the Nutrition Facts label.[1]  The revisions cover a wide spectrum of issues, including formatting, required nutrient declarations, and serving sizes.  According to FDA, the changes reflect new scientific information and will allow consumers to make “better informed food choices.”[2]  The voluminous preambles to the final rules represent the significant comments and discussion generated by FDA’s proposed rules.  Understanding the nuances of the Agency’s final rules will be key to industry compliance and implementation.  Furthermore, although primarily focusing on nutrition labeling, the practical impact of the final rules will likely affect other aspects of food product labels and labeling, especially nutrient content claims.  Accordingly, manufacturers should carefully review their food products’ entire labels and labeling when implementing the revised rules. 

In this alert, we highlight some of the major changes effected by the final rules.  These changes will impact nearly all conventional foods under FDA’s jurisdiction, including foods imported to the United States.  Many food manufacturers will be required to implement these changes by July 26, 2018.[3]  Manufacturers with less than $10 million in annual food sales will have an additional year to comply with the new rules.[4]

The “New” Nutrition Facts Label

Formatting
For the first time in 20 years, the Nutrition Facts panel will look significantly different.  FDA made these changes to emphasize particular elements that it considers important in making informed food choices.  As depicted on FDA’s website, we provide below a comparison of the current Nutrition Facts panel (“original”) versus the new Nutrition Facts panel (“new”) as implemented by the 2016 final rule.[5]  

Under the final rules, some of the primary formatting differences include:

• Highlighting of “Calories” and the “Serving size” declaration in larger and bold font and “servings per container” in larger font.
• Removing the declaration of “Calories from Fat” because, according to FDA, “current science supports a view that the type of fat is more relevant than overall total fat intake in increased risk of chronic diseases.”[6]
• Changing “Sugars” to “Total Sugars” and requiring that “Includes ‘X’g Added Sugars” be indented and declared directly below “Total Sugars” on the label.
• Requiring the declaration of “Added Sugars,” both in grams and percent daily value (“%DV”).  We discuss this change further below.
• Requiring declaration of the actual amount of vitamin D, calcium, iron, and potassium, in addition to %DV.  Vitamins A and C are no longer mandatory declarations on the Nutrition Facts panel.[7]
• Revising the footnote regarding %DV to better explain what %DV means.

• The Nutrition Facts panel must now provide the gram amount of “added sugars” in a serving of the product and the %DV.  Careful attention should be paid to what is considered an “added sugar.”  Under the new regulation, “added sugars” include sugars, sugars from syrups and honey, and sugars from concentrated fruit or vegetable juices.[8]  The sugars from concentrated fruit or vegetable juices are those “in excess of what would be expected from the same volume of 100 percent fruit or vegetable juice of the same type.”[9]  However, fruit or vegetable juice concentrate used “towards the total juice percentage label declaration” or used to formulate the fruit component of jellies, jams, preserves, or fruit spreads are not considered “added sugars.”[10]
• FDA establishes a definition for “dietary fiber,” one of the nutrients required to be listed on the Nutrition Facts panel.[11]  “Dietary fiber” is defined as “non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact 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.”[12]  FDA includes in its definition of dietary fiber the following isolated or synthetic non-digestible carbohydrates: [beta]-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum, and hydroxypropylmethylcellulose.[13]  Manufacturers must make and maintain records of their analyses of the amount of dietary fiber in their food products.[14] 
  
  FDA recognizes that companies produce a wide variety of isolated or synthetic non-digestible carbohydrates that the Agency does not presently include in the definition of “dietary fiber.”  In the preamble to the final rule, FDA explains its intention to publish a separate notice to seek comment on the available scientific data on other non-digestible carbohydrates.   FDA also intends to issue a guidance document on the information recommended to be provided to the Agency for scientific review of other fibers and the approach it intends to use to evaluate the studies.
• FDA updates the daily values for nutrients like sodium, dietary fiber, and vitamin D based on newer scientific evidence from the Institute of Medicine and other reports, such as the 2015 Dietary Guidelines Advisory Committee Report.
• FDA amends requirements for foods represented or purported to be specifically for children under 4 years old and pregnant and lactating women and establishes nutrient reference values specifically for these population subgroups.[15]

Changes to Serving Sizes
According to FDA, recent consumption data and research demonstrates that American food and drink consumption habits have changed significantly since 1993, when the serving size requirements were originally published.  Because serving sizes must be based on amounts of foods and beverages that people are actually eating, FDA is updating the reference amounts customarily consumed (“RACCs”) for certain foods that are used to determine serving sizes.[16]  For example, FDA revised the reference amount used to set a serving of ice cream from ½ cup to ⅔ cup and for a serving of soda from 8 ounces to 12 ounces.[17]

FDA also is revising serving size labeling.  To address products that people would typically consume in one sitting, FDA is requiring all containers that contain less than 2 servings (i.e., less than 200 percent of the RACC) to be labeled as one serving.[18]  For containers that may be consumed in one or more sittings or shared and that contain between 2–3 servings (i.e., at least 200 percent and up to and including 300 percent of the RACC), FDA is requiring the products to be labeled with dual columns to indicate the amount of calories and nutrients on both a “per serving” and “per package”/“per unit” basis (see example from revised regulations below):[19]

Recordkeeping
Under the final rule, manufacturers are required to make and keep records to verify the declaration of added sugars, certain fibers, vitamin E, folic acid, and folate.[20]  The records must be kept for at least two years after introduction or delivery for introduction of the food into interstate commerce.[21]

Conclusion
The above discussion addresses some of the key aspects of the final rules.  The nuanced application of the final rules to specific food products will require careful analysis.  The preambles to the final rules and other public statements made by FDA will be particularly instructive for industry.  Thus far, FDA has issued summaries, questions and answers, highlights, presentations, and press releases on these issues.[22]  FDA also intends to revise its Food Labeling Guide to correspond with the final rules.

The effects of FDA’s final rulemaking may extend beyond the Nutrition Facts panel for some food products.  For instance, as FDA recognizes, changes to the list of nutrients declared on the Nutrition Facts label, the RDIs or DRVs of nutrients, and RACCs could affect the nutrient content or health claims allowed for a given food product.[23]  Although FDA currently intends to “revisit” certain impacted regulations—such as the nutrient content and health claims regulations—it will not do so until a later date.  Additionally, the preambles identify other issues related to nutrition labeling that FDA intends to address through future rulemaking, guidances, and requests for comments and information.  To date, the following issues remain outside the scope of the current rulemaking: declaration of presence of genetically modified organisms, ingredient listing, front-of-package labeling, and declaring whether a product contains caffeine, allergens, or toxins.[24]

Due to the final rules’ broad impact, food manufacturers should begin reviewing their food product labels and labeling holistically to start considering the impact of the new nutrition labeling and serving size regulations.  We would be pleased to provide assistance in this regard, including conducting product label and labeling reviews.

Notes:
[1] See Food Labeling: Revision of the Nutrition and Supplement Facts Labels, 81 Fed. Reg. 33742 (May 27, 2016) (“Nutrition Facts Federal Register Notice”); Food Labeling: 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, 81 Fed. Reg. 34000 (May 27, 2016) (“Serving Size Federal Register Notice”). 
In the Nutrition Facts final rule, FDA also made “minor changes to the Supplement Facts label found on dietary supplements to make it consistent with the Nutrition Facts label.”  FDA Press Release, “FDA modernizes Nutrition Facts label for packaged foods” (FDA May 20, 2016), available here.  We do not address changes to the Supplement Facts label in this Alert, but would be pleased to assist with related questions.