Recently, FDA released two final rules revising its nutrition labeling requirements for foods and dietary supplements. The two final rules are:
The changes, while in many cases relatively minor, are quite numerous and will likely affect the vast majority of food products in the marketplace. Companies will be required to comply with the new rules by July 26, 2018, except that companies with less than $10 million in revenue from food products have an extra year to implement changes and must comply with the new rules by July 26, 2019.
Published in the Federal Register on Friday, May 27, 2016, the final rules make various changes to the 1993 nutrition labeling requirements for foods and dietary supplements and update the established reference amounts customarily consumed (RACCs) upon which serving sizes are based. The revisions are intended to reflect the changes in science and dietary habits that have occurred since the nutrition labeling regulations were established. Many of the changes to the existing regulations from the two final rules are summarized below:
- The format of Nutrition Facts labels was revised in various ways. For instance, the prominence of the term “Calories” was increased and the footnote table listing the reference values for certain nutrients for 2,000 and 2,500 calorie diets is no longer required. Sample illustrations of the revised format can be found on FDA’s website
- “Calories from fat” will no longer be declared on nutrition labeling.
- In Nutrition Facts and Supplement Facts, “Sugars” was changed to “Total Sugars,” and the statement “Includes [X] g Added Sugars” must be included, indented under “Total Sugars.” The final rule also requires a declaration of the percent Daily Value (DV) for added sugars based on the Daily Reference Value (DRV) for added sugars established in the final rule (50 g for adults and children ≥ 4 years, based on the reference caloric intake of 2,000 calories; 25 g for children 1 through 3 years, based on the reference caloric intake of 1,000 calories).
- The vitamins and minerals that are required to be declared on the label were changed. Vitamins A and C will no longer be required to be declared, and vitamin D and potassium are now required to be declared. Therefore, in addition to sodium (which is statutorily required), the regulations now require 4 essential vitamins and minerals to be declared in the Nutrition Facts: Vitamin D, Calcium, Iron, and Potassium. The quantitative amount of each must be declared in addition to the percent DV. These may appear in the above order either vertically in a column or horizontally. If listed horizontally in two columns, vitamin D and calcium should be listed on the first line and iron and potassium should be listed on the second line.
- Fluoride and choline were added as nutrients that may voluntarily be declared on the nutrition label. Declaration is mandatory if claims are made on the label or in labeling about the fluoride or choline content of the food.
- Reference values used to calculate the percent DVs for nutrients for declaration on the Nutrition Facts and Supplement Facts labels were updated for the vast majority of nutrients. In some cases, the units of measure were also changed from the previous regulations. For example:
- Vitamin A must now be declared in mcg Retinol Activity Equivalents (RAE) instead of International Units (IU). One mcg RAE is equivalent to 1 mcg retinol, 2 mcg supplemental ß-carotene, 12 mcg of dietary ß-carotene, or 24 mcg of other dietary provitamin A carotenoids (α-carotene or ß-cryptoxanthin)
- Folate is distinguished from folic acid. The amount of folate and folic acid must be declared in mcg Dietary Folate Equivalents (DFE). One mcg DFE is equivalent to 1 mcg of naturally-occurring folate or to 0.6 mcg folic acid.
- Vitamin D must be declared in mcg instead of IUs. However, the amount of vitamin D in IUs may optionally be declared in parentheses after the declaration of the amount of vitamin D in mcg.
- Vitamin E must be declared in mg instead of IUs.
- The age ranges for the age categories of infants and children have been revised. “Infants” now refers to infants through 12 months of age. The category of “children less than 4 years” is now replaced with “children 1 through 3 years of age.”
- The regulations added a requirement to maintain records to support the declarations for certain nutrients (added sugars, dietary fiber, soluble fiber, insoluble fiber, vitamin E, and folate/folic acid) under the following specified circumstances:
- When a mixture of dietary fiber, and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber, is present in food
- When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in food
- When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in food
- When a mixture of naturally occurring and added sugars is present in a food
- When the amount of sugars added to food products is reduced through non-enzymatic browning and/or fermentation
- When a mixture of all rac-α-tocopherol and RRR-α-tocopherol is present in a food
- When a mixture of folate and folic acid is present in a food
- The records specified in the regulations to be maintained in the above circumstances must be kept for a period of at least 2 years after introduction or delivery for introduction of the food into interstate commerce and must be provided to FDA upon request. Failure to make and keep these records or provide them to appropriate regulatory authorities would result in the food being misbranded.
- The reference amounts customarily consumed (RACCs) and serving sizes for several food product categories were updated and new food product categories were added. For example:
- The reference amounts for beverages was changed from 8 fl. oz./240 mL to 12 fl. oz/360 mL
- The reference amount for ice cream, frozen yogurt, and other desserts, including frozen flavored ice pops, was changed from 1/2 cup to 2/3 cup
- The reference amount for sugar was changed from 4 g to 8 g
- New categories were added, including categories that apply to bagels, unsweetened cocoa powder, fruit juice concentrates, seasoning oils and sauces such as sesame oil, seasoning pastes such as curry paste, appetizers and hors d’oeuvres, and sprouts
- The definition of a single-serving container was revised. A product that is packaged and sold individually that contains less than 200 percent of the applicable reference amount is now considered a single-serving container and the entire content must be labeled as one serving. A column may optionally be added to the Nutrition Facts label to provide nutrition information per common household measure that most closely approximates the reference amount.
- Foods that contain 200 percent to 300 percent of the applicable RACC must be labeled with dual columns, the first that lists the quantitative amounts and percent DVs per serving size (which should approximate the RACC), and the second that lists this information per individual unit.
- Standard serving sizes are provided for purposes of nutrition labeling of a variety or assortment of foods in a gift package for which there is no appropriate RACC. These standard serving sizes are: 1 ounce for solid foods; 2 fluid ounces for nonbeverage liquids (e.g., syrups); 8 ounces for beverages that consist of milk and fruit juices, nectars and fruit drinks; and 12 ounces for other beverages.