On May 20, 2016, the U.S. Food and Drug Administration (FDA or the Agency) issued a final rule (Rule) that overhauls the design and content of nutrition labeling for foods and dietary supplements (known as the Nutrition Facts label for packaged foods and the Supplement Facts label for dietary supplements). These changes are largely consistent with those proposed by the Agency in 2014.
Nutrition Facts Label Changes
The Rule includes both design changes to the Nutrition Facts panel and changes the Agency characterizes as being based on nutrition science.
When viewing a side-by-side comparison of the original and new versions of the Nutrition Facts label, it might appear that the labels are rather similar. However, the new label contains some notable changes, including:
- Increasing the type size for “Calories,” “servings per container,” and the “Serving size” declaration; and
- Bolding the number of calories and the “Serving size” declaration.
Beyond these changes, manufacturers must also declare the actual amount, in addition to the Percent Daily Value (DV) of vitamin D, calcium, iron and potassium. Manufacturers can voluntarily declare the gram amount for other vitamins and minerals, but the Rule does not require this.
In addition, the new label contains a revised DV footnote. The new footnote will read: “*The Percent Daily Value 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.”
To see what’s different about the original and new versions of the label, click here.
Changes Based on Nutrition Science
The Rule requires several changes based on what the Agency characterizes as updated information regarding nutrition science. One of the more notable changes is that the new label will contain “Added sugars,” in grams and as Percent DV.
With regard to nutrients on the label, the Agency will be requiring vitamin D and potassium to appear on the label. Calcium and iron will continue to be required. Notably, vitamins A and C will no longer be required to appear on the label, but companies may continue to include them if they desire.
On the topic of fat, the Rule will continue to require “Total Fat,” “Saturated Fat,” and “Trans Fat” on the label, whereas the Agency is removing “Calories from Fat” from the label.
Finally, DVs for nutrients such as fat, sodium, dietary fiber, and vitamin D are being updated based on newer scientific evidence from the Institute of Medicine and other reports, such as the 2015 Dietary Guidelines Advisory Committee Report. FDA has acknowledged that these DV changes may alter eligibility for certain nutrient content claims and health claims and that revisions for the definitions of such claims (e.g., “healthy”) may need to be revised in a future rulemaking.
Updated Serving Sizes and Requirements for Certain Package Sizes
In addressing why serving sizes are being updated, FDA noted that how much people eat and drink has changed since the previous serving size requirements were published in 1993.
For packages that are between one and two servings (e.g., a 20-ounce soda or a 15-ounce can of soup), the Agency is requiring calories and other nutrients to be labeled as one serving because, according to FDA, people typically consume such items in one sitting.
To the extent a product is larger than a single serving but could be consumed in one sitting or multiple sittings, manufacturers will need to provide “dual column” labels to indicate the amount of calories and nutrients on both a “per serving” and “per package”/“per unit” basis (e.g., a 24-ounce bottle of soda or a pint of ice cream).
Compliance Dates; Extension for “Small” Manufacturers
In general, companies will need to implement the new label by July 26, 2018, except for companies with less than $10 million in annual food sales, who will have an additional year to comply (i.e., July 26, 2019).
Supplement Facts Label Changes
The Rule amends both the content and format of the Supplement Facts label, as well. In many respects, these changes to correspond to the changes required in the Nutrition Facts label.
More specifically, per the Rule, the Supplement Facts label will, among other things,
- No longer be required to declare vitamin A, vitamin C, or Calories from Fat;
- Be required to contain vitamin D and potassium; and
- Be required to declare added sugars.
With regard to the order of nutrients declared on the label, the Rule 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 in 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); and
- Adds fluoride to the end of the list of nutrients in § 101.36(b)(2)(i)(B) such that, when it is declared (voluntarily), it should be placed below potassium on the label.
On the topic of nutrients, FDA clarified in the Rule that “folic acid” is the term used to declare the folic acid content of dietary supplements. The Rule requires removal of “folate” and “folacin” from the list of synonyms that may be used to declare folic acid on the Supplement Facts label.
FDA also addressed units of measurement in its Rule, and will now require that, when β-carotene is included in parentheses following the percentage statement for vitamin A, it should be measured in micrograms (mcg). Moreover, the Rule requires the units of measure to be mcg Retinol Activity Equivalents (RAE) for vitamin A, mcg for vitamin D, and milligrams (mg) of α-tocopherol for vitamin E.
The Rule also establishes reference daily intakes (RDIs)/daily reference values (DRVs) for infants aged 7–12 months, and children aged 1–3 years. More specifically:
- The Rule changes the Percent DV categories of 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 DRV has been established for polyunsaturated fat, monounsaturated fat, insoluble fiber, soluble fiber, added sugars, sugar alcohols, , and fluoride;
- With respect to sodium, no DRV has been established for infants 7 – 12 months, but a DRV of 1500 g has been established for sodium for children 1 through 3 years of age; and
- 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 DV 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.”
With respect to specific DVs for pregnant and lactating women, the Rule establishes RDIs of 71 grams of protein and 50 grams of added sugars. No DRVs for this population have been established for trans fat, polyunsaturated and monounsaturated fat, insoluble fiber, soluble fiber, sugars, or sugar alcohols, and fluoride, yet the Rule establishes specific RDIs for various vitamins and minerals.
Compliance Date; Extension for “Small” Manufacturers
As with the compliance date for changes to the Nutrition Facts label, companies marketing dietary supplements will need to implement the revised Supplement Facts label by July 26, 2018, except for companies with less than $10 million in annual sales, who will have an additional year to comply (i.e., July 26, 2019).
If you have questions regarding the issues raised in this alert, please contact one of the authors.