|Footnotes for this article are available at the end of this page.
The Food and Drug Administration issued new regulations requiring changes to the nutrition and supplements facts labels of conventional food and dietary supplements, respectively, on May 27, 2016.1 Eventually, implementation dates for these new regulations were set so that manufacturers with $10 million or more in annual sales were required to switch to the new label by January 1, 2020, and manufacturers with less than $10 million in annual food sales have until January 1, 2021, to comply.2 FDA also announced that it intended to exercise enforcement discretion to “work cooperatively with manufacturers and will not focus on enforcement actions during 2020 for larger manufacturers and during 2021 for smaller manufacturers.”3
Manufacturers and distributors qualifying for the first implementation date, January 1, 2020, should already have completed a review of all product labels, identified changes required to those labels in order to comply with the new regulatory requirements, and be actively ensuring that products labeled on or after the implementation date are compliant. Manufacturers and distributors required to satisfy the new label requirements by the second implementation date, January 1, 2021, at a minimum, should have initiated this same process. To help companies better understand what is required, some of the more significant requirements of the revisions to Nutrition and Supplement Facts labels include, but are not limited to:
- A change in the methodology used to calculate “Serving Size”;
- A change to the declaration of “Calories” on the Nutrition Facts label to make it more prominent;
- Removal of “calories from fat” as currently used;
- Changes to FDA’s definitions of dietary fiber and added sugars;
- Vitamin A, vitamin C, and calories from fat are no longer mandatory ingredients (i.e.,“(b)(2) ingredients” dietary ingredients) that must be declared if present in the product;
- Vitamin D, potassium, and added sugar are now mandatory ingredients and must be declared if present in the product;
- “Total Sugars” replacing sugars as a mandatory ingredient that must be declared if present in the product;
- “Added Sugars” are now mandatory ingredients and must be tracked and included on the label if present in the product;
- Changes to the order in which other vitamins and minerals are listed;
- Folic acid must now be distinguished from naturally-occurring folate;
- A revision of the recommended dietary intakes and daily reference values, including new values for children 1-3 years of age; and
- Updated requirements for various units of measure to denote the amount of ingredients.
- Products labeled on or after the implementation dates set by FDA are required to satisfy the updated Nutrition and Supplement Facts label regulations.
- Manufacturers and distributors should be proactively conducting label reviews and making required revisions prior to the next printing of labels for themselves or their customers.
- Product label and labeling that is online must also need to be reviewed and revised as necessary.
- FDA has indicated that it views added sugars as information important to allow consumers to make informed choices.
- The daily values for nutrients like fiber, sodium, and vitamin D have been revised; prior calculations for the daily value of a product’s nutrients cannot be relied on.
- To date, FDA’s compliance and enforcement activities relative to companies falling into the first implementation period has been low. We expect this to change now that the second implementation deadline is approaching and FDA has modified its inspection and enforcement activities to address the current COVID-19 outbreak.
- In addition to regulatory concerns, improperly formatted Nutrition and Supplement Facts labels can present a risk of product liability or false marketing issues.
- We are already working with industry stakeholders to assist in label and website reviews to ensure compliance with all statutory and regulatory requirements.
For questions, please contact Bob Durkin.
 See: 81 Fed. Reg. 33742
 See: 83 Fed. Reg. 19619
 See: https://www.fda.gov/food/food-labeling-nutrition/industry-resources-changes-nutrition-facts-label#Compliance