FDA submits final rules on Nutrition Facts panel and serving sizes to OMB

The FDA has submitted final rules for updating the Nutrition Facts panel and serving sizes to the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB) for a regulatory impact analysis. 

The rules have not been made public yet, but regulatory affairs experts will now be looking out for an update in the federal register.

Asked when the rules would be released, an FDA spokeswoman said: “The Nutrition Facts label final rule is being reviewed. The FDA has yet to determine a release date.”

The FDA has proposed several changes to the Nutrition Facts panel on foods & beverages. However, its plan to include ‘added sugars,’ tweak rules on dietary fiber labeling, and update the reference values used to calculate percent DVs of nutrients have proved the most controversial.

To read the proposals in full, click HERE, but here’s a summary of the key changes:

  • Remove ‘calories from fat’.
  • Declare ‘added sugars’.
  • Require pre-approval for some fiber ingredients included in dietary fiber calculation.
  • Keep mandatory requirement to list calcium & iron, make vitamins A & C voluntary.
  • Add mandatory requirement to list vitamin D & potassium.
  • Update reference values used to calculate % DVs of nutrients.
  • Update reference value for sodium from 2,400mg to 2,300mg.  
  • Make ‘calories’ more prominent.

Separately, the FDA is also proposing to tweak serving sizes to better reflect real-life consumption behavior (who eats half a muffin washed down with half a can of energy drink?).

To read the proposals in full, click HERE, but here’s a summary of the key changes: 

  • Amend definition of a single-serving container.
  • Require dual-column labeling for certain containers.
  • Update and modify several reference amounts customarily consumed (RACC).
  • Add several food products and categories to the RACC per eating occasion for the general food supply.
  • Make technical amendments to various aspects of the serving size regulations.