In this edition of the Weekly Compliance Digest, we cover the extension of the compliance date for U.S. FDA final rules on changes to nutrition facts labels on foods.
Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods; Proposed Extension of Compliance Dates
What is it?
On October 2, 2017, the U.S. FDA published a proposed rule that would extend the compliance date for final rules providing updated nutrition information on the labels of foods, including dietary supplements. The final rules were published on May 27, 2016.
The FDA is taking this measure because the agency believes that the additional time would help ensure that all manufacturers covered by the final rules have guidance from FDA to address, for example, certain technical questions, and that they are able to complete and print updated Nutrition Facts labels for their products before they are expected to be in compliance with the final rules.
What are the requirements of the rules?
Under the Obama administration, the FDA had published two final rules in May 2016:
The Nutrition Facts Label Final Rule revises the Nutrition Facts label by:
- Increasing the prominence of the number of calories.
- Changing “Sugars” to “Total Sugars”.
- Requiring that “Added Sugars” be declared on the label.
- Updating the list of vitamins and minerals of public health significance.
- Updating certain reference values used in the declaration of percent Daily Values (DVs) of nutrients on the labels.
The Serving Size Final Rule requires all containers containing less than 200% of the reference amounts customarily consumed (RACC) to be labeled as a single-serving container. The rule also requires that containers and units that contain at least 200% and up to and including 300% of the RACC be labeled with a column of nutrition information within the Nutrition Facts label that lists the quantitative amounts and percent DVs for the entire container, not just for a serving size that is less than the entire container.
What is the new proposed compliance date?
The compliance date for manufacturers with $10 million or more in annual food sales would extend from July 26, 2018 to January 1, 2020. The compliance date for manufacturers with less than $10 million in annual food sales would extend to January 1, 2021. Comments can be submitted electronically or in writing until November 1, 2017.
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