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FDA Labeling Requirements for “Added Sugars”

Apr 18, 2018

Written by Anna Benevente


As part of the U.S. Food and Drug Administration’s (FDA) Revision of the Nutrition and Supplement Facts Labels Final Rule, many foods, beverages, and dietary supplements are required to bear a declaration for “added sugars.”  The requirement is perhaps one of the most perplexing aspects of the rule, leaving many businesses with a lot of questions as they transition their label to meet FDA’s new regulations.

What is the Requirement?

Under the rule, labels for products containing 1 gram or more of “added sugar” per serving must indent “Includes ‘X’ g Added Sugars” beneath a declaration for “Total Sugars.”  Labels for products containing less than 1 gram of extra sugar are not required to declare the values if they do not make any sweetener or sugar claims.  These labels may instead be required to display “Not a significant source of added sugars” at the bottom of the table of nutrient values.

The rule defines additional sugars as “sugars that are added during food processing, or are packaged as such,” meaning they are packaged with the intention of being added to a food.  The definition includes sugars from syrups and honey as well as sugars from concentrated juices that exceed amounts typically expected from 100 percent fruit or vegetable juices of the same volume and type.  Labels for certain honey, maple syrup, and cranberry products are permitted to explain that these sugars are either naturally occurring or used to improve palatability.

FDA requires manufacturers to keep records of sugars added before and during processing as well as sugar packaged with the food as separate ingredients.  If the sugars are reduced through fermentation or caramelization, the manufacturer may keep records of scientific data that verify the declared amount is correct or petition an alternative means of compliance.  The manufacturer must justify the accuracy of all data.  FDA requires records to be kept for two years following the product’s introduction to the U.S. market.

Why is FDA Requiring the Added Sugars Declaration?

Certain public comments to the 1990 proposed rule that mandated nutrition labeling for most foods favored requiring a declaration for added sugars rather than total sugars.  Some comments proposed requiring both.  At the time, FDA determined such a requirement was not necessary, nor was it feasible to differentiate between added and naturally occurring sugars in most foods.

The 2015 Dietary Guidelines Advisory Committee (DGAC) report recommended a reduction of added sugar in the American diet, due to a strong correlation between low sugar intake and a decreased risk of cardiovascular disease.  The DGAC report contributed to FDA’s reconsideration of its previous determination, and the Agency cited this data to rationalize the added sugars declaration in its 2016 final rule.

The added sugar declaration is just one requirement in two comprehensive new food labeling rules, which issue changes to daily values, serving sizes, and more. Businesses averaging $10,000,000 or more in annual food sales have less than two years (January 1, 2020) to comply.  Businesses averaging less than $10,000,000 in annual food sales have an additional year.

Updating your label to meet new requirements can be a lengthy process. We urge companies to transition now to ensure compliance before the deadline.  Registrar Corp can update your labeling to comply with FDA’s new label rules.  In addition to a comprehensive report explaining our recommended revisions, you will receive a print-ready, FDA-compliant label.  For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

Author


Anna Benevente

Highly regarded as a top expert on FDA labeling regulations, Anna Benevente continues to educate companies on existing regulations and updates from U.S. FDA for food and beverage, cosmetic, drug, and medical device products. She has researched thousands of products to determine whether they meet the FDA requirements for compliance. In addition, Ms. Benevente has conducted multiple seminars for trade and customs broker associations.

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