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FDA Publishes Long-Awaited Guidance on Labeling Rules


FDA Publishes Long-Awaited Guidance on Labeling Rules

Two and a half years after the issuance of two food labeling final rules, FDA has published related guidance documents. Although the original compliance deadlines were scheduled for this summer, FDA recognized that manufacturers needed additional time to make all the required changes and extended the date to January 1, 2020, for manufacturers with $10 million or more in annual food sales, and January 1, 2021, for those with less.


The two new guidance documents, which have been long awaited to provide FDA’s thinking on how to implement the new requirements, are:

Perhaps most importantly in the guidance, FDA explains exactly what it means to be compliant by the January deadlines. Total annual sales are based on both domestic and international food sales, and companies can use either their smallest sales volume from the previous three years or an average of the previous three years sales volume.


Additionally, products that are labeled before the compliance date do not need to bear the new nutrition label, regardless of their location. So, if the product is labeled on December 31, 2019, the new requirements are not applicable, even if it is still at the manufacturing facility awaiting shipment. FDA will also allow the use of a sticker for providing the revised nutrition label before new packaging is printed, as long as it doesn’t cover any other mandatory information.


Underlying many of the more visual changes to the label, FDA updated the reference amounts customarily consumed per eating occasion (RACCs), to more accurately represent what we are eating today, which will be reflected in the serving size on the new labels. Some of the more notable changes are that ice cream now has a RACC of 2/3 cup instead of 1/2 cup, and soda is going up to 12 ounces from 8 ounces. The guidance explains how to use the RACC tables in 21 CFR §101.12 to determine the serving size and declare servings for products such as meal and main dish products, bulk product, and products that vary in size, among others.


Depending on the size of the package in reference to the RACC, some products will have new labeling requirements that declare either the nutrition information for the entire package (containing less than 200% of the RACC) or the nutrition information per serving and for the entire package (containing 200%-300% of the RACC). This is because of the change to the definition of “single-serving container.” However, there are some nuances to the rules that allow companies to voluntarily declare the nutrition information as a single serving or provide per unit nutritional information for discrete units; these are further clarified in the guidance.


On the more technical side, the guidance documents answer many questions about how to calculate and declare added sugars in relation to the total sugars of the product, as well as the amounts of vitamins and minerals. While there is no required formula for calculating added sugars, the guidance clarifies how a company can use dilutions, Brix values, chemical analysis, and supplier information to evaluate concentrated fruit and vegetable juices, powders, purees, and pulps to determine if they must be considered an added sugar used to sweeten a product. For cases in which added sugars are lost through fermentation or other processes during production, FDA provides its thinking on how to evaluate those situations, as well as the data and records that must be maintained to substantiate the added sugar claimed on the product label.


Even with the additional time provided for compliance, there are many reasons to start working on updating labels now, as the changes to the RACCs may affect labeling claims, and it may take time to gather nutritionals and evaluate naturally occurring and added sugars, as well as dietary fiber. (Dietary fiber guidance was issued in June 2018.) Plus, as the new requirements provide the greatest benefit to the consumer, it always helps to be ahead of the game.

About The Acheson Group (TAG)

Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.achesongroup.com

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