[quote align=”center”]United States Food and Drug Administration’s (USFDA) recently updated Nutrition Facts and Serving Size regulations are causing a stir as food firms rethink how product chemistry is assessed and reflected and food manufacturers work to completely redesign their labels to meet FDA’s latest requirements. This huge undertaking impacts over 800,000 product labels and applies to all food products whether produced in or imported into the United States.[/quote]
Amy Scanlin, M.S., EAS Consulting Group, LLC.
FDA’s goal with the revised food labels is a more realistic reflection of the American diet. Serving sizes have been updated to better reflect what is consumed at one sitting, and the nutrition facts on the label have been updated to better meet the latest U.S. Dietary Guidelines for Americans (2015-2020).
This sample Nutrition Facts Panel [see below] demonstrates the changes such as an increase in the prominence of “Calories”, removal of the declaration of “Calories from fat”, changes the reference of “Sugars” to “Total Sugars” and includes a new footnote with updated daily values for certain nutrients, an updated list of mandatory and voluntary vitamins and minerals as well as re-evaluated Reference Amount Customarily Consumed (RACC). Lack of compliance with these formatting and content changes can lead a product to be considered “misbranded” resulting in the receipt of an FDA warning letter or in more egregious cases detention.
Manufacturers must have a clear understanding of the required changes in each nutrient category and how the categories are now referenced, not always an easy task. For instance, in the category “added sugars”, those that are free, mono- and disaccharides, sugars from syrups and honey, from concentrated fruit and vegetable juices in excess of what would be expected from the same volume of 100% natural juice and D-tagatose, isomaltulose, and psicose must be included in the definition. However, fruit and vegetable juice concentrate sold to consumers or used for Brix standardization or used to formulate the fruit component of jellies, jams, preserves, or fruit spreads shall not be included. Nor is whole fruit, 100% fruit and vegetable juice, fruit pieces, pulps, purees or dairy products containing lactose to be included.
Similarly there are new requirements for fiber and how mixtures of defined versus undefined fibers and isolated fibers are identified. The results of these changes must also be reflected on the nutrition facts panel.
Certain nutrients on food labels are now required to have updated units of measure, for instance Vitamin A is changed from IU to mcg Retinol Activity Equivalent (RAE). Changes in unit of measure are also required for Vitamin E and Folate.
On the subject of records, FDA now requires records be kept for two years for certain nutrients including added sugars, some dietary fibers and in some cases vitamin E and folate. When analytical methods cannot be used to verify the amounts of declared nutrients, manufacturers must make and keep written records for two years after the food is introduced into interstate commerce. These and other records must of course be provided to FDA upon request during an official inspection.
Compliance with these new requirements must be met by July 26, 2018 for food firms with greater than $10 million US sales annually and by July 26, 2019 for firms with less than $10 million US sales annually. Products being imported into the US need to comply at entry through customs, therefore, foreign firms must schedule for label changes taking into account time required for shipping.
In some cases food manufacturers are finding that outsourcing some of their compliance questions is beneficial from an accuracy and cost perspective. Experts in food chemistry and USFDA labeling requirements can make the transition to FDA’s new food label requirements a smoother process and reduce the risk of error. Companies such as EAS Consulting Group, LLC, Almater’s newest partner in USFDA regulatory issues is one such option allowing companies peace of mind in meeting USFDA compliance requirements.
Now that the Nutrition Facts Panel and Serving Size requirements have been decided, the food industry awaits FDA’s next effort in updating how it defines the claims “natural” and “healthy” made on the front of the food packaging. “It is well accepted that nutrition information on the front of a food package attracts more consumer attention than information on the back,” says EAS Independent Consultant, Bruce Silverglade. “Expect FDA’s treatment of nutrition and health claims to be just as or more controversial as the changes the agency has made to the Nutrition Facts label.” New revisions may be required depending on current claims and in other cases previously unacceptable claims may now be used. Stay tuned as USFDA continues its efforts at transparency in on their food product labels.