Regulatory DevelopmentsJune 30, 2014
On June 26, 2014, the U.S. Food and Drug Administration (FDA) held a public meeting to discuss the proposed changes to the nutrition label and serving sizes. The meeting was attended by interested parties both in Washington, D.C. and via webcast. The Acting U.S. Surgeon General, Rear Admiral Boris D. Lushniak, M.D., M.P.H., gave the opening remarks stating the importance of these changes in relation to the Surgeon General's national prevention strategy started in June 2011. FDA has posted multiple resources for those interested in reviewing the changes as well as the comments made. FDA indicated the public meeting would be made available in the near future. More information is available online.
It has been 20 years since Congress charged FDA, through the Nutritional Labeling and Education Act (NLEA), to craft the original nutrition label and serving size legislation. The data used to determine the critical elements were derived from information gathered in the 1970s and 1980s. The new proposed regulation is intended to capture changes in U.S. eating habits, and changes in dietary science and dietary guidance that have occurred over the past 20 years. The comment periods for both Docket # FDA-2004-N-0258 and FDA-2012-N-1210 will be open until August 1, 2014, and FDA encouraged participants to provide feedback.
High Level Changes
FDA has proposed revisions to the nutrition and supplement fact information required to be listed on product labels. Under the proposal, the label no longer allows "calories from fat" labeling, and instead mandates disclosure of "added sugars." Values for Vitamin D and potassium must also be included, and the listing of Vitamins C and A is optional. The daily values (DV) have also been revised, the definition for dietary fiber has been amended, and the units of measure for vitamins and minerals have been revised, as has the label format itself. Importantly, serving size criteria have been amended, a subject of considerable discussion leading up to the proposal. FDA also included a recordkeeping element for those nutrients where the detection methods are similar and the distinction between what is stated and what is present may not be possible, like natural and added sugars.
Among the changes identified in the proposed rule for serving size is an amendment to the definition of a single serving, dual column labels, and updates to certain reference amounts customarily consumed (RACC). The package and serving size changes are being introduced to raise awareness and reflect the changes that have occurred in our eating habits. The updates to RACCs will result in changes to increase DVs for fiber, potassium, calcium, and Vitamin D, and a decrease in the DV for sodium. No DV is proposed for "added sugars."
FDA has also proposed to amend the label format. Changes include a more prominent bold type for calories, increased font for serving size, the shift of the percent DV to the left from the right, and the removal of the words "daily value" to just the abbreviation "DV." FDA also proposed an alternate format label that includes terms to describe the information including "get enough" and "avoid too much."
During the meeting, FDA engaged stakeholders in a panel discussion, public comments, and a question and answer session. Almost all of those who participated in these sessions expressed the importance of these changes as significant and acknowledged the amount of work FDA has done to prepare the proposed rule. The changes that elicited the most comments were the addition of the "added sugars," the lack of a DV for "added sugars," the proposed alternate format with the prescriptive text, the dual column format for serving size logic, and the decrease in the DV for sodium.
Comments on "added sugars" and DV for sodium were mixed. The clarity of the changes and the science behind both proposals were questioned throughout the comment sessions. Some praised the addition of "added sugars" as scientifically justified, while others questioned the science and definitions behind it. All agreed the reduction of the sodium DV was a critical health benefit; some expressed the view that FDA did not go far enough.
One of the biggest concerns for industry is the timeline for implementation if the proposed rule is issued in final as proposed. As many of the food industry association representatives stated, the proposed two years to achieve compliance would not be sufficient to determine many of the new elements that are required, and comply with the new requirements. A few proposed a rolling timeline, while others suggested three to five years.