By Elizabeth Campbell, EAS Senior Advisor for Labeling & Claims
In March, FDA published proposals for changes to Nutrition Facts and Supplement Facts. The proposed changes include reformatting of all conventional food labels in the servings per container and calorie declarations. The specifics of the new format may change a little based on information in comments, but it is likely that the basic approach of increasing emphasis on calorie consumption will remain in the final requirements. Most dietary supplement labels would not have to make this change. Other major changes include the addition of Vitamin D and potassium as mandatory nutrients instead of vitamins C and E and the requirement for declaration of added sugars. These changes will impact essentially all labels.
Proposed revisions in Daily Values (DV) may not only require revising the label, but some companies would need to consider reformulating some of their products. Changes in Reference Amounts Customarily Consumed (RACC) would result in serving size changes, but just as important, would result in changes in whether some products qualify for claims. The proposed DVs and RACCs are not likely to be different in the final regulation unless new, persuasive data are provided to FDA in comments.
For more information including the proposals and information on submitting comments see: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ LabelingNutrition/ucm385663.htm. Companies should be diligently studying the proposals to see how the changes will affect them so that they can submit comments to FDA to ask for different provisions. FDA had originally set June 2 as the deadline for comments, but they have now extended the deadline until August 1. Comments must include data and/or other information to justify requests for different requirements.
Once the comment period has closed, FDA will analyze the issues raised in the comments, prepare responses to all the issues and develop a final regulation. This ordinarily would take about two years, but there appears to be a sense of urgency at the agency that could result in a final regulation by the end of 2015. FDA proposed 60 days after publication of the final rule for the effective date of the regulation and there would be two years after that date for changing labels. The agency didn’t specifically say how we should interpret these dates, but I think it means that any label revised after the effective date must comply with the new requirements and all changes must be completed within the two years. Generally, that would mean any product initially shipped in interstate commerce after the final date (60 days + 2 years after publication) must comply with the new requirements.
The sooner that companies begin to absorb the changes, the smoother will be the changeover. Some industry staff can remember the trauma of creating the Nutrition Facts in the early 1990’s when the NLEA became effective. Numbers of companies found themselves in tight straights with late changes and waiting lines at the printers at the last minute. More recently, there was the addition of trans fat to Nutrition Facts in 2006, which required a relatively small adjustment compared to the changes coming now.
Betty Campbell will be speaking more on this subject in a session called “Anticipating FDA Proposed Changes to Nutritional Facts Labels,” Monday, June 23, 2014 from 8:30am-10:00 a.m., at the Institute of Food Technologists Annual Meeting in New Orleans, LA. For more information, click here.
Food Label Compass
EAS has entered into an alliance with FoodMinds Inc., and Nutrition Impact LLC, called Food Label Compass, to offer a suite of labeling services to assist clients in adapting to the new Nutrition Facts requirements.
Food Label Compass combines the expertise of all three partners and will provide nutrition analysis, regulatory consulting and strategic services to food and beverage companies. If you need assistance with serving sizes, Daily Values (DVs) or nutrition claims Food Label Compass can help.