All food and supplement suppliers, manufacturers, and retailers labels be affected by the finalized nutrition label changes, in both the United States and Canada. Companies need to be aware of the proposed changes in order to think strategically about the ability for products to maintain claims in the U.S. and Canada, as well as the opportunity for products to take advantage of the nutrient and health claims available for their product. FDA has stated that “January 1, 2018 will be the uniform compliance date for food labeling regulations that are issued in calendar years 2015 and 2016.”[1] In Canada, however, the passage of the Nutrition Facts Table (NFt) package is largely dependent on the October 2016 election; the new government elected may decide to suspend the existing proposed revisions to the NFt for changes, or even send the entire package of revisions back to the drawing board.[2]
Since National Labeling and Education Act (NLEA) was implemented in 1994, the American diet has been very much altered, and FDA has also found that consumption can be influenced by nutrition information. FDA looked at a study by USDA that measured how consumers changed their consumption of fat and cholesterol in response to nutrition information flags on grocery store shelves. This study found “fat consumption fell an average of 1.25 percent and cholesterol an average of 0.1 percent for consumers at that grocery store in response to the nutrition values posted at the point of sale.”[3] Due to this information, FDA feels that it is important to update the nutrition label information to more adequately reflect consumers’ diets and behaviors.
Products that contain fiber, vitamin D, potassium, fat, saturated fat, sodium, and cholesterol will need to make sure that their daily values (DV) match with the new DVs proposed by FDA (Figure 1) and Health Canada (Figure 2) for products sold in those respective countries.
Figure 1. U.S. Proposed Nutrition Label Changes
Figure 2. Canadian Proposed Nutrition Label Changes
Serving sizes in the U.S. and Canada do not currently reflect a single portion eaten by a consumer; for this reason, FDA and Health Canada are both considering changes to the serving sizes listed on food nutrition labels. By law, serving sizes in the U.S. and Canada are determined by current food consumption data. In the proposed changes in the U.S., the serving sizes must reflect actual consumption instead of ideal consumption. This change would mean that calorie content, as well as fat, sugar, and sodium content on the Nutrition Facts label will increase dramatically in some cases; even doubling of the serving sizes for products such as ice cream (Figure 3).[4] Health Canada, on the other hand, has taken a different approach to serving sizes; rather than emphasizing that a “serving” should be typically eaten in one sitting, Health Canada attempts to make serving size more easily comparable between similar products (Figure 4).
Figure 3. U.S. Serving Size Proposed Changes
Figure 4. Canadian Proposed Serving Size Changes
Fiber
FDA is proposing to change the definition of fiber, and certain ingredients will no longer be counted as “fiber” for disclosure purposes on the Nutrition Facts label. Companies with products that contain fiber, especially products that promote themselves as an “excellent source of fiber,” will need to revisit their formulations in order to guarantee that their product meets the new FDA requirement for this nutrient claim.
“Manufacturers would be required to provide evidence to FDA to demonstrate the physiological effects that are beneficial to human health, of isolated and synthetic non-digestible carbohydrates added to food, and FDA would have to grant a petition or authorize a health claim before they can be considered as “dietary fiber” for declaration on the Nutrition Facts label. Manufacturers would use the citizen petition process in § 10.30 or, in case of a related health claim, the health claims petition process in § 101.70.”[5]
In Canada, the DV for fiber will no longer be required on the label; however, companies with products contain fiber should still be wary of fiber claims made on products and understand the minimum amount and types of fiber necessary to support any claims. Claims are not restricted to fiber from the same source. Nutrient content claims for dietary fiber can be made for foods that are considered sources of dietary fiber. Terms that describe the fiber as “good” or “excellent,” however, are not permitted. Any fiber source that has not been evaluated by Health Canada will be considered a novel fiber source and no fiber claims may be made for it. To find more information about which dietary fibers are accepted, you can visit:[6] http://www.inspection.gc.ca/food/labelling/food-labelling-for-industry/nutrient-content/specific-claim-requirements/eng/1389907770176/1389907817577?chap=12
Vitamin D and Potassium
Unlike on the current nutrition facts label, vitamin D and potassium content and % Daily Value (%DV) will be required to be disclosed on the label in the U.S., and the NFt in Canada. In addition, in Canada, the proposed DV for vitamin D and potassium will increase. In the U.S., this proposed change presents an opportunity for companies with products high in vitamin D or potassium to consider utilizing authorized health claims for these products.
Fat, Saturated Fat, Sodium, and Cholesterol
The proposed changes for both countries plan to decrease the current daily values (DVs) for fat, saturated fat, and sodium (cholesterol will be impacted in the U.S., however, not in Canada). This may affect a product’s ability to make claims; if products contain over the designated amount of fat, saturated fat, sodium or cholesterol (20% of the DV in the U.S.), the product will no longer be able to make nutrition or health claims.
Sugar
Both the U.S. and Canada are examining the impact of sugar, especially “added sugars”, on health, and attempting to influence consumer behavior to decrease their total daily consumption of sugar. With the proposed changes, companies will be required to track and manage their total sugar and added sugars, and indicate these on the nutrient label. Health Canada proposes to include a recommended maximum DV of total sugar at 100 grams (an amount determined by the World Health Organization Guidelines for Sugars Intake for Adult and Children).[7] The mandatory inclusion of %DV will help consumers to identify the relative amount of sugar in the food, which will allow consumers to more easily identify foods that are low (5% or less) and high (15% or more) in sugar content.[8] Health Canada has not stated whether companies would be able to make label claims, such as “low in added sugars” or “high in added sugars,” but it would follow that these claims may be possible in Canada once the regulation is finalized. Currently, products in Canada can claim that they contain “no added sugar” as long as they follow the criteria that (1) the food contains no added sugars and no ingredients containing added sugar or ingredients that contain sugars that functionally substitute for added sugars, (2) the sugars content is not increased through some other means except if the functional effect is not to increase the sugars content of the food; and (3) the similar reference food contains added sugars.[9]
In the U.S., there is currently much debate about requiring added sugars on the label; historically, FDA has only included nutritional content that directly relates to a disease, however, FDA argues that added sugars impact the nutrient density of a product and essentially leave less room for consumers to eat nutrient dense foods. This added sugar information attempts to help consumers understand how much sugar occurs naturally in the food and how much is added to enhance the taste or performance of the product. The added sugar does not enhance the nutritional value of the food and is often referred to as “empty calories.” FDA states that “no specific recommendation for added sugars are being made but that the added sugar information will allow consumers, who want to limit their added sugar intake, to compare various brands of similar products.” [10]
FDA has yet to complete its consumer research to prove that consumers will adequately understand the added sugar disclosure on the label and grasp the difference between added and total sugars. Similar concerns exist in Canada, and the Canadian approach includes three different potential approaches for addresses added sugar on the label: (1) mandatory declaration of added sugars on NFt, (2) mandatory declaration of % DV for total sugars on NFt, or (3) the grouping of sugars-based ingredients in List of Ingredients.[11]
Other DV changes
DVs are expected to increase and decrease, in some cases because of updated consumer nutrition information. In Canada, the daily values for Vitamin A, C, D, E, K, folate, B12, calcium, potassium, iron, phosphorus, magnesium, manganese, zinc and selenium are expected to increase, while the DVs for thiamin, riboflavin, vitamin B6, iodide, copper, chromium, molybdenum are expected to decrease. Some DVs will need to be updated due to the change in the serving size of the product; FDA is planning to change serving sizes in order to more realistically “reflect how much people typically eat at one time.”
The proposed changes will have a huge impact on industry, which will need to reformulate and repackage some products in order to meet their marketing and sales goals. Joslyn Higginson, Vice President Public & Regulatory Affairs of the Food & Consumer Products Canada (FCPC) estimates that costs for food and beverage sector range anywhere from $308,000,000 to $915,000,000, just based on estimate of total SKUs of FCPC membership. FCPC also assumes that the proposed changes “will trigger a major level packaging change for all products.”[12] These “major level” changes may include, but are not limited to:
“Product reformulation
Regulatory consultation for label compliance and review
New packaging design and artwork
New packaging printing costs
Labour to manage, contribute and approve each package produced,”
These major changes may even only be the tip of the iceberg for some products, which may require extensive of reformulation, possibly even adding new ingredients in order to keep the nutrient content or health claim for the product or, to preserve the taste, consistency and appearance of the product. FDA estimates that “the one-time cost to industry of labeling, reformulation, and initial recordkeeping is $2.3 billion, with a small annual cost associated with recurring recordkeeping,” a conservative estimate when all major, and minor, changes are considered.
Changes in regulations require lengthy and time-consuming tasks from companies, but these tasks are critical in order to mitigate risk and ensure positive brand equity in the long term. The best time to start planning for these upcoming changes in regulation is before the changes become law; if companies analyze their food products affected by the proposed changes in regulation now, they will be able to identify the need for major formulation and packaging changes, potentially minimizing costs, avoiding fast approaching deadlines, and even taking advantage of new product marketing opportunities.
References
[1] FDA Announces Uniform Compliance Date for Food Labeling Regulations: Constituent Update. FDA.gov. December 9, 2014. http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm425647.htm
[2]Joslyn Higginson, Vice President Public & Regulatory Affairs, Food & Consumer Products Canada (FCPC).
FDLI Webinar. April 2, 2015. “US and Canadian Proposed Nutrition Label Changes: Doing Business in Both Countries.” http://www.fdli.org/us-canadian-label-changes/general-information
[3] USDA.gov. “Economics of Food Labeling. Part II: Case Studies and Examples.” http://www.ers.usda.gov/media/532240/aer793e.pdf
[4] Bruce Silverglade, Principal, OFW Law. Food and Drug law (FDLI) Webinar. April 2, 2015. “US and Canadian Proposed Nutrition Label Changes: Doing Business in Both Countries.” http://www.fdli.org/us-canadian-label-changes/general-information
[5] The Federal Register. “Food Labeling: Revision of the Nutrition and Supplement Facts Labels: Dietary Fiber.” Visited May 1, 2015. Last updated February 4, 2014. https://www.federalregister.gov/articles/2014/03/03/2014-04387/food-labeling-revision-of-the-nutrition-and-supplement-facts-labels#h-50
[6] Government of Canada. Specific Nutrient Content Claim Requirements: Dietary Fibre Claims. Visited May 4, 2015. Date modified September 11, 2014. http://www.inspection.gc.ca/food/labelling/food-labelling-for-industry/nutrient-content/specific-claim-requirements/eng/1389907770176/1389907817577?chap=12
[7] World Health Organization. 2015 Report. “Guidelines for Sugars Intake for Adult and Children.” http://www.who.int/nutrition/publications/guidelines/sugars_intake/en/
[8]Health Canada. “Improving Nutrition Information on Labels: Better Understanding the Sugar Content in our Foods.” Visited May 4, 2015. Page modified on July 11, 2014. http://www.hc-sc.gc.ca/fn-an/label-etiquet/sugars-sucres-fs-fr-eng.php
[9]Government of Canada. Criteria for the Nutrient Content Claim No Added Sugar. Visited May 11, 2015. Last updated September 4, 2014. http://inspection.gc.ca/food/labelling/food-labelling-for-industry/nutrition-labelling/no-added-sugars/eng/1409805993240/1409806059770
[10] “Proposed Changes to the Nutrition Facts Label.” FDA.gov. Visited May 4, 2015. Page last updated August 1, 2014. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm
[11]Adrienne Blanchard, Partner, Norton Rose Fulbright Canada LLP. FDLI Webinar. April 2, 2015. “US and Canadian Proposed Nutrition Label Changes: Doing Business in Both Countries.” http://www.fdli.org/us-canadian-label-changes/general-information
[12] Joslyn Higginson, Vice President Public & Regulatory Affairs, Food & Consumer Products Canada (FCPC). Food and Drug Law Institute Webinar. April 2, 2015. “US and Canadian Proposed Nutrition Label Changes: Doing Business in Both Countries.” http://www.fdli.org/us-canadian-label-changes/general-information