October 24, 2011 | Kelley Drye Client Advisory
In 2009, Congress requested an Institute of Medicine ("IOM") study examining "front-of-package" ("FOP") nutrition labeling systems and symbols and the effect that FOP labeling could have on consumer food choices. The resulting IOM study, which was conducted in two phases by a committee ("IOM Committee" or "Committee") convened at the request of Congress, was sponsored by the Centers for Disease Control and Prevention ("CDC"), the Food and Drug Administration ("FDA"), and the U.S. Department of Agriculture ("USDA") Center for Nutrition Policy and Promotion. The IOM Committee completed Phase I, which evaluated current FOP labeling systems and nutritional criteria, in October 2010, and issued a report entitled "Examination of Front-of-Package Nutrition Rating Systems and Symbols: Phase I Report" on October 13, 2010. A year later, the IOM Committee completed Phase II, which focused on consumer understanding and use of FOP systems and symbols, and issued its recommendations in a report entitled "Front-of-Package Nutrition Rating Systems and Symbols: Promoting Healthier Choices" on October 20, 2011.
In its Phase II report, the IOM Committee reports that there is sufficient evidence for FDA and USDA to "consider a fundamental shift in strategy," beyond the prevailing "cognitive" approach which focuses on "informing consumers about nutrition facts," to "encourage healthier choices and purchase behaviors."1 The report concludes that this can be better achieved by "a simple FOP symbol [on the front of food packages] that serves as a signal or cue to consumers"; rather, than by providing detailed nutrition information about food and beverages on the front of food packages.2 The Committee points to the Energy Star® program which has been "highly successful in changing consumer purchase patterns for household appliances and electronics" (discussed below) as an example of the system the Committee envisions for food products.
The IOM report recommends that:
- "Federal agencies should develop a new nutrition rating system with symbols to display on the front of food and beverage packaging that graphically convey[s] calorie counts by serving size and a ‘point' value showing whether the saturated and trans fats, sodium, and added sugars in the products are below threshold levels" and
- "This new front-of-package system should apply to all foods and beverages and replace any other symbols currently being used on the front of packaging."3
Phase II Background
While Phase I examined existing FOP label systems and considered what framework would best promote diet-related public health objectives, Phase II focused on the potential benefit of a single, standardized labeling scheme.
In Phase I, the IOM Committee concluded that:
- FOP rating systems and symbols should be geared toward the general population rather than particular subpopulations based on age or health conditions;
- The FOP labeling systems should be designed to help consumers identify and select foods based on specific nutrients (e.g., calories, saturated fat and trans fat, and sodium) that are linked to diet-related disease/health risks affecting the largest number of Americans (e.g., obesity, cardiovascular disease, diabetes, hypertension); and
- There is insufficient evidence to suggest that it would be useful to include the following nutrients in FOP labeling-total fat, cholesterol, total carbohydrates, total sugars, added sugars, protein, fiber, vitamins, and minerals other than sodium.4
In preparation for the Phase II report, the Committee undertook a number of preliminary steps, including the following:
- Reconsidering certain conclusions of Phase I based on subsequently published evidence-- specifically the Committee determined that added sugars should be included as one of the nutrient categories addressed by a FOP rating system;
- Hosting two public sessions with expert presentations to facilitate discussion on consumer understanding and use of FOP labels;
- Gathering comprehensive evidence from peer-reviewed and non-peer reviewed sources and establishing a process for analyzing the data; and
- Enlisting consultants to consider what types of symbols would best create an effective standardized FOP labeling scheme.5
Key Phase II Study Recommendations
The IOM's Phase II recommendations are based on existing federal agency regulations, the USDA's 2010 Dietary Guidelines for Americans ("Dietary Guidelines"), and a comprehensive review of peer-reviewed published evidence, as well as non-peer reviewed evidence submitted by industry, government, and non-government stakeholders. The IOM Committee believes that federal agencies, such as the FDA and USDA, should use the model FOP system and the products' rating approach that has been recommended by the Committee in its Phase II report to "develop, test, and implement a single, standard FOP system to appear on all products."6
IOM Model Front-of-Package Symbol System
The IOM committee determined that, in order for a nutrition rating symbol system to successfully help consumers make healthier food choices, the system must be:
- Simple - The system should be easily understood by consumers and not require consumers to have nutritional or sophisticated food knowledge to understand the symbol's meaning.
- Interpretive - The system should not be intended to provide specific nutritional information, but rather should offer guidance based on specific nutrition information.
- Ordinal - Nutritional guidance should be provided using a scaled or ranked approach.
- Educational - The system should be supported by a consumer education program.
In addition to the system goals listed above, the IOM Committee identified eight characteristics needed for a successful, easily understood FOP system, which include the following:
(1) The system should use one simple, standard symbol (e.g., a check, star, or other indicator) that translates information regarding saturated and trans fat, sodium, and added sugars into a FOP label that "mak[es] healthier options unmistakable."Examples of the IOM Committee's recommendations for a FOP label system are provided here, here, and here.7
(2) The FOP label should display (a) calories per common household measure serving size and (b) zero to three "nutritional" points, based on eligibility and qualifying criteria set for saturated and trans fat, sodium, and added sugars.
(3) The FOP should appear on all grocery products and replace any other FOP nutrition labeling systems, such as those endorsed by food association groups and private grocery chains.
(4) The FOP label should appear in a consistent location on all products, such as the upper right hand corner of a package's principal display panel.
(5) The system should be practical to implement, which, according to the IOM Committee, can be achieved by making the system consistent with nutrition labeling regulations.
(6) The FOP system should be integrated with the Nutrition Facts Panel, such as by placing a check, star, or other indicator inside or next to the Nutrition Facts Panel adjacent to the nutrition component that earned a point.
(7) The FOP should provide a non-proprietary, transparent system to translate nutrition information into quick and easily understood information for consumers.
(8) Interested parties, including federal agencies and private parties, should support FOP consumer education and other promotion programs to make FOP labeling prominent and useful for consumers.
IOM Criteria for Evaluating Nutrients
As discussed above, the IOM Committee has recommended that all grocery packages carry a FOP label that displays calories per household serving size and zero to three nutritional "points." To determine how many points a product should be able to display on the FOP label, the IOM Committee has recommended a two-step process.
Step 1: Determine Whether the Product is Eligible to Earn FOP Points. Eligibility criteria determine whether a product may earn any FOP points for low levels of saturated and trans fats, sodium, or added sugars. If a product contains any one or more of those stated nutrient components in an amount that is inconsistent with the Dietary Guidelines recommendations, the product is ineligible for FOP points (e.g., if a product contains levels of sodium that are higher than amounts recommended in the Dietary Guidelines, the product cannot display any FOP points even if it has low levels of saturated and trans fat, and added sugars).
Step 2: Determine the Number of FOP Points a Product Qualifies to Receive. If the Step 1 analysis determines that a product is eligible to earn FOP points, a Step 2 analysis is conducted to determine how many FOP points a product qualifies to receive. The report outlines a system for assigning up to one point each for saturated fat and trans fats (represented by a single point), sodium, and added sugars, with a maximum of three points being available for a food or beverage product.
The report recommends that the nutritional criteria for the Step 2 determination be more restrictive than those that are used for the Step 1 determination, and outlines nutritional criteria that could be used for both the Step 1 and Step 2 determinations that are drawn from existing FDA regulations governing nutrient content claims (e.g., "low," "healthy," "no added sugars") and certain Nutrition Facts requirements (e.g., regarding trans fats).
While, the IOM report advises that the nutritional criteria employed for the FOP labeling system should be based on FDA regulations, it also highlights limitations of the existing regulatory framework which has the potential to generate overly restrictive FOP eligibility and qualifying criteria and inappropriate FOP signals concerning the relative healthiness of a particular food or beverage product. For example, the IOM report notes that criteria based on current FDA regulations would have the potential to disqualify certain foods and beverages from a FOP labeling system, even though the food or beverage meets current Dietary Guidelines recommendations and is eligible for the Women Infant and Children ("WIC") program. In this regard, the IOM Committee report recommends that FDA food labeling regulations be changed, stating, "[c]urrent FDA regulations will require modifications and/or exemptions, and new regulations will need to be developed along with food group specifications to find an appropriate balance between restrictiveness and practicality."8
The chart below highlights the IOM Committee's approach for determining eligibility and qualifying criteria using FDA regulations:
||Eligibility Criteria to Earn FOP Points||Qualifying Criteria for FOP Points9
|Saturated Fat||The IOM Committee recommended that foods would be ineligible to earn FOP points if--
(1) For individual food/beverage products, the product contains 20% or more of the Daily Value for saturated fat per RACC;10
(2) For main dish products, the product contains 30% or more of the Daily Value for saturated fat per RACC; or
(3) For meal products, the product contains 40% or more of the Daily Value for saturated fat per RACC.
| The IOM report recommended using FDA criteria for "low saturated fat" claims as a starting point for determining which foods would qualify for an FOP point. Under this criteria, the following levels of saturated fat would qualify a food for a FOP point (provided the food also meets the trans fat qualifying criteria)--
(1) For individual foods, the food contains less than or equal to 1 g per RACC of saturated fat and the saturated fat is less than or equal to 15% of calories in the product;
(2) For seafood and game meat, the product contains less than 2 g of saturated fat per RACC and per 100 g of food;
(3) For main dishes and meal products, the food contains less than or equal to 1 g of saturated fat per 100 g of food and equal to or less than 10% of calories in the food product;
| Trans Fat
||The IOM Committee did not provide any recommended criteria for trans fat eligibility because there are no regulatory criteria for "low" or "high" amounts of trans fat.||According to the IOM Committee, a product would earn an FOP point (provided the food also meets the saturated fat qualifying criteria) if--
(1) A product's Nutrition Facts Panel declares 0 g trans fat per serving (i.e., less than 0.5 g per labeled serving); or
(2) A product's Nutrition Facts Panel declares 0.5 g or more trans fat per serving and the ingredients statement does not list a partially hydrogenated vegetable oil.
||Similar to saturated fat, the IOM Committee recommended that foods would be ineligible to earn FOP points if--
(1) For individual food/beverage products, the product contains 20% or more of the Daily Value for sodium per RACC;
(2) For main dish products, the product contains 30% or more of the Daily Value for sodium per RACC; or
(3) For meal products, the product contains 40% or more of the Daily Value for sodium per RACC.
|The IOM Committee suggested that the FDA defined criteria for "low sodium" (i.e., less than or equal to 140 mg per RACC) and "healthy" claims (less than or equal to 480 mg per RACC) could be used for sodium point qualifying criteria.|
|Added Sugars||Any product that is categorized as Sugars, Sweets, and Beverages in the USDA Food and Nutrient Database for Dietary Studies and contains added sugars would be ineligible for the FOP point program.||The IOM Committee recommended the following criteria for individual foods--based on FDA criteria for "sugar free" and "no added sugars" claims-to determine if a food could display an added sugars FOP point (i.e., if foods meet this criteria one point could be displayed for added sugars):
(1) Foods that meet FDA criteria for "sugar free" and "no added sugars";
(2) Foods that contain less than or equal to 6 g of total sugar per ounce if it is a breakfast cereal that meets WIC requirements for sugars;
(3) Foods that contain less than or equal to 5 g of total sugar per RACC for products with an ingredient recognized as added sugars except for canned vegetable products and yogurt products;
(4) Foods that contain less than or equal to 10 g of total sugar per RACC for canned vegetable products that contain naturally occurring sugars as well as an ingredient recognized as added sugars; and
(5) Foods that contain less than or equal to 20 g of total sugar per RACC for yogurt products and substitutes that contain a low calorie sweetener and ingredient recognized as added sugars.
Energy Star® Equivalent Rating System for Foods
According to the IOM Committee, the Phase II report is intended to offer a "path to develop an Energy Star equivalent for foods and beverages." The Energy Star program is a voluntary labeling system created by the Environmental Protection Agency ("EPA") and Department of Energy ("DOE") which is designed to encourage consumers to purchase more energy-efficient products. Under the program, manufacturers have the option to apply for an Energy Star certification by submitting products to an EPA-recognized third-party testing entity. If the product is established to satisfy minimum standards for energy efficiency which have been established by the EPA and DOE, the product is authorized to display the Energy Star label on its packaging.11
The Energy Star program is entirely voluntary and manufacturers are under no obligation to pursue an Energy Star certification for their products. In highlighting the Energy Star program as a model, the IOM report recognizes that a key factor that has contributed to the effectiveness of the program has been the extensive degree to which it has been embraced and adopted. While the IOM report does not make explicit recommendations concerning how a FOP labeling system should be implemented from a legal or regulatory standpoint (e.g., mandatory or voluntary), the report emphasizes that for a FOP labeling system to be maximally effective in encouraging healthier consumer choices and purchase behaviors, "[o]ne simple, standard symbol [representing products' calories and point values should] appear[ ] on all grocery products . . . ."12
Kelley Drye & Warren LLP
Kelley Drye's team of Food and Drug lawyers strives to integrate our clients' business strategies with FDA compliance and to help resolve regulatory enforcement matters when they arise. Working side-by-side with business development and marketing professionals, we provide comprehensive regulatory counseling and assist in developing products, labels, and promotional materials that achieve our clients' goals without running afoul of regulatory requirements. With close knowledge of FDA's enforcement priorities and deep experience with the FTC's regulation of advertising, our team can provide comprehensive legal advice with an eye towards giving clients a competitive edge.
Appendix A: Institute of Medicine of the National Academies Committee Phase II Recommendations
FDA and USDA should develop, test, and implement a single, standard FOP system to appear on all products. The system should have the following characteristics:
- One simple, standard symbol translating information from the Nutrition Facts panel (NFP) on each product into a quickly and easily grasped health meaning, making healthier options unmistakable;
- Calories in common household measure serving sizes (shelf tags to be used on bulk items such as fruits and vegetables as well as packaged goods), and
- Zero to three nutritional "points" (for saturated and trans fats, sodium, and added sugars);
- Appearing on all grocery products, allowing consumers to compare food choices across and within categories (determination for universal implementation of the symbol system must be preceded by consumer testing and conducted in conjunction with an education and promotion program);
- Appearing in a consistent location across products;
- Practical to implement by being consistent with nutrition labeling regulations;
- Integrated with the NFP so that the FOP symbol system and the NFP are mutually reinforcing;
- Providing a non-proprietary, transparent translation of nutrition information into health meaning; and
- Made prominent and useful to consumers through an ongoing and frequently refreshed program of promotion integrating the efforts of all concerned parties.
Implementation of a new FOP symbol system should include a multi-stakeholder, multi-faceted awareness and promotion campaign that includes ongoing monitoring, research, and evaluation.
1 See Institute of Medicine, "Front-of-Package Nutrition Rating Systems and Symbols: Promoting Healthier Choices" (Pre Publication Copy) (Oct. 20, 2011), available at, http://www.iom.edu/Reports/2011/Front-of-Package-Nutrition-Rating-Systems-and-Symbols-Promoting-Healthier-Choices.aspx.
3 See National Academies, "Calorie Count Plus Points Based on Added Sugars, Sodium, and Saturated and Trans Fats Recommended as New Front-of-Package Nutrition Labeling System" (Oct. 20, 2011), at 1; see also Appendix A: Institute of Medicine of the National Academies Committee Phase II Recommendations.
4 See Kelley Drye and Warren, IOM Issues Phase I Report Regarding Front-of-Package Nutrition Rating Systems and Symbols (Oct. 21, 2010), available at, http://www.kelleydrye.com/publications/client_advisories/0603; Kelley Drye and Warren, FDA Seeks Public Comment on Front-of-Package Labeling (May 4, 2010), available at, http://www.kelleydrye.com/publications/client_advisories/0558.
5 See Kelley Drye and Warren, IOM Holds First Meeting Regarding Phase II of "Examination of Front-of-Package Nutrition Rating Systems and Symbols" (Oct. 27, 2010), available at, http://www.adlawaccess.com/2010/10/articles/food-and-drug/iom-holds-first-meeting-regarding-phase-ii-of-examination-of-frontof-package-nutrition-rating-systems-and-symbols/.
6See Institute of Medicine, "Front-of-Package Nutrition Rating Systems and Symbols: Promoting Healthier Choices" (Pre Publication Copy) (Oct. 20, 2011), available at, http://www.iom.edu/Reports/2011/Front-of-Package-Nutrition-Rating-Systems-and-Symbols-Promoting-Healthier-Choices.aspx.
7 See Appendix B: Institute of Medicine of the National Academies Phase II Report--Examples of Front-of-Package Nutrition Rating Systems and Symbols.
9 Based on the IOM Committee's recommendations, food products that would be eligible to earn FOP points (i.e., those meeting the criteria suggested in the "Eligibility Criteria to Earn Points" column) would earn one point for every nutrient category (i.e., saturated and trans fat, sodium, and added sugars) that equals or is below the amount listed in the "Qualifying Criteria for Points" column. The IOM Committee report indicates that the proposed eligibility and qualifying criteria are not intended to be the final criteria for an FOP nutrition rating system, but instead to serve as a starting point for the FDA, USDA, and other agencies to solicit public comment and test appropriate criteria.
10 The term "RACC" refers to "Reference Amounts Customarily Consumed."
11 See EPA and DOE Energy Star Information Web Page, available at, http://www.energystar.gov/index.cfm?c=about.ab_history.
12 See Institute of Medicine, "Front-of-Package Nutrition Rating Systems and Symbols: Promoting Healthier Choices" (Pre Publication Copy) (Oct. 20, 2011), available at, http://www.iom.edu/Reports/2011/Front-of-Package-Nutrition-Rating-Systems-and-Symbols-Promoting-Healthier-Choices.aspx.