Heart-Check Certification Mark

Transcription

1 MEMORANDUM Heart-Check Certification Mark November 16, 2009 Re: American Heart Association s Heart-check Certification Mark Group 7: Phil Heiselmann, Gareth Lacy, Gen Norwood, and Sheri Wardwell I. INTRODUCTION The American Heart Association (AHA) is a non-profit organization whose mission is to build healthier lives, free of cardiovascular diseases and stroke. 1 The AHA developed the Food Certification Program to help consumers identify heart-healthy food choices in their grocery stores by certifying food that meets the AHA s guidelines for saturated fat and cholesterol for individuals over the age of two. 2 To distinguish heart-healthy products the AHA created the heart-check mark, consisting of a red heart with a white check through the center, to be placed on the front of food packaging. There are currently three AHA heart-check certification marks within the Food Certification Program: (1) the Standard Certification Mark; (2) the Whole-Grains Certification Mark; and (3) the Whole-Oats Soluble Fiber Certification Mark. 3 The marks can be found on many items in any local grocery store including Cheerios, Quaker Instant Oatmeal, Florida s Natural Orange Juice, and Foster Farms Oven Roasted Turkey Breast. 4 II. LEGAL STATUS The AHA s Food Certification Program is a voluntary food certification program. However, while the AHA is an independent certifying organization that has developed its own criteria for heart-healthy foods, the certification marks must comply with the public standards promulgated by the US government. Once the heart-check marks are placed on a food package, the AHA s heart-healthy claims must satisfy the Food and Drug 1 See AHA, About Us, (last visited Nov. 8, 2009). 2 AHA, Food Certification Program Home, (last visited Nov. 8, 2009). 3 See Appendix VIII Figures 1-3 infra at 8; AHA, Nutritional Criteria for Certified Foods, (last visited Nov. 8, 2009). 4 Since the program launched in 1995 approximately 1,000 products have obtained heart-check certification. For a complete list of products certified by the AHA see AHA, Products Ordered by Manufacturer, (last visited Nov. 8, 2009). In an interview with Jacy Cochran, Manager of Marketing & Account Services for the AHA, Ms. Cochran noted that a 2009 consumer research report found that 83% of consumers recognized the heart-check mark and 63% of consumers trusted products containing the mark than other food symbols tested.

2 Administration (FDA) and the United States Department of Agriculture (USDA) requirements for food labeling. Because the heart-check certification marks are making claims regarding the nutritional content of fat and cholesterol and the heart-healthy benefits of the packaged food, the claims must meet the requirements for food labeling established by the FDA. 5 Under the Fair Packaging and Labeling Act, the FDA has promulgated regulations setting the standard nutritional values that food must contain in order for claims to be made regarding the nutrients present in a particular food item and the potential health benefits a consumer can reasonably expect to receive by consuming such food item. 6 For instance, the following claims made by the AHA in association with the heart-check mark are regulated by the FDA: (1) health claim associating the reduced risk of coronary heart disease or heart disease with a diet low in saturated fat and cholesterol; 7 (2) nutrient content claims for fat and cholesterol; 8 and (3) health claim associating the reduced risk of coronary heart disease or heart disease with a diet including soluble fiber, such as whole-grains and whole-oats, along with a diet low in saturated fat and cholesterol. 9 Additionally, the heart-check marks for heart-healthy meat and poultry food items must meet the labeling requirements established by the USDA for making healthy nutritional content claims See 15 U.S.C.A (2009) (Congressional grant of authority for the FDA to regulate food labels). See also FDA, Guidance for Industry; Food Labeling Guide (April 2008), available at Nutrition/FoodLabelingGuide/default.htm. 621 C.F.R. 101 et seq. See FDA, Guidance for Industry: Dear Manufacturer Letter Regarding Front-of- Package Symbols (Dec. 2008) Nutrition/ucm htm. A nutrient content claim is a claim that directly or indirectly characterizes the level of a nutrient in the food. 21 C.F.R (a)-(b). For instance, low-fat is a nutrient content claim. A nutrient content claim may also be made implicitly by making a health claim. A health claim is any claim that expressly or implicitly, either by reference, vignettes, or symbols, that suggests a relationship between the quantity of a substance in the food and a disease or health condition that is supported by scientific evidence. 21 C.F.R (a)(1). For instance, the heart-check mark symbol is likely considered an implied health claim. Id C.F.R The health claim that the risk for coronary heart disease is reduced by consuming a diet low in fat and cholesterol is considered an authorized health claim. Authorized health claims are claims that the FDA has found to meet the Significant Scientific Agreement (SSA) standard under 21 U.S.C. 343(r)(3)(B)(i), which roughly means that that the claim is supported by evidence confirmed by significant scientific agreement among experts. See FDA, Evidence-Based Review System for the Scientific Evaluation of Health Claims- Final, (Jan. 2009) available at Nutrition/ucm htm C.F.R C.F.R See 9 C.F.R (meat); 9 C.F.R (poultry). USDA has power to regulate meat and poultry labeling under the Federal Meat Inspection Act, 21 U.S.C. 601 et seq, and the Poultry Products Inspection Act, 21 U.S.C. 451 et seq. 2

3 III. STANDARD SETTING Evolving scientific research is continually lending itself to a better understanding of the foods that should be recommended to improve cardiovascular health, and the AHA is dedicated to reducing disability and death from cardiovascular diseases and stroke, the United States' No. 1 and No. 3 killers, which take over 910,000 lives annually. 11 With dietary factors, such as high blood cholesterol and high intake of saturated fats, leading to coronary heart disease, fifty-two percent of consumers prefer heart-healthy diets. 12 In 1995, the FDA lacked sufficient resources to create a more convenient, straightforward method for evaluating food purchases, so the AHA created a food certification program to provide consumers with a reliable, easy-to-use method to identify heart-healthy products. 13 Rather than forcing consumers to decipher a Nutrition Facts Panel, the heart-check mark usually placed on the front of the package helps consumers quickly choose foods that meet all federal regulations of helping to prevent heart disease. 14 This includes meeting the FDA regulatory definitions for "low saturated fat" and "low cholesterol." 15 The FDA and USDA created these food standards for the safety of the public. 16 Prior to the Food and Drug Administration Act of 1997, health and nutritional claims could only be based on the FDA s published regulations, but that standard has since been broadened to acknowledge authoritative statements from approved, federal scientific bodies reports that have been submitted for FDA approval Progressive Grocer, American Heart Association Creates Certification for Whole Grain Products, (last visited November 13, 2009). 12 FDA, Consumer Health Information for Better Nutrition Initiative - Attachment A - Possible Regulatory Frameworks for Qualified Health Claims, (July 2003), available at itions/ucm htm (noting that the tragic consequences of the current obesity epidemic has manifested itself in premature death and disability, in health care costs, in lost productivity, and in social stigmatization. Approximately 300,000 deaths a year in this country are associated with overweight and obesity, with an estimated total cost of $117 billion in ). 13 ROSE MARIE ROBERTSON ON FOOD LABELING: USE OF SYMBOLS TO COMMUNICATE NUTRITION INFORMATION (2007), 20on%20Nutrition%20Icons.pdf (last visited November 12, 2009) C.F.R CFR (c)(2) and 21 CFR (d)(2). 16 ANSI, You Are What You Eat Food Safety Standards, (last visited November 12, 2009). 17 FDA, Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body, (June 1998), available at Nutrition/ucm htm. 3

4 The AHA s certification marks reflect FDA and USDA standards, which means that the AHA s requirements are subject to reform. 18 In response to scientific studies showing that diets rich in whole grains protect against heart disease, the AHA added a second certification mark in 2006: [m]eets American Heart Association food criteria for saturated fat, cholesterol and whole grains for healthy people over age 2." 19 In adding this language to their certification mark program, the AHA adopted the FDA's Whole-Grain Foods with Moderate Fat Content and CHD health claim specifications. 20 In January, 2008, the AHA added a trans-fat criterion to their certification marks to comply with updated FDA requirements. 21 The AHA is concerned about the potential confusion created by competing certification marks. 22 There are 25 U.S. icon systems and many European systems. 23 Of the U.S. certification marks, only 15 publish their varying criteria. Though the purpose of certification marks is to standardize the system, certification marks that are similar in appearance to the heart-check mark, but with less stringent standards, are possibly 18 Interview with Jacy Cochran, American Heart Association, (Oct 26, 2009).. For example, there are certain FDA requirements for saying something is low fat. Anytime there is a heart on a package, that may trigger a Heart Healthy claim with the FDA which must meet FDA s Heart Healthy standards. AHA reserves the right to change the mark requirements based on prevailing science within 120 days. 19 Progressive Grocer, American Heart Association Creates Certification for Whole Grain Products, (last visited November 14, 2009). 20 FDA Warning Letter to Ken Powell, General Mills Chairman of the Board and CEO, (May 2009), available at (noting that FDA has issued a regulation authorizing a health claim associating soluble fiber from whole grain oats with a reduced risk of coronary heart disease (21 CFR ). Like FDA's other regulations authorizing health claims about a food substance and reduced risk of coronary heart disease, this regulation provides for the claim to include an optional statement, as part of the health claim, that the substance reduces the risk of coronary heart disease through the intermediate link of lowering blood total and LDL cholesterol. ). 21 Supermarket News, AHA Introduces Trans Fat Criteria for Heart Check program, (last visited November 10, 2009). The transfat criterion is less than.5 grams of the Reference Amount Customarily Consumed. 22 In an interview with Jacy Cochran, Manager of Marketing & Account Services for the AHA, Ms. Cochran mentioned competing heart certification marks. The Connecticut Attorney General put that the Smart Choices mark on hold, though Nuval still exists. Nuval is placed on hang tags and uses a complicated algorithm to rank foods from 1 to 100. The average person cannot understand the rating system. The AHA mark differs in that it targets healthy people to be used as part of balanced diet. The USDA and FDA are supportive of the AHA mark and the AHA has not dealt with USTPO since applying for the mark in AHA, Statement by American Heart Association CEO Nancy Brown on FDA Front of Package Nutrition Label Letter to Industry, (last visited November 13, 2009)(providing that Nutrition symbols and other messaging on the front of food packaging can help consumers make informed choices about health and diet. But these health-related icons have proliferated in the marketplace over the last decade with numerous icon systems and more emerging which can be confusing to consumers. The American Heart Association applauds the U.S. Food and Drug Administration s (FDA) efforts to move toward tougher regulatory action to make sure point-of-purchase labels are not false or misleading. Some of marks arising in Europe include Swedish Green Keyhole System, the United Kingdom Nutrition signpost labeling, and the IKB Foundation I choose consciously. ). 4

5 reducing the impact of the heart-check mark in helping people choose foods that help prevent heart-disease. 24 Because competing symbols lead to consumer confusion due to their lack of dietary uniformity, the AHA prefers that the FDA establish a standardized, comprehensive system to help combat the many competing certification marks. IV. STANDARD ADOPTION As of 2007, there were approximately 800 products with the heart-check certification mark, including products by industry leaders such as General Mills, ConAgra, Campbell, Kellogg and Quaker Oats manufactures feature the whole-grains certification claim. 26 General Mills adopted this mark for Cheerios. 27 AHA lists the products they refuse to certify: medical foods, dietary supplements, meal replacements, alcoholic beverages, candy or confections, beef ribeye or strip steaks, pet food, appliances, bottled water, nuts, any product containing stanol-sterols, jams/jellies/preserves, marinades, tea, minor condiments, carbonated cola beverages, or other products that do not align with AHA science. 28 This exclusion, combined with the required certification-mark fee precluding some companies from participating, could result in consumers lacking an accurate understanding of all the healthy products available to them and only gravitating towards those with heart-check certification marks. 29 An 24 ROSE MARIE ROBERTSON ON FOOD LABELING: USE OF SYMBOLS TO COMMUNICATE NUTRITION INFORMATION (2007), 20on%20Nutrition%20Icons.pdf (stating that 92% of shoppers say it (AHA certification mark) influences their decision to purchase a food; 45% are more likely to purchase a product with AHA s mark than a product bearing a generic heart; and 26% are more likely to purchase a product with the mark than a product bearing a manufacturer s nutrition symbol. ). 25 ROSE MARIE ROBERTSON ON FOOD LABELING: USE OF SYMBOLS TO COMMUNICATE NUTRITION INFORMATION (2007), 20on%20Nutrition%20Icons.pdf (last visited November 12, 2009). 26 Lorraine Heller, AHA Heart Health mark grows on AHA claims, FOOD NAVIGATOR (Oct. 2006) 27 AHA, Products by Manufacturer, (last visited November 14, 2009) (listing manufacturers that have received certification). 28 AHA, Nutritional Criteria for Certified Foods, available at visited November 14, 2009). Other foods excluded include those manufactured by a tobacco company or its subsidiaries. This excludes all products from Nabisco, Kraft, Post, and Jello. Marian Burros, Eating Well; Endorsements Raise Money and Questions, NEW YORK TIMES (Oct. 1997), available at 29 ROSE MARIE ROBERTSON ON FOOD LABELING: USE OF SYMBOLS TO COMMUNICATE NUTRITION INFORMATION (2007), 20on%20Nutrition%20Icons.pdf (noting that consumers are less likely to be affected by the check mark on 5

6 additional concern is that products can receive an exclusive agreement with the AHA, which could be a conflict of interest, despite the AHA claiming that the program is revenue neutral. 30 V. STANDARD IMPLEMENTATION Unlike other food packaging programs, the AHA program is entirely voluntary and has implemented requirements that are more stringent than the FDA A level unqualified health claim requirements. 31 Under FDA guidelines, the actual nutritional content may vary up to 20 percent from the fact panel listing. But AHA certification means a product has been tested to ensure it does exceed maximum recommended values. The AHA reviews the nutrition information and reduces the amount of leeway allowed under the FDA and USDA s 20 percent variance allowance on food labels. VI. CONFORMITY ASSESSMENT The heart-check certification marks are designed to provide consumers an easy, reliable way to identify heart-healthy foods. 32 AHA allows manufacturers with a heartcheck certification to have additional health-related certifications such as Organic, or any other marks related to nutritional content so long as long as they continue to meet the nutritional content standard. 33 The AHA will not certify products with nutritional content exceeding FDA recommended daily values. 34 If negative nutritional content listed in the FDA fact panel is products that they already believe to be healthy such as fruits and vegetables and more likely to be affected by the mark on products they initially perceive as less healthy. ). 30 Marian Burros, Eating Well; Endoresements Raise Money and Questions, New York Times (Oct. 1997), available at (discussing how Florida citrus growers wanted an exclusive agreement with the American Heart Association, and in 1997 the cost was $55,000 per quarter as opposed to the $25,000 per quarter fee without exclusivity). 31 FDA, Questions and Answers: Qualified Health Claims in Food Labeling - Draft Report on Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claims (Sept. 2005), (providing that [a] claim that meets the significant scientific agreement standard indicates a strong, high quality, relevant and consistent body of evidence that is not likely to be changed by new and evolving science. This means that there is a high level of comfort among scientists that the claim is valid. These are referred to as A level claims. ). 32 AHA, Make Health Food Choices, (last visited Nov. 15, 2009). 33 Interview with Jacy Cochran, American Heart Association, Manager of Marketing & Account Services for the AHA (Oct. 26, 2009). 34 Id. The AHA criteria does not, however, consider trans fat or refined sugars. See Petition for Advance Notice of Proposed Rulemaking on the Use of Symbols on the Principal Display Panel to Communicate the Healthfulness of Foods, available at Nor does 6

7 within 20 percent of FDA s maximum recommended daily amount, AHA requires a laboratory test to determine whether the product exceeds maximum recommended levels. AHA requires the test because the FDA allows actual nutritional content to vary up to 20 percent from the value listed on the fact panel. 35 AHA will not certify products whose actual nutritional content exceeds the FDA requirement. 36 AHA has an in-house nutritionist and registered dietician review the product s nutritional content to determine whether further verification is necessary. 37 If a product is within 20 percent of the maximum value, the AHA has an independent laboratory test three random samples to calculate the average nutritional content. If the product fails to meet the required nutritional content for heart-check certification, the manufacturer has the opportunity to reformulate its product. Manufacturers must renew their certification status annually although this renewal is somewhat abbreviated. 38 Once a product meets the heart-check standard there are no specific requirements for the mark s position, size and location on the product. 39 AHA prefers manufactures place the certification symbol on the front of their packaging but this is not required. 40 AHA also reviews all packaging to ensure graphic designers have conformed to the standard and have not, for instance, edited the mark or deleted the text. AHA also reviews and approves any advertising that uses the mark to ensure it is not misleading. The most commonly observed problem is advertisements displaying serving sizes that exceed the quantity for which certification was granted. 41 AHA reviews that advertising and tells the manufacturer to use a picture representing the actual serving size. The AHA program is not accredited by any voluntary accrediting body, but it may have to comply with FDA requirements for health or nutritional claims. The FDA sets standards for all health claims, qualified health claims, dietary guidance, nutrient content claims, or structure/function claims and therefore the AHA s certification must meet FDA requirements. It is not immediately clear whether the heart-check symbol qualifies as a health claim and therefore requiring AHA to submit a Petition for a Health Claim under AHA allow foods to be fortified with vitamins and minerals in order to qualify for certain symbols the nutrients must occur naturally in qualifying food products. Id. 35 Id. 36 Id. 37 Id. According to AHA, the majority of manufactures applying for certification meet the baseline FDA numbers and therefore do not require product testing. 38 Id. 39 Id. Although producers must comply with all FDA labeling requirements. See generally Guidance for Industry: A Food Labeling Guide, (April 2008) available at ( Food Labeling Guide ). 40 Id. 41 Id. 7

8 21 C.F.R. 101 subpart E or falls under FDA rules governing other claims such as dietary guidance. 42 The FDA took a tentative position that AHA programs would be regulated as implied health claims. 43 But the FDA reconsidered that position after comments convinced the agency that it would not be appropriate to establish which specific types of statements may be used on food labeling because the guidance offered may not always references to both substance and disease. 44 FDA therefore concluded that publically available dietary information provided to consumers by Federal or private programs and used in food labeling may be either dietary guidance or a health claim depending upon the content and context in which the information is presented in the labeling. 45 Despite this ambiguity, FDA made clear any labeling containing explicit or implicit references then both elements of a health claim is subject to the health claims provisions of the act. 46 In sum, it appears the AHA may have avoided subjecting itself to FDA requirements for health claims by eliminating direct or indirect references to disease in its label. This position seems questionable given that the symbol itself is a heart, which strongly suggests a heart-related health benefit tied to the nutritional recommendation. 47 Inquiries to AHA regarding this issue were not returned. VII. ENFORCEMENT The AHA enforcement system appears, for the most part, to make further enforcement measures by FDA and USDA unnecessary. The AHA selected its heart-check certification criteria to align with select FDA A-level unqualified health claims related to the 42 See Guidance for Industry: A Food Labeling Guide, Section VIII, H2 (April 2008) available at ( Food Labeling Guide ). Health claims characterize a relationship between a substance and a health-related condition. See 21 C.F.R (a) ( Health claim means any claim... that expressly or by implication, including third party references, written statements (e.g., a brand name including a term such as heart ), symbols (e.g., a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health-related condition. ). Health claims therefore contain (1) a substance and (2) a disease. An example would include, diets low in sodium may reduce the risk of high blood pressure. Dietary guidance, in contrast, does not contain both elements. See 58 FR 2478 at 2487 (January 6, 1993). For example, diets rich in vegetables may reduce the risk of some types of cancer is dietary guidance F.R at F.R at Id. 46 Id. 47 Under 21 C.F.R (a)(1), (a)(5) and 21 C.F.R (d)(2)(iv) any health symbol including a heart symbol used on food labels must follow same requirements as for written health claims. 47 For each, the health claim must be permitted under a regulation in 21 C.F.R. Subpart E, and the food must meet the criteria for health claims for total fat, saturated fat, cholesterol, and sodium content. In addition to the symbol, the label must include the same complete health claim information such as including the appropriate claim information next to the symbol. Guidance for Industry: A Food Labeling Guide, Section VIII, H2 (April 2008) available at ( Food Labeling Guide ). 8

9 risk of coronary heart disease. 48 However, AHA nutritional criteria are stricter than those employed by either the FDA or USDA: products must meet the certification criteria and are not given any leeway such as the 20% variance that the FDA and USDA allow for values displayed on the Nutritional Facts Panel. 49 A review of FDA enforcement actions identified a single warning letter providing that the use of the heart-check mark and subsequent health claims made concerning Ocean Spray grapefruit products violates the 21 C.F.R. 101 subpart E for failing to contain the nutritional elements required to make a health claim. 50 This particular warning appears less dramatic in the context of the FDA letter as a whole -- as the letter contained a veritable laundry list of statutory and regulatory health claim violations on the Ocean Spray website. 51 The AHA enforces it heart-check certification program from three distinct angles: (1) packing approval; (2) advertising approval; and (3) in-store audits. It closely monitors food products that have been accepted into the program: To ensure that food products continue to meet our certification criteria after they are accepted into the program, AHA maintains a stringent monitoring and enforcement program. For example, AHA requires manufacturers to submit product packaging and promotional materials to the Association for pre-approval; and products must renew each year to assure their formulations continue to meet our criteria. We also conduct annual grocery 48 ROSE MARIE ROBERTSON ON FOOD LABELING: USE OF SYMBOLS TO COMMUNICATE NUTRITION INFORMATION (2007), 20on%20Nutrition%20Icons.pdf, citing 21 CFR Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease; and Docket 03Q-0547 Whole Grains with Moderate Fat Content and Risk of Coronary Heart Disease. 49 Id. 50 FDA Warning Letter to Robert Hawthorne, President, Ocean Spray Cranberries, Inc., (stating Dear Mr [sic] Hawthorne.... Your Grapefruit Health and Cran-Health website links also contain other health claims that, as written, do not contain all the elements set forth in Title 21 Code of Federal Regulations [21 CFR] Part 101, Subpart E, for their respective health claims. Therefore, claims such as those listed below are also unauthorized health claims, which cause the products to be misbranded under section 403(r)(1)(B) of the [Food, Drug, and Cosmetic Act]:... American Heart Association stamp of approval to all Ocean Spray Grapefruit juices and Ocean Spray fresh grapefruit... AHA's "heart check" food certification mark informs consumers these products are low in fat and cholesterol which reduces the risk of heart disease [21 CFR ]... We request that you take prompt action to correct these violations. Failure to promptly correct violations may result in enforcement action being initiated by the FDA without further notice. The Act provides for the seizure of illegal products and for injunction against the manufacturer and/or distributor of illegal products. ). 51 Id. This laundry list includes health claims regarding cancer, cataracts, birth defects, and osteoporosis. 9

10 store audits in which certified products are randomly selected and tested by a contract laboratory to assure compliance with nutrient criteria. 52 It closely monitors food products that have been removed from the program: AHA does not hesitate to enforce our criteria and order the removal of our mark from any product found not to be in compliance. If such action is taken, we monitor the products that have exited the program to ensure that they no longer display the mark. 53 And it monitors instore product promotion materials bearing the heart-check mark to ensure that they meet certification standards. 54 In sum, the AHA appears to have a virtually self-sufficient enforcement system in place. VIII. APPENDIX: GRAPHICS Figure 1: Standard Certification Mark Figure 2: Whole-Grains Certification Mark Figure 3: Whole-Oats Soluble Fiber Certification Mark IX. IMPORTANT SOURCES 1. AHA, Food Certification Program Home, (last visited Nov. 8, 2009). 2. FDA, Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body (June, 1998), available at ingnutrition/ucm htm. 3. FDA Warning Letter to Robert Hawthorne, President, Ocean Spray Cranberries, Inc. (Jan. 2001), available at 4. Guidance for Industry: A Food Labeling Guide, (April 2008) available at ( Food Labeling Guide ). 52 ROSE MARIE ROBERTSON ON FOOD LABELING: USE OF SYMBOLS TO COMMUNICATE NUTRITION INFORMATION (2007). 53 Id. 54 Id. 10

11 5. Interview with Jacy Cochran, American Heart Association, Manager of Marketing & Account Services for the AHA (Oct. 26, 2009). 6. ROSE MARIE ROBERTSON ON FOOD LABELING: USE OF SYMBOLS TO COMMUNICATE NUTRITION INFORMATION (2007), available at DA%20on%20Nutrition%20Icons.pdf C.F.R. 101 et seq. 11