3

The Regulatory Environment

As discussed in 1 To accomplish this, both the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) have established regulations concerning mandatory labeling components. In addition, the Federal Trade Commission (FTC) has jurisdiction over advertising and takes action to prohibit unfair and deceptive practices.

MANDATORY LABELING COMPONENTS

Foods Regulated by the Food and Drug Administration

The Federal Food, Drug, and Cosmetic Act2 (FD&C Act) governs the labeling of foods regulated by FDA (see Agency Jurisdiction Over Labeling, below). The FD&C Act mandates the inclusion of certain information on labels of packaged foods to promote honesty and fair dealing in the interest of consumers. The mandatory components include the common or usual name of the food (i.e., the statement of identity); the common or usual name of each ingredient when the food is fabricated from two or more ingredients; the name and place of business of the manufacturer, packer, or distributor; an accurate statement of the quantity of contents in terms of weight, measure, or numerical count; allergen information; and nutrition information.3 The FD&C Act specifies that the nutrition information must include the serving size that is appropriate for the food; the number of servings per container; the total number of calories; and the amounts of total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, protein, and any vitamin and mineral when such information is determined to assist consumers in maintaining healthy dietary practices.4 The act then provides for nutrients to be added or deleted when such actions are determined to assist consumers in maintaining such practices. Required

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1 FD&C Act, Sec. 201 and 403.

2 FD&C Act, Sec. 403.

3 FD&C Act, Sec. 403.

4 FD&C Act, Sec. 403(q).



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3 The Regulatory Environment As discussed in Chapter 2, food labels contain a wide array of information and are used to capture consum - ers’ attention and promote products. The federal government’s responsibility is to see that the information on food labels is not false or misleading and that labels contain information that is material with respect to consequences that may result from consumption of the food.1 To accomplish this, both the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) have established regulations concerning mandatory labeling components. In addition, the Federal Trade Commission (FTC) has jurisdiction over advertising and takes action to prohibit unfair and deceptive practices. MANDATORY LABELING COMPONENTS Foods Regulated by the Food and Drug Administration The Federal Food, Drug, and Cosmetic Act2 (FD&C Act) governs the labeling of foods regulated by FDA (see Agency Jurisdiction Over Labeling, below). The FD&C Act mandates the inclusion of certain information on labels of packaged foods to promote honesty and fair dealing in the interest of consumers. The mandatory components include the common or usual name of the food (i.e., the statement of identity); the common or usual name of each ingredient when the food is fabricated from two or more ingredients; the name and place of business of the manufacturer, packer, or distributor; an accurate statement of the quantity of contents in terms of weight, measure, or numerical count; allergen information; and nutrition information. 3 The FD&C Act specifies that the nutrition information must include the serving size that is appropriate for the food; the number of servings per container; the total number of calories; and the amounts of total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, protein, and any vitamin and mineral when such information is determined to assist consumers in maintaining healthy dietary practices. 4 The act then provides for nutrients to be added or deleted when such actions are determined to assist consumers in maintaining such practices. Required 1 FD&C Act, Sec. 201 and 403. 2 FD&C Act, Sec. 403. 3 FD&C Act, Sec. 403. 4 FD&C Act, Sec. 403(q). 21

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22 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS nutrition information for foods sold from bulk containers should be available at the point of purchase, 5 and vendors of raw fruit, vegetables, and fish can utilize a voluntary nutrition labeling program. 6 The Food Allergen Labeling and Consumer Protection Act of 2004 amended the FD&C Act to help consumers avoid health risks posed by food allergens.7 To do this, the act requires labels of FDA-regulated foods to clearly identify the food source names of all ingredients that are, or contain any protein derived from, the eight most common food allergens,8 i.e., milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. A label meets this requirement when the common or usual name of an ingredient that is a major allergen already identifies the allergen’s food source (e.g., milk, in the case of condensed milk) or when it lists the name of the food source of a major allergen (1) in parentheses following the name of the ingredient (i.e., “flour (wheat)”) or (2) immediately after or next to the list of ingredients in a “contains” statement (i.e., “Contains Milk and Eggs”). 9 In addition to the above mandatory labeling components for all foods, FDA regulations sometimes require label statements such as warnings, notices, or safe handling instructions for specific commodities. For example, shell eggs must bear the safe handling instruction “SAFE HANDLING INSTRUCTIONS: To prevent illness from bacteria: keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly.” 10 Also, regulations of the USDA’s Agricultural Marketing Service (AMS) require country-of-origin labeling on perishable agricultural commodities (fresh and frozen fruits and vegetables), fish and shellfish, macadamia nuts, pecans, peanuts, and ginseng when sold by full-line grocers (fish markets are exempt from this requirement). 11 FDA’s implementing regulations require that the common or usual name of the food be placed on the princi - pal display panel, which is that part of the label that is most likely to be presented or examined under customary conditions of display for retail sale.12 Likewise, the net weight (or other unit of measure) must be present on the principal display panel, specifically on the bottom 30 percent of the panel. 13 The remaining mandatory labeling components may be placed on either the principal display panel or the information panel, which is that part of the label immediately contiguous and to the right of the principal display panel. 14 When there is insufficient space on these two panels, regulations allow for some of the mandatory information to move to other panels. Foods Regulated by the Food Safety and Inspection Service, U.S. Department of Agriculture FSIS is responsible for the labeling of meat, poultry, and some egg products under the authority of the Federal Meat Inspection Act (FMIA),15 the Poultry Products Inspection Act (PPIA),16 and the Egg Products Inspection Act (EPIA). These acts require inspection programs designed to insure that meat and poultry products are, among other things, properly labeled.17 Retail package labels must include the components required for FDA-regulated foods, except for allergen information, and components specific to meat, poultry, or egg products. 18 Containers of federally inspected meat and poultry products must bear a USDA inspection legend (i.e., shield) and establishment or plant number.19 The inspection legend must be placed on the principal display panel, while the establishment number may be placed within the legend or elsewhere on the container or its labeling (e.g., the lid of the can). Labels of meat and poultry products that require special handling to maintain their wholesome condition must 5 FD&C Act, Sec. 403(q)(3); 21 CFR § 101.9(j)(16). 6 FD&C Act, Sec. 403(q)(4); 21 CFR § 101.9(j)(10). 7 Title 11, Public Law 108-282, Title II. 8 FD&C Act, Sec 403(w), 21 USC § 343 et seq. 9 Available online: http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm079311.htm (accessed February 25, 2011). 10 21 CFR § 101.17(h). 11 74 FR 2658 and avalable at: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5074846 (accessed February 25, 2011). 12 21 CFR §101.1 and §101.2. 13 21 CFR §101.105. 14 21 CFR §101.2. 15 21 U.S.C. 601 et seq. 16 21 U.S.C. 451 et seq. 17 58 FR 632 at 634. 18 9 CFR 317 [meat] and 9 DFR 381 [poultry]. 19 9 CFR § 317(c)(5) [meat] and 9 CFR § 381.123 [poultry].

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23 THE REGULATORY ENVIRONMENT TABLE 3-1 Mandatory Labeling Components on Retail Packages Foods Regulated by FSIS, USDA Foods Regulated by FDA Meat and poultry products Egg products 1. Name of food 1. Name of food 1. Name of food 2. Ingredient list 2. Ingredient list 2. Ingredient list 3. Manufacturer, packer, or 3. Manufacturer, packer, or 3. Manufacturer, packer, or distributor’s distributor’s name and place of distributor’s name and place of name and place of business business business 4. Net weight statement 4. Net weight statement 4. Net weight statement 5. Nutrition information 5. Nutrition information 5. Nutrition information USDA shield and plant numbera 6. Allergen information 6. Inspection legend and 6. establishment number 7. Country of origin on specified 7. Handling statement 7. Notice of required refrigeration on imported products shell eggs 8. Safe handling instructions on 8. Safe handling instructions on 8. USDA label approval number on egg productsa certain products certain products 9. Country of origin on specified imported products a Applies to egg products that go through the USDA inspection system. also prominently display an applicable handling statement, such as “keep refrigerated” or “keep frozen” on the principal display panel.20 In addition, safe handling instructions are required if the meat or poultry in a product is raw or only partially cooked and if the product is intended for household consumers or institutional users. 21 The safe handling instructions can be placed anywhere on the label but must be set off by a border and appear in one color type on a contrasting background of one color. Similar to FDA regulations of country-of-origin labeling on specified food products, AMS regulations require muscle cuts of beef (including veal), lamb, pork, chicken, and goat, and ground products of the same species, to bear the name of the country of origin when sold by full-line grocers (butcher shops are exempt from the requirement).22 Retailers are allowed a variety of options for marking containers, from labels to placards, signs, stickers, or other formats. Labeling requirements for egg products are found in regulations of the FDA, FSIS, and AMS. In addition to the five basic mandatory labeling components set forth for FDA-regulated foods, egg products that go through the USDA inspection system are required to include an official USDA shield on the principal display panel. The official plant number of the egg processing plant where inspection took place must be printed within the shield or elsewhere on the container preceded by the letter “P” or the word “Plant.” 23 Shell eggs must be labeled to indicate that refrigeration is required, e.g., “Keep Refrigerated,”24 and FSIS-regulated products that require premarket label approval must display the label approval number.25 Table 3-1 identifies the mandatory labeling components for food products regulated by FDA, FSIS, and USDA. AGENCY JURISDICTION OVER LABELING As a general rule, FSIS has jurisdictional authority over food labeling for meat, poultry, and egg products and FDA for all other food products. However, the FMIA, PPIA, and EPIA authorize USDA (by delegation, FSIS) to 20 9 CFR § 317.2(k) [meat] and 9 CFR § 381.125(a) [poultry]. 21 9 CFR § 317.2(l) [meat] and 9 CFR § 381.125(b) [poultry]. 22 74 FR 2658 and available online: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5074846 (accessed February 25, 2011). 23 9 CFR § 590.412. 24 9 CFR § 590.410. 25 Available online: www.fsis.usda.gov/pdf/Labeling_Requirements_Guide.pdf (accessed February 25, 2011).

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24 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS exempt from its regulatory coverage food products that contain meat, poultry, or egg products “only in a relative small proportion or historically have not been considered by consumers as products of the meat/poultry/egg food industry.”26 As a result, USDA has determined that food products are not subject to FSIS inspection and labeling regulations if, in part, they contain 3 percent or less raw meat; less than 2 percent cooked meat or poultry; or less than 10 percent cooked poultry skins, giblets, fat, and meat in combination (FSIS, 2007). Decisions about the jurisdictional coverage (i.e., “amenability”) are based on how a food is formulated rather than on the composition of the final product. The end result is a complex system by which regulatory authority for labeling is determined. Lines between regulatory authority for FDA and FSIS can be complicated; for example, FDA is responsible for labeling of cheese and vegetarian pizzas, while FSIS is responsible for meat pizzas; likewise FDA is responsible for labeling of closed-faced sandwiches, FSIS, for open-faced sandwiches. These and other examples are summarized in Table 3-2 outlining the jurisdictional overlap for labeling of meat, poultry, and egg products (FDA, 2010). 27 ADDITIONAL COMPONENTS OF NUTRITION LABELING Background Mandatory inclusion of the Nutrition Facts panel (NFP) on labels of most packaged foods represents only a portion of the possible nutrition-related components on food labels that fall under federal jurisdiction. Other forms of nutrition labeling ascribed to FDA-regulated food products in the FD&C Act include nutrient content claims, health claims, and the voluntary nutrition labeling program provided for raw fruits, vegetables, and fish. 28 In addition, FDA allows the use of structure/function claims and dietary guidance statements. These regulations apply to claims made on both food labels and labeling (i.e., information made available in close proximity to the food item, such as shelf tags). A historical review of nutrition labeling was included in the Phase I report (IOM, 2010) and is found in Appendix B of this report. It describes the proliferation of nutrition-related claims used in food labeling in the 1970s and 1980s as scientific knowledge about the relationship between diet and health grew rapidly and, with it, consumers’ interest in more information about the nutritional content of foods. Many of the claims being made were new and undefined, creating consumer confusion about their meanings. To respond to growing concerns, Congress included in the Nutrition Labeling and Education Act of 1990 (NLEA), which amended the FD&C Act, a requirement that claims that characterize the level of a nutrient, i.e., nutrient content claims, may only be made if they use terms that are defined in regulations promulgated by FDA29 (see Appendix C for a list of nutrient content claims defined by FDA). Congress also required that if a claim is made on a food that contains another nutrient at a level that increases the risk of a diet-related disease or health condition then that fact must be disclosed adjacent to the claim by the statement “See nutrition information for ___ content” with the blank filled in with the name of the nutrient.30 In addition to nutrient content claims, some food manufacturers were interested in making claims about the health benefits of food products. However, at that time FDA’s regulations prohibited such claims on food labeling, stating that a food would be considered misbranded if its labeling “represents, suggests, or implies: That the food because of the presence or absence of certain dietary properties is adequate or effective in the prevention, cure, mitigation, or treatment of any disease or symptom.”31 In 1984, FDA’s position was challenged by the Kellogg Company when it worked cooperatively with the National Cancer Institute to begin a labeling campaign using the back panel of a high-fiber breakfast cereal to link fiber consumption to a possible reduction in the risk of some cancers. Soon after, other companies began making similar claims, and FDA was faced with the need to reconsider its policies. In response, FDA initiated rulemaking to change its policy by permitting health claims to be made 26 21 U.S.C. § 601(j) [meat], 21 U.S.C. § 453(f) [poultry], and 21 U.S.C. § 1033(f) [egg]. 27 Available online: http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM123506.pdf (accessed February 27, 2011). 28 FD&C Act, Sec. 403(q) and (r). 29 FD&C Act, Sec. 403(r)(2) 30 FD&C Act, Sec. 403(r)(2)(B); 21 CFR § 101.13(h). 31 21 CFR § 101.9(i), prior to 1993.

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25 THE REGULATORY ENVIRONMENT under specified conditions, and Congressional hearings were held. The issues were not settled until Congress included provisions in the NLEA to authorize health claims, defined as claims characterizing the relationship of a nutrient to a disease or health-related condition, if the Secretary (and, by delegation, FDA) determined “based on the totality of publicly available scientific evidence … that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence.”32 Although FDA issued regulations providing for health claims that met this “significant scientific agree- ment” standard, reaching such agreement about additional diet and health relationships proved difficult (Taylor and Wilkening, 2008). In an effort to provide for more health claims, Congress expanded on the “significant scientific agreement” standard in 1997 to allow for health claims based on “authoritative statements” about the relationship between a nutrient and a disease or health-related condition made by certain other scientific bodies of the U.S. government and the National Academy of Sciences.33 FDA was subsequently petitioned to allow additional health claims. When the agency denied petitions on the grounds that the claims did not meet the significant scientific agreement standard and were not based on an authoritative statement, a lawsuit claiming that the denial impaired the petitioner’s First Amendment rights was filed.34 The issue was whether the government could prohibit speech about a diet/disease relationship if the basis for the speech does not meet the standard of significant scientific agreement. In its decision, the Court affirmed the First Amendment’s protection of commercial speech and hence the need for FDA to provide for additional health claims based on less scientific evidence as long as the claims do not mislead consumers, thereby allowing claims that are accompanied by “qualifying” language to inform consumers about the relative strength of the science 35 (McColl and Bump, 2005). FDA began to consider such claims, known as “qualified health claims,” in 2003. 36 As noted above, other types of nutrition-related statements that are allowed on labels of FDA-regulated foods include (1) structure/function claims that describe the effect that a nutrient or dietary ingredient has on the structure or function of the body but do not make reference to a disease (e.g., calcium builds strong bones and teeth) 37 and (2) dietary guidance statements that focus on general dietary recommendations and practices 38 (e.g., “Fruits and Veggies—More Matters,” the National Cancer Institute’s initiative to encourage greater consumption of fruits and vegetables for better health39). These two types of label statements may be made without prior authorization from FDA but must be truthful and non-misleading. In addition to claims, the FD&C Act addresses labeling of raw commodities and fish through a voluntary nutrition labeling program for the 20 most frequently consumed raw fruits, vegetables, and fish. 40 The act required FDA to establish guidelines for the voluntary program and then to periodically survey food retailers to see if they are in substantial compliance with the guidelines. If there is not substantial compliance, then FDA is to initiate rulemaking to make such labeling mandatory. In accordance with the act, FDA established guidelines, identified the 20 most frequently consumed fruits, the 20 most frequently consumed vegetables, and the 20 most frequently consumed fish41 and provided food retailers with the nutrient values to be used in the nutrition labeling of those food items.42 The required nutrition labeling information can be provided to consumers in a variety of ways. The 32 FD&C Act, Sec. 403(r)(3). 33 FD&C Act, Sec. 403(r)(3)(C) . 34 Pearson v. Shalala, United States District Court of Appeals for the District of Columbia, No. 98-053 (January 15, 1999). 35 67 FR 78002, December 20, 2002. 36 Available online: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ ucm053843.htm (accessed August 30, 2011). 37 Available online: http://www.fda.gov/Food/LabelingNutrition/LabelClaims/StructureFunctionClaims/default.htm (accessed August 30, 2011). 38 Available online: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ ucm053425.htm (accessed August 30.2011). 39 Available online: http://www.fruitsandveggiesmatter.gov (accessed September 1, 2011). 40 FD&C Act, Sec. 403(q)(4). 41 21 CFR § 101.42-§ 101.45. 42 21 CFR § 101, Appendix C.

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26 TABLE 3-2 Summary of Jurisdiction Overlap for Commercial Products Regulated by the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) FDA Jurisdiction USDA Jurisdiction USDA Jurisdiction USDA Jurisdiction 21 U.S.C. 392(b) Meats and meat The Federal Meat Inspection Act The Poultry Products Inspection Act The Egg Products Inspection Act (EPIA) food products shall be exempt (FMIA) regulates the inspection (PPIA) defines the term poultry as defines egg to mean the shell egg of from the provisions of this Act to of the following amenable species: any domesticated bird. USDA has domesticated chicken, turkey, duck, goose, the extent of the application or cattle, sheep, swine, goats, horses, interpreted this to include domestic or guinea. Voluntary grading of shell eggs the extension thereto of the Meat mules, or other equines, including chickens, turkeys, ducks, geese, and is done under USDA supervision. (FDA Inspection Act. FDA responsible for their carcasses and parts. It also guineas. The PPIA states poultry enforces labels/labeling of shell eggs; all non-specified red meats (bison, covers any additional species of and poultry products shall be exempt USDA signs off on shell egg labels often rabbit, game animals, zoo animals, livestock that the Secretary of from the provisions of the FD&C in consultation with FDA.) and all members of the deer family Agriculture considers appropriate. Act to the extent they are covered including elk [wapiti] and moose). Mandatory inspection of Ratites and by the PPIA. Mandatory inspection FDA responsible for all non-specified Squab (including emu) announced by of Ratites and Squab announced by birds, including wild turkeys, wild USDA/FSIS April 2001. USDA/FSIS April 2001. ducks, and geese. Products with 3% or less raw meat; Products containing greater than 3% Products containing 2% or more Egg products processing plants (egg less than 2% cooked meat or other raw meat, 2% or more cooked meat or cooked poultry; more than 10% breaking and pasteurizing operations) are portions of the carcass; or less than other portions or the carcass; or 30% cooked poultry skins, giblets, fat, and under USDA jurisdiction. 30% fat, tallow, or meat extract, alone or more fat, tallow, or meat extract, poultry meat in any combination.a or in combination. alone or in combination.a Products containing less than 2% cooked poultry meat; less than 10% cooked poultry skins, giblets, fat, and poultry meat (limited to less than 2%) in any combination.a Closed-face sandwiches. Open-faced sandwiches.

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FDA is responsible for shell eggs Products that meet USDA’s definition and egg-containing products that do of “egg product” are under USDA not meet USDA’s definition of “egg jurisdiction. The definition includes dried, product.” FDA also has jurisdiction in frozen, or liquid eggs, with or without establishments not covered by USDA; added ingredients, but mentions many e.g., restaurants, bakeries, cake mix exceptions. The following products, among plants, etc. others, are exempted as not being egg products: freeze-dried products, imitation Egg processing plants (egg washing, egg products, egg substitutes, dietary sorting, and packing) are under FDA foods, dried no-bake custard mixes, egg jurisdiction. nog mixes, acidic dressings, noodles, milk and egg dip, cake mixes, French toast, sandwiches containing eggs or egg products, and balut and other similar ethnic delicacies. Products that do not fall under the definition, such as egg substitutes and cooked products, are under FDA jurisdiction. Cheese pizza, onion and mushroom Pepperoni pizza, meat-lovers stuffed Chicken sandwich (open face), pizza, meat-flavored spaghetti crust pizza, meat sauces (3% red meat chicken noodle soup. sauce (less than 3% red meat), or more), spaghetti sauce with meat meat-flavored spaghetti sauce with balls, open-faced roast beef sandwich, mushrooms (2% meat), pork and hot dogs, corn dogs, beef/vegetable beans, sliced egg sandwich (closed- pot pie. face), frozen fish dinner, rabbit stew, shrimp-flavored instant noodles, venison jerky, buffalo burgers, alligator nuggets, noodle soup chicken flavor. NOTE: Jurisdiction for products produced under the School Lunch Program, for military use, etc. is determined via the same algorithm although the purchases are made under strict speci- fications so that the burden of compliance falls on the contractor. Compliance Policy Guide 565.100, 567.200, and 567.300 provide additional examples of jurisdiction. IOM 3.2.1 and 2.7.1 provide more information on our interactions with USDA and Detention Authority. a Percentages are based on the amount of meat or poultry product used in the product formulation. SOURCE: U.S. Food and Drug Administration. 27

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28 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS information can be displayed at the point of purchase through labeling, such as posters, shelf tags, signs, brochures, notebooks, or leaflets, or on labels affixed to the food.43 As noted in Appendix B, although the FD&C Act pertains only to FDA-regulated food products, FSIS made the decision to apply requirements for nutrition labeling to meat and poultry products it regulates so that all foods would provide consistent nutrition information to the extent possible (McCutcheon, 1995). Accordingly, FSIS has issued regulations that require similar nutrition labeling on meat and poultry products and provides for nutri - ent content claims in a similar manner.44 However, FSIS has not issued regulations for the use of health claims, although it permits claims that have been authorized by FDA or that are in accordance with a third-party certifica - tion program to be used on a case-by-case basis.45 In keeping with statutory requirements for the voluntary nutrition labeling program for raw commodities and fish, FSIS issued regulations for a voluntary nutrition labeling program for single-ingredient raw meat and poultry products, including single-ingredient, raw, ground or chopped products. 46 In accordance with provisions of the FD&C Act, these regulations required periodic surveys of food retailers to see if they were in substantial com - pliance with the voluntary program. When FSIS failed to find significant participation in the voluntary nutrition labeling program, it became obligated to institute rulemaking to require such labeling. In response, FSIS issued final regulations on December 29, 2010, requiring nutrition labeling of the major cuts of single-ingredient raw meat and poultry products and single-ingredient, raw, ground, or chopped products. In the case of major cuts of raw meat and poultry that are not ground or chopped, the required nutrition information may be provided on the label or at point of purchase.47 Front-of-Package Symbols in Conjunction with Claims Although front-of-package (FOP) rating systems and symbols were not envisioned in 1990 when the NLEA was passed, some of the current programs (see Phase I report, Table S-1) bear similarities to nutrient content and health claims as defined in that act.48 Acknowledging this, FDA issued guidance for industry in 2008 pointing out that “FDA will proceed with enforcement action against products that bear FOP labeling that are explicit or implied nutrient content claims and that are not consistent with current nutrient content claim requirements.” 49 As noted above, nutrient content claims are defined as “claims that characterize the level of a nutrient,” and they must be defined in regulations in order to be used. Such claims can be made expressly or implicitly. An expressed nutrient content claim is a direct statement about the level of a nutrient, whereas an implicit claim is one that describes the food in a manner that suggests that a nutrient is present or absent in a certain amount (e.g., “high in oat bran” suggests that the food is high in fiber). Accordingly, when an FOP symbol is used that meets the definition of a nutrient content claim, it must meet all requirements for such claims, including disclosure statements if the food exceeds disclosure levels (more than 20 percent of the Daily Value for individual foods) for total fat, saturated fat, cholesterol, or sodium. In addition to nutrient content claims, some FOP symbols may be considered to be health claims. As stated above, a health claim is any claim that expressly or by implication characterizes the relationship of any substance to a disease or health condition. This includes third-party endorsements, symbols, and vignettes. As such, the American Heart Association’s Heart Check50 symbol is considered to be a health claim in that its heart shape characterizes the relationship between the food whose label it is on and heart disease. Unlike food labels that must 43 21 CFR § 101.45. 44 58 FR 632, January 6, 1993. 45 A Guide to Federal Food Labeling Requirements for Meat and Poultry Products. Available online: http://www.fsis.usda.gov/pdf/Labeling_ Requirements_Guide.pdf (accessed August 31, 2011). 46 58 FR 632, January 6, 1993. 47 75 FR 82148, December 29, 2010. 48 Available online: http://www.regulations.gov/search/Regs/home.html#documentDetail?R=09000064809623e8 (accessed July 3, 2011). 49 Available online: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ ucm120274.htm (accessed August 30, 2011). 50 Heart Check Mark is a registered trademark of the American Heart Association.

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29 THE REGULATORY ENVIRONMENT include disclosure statements if they bear nutrient content claims and contain more than 20 percent of the Daily Value for total fat, saturated fat, cholesterol, or sodium, foods are disqualified from bearing health claims if they contain those same levels (known as disqualifying levels in the case of health claims) of total fat, saturated fat, cholesterol, or sodium.51 REGULATORY ACTIONS REGARDING FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS In response to actions taken by food manufacturers and retailers to include symbols that indicate nutritional quality on the label or labeling of a food, FDA held a public hearing in 2007 to solicit information about the systems being used, the nutrient thresholds or algorithms used to determine which foods carry the symbol, and consumer and economic issues concerning use of the symbols.52 In a summary of comments received, FDA revealed plans to evaluate the symbol systems for compliance with labeling statutes and to plan additional research into consumer use and understanding of nutrition symbols.53 As FOP symbols continued to proliferate on food labels, FDA and USDA jointly wrote a letter of concern in 2009 to the General Manager of the Smart Choices Program, 54 a nutrient-criteria-based FOP system developed by a consortium of industry, public health, and academic nutrition leaders. The letter stated that the agencies “would be concerned if FOP labeling systems used criteria that were not stringent enough to protect consumers against misleading claims; were inconsistent with the 2010 Dietary Guidelines for Americans (USDA, 2010); or had the effect of encouraging consumers to choose highly processed foods and refined grains instead of fruits, vegetables, and whole grains.” FDA followed by issuing guidance for the industry regarding point-of-purchase food labeling including FOP labeling. 55 In its guidance, FDA noted the different nutritional criteria used by various systems and expressed concern that some FOP labels may be mis - leading or not in compliance with regulatory criteria for nutrient content claims (i.e., claiming a food is high in a nutrient in the FOP label, but not meeting FDA criteria for that claim). However, the agency also noted its belief that FOP labeling “can be a way of promoting informed food choices and helping consumers construct healthier diets in accordance with the Dietary Guidelines for Americans.” To that end, FDA stated that it wanted to work with the food industry, nutrition and design experts, and the IOM to develop an approach to FOP labeling that would help Americans build better diets and improve health. FDA then issued a request for comment, informa - tion, and data on consumer use and understanding of possible approaches to FOP labeling of food packages or on shelf tags in retail stores.56 To help determine how FOP systems should be used as a nutrition education tool, Congress directed the Centers for Disease Control and Prevention (CDC) to undertake a study with the IOM to examine and provide recommendations regarding FOP labeling systems and symbols.57 This study has also been supported by FDA and the USDA’s Center for Nutrition Policy and Promotion. In addition, FDA also undertook experimental studies to assess quantitatively consumer reactions to various FOP labeling schemes 58 in anticipation of future rulemaking on this issue. NEED FOR PERIODIC REASSESSMENT OF THE NUTRITION FACTS PANEL Congressional intent when passing the NLEA was that the food label should become a more effective public health tool (Kessler et al., 2003). To this end, one of the primary purposes of the implementing regulations was to 51 FD&C Act, Sec. 403(r)(3)(A); 21 CFR § 101.14(a)(4). 52 72 FR 39815, July 20, 2007. 53 Available online: http://www.regulations.gov/search/Regs/home.html#documentDetail?R=09000064809623e8 (accessed July 3, 2011). 54 Available online: http://fda/gov/Food/Labeling Nutrition/LabelClaims/ucm180146.htm (accessed July 3, 2011). 55 Available online: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ ucm187208.htm (accessed July 3, 2011). 56 75 FR 22602, April 29, 2010. 57 HR 1105; in 2010 Congress directed CDC to continue the study (HR 111-366, Conference Report to accompany HR 3288, ordered to be printed December 8, 2009). 58 74 FR 62786, December 1, 2009. Also see Chapter 5.

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30 FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS help consumers choose healthier diets (Kessler, 1995). Although research conducted since the implementation of mandatory nutrition labeling indicates that reading food labels is correlated with better dietary patterns (Ollberding et al., 2010), maintaining such results is dependent on maintaining the scientific basis that supports the nutrition information on the label. Nutrition science is a continually evolving field. In acknowledgment of this, the Dietary Guidelines for Americans are required by law to be reviewed, updated if necessary, and published every 5 years. 59 Once an external scientific Dietary Guidelines Advisory Committee conducts an analysis of new scientific information on diet and health and writes a report summarizing its findings, HHS and USDA develop a policy document, the 2010 Dietary Guidelines for Americans, and educational materials for the public (USDA, 2010). The committee believes that it would be helpful if FDA and FSIS would likewise develop a formalized process that triggers an automatic reassessment of those aspects of the NFP that are subject to change over time. These include the list of required nutrients; the Daily Value (DV), i.e., reference intake levels; the Reference Amounts Customarily Consumed (RACC), which are used to determine serving sizes; and criteria used to define nutrient content claims and to provide for health claims. One of this committee’s guiding principles is the need to maintain consistency between FOP labeling and existing nutrition labeling regulations. To maximize the health benefits to consumers of any resulting FOP labeling system or symbol, criteria for development and the content of such labeling must be anchored to the most recent version of the Dietary Guidelines for Americans and current consensus reports. This can only happen when there is continued reassessment and updates for all aspects of the food label, i.e., FOP labeling, the NFP, and claims. FINDINGS AND CONCLUSIONS Findings In order to ensure that food packages are truthful and not misleading, federal statutes have given FDA and FSIS regulatory oversight over food labeling. To fulfill this responsibility, the two agencies have set forth manda - tory labeling components, including statements of identity; ingredient lists on products composed of two or more ingredients; statements of the net quantity of contents; identification of the name and place of business of the manufacturer, packer, or distributor; allergen labeling; and nutrition information. In addition, some labels may be required to include additional information such as warning statements, safe handling instructions, country-of-origin notifications, inspection legends, and plant or establishment numbers. Conclusions One of the goals of nutrition labeling, to help consumers choose healthier diets, requires that nutrition informa - tion on the food label be based on the most recent Dietary Guidelines for Americans and current dietary guidance. To accomplish this, a formalized process should be developed within FDA and FSIS that triggers an automatic reassessment of the scientific basis behind all aspects of nutrition labeling, i.e., the NFP, nutrient content and health claims, and any future FOP labeling system, so that they remain anchored to the most recent version of the Dietary Guidelines for Americans and current consensus reports. REFERENCES FDA (Food and Drug Administration). 2010. Investigations Operations Manual. Washington, DC: Food and Drug Administration. FSIS (Food Safety and Inspection Service). 2007. A Guide to Federal Food Labeling Requirements for Meat and Poultry Products. Washington, DC: U.S. Department of Agriculture. Available online: http://www.fsis.usda.gov/pdf/labeling_ requirements_guide.pdf. 59 56 FR 60366.

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31 THE REGULATORY ENVIRONMENT IOM (Institute of Medicine). 2010. Front-of-Package Nutrition Rating Systems and Symbols: Phase I Report. Washington, DC: The National Academies Press. Kessler, D. A. 1995. The evolution of national nutrition policy. In Annual Review of Nutrition, edited by D. B. McCormick. Palo Alto, CA: Annual Reviews. Kessler, D., J. Mande, F. Scarbrough, R. Schapiro, and K. Feiden. 2003. Developing the “Nutrition Facts” food label. Harvard Health Policy Review 4:13-24. McColl, D. B., and C. P. Bump. 2005. Qualified health claims: Creatures of case law. Food and Drug Law Institute Update November/December:33-36. McCutcheon, J. 1995. Nutrition labeling of meat and poultry products—An overview of regulations from the U.S. Department of Agriculture. In Nutriton Labeling Handbook, edited by R. Shapiro. New York: Marcel Dekker. Pp. 53-63. Ollberding, N. J., R. Wolf, and I. Contento. 2010. Food label use and its relation to dietary intake among U.S. adults. Journal of the American Dietetic Association 110:1233-1237. Taylor, C. L., and V. L. Wilkening. 2008. How the nutrition food label was developed, part 2: The purpose and promise of nutrition labeling. Journal of the American Dietetic Association 108:618-623. USDA (U.S. Department of Agriculture). 2010. Dietary Guidelines for Americans. Washington, DC: U.S. Government Print- ing Office.

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