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Health and Wellness Related Labeling Claims for Functional Foods and Dietary Supplements in the USA
Health and Wellness Related Labeling Claims for Functional Foods and Dietary Supplements in the USA
10
Sanjiv Agarwal1, Stein Hordvik2 and Sandra Morar3 1
Sara Lee Food & Beverage, Downers Grove, IL, USA Hordvik’s Consulting , Elkhorn, NE, USA 3 McGrath North Mullin & Kratz PC LLO, Omaha, NE, USA 2
Abstract Food and supplement labels are an important educational tool to assist consumers in making healthier choices. In addition to mandatory nutritional labeling information, manufacturers have a variety of options on the food/supplement packages to communicate the nutrition/ health benefits of their products. This chapter describes the different types of claims that can be made for foods and dietary supplements.
Introduction A diet and health relationship was initially proposed in the fourth century BC by Hippocrates. Although, there is significant scientific agreement that diet plays an important role in health, only about 12% of Americans are eating healthy and many Nutraceutical and Functional Food Regulations ISBN: 978-0-12-373901-8
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134 Health and Wellness Related Labeling Claims
ms
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ion educt h claim ase risk r rosis’ lt a e H ise po le in d osteo nt’s ro the risk of ie r t u n ribes educe Desc ium may r lc a ‘C
ance claim ction h mainten n u F / ealt ture s’ Struc ’s role in h ong bone nt str ie d r t il u u n elps b ribes ium h Desc ‘Calc nt t claim onten l of nutrie c t n e ie v r t le ’ u N the ium izing e of calc c acter Char ood sour ‘G
Figure 10.1 Different types of labeling claims for functional foods and dietary supplements.
are not meeting the dietary guidelines recommendations and not consuming enough nutrients including vitamins and minerals from foods (1,2). Food labels are important tools to educate consumers about the healthfulness of specific foods and the benefits of following a nutritious diet. In addition to the mandatory nutrition labeling information (Nutrition Facts or Supplement Facts), current Food and Drug Administration (FDA) regulations (3) provide several provisions to communicate the healthfulness of the food products to the consumers (Fig. 10.1).
Nutrient Content Claims Nutrient content claims are regulated by the FDA under the Nutrition Labeling and Education Act (4). They explicitly or implicitly characterize the level of a nutrient in a food. These claims are made to describe the nutrient levels using such terms as ‘free’, ‘low’ and ‘high’ as well as to compare the nutrient levels using terms ‘more’, ‘reduced’ and ‘light’: 1. Characterizing the nutrient levels ● Free – identifies food that contains a nutrient at inconsequential levels. ● Low – identifies food that is distinctly low in a nutrient compared to a daily value (DV). ● Good source/excellent source – identifies foods that contain higher levels and contribute significantly toward the DV. 2. Comparing the nutrient levels ● Reduced, more or light – identifies nutritionally meaningful differences from a reference product. 3. Implied nutrient claim
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Table 10.1 Currently permitted nutrient content claims (numbers are rounded) as of March 2007 Nutrients
Claims
CFR reference
Calories
Free – less than five calories per reference amount (RACC) and serving Low – 40 calories or less per RACC or per 50 g if RACC is 30 g or less. 120 calories or less for meals and main dishes Reduced or less – at least 25% fewer calories per RACC than an appropriate reference food Free – less than 0.5 g fat per RACC and serving Low – 3 g or less fat per RACC or per 50 g if RACC is 30 g or less. 3 g or less fat per 100 g and not more than 30% calories from fat for meals and main dishes Reduced or less – at least 25% less fat per RACC than an appropriate reference food Free – less than 0.5 g saturated fat and less than 0.5 g trans fat per RACC and serving Low – 1–g or less saturated fat per RACC and less than 15% calories from saturated fat. 1 g or less fat per 100 g and not more than 10% calories from fat for meals and main dishes Reduced or less – at least 25% less saturated fat per RACC than an appropriate reference food Free – less than 2 mg cholesterol per RACC and serving or per serving for meals and main dishes and 2 g or less saturated fat per RACC or per serving for meals and main dishes Low – 20 mg or less cholesterol per RACC or per 50 g if RACC is 30 g or less. 20 mg or less cholesterol per 100 g for meals and main dishes. 2 g or less saturated fat per RACC or per serving for meals and main dishes Reduced or less – at least 25% less cholesterol per RACC than an appropriate reference food Free – less than 5 mg sodium per RACC and serving or per serving for meals and main dishes Low – 140 mg or less sodium per RACC or per 50 g if RACC is 30 g or less. 140 mg or less sodium per 100 g for meals and main dishes Reduced or less – at least 25% less sodium per RACC than an appropriate reference food Free – less than 0.5 g sugar per RACC and serving or per serving for meals and main dishes Low – claim is not defined and therefore not permitted Reduced or less – at least 25% less sugar per RACC than an appropriate reference food Good source – 10–19% DV per RACC Excellent source – 20% or more DV per RACC
101.60
Total fat
Saturated fat
Cholesterol
Sodium
Sugar
Vitamins, minerals, fiber and protein
101.62
101.62
101.62
101.61
101.60
101.54
CFR: Code of Federal Regulations
Implied nutrient content claims are claims about a food or an ingredient in a food suggesting that a nutrient or ingredient is present in certain amounts. ● ●
Healthy is an implied nutrient content claim. Lean and Extra Lean are terms that can be used to describe the fat content of meat, poultry, seafood and game meats.
Table 10.1 provides a list of nutrient content claims and their specific requirements (as of March 2007). These claims are, by and large, allowed for those nutrients for
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Table 10.2 Implied nutrient content claims as of March 2007 Claim
Requirements
CFR reference
Healthy
‘Low fat’, ‘Low saturated fat’, Cholesterol below 60 mg (90 mg for meals and main dishes) and Sodium below 480 mg (600 mg for meals/main dishes). At least 10% of the DV for one (individual foods), two (main dishes) or three (meals) of the six nutrients (Vitamin A, Vitamin C, iron, calcium, protein or fiber) Less than 10 g total fat, 4.5 g saturated fat and 95 mg of cholesterol per reference amount and labeled serving (per 100 g and per serving for meals/main dishes) Less than 5 g total fat, 2 g saturated fat and 95 mg of cholesterol per reference amount and labeled serving (per 100 g and per serving for meals/main dishes)
101.65
Lean
Extra Lean
101.62
101.62
CFR: Code of Federal Regulations
which the FDA has established a daily value. Nutrient content claims are currently permitted for calories, fat, saturated fat, cholesterol, sodium, sugar, vitamins, minerals, fiber and protein. Nutrient content claims for total carbohydrate (except for sugar and fiber) are currently not defined by the FDA and therefore are prohibited. A number of food manufacturers and trade organizations, in 2004, petitioned the FDA to allow nutrient content claims for carbohydrates and to define ‘free’, ‘low’, ‘good source’ and ‘excellent source’ claims for total carbohydrates. The FDA is currently reviewing the petitions. For nutrients/food components, which do not have a daily value, a factual statement specifying the nutrient quantity present in the food, e.g. ‘… mg of … per serving’ can be used on a food label. However, statements that characterize the amount of the nutrient as being high or low, e.g. ‘only … mg of … per serving’ are not permissible and would be considered to be implied nutrient content claims. Also, quantitative statements must include the unit of measure. The general principles for making these claims are provided in 21 CFR § 101.13, 101.54–101.69 (6). Additional requirements for nutrient content claims are: (a) for foods with a RACC less than 30 g, nutrient content claims must be determined as if there were 50 g of product; and (b) a disclosure statement, ‘See nutrition information for … content’, is also required as part of the claim when levels of fat, saturated fat, cholesterol and/or sodium exceed 13 g, 4 g, 60 mg, 480 mg, respectively, to call the consumer’s attention to one or more nutrients in the food that may increase the risk of a disease or health-related condition that is diet related. Table 10.2 provides a list of implied nutrient content claims and their requirements (as of March 2007).
Structure/Function Claims Structure/function claims describe the role of a nutrient or a substance in food or a food supplement in affecting the normal structure or function in the body. These also refer to a change in, the support of, maintenance or functions of the body and may
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Health Claims 137
Table 10.3 Common structure/function claims currently in the marketplace Structure/function claims
Nutrient
Calcium is important for both men and women to help build strong bones Fiber promotes digestive health Protein for muscle strength Grape juice may promote healthy arteries
Calcium Fiber Protein Flavonoids
Antioxidant Vitamins A, C and E help the body’s natural defenses
Vitamin A, C and E
Antioxidants may help protect against the damaging effects of free radicals Antioxidants help provide support for your body’s natural defenses
Lycopene, Vitamin A, C and E, selenium, flavonoids Lycopene, Vitamin A, C and E, selenium, flavonoids Lutein, Vitamin A
For healthy eyes
also describe the mechanism of action. These, however, do not relate to a disease or a health-related condition. For example, ‘calcium helps build strong bones’ is a structure/function claim, whereas ‘calcium reduces the risk of osteoporosis’ is a health claim (see Fig. 10.1). The key components of structure/function claims are safety, scientific basis and the nutritive value. Table 10.3 provides some examples of structure/function claims used in the market. Some of these claims may not have strong scientific support and therefore the regulatory agencies may consider them as ‘misleading to consumers’. Premarket approval for structure/function claims is not required. The FDA requires that these claims be truthful, non-misleading and substantiated by the appropriate scientific data and the food/supplement manufacturer must ensure their accuracy and truthfulness. In the case of dietary supplements, these claims are accompanied by a disclaimer stating that ‘the FDA has not evaluated this claim and this product is not intended to diagnose, treat, cure or prevent any disease’. Moreover, the FDA has to be notified about the claim, including the text, within 30 days of marketing a dietary supplement bearing a new structure/function claim. The FDA has provided a guidance document to distinguish between structure/function claims and disease claims (5).
Health Claims Health claims describe the relationship between a substance (food, food component or dietary supplement) and a disease or a health-related condition (see Fig. 10.1). There are two important constituents of a health claim: a substance and a disease or health-related condition. Claims relating to a dietary pattern instead of a substance are not considered as health claims. Unlike structure/function claims, health claims must be pre-approved by the FDA. The FDA conducts an evidence-based review to ascertain the scientific validity of the claim. FDA reviews and authorizes the health claims by three means (6): 1. Claims based on significant scientific agreement: The Nutrition Labeling and Education Act 1990 (NLEA) and the Dietary Supplement Health and
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Table 10.4 Approved NLEA health claims with significant scientific agreement as of March 2007 Health claim
CFR reference
Calcium and osteoporosis Dietary lipids (fat) and cancer Sodium and hypertension Dietary saturated fat and cholesterol and risk of coronary heart disease Fiber-containing grain products, fruits and vegetables and cancer Fruits, vegetables and grain products that contain fiber, particularly soluble fiber and risk of coronary heart disease Fruits and vegetables and cancer Folic acid and neural tube defects Dietary carbohydrate sweeteners and dental caries Soluble fiber from certain foods and risk of coronary heart disease Soy protein and risk of coronary heart disease Stanols/sterols and risk of coronary heart disease
21 CFR 101.72 21 CFR 101.73 21 CFR 101.74 21 CFR 101.75 21 CFR 101.76 21 CFR 101.77 21 CFR 101.78 21 CFR 101.79 21 CFR 101.80 21 CFR 101.81 21 CFR 101.82 21 CFR 101.83
CFR: Code of Federal Regulations
Table 10.5 Currently authorized FDAMA health claims as of March 2007 Health claim
Docket reference
Whole grain foods and the risk of heart disease and certain cancers Potassium and the risk of high blood pressure and stroke Nutrient content claim (good source) of choline Fluoridated water and the risk of dental caries or tooth decay Saturated fat, cholesterol and trans fat and the risk of heart disease
99P-2209 and 03Q-0547 00Q-1582 01Q-0352 2006Q-0418 2006Q-0458
Education Act (DSHEA) of 1994 allow health claims on food or supplement labels describing the role of a substance in disease risk reduction. The FDA authorizes these claims based on the totality of publicly available scientific evidence and using significant scientific agreement (SSA) criteria to determine the validity of the substance/disease relationship. A list of current (as of March 2007) FDA approved SSA health claims are presented in Table 10.4. 2. Claims based on authoritative statement: The FDA Modernization Act (FDAMA) of 1997 also allows health claims based on an authoritative statement issued by a scientific body of the US Government bearing a public health protection responsibility, such as The National Institutes of Health (NIH), The Centers for Disease Control (CDC) or The National Academy of Science (NAS). However, FDAMA claims are not available for dietary supplements. Table 10.5 lists the health claims that are currently (as of March 2007) approved under the FDAMA process. 3. Qualified health claims: Consumer Health Information for Better Nutrition Initiative of FDA (2003) provides the use of health claims (qualified health claims (QHC)) for foods or dietary supplements where the scientific evidence to support a substance/disease relationship is still emerging and has not developed enough to meet the SSA standard. These claims have to include qualifying
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Table 10.6 Qualified health claims as of March 2007 Permitted qualified health claims
Docket reference
0.8 mg folic acid and the risk of neural tube birth defects* B Vitamins (B6, B12 and folic acid) and the risk of vascular disease* Selenium and the risk of cancer* Phosphatidylserine and the risk of cognitive dysfunction and dementia* Antioxidant vitamins (Vitamin C and E) and the risk of cancer* Nuts and the risk of heart disease Walnuts and the risk of heart disease Omega-3 fatty acids (EPA and DHA) and the risk of coronary heart disease Monounsaturated fatty acids from olive oil and the risk of coronary heart disease Green tea and the risk of cancer Calcium and the risk of colorectal cancer* Calcium and the risk of hypertension* Chromium picolinate and the risk of insulin resistance or type II diabetes* Tomatoes and/or tomato sauce and the risk of prostate, ovarian, gastric and pancreatic cancer Unsaturated fatty acids from canola oil and the risk of coronary heart disease Corn oil and corn oil-containing products and a reduced risk of heart disease
91N-100H 99P-3029 02P-0457 02P-0413 91N-0101 02P-0505 02P-0292 2004Q-0401 2003Q-0559 2004Q-0083 2004Q-0097 2004Q-0098 2004Q-0144 2004Q-0201 2006Q-0091 2006P-0243
*Approved only for the dietary supplements
language as part of the claim indicating that the evidence supporting the claim is limited. In July 2003, the FDA provided interim guidelines outlining the petition process and the evidence-based ranking system to evaluate the scientific data concerning the claim. Since July 2003, the FDA has authorized several qualified health xlaims for foods and dietary supplements. Table 10.6 shows all the approved qualified health claims to date (as of March 2007). Health claims in general relate to disease risk reduction, but do not quantify the degree of risk reduction. Health claims language always uses ‘may’or ‘might’ to express the substance and disease relationship. All FDA approved health claims are generic and not for the exclusive use of the petitioner. These claims are available to any conventional food or dietary supplement product that meets the SSA or FDAMA claims criteria or the QHC enforcement discretion conditions specified by the FDA. Additionally, the foods bearing the health claims must contain 10% or more of the DV for one or more of the six nutrients (vitamin A, vitamin C, iron, calcium, protein or fiber) without fortification. Dietary supplements are exempt from this requirement. Foods bearing the health claims must also contain less than the 13 g, 4 g, 60 mg, 480 mg of fat, saturated fat, cholesterol and sodium, respectively, the disqualifying nutrients 21 CFR § 101.14 (6).
Dietary Guidance Statements The FDA also allowed dietary guidance statements on food labels to encourage good nutrition among consumers as a part of the Consumer Health Information for Better Nutrition Initiative (7). These statements address the role of dietary patterns
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or of general categories of foods (e.g. fruits and vegetables) in health and are not considered health claims. Although dietary guidance statements are not subject to FDA review and authorization, these must be truthful and non-misleading. The FDA recently offered a dietary guidance statement for fruits and vegetables: ‘Diets rich in fruits and vegetables may reduce the risk of some types of cancer and other chronic diseases’ (8).
Factual Statements There are several other claims/factual statements that are often used by the manufacturers. Some of the common examples are provided below. Many of these may not have strong scientific support or regulatory guidance and therefore the regulatory agencies may view them as misleading to consumers. Legal counsel should be consulted prior to making any claims not clearly defined in the regulations. 1. Net carbs: Net carbs is a way of representing the amount of carbohydrate not contributing significantly towards energy or blood sugar. The net carbs number is often calculated by subtracting fiber and/or sugar alcohol from total carbohydrate. The net carbs calculation is generally presented next to the claim. The FDA has not provided any guidance on how to calculate or make net carb claims. 2. ‘Zero’ g trans fat or 0 g trans fat: This is a factual statement. In absence of any guidance from the FDA about ‘trans fat free’, this statement is becoming a common claim of expressing that the product does not have any significant amount of trans fat. 3. Whole grain goodness: This is a statement indicating that the product contains whole grain and therefore may provide the health benefits that are associated with whole grain. 4. Loaded with nutrition/complete nutritious food: It suggests that the product contains nutrients. 5. Glycemic index (GI): This is measured as a rise in the blood sugar following ingestion of a food and is representative of the quality of carbohydrate in the food. Usually foods with a glycemic index of 55 or less are considered as low GI foods. 6. Other common factual statements are: ‘as much calcium as a glass of milk’, ‘contains same amount of vitamin C as a glass of orange juice’ and ‘as much fiber as in an apple’.
Nutritional Claims Display on Packages Manufacturers use a variety of ways to communicate the nutritional attributes and health advantages of their products: 1. Attribute on the principle display panel as a burst. 2. List of attributes in a check box style on the side panel. 3. Goodness corner to highlight the attributes.
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References 141
4. Complete back panel to display the nutritional attributes and their associated functional/health benefits. 5. Company/brand’s website. 6. Sales literature and other materials available at the point of purchase (grocery store/health food store). According to a Food Label Package Survey conducted by the FDA (9), 49.7% of the FDA regulated products sold during 2000–2001 had nutrient content claims, 6.2% had structure/function claims and 4.4% had health claims on food labels.
References 1. Frazao E. (1995). The American diet: health and economic consequences. USDA/ ERS, AIB-711. 2. Moshfegh A, Goldman J, Cleveland L. (2005). What we eat in America, NHANES 2001–2002: usual nutrient intakes from food compared to dietary reference intakes. USDA, ARS. 3. FDA. (2004). Code of Federal Regulation, Title 21, Part 101 Food Labeling, http://www.access.gpo.gov/nara/cfr/waisidx04/21cfr10104.html 4. Nutrition Labeling and Education Act of 1990. (1990). Public Law 101–535, 1990. 5. FDA. (2002). Guidance for Industry, Structure Function Claims – Small Entity Compliance Guide, http://www.cfsan.fda.gov/~dms/sclmguid.html 6. CFSAN. (2003). Claims that can be made for conventional foods and dietary supplements, http://www.cfsan.fda.gov/~dms/hclaims.html 7. FDA. (2003). Consumer Health Information for Better Nutrition Initiative, http:// www.cfsan.fda.gov/~dms/nuttftoc.html 8. CFSAN. (2003). Dietary guidance message about fruits and vegetables, http://www. cfsan.fda.gov/~dms/lab-dg.html 9. LeGault L, Brandt MB, McCabe N, Adler C, Brown A-M, Brecher S. (2004). 2000– 2001 Food label and package survey: an update on prevalence of nutrition labeling and claims on processed, packaged foods. J Am Diet Assoc 104, 952–958. 10. Dietary Supplement Health and Education Act of 1994. (1994). Public Law 103–417. 11. FDA Modernization Act of 1997. (1997). http://www.cfsan.fda.gov/~dms/labfdama. html
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10
Sanjiv Agarwal1, Stein Hordvik2 and Sandra Morar3 1
Sara Lee Food & Beverage, Downers Grove, IL, USA Hordvik’s Consulting , Elkhorn, NE, USA 3 McGrath North Mullin & Kratz PC LLO, Omaha, NE, USA 2
Abstract Food and supplement labels are an important educational tool to assist consumers in making healthier choices. In addition to mandatory nutritional labeling information, manufacturers have a variety of options on the food/supplement packages to communicate the nutrition/ health benefits of their products. This chapter describes the different types of claims that can be made for foods and dietary supplements.
Introduction A diet and health relationship was initially proposed in the fourth century BC by Hippocrates. Although, there is significant scientific agreement that diet plays an important role in health, only about 12% of Americans are eating healthy and many Nutraceutical and Functional Food Regulations ISBN: 978-0-12-373901-8
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Copyright © 2008, Elsevier Inc. All rights reserved
6/19/2008 1:57:03 PM
134 Health and Wellness Related Labeling Claims
ms
lai gc lin
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p Ty
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lab
ion educt h claim ase risk r rosis’ lt a e H ise po le in d osteo nt’s ro the risk of ie r t u n ribes educe Desc ium may r lc a ‘C
ance claim ction h mainten n u F / ealt ture s’ Struc ’s role in h ong bone nt str ie d r t il u u n elps b ribes ium h Desc ‘Calc nt t claim onten l of nutrie c t n e ie v r t le ’ u N the ium izing e of calc c acter Char ood sour ‘G
Figure 10.1 Different types of labeling claims for functional foods and dietary supplements.
are not meeting the dietary guidelines recommendations and not consuming enough nutrients including vitamins and minerals from foods (1,2). Food labels are important tools to educate consumers about the healthfulness of specific foods and the benefits of following a nutritious diet. In addition to the mandatory nutrition labeling information (Nutrition Facts or Supplement Facts), current Food and Drug Administration (FDA) regulations (3) provide several provisions to communicate the healthfulness of the food products to the consumers (Fig. 10.1).
Nutrient Content Claims Nutrient content claims are regulated by the FDA under the Nutrition Labeling and Education Act (4). They explicitly or implicitly characterize the level of a nutrient in a food. These claims are made to describe the nutrient levels using such terms as ‘free’, ‘low’ and ‘high’ as well as to compare the nutrient levels using terms ‘more’, ‘reduced’ and ‘light’: 1. Characterizing the nutrient levels ● Free – identifies food that contains a nutrient at inconsequential levels. ● Low – identifies food that is distinctly low in a nutrient compared to a daily value (DV). ● Good source/excellent source – identifies foods that contain higher levels and contribute significantly toward the DV. 2. Comparing the nutrient levels ● Reduced, more or light – identifies nutritionally meaningful differences from a reference product. 3. Implied nutrient claim
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Table 10.1 Currently permitted nutrient content claims (numbers are rounded) as of March 2007 Nutrients
Claims
CFR reference
Calories
Free – less than five calories per reference amount (RACC) and serving Low – 40 calories or less per RACC or per 50 g if RACC is 30 g or less. 120 calories or less for meals and main dishes Reduced or less – at least 25% fewer calories per RACC than an appropriate reference food Free – less than 0.5 g fat per RACC and serving Low – 3 g or less fat per RACC or per 50 g if RACC is 30 g or less. 3 g or less fat per 100 g and not more than 30% calories from fat for meals and main dishes Reduced or less – at least 25% less fat per RACC than an appropriate reference food Free – less than 0.5 g saturated fat and less than 0.5 g trans fat per RACC and serving Low – 1–g or less saturated fat per RACC and less than 15% calories from saturated fat. 1 g or less fat per 100 g and not more than 10% calories from fat for meals and main dishes Reduced or less – at least 25% less saturated fat per RACC than an appropriate reference food Free – less than 2 mg cholesterol per RACC and serving or per serving for meals and main dishes and 2 g or less saturated fat per RACC or per serving for meals and main dishes Low – 20 mg or less cholesterol per RACC or per 50 g if RACC is 30 g or less. 20 mg or less cholesterol per 100 g for meals and main dishes. 2 g or less saturated fat per RACC or per serving for meals and main dishes Reduced or less – at least 25% less cholesterol per RACC than an appropriate reference food Free – less than 5 mg sodium per RACC and serving or per serving for meals and main dishes Low – 140 mg or less sodium per RACC or per 50 g if RACC is 30 g or less. 140 mg or less sodium per 100 g for meals and main dishes Reduced or less – at least 25% less sodium per RACC than an appropriate reference food Free – less than 0.5 g sugar per RACC and serving or per serving for meals and main dishes Low – claim is not defined and therefore not permitted Reduced or less – at least 25% less sugar per RACC than an appropriate reference food Good source – 10–19% DV per RACC Excellent source – 20% or more DV per RACC
101.60
Total fat
Saturated fat
Cholesterol
Sodium
Sugar
Vitamins, minerals, fiber and protein
101.62
101.62
101.62
101.61
101.60
101.54
CFR: Code of Federal Regulations
Implied nutrient content claims are claims about a food or an ingredient in a food suggesting that a nutrient or ingredient is present in certain amounts. ● ●
Healthy is an implied nutrient content claim. Lean and Extra Lean are terms that can be used to describe the fat content of meat, poultry, seafood and game meats.
Table 10.1 provides a list of nutrient content claims and their specific requirements (as of March 2007). These claims are, by and large, allowed for those nutrients for
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Table 10.2 Implied nutrient content claims as of March 2007 Claim
Requirements
CFR reference
Healthy
‘Low fat’, ‘Low saturated fat’, Cholesterol below 60 mg (90 mg for meals and main dishes) and Sodium below 480 mg (600 mg for meals/main dishes). At least 10% of the DV for one (individual foods), two (main dishes) or three (meals) of the six nutrients (Vitamin A, Vitamin C, iron, calcium, protein or fiber) Less than 10 g total fat, 4.5 g saturated fat and 95 mg of cholesterol per reference amount and labeled serving (per 100 g and per serving for meals/main dishes) Less than 5 g total fat, 2 g saturated fat and 95 mg of cholesterol per reference amount and labeled serving (per 100 g and per serving for meals/main dishes)
101.65
Lean
Extra Lean
101.62
101.62
CFR: Code of Federal Regulations
which the FDA has established a daily value. Nutrient content claims are currently permitted for calories, fat, saturated fat, cholesterol, sodium, sugar, vitamins, minerals, fiber and protein. Nutrient content claims for total carbohydrate (except for sugar and fiber) are currently not defined by the FDA and therefore are prohibited. A number of food manufacturers and trade organizations, in 2004, petitioned the FDA to allow nutrient content claims for carbohydrates and to define ‘free’, ‘low’, ‘good source’ and ‘excellent source’ claims for total carbohydrates. The FDA is currently reviewing the petitions. For nutrients/food components, which do not have a daily value, a factual statement specifying the nutrient quantity present in the food, e.g. ‘… mg of … per serving’ can be used on a food label. However, statements that characterize the amount of the nutrient as being high or low, e.g. ‘only … mg of … per serving’ are not permissible and would be considered to be implied nutrient content claims. Also, quantitative statements must include the unit of measure. The general principles for making these claims are provided in 21 CFR § 101.13, 101.54–101.69 (6). Additional requirements for nutrient content claims are: (a) for foods with a RACC less than 30 g, nutrient content claims must be determined as if there were 50 g of product; and (b) a disclosure statement, ‘See nutrition information for … content’, is also required as part of the claim when levels of fat, saturated fat, cholesterol and/or sodium exceed 13 g, 4 g, 60 mg, 480 mg, respectively, to call the consumer’s attention to one or more nutrients in the food that may increase the risk of a disease or health-related condition that is diet related. Table 10.2 provides a list of implied nutrient content claims and their requirements (as of March 2007).
Structure/Function Claims Structure/function claims describe the role of a nutrient or a substance in food or a food supplement in affecting the normal structure or function in the body. These also refer to a change in, the support of, maintenance or functions of the body and may
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Health Claims 137
Table 10.3 Common structure/function claims currently in the marketplace Structure/function claims
Nutrient
Calcium is important for both men and women to help build strong bones Fiber promotes digestive health Protein for muscle strength Grape juice may promote healthy arteries
Calcium Fiber Protein Flavonoids
Antioxidant Vitamins A, C and E help the body’s natural defenses
Vitamin A, C and E
Antioxidants may help protect against the damaging effects of free radicals Antioxidants help provide support for your body’s natural defenses
Lycopene, Vitamin A, C and E, selenium, flavonoids Lycopene, Vitamin A, C and E, selenium, flavonoids Lutein, Vitamin A
For healthy eyes
also describe the mechanism of action. These, however, do not relate to a disease or a health-related condition. For example, ‘calcium helps build strong bones’ is a structure/function claim, whereas ‘calcium reduces the risk of osteoporosis’ is a health claim (see Fig. 10.1). The key components of structure/function claims are safety, scientific basis and the nutritive value. Table 10.3 provides some examples of structure/function claims used in the market. Some of these claims may not have strong scientific support and therefore the regulatory agencies may consider them as ‘misleading to consumers’. Premarket approval for structure/function claims is not required. The FDA requires that these claims be truthful, non-misleading and substantiated by the appropriate scientific data and the food/supplement manufacturer must ensure their accuracy and truthfulness. In the case of dietary supplements, these claims are accompanied by a disclaimer stating that ‘the FDA has not evaluated this claim and this product is not intended to diagnose, treat, cure or prevent any disease’. Moreover, the FDA has to be notified about the claim, including the text, within 30 days of marketing a dietary supplement bearing a new structure/function claim. The FDA has provided a guidance document to distinguish between structure/function claims and disease claims (5).
Health Claims Health claims describe the relationship between a substance (food, food component or dietary supplement) and a disease or a health-related condition (see Fig. 10.1). There are two important constituents of a health claim: a substance and a disease or health-related condition. Claims relating to a dietary pattern instead of a substance are not considered as health claims. Unlike structure/function claims, health claims must be pre-approved by the FDA. The FDA conducts an evidence-based review to ascertain the scientific validity of the claim. FDA reviews and authorizes the health claims by three means (6): 1. Claims based on significant scientific agreement: The Nutrition Labeling and Education Act 1990 (NLEA) and the Dietary Supplement Health and
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Table 10.4 Approved NLEA health claims with significant scientific agreement as of March 2007 Health claim
CFR reference
Calcium and osteoporosis Dietary lipids (fat) and cancer Sodium and hypertension Dietary saturated fat and cholesterol and risk of coronary heart disease Fiber-containing grain products, fruits and vegetables and cancer Fruits, vegetables and grain products that contain fiber, particularly soluble fiber and risk of coronary heart disease Fruits and vegetables and cancer Folic acid and neural tube defects Dietary carbohydrate sweeteners and dental caries Soluble fiber from certain foods and risk of coronary heart disease Soy protein and risk of coronary heart disease Stanols/sterols and risk of coronary heart disease
21 CFR 101.72 21 CFR 101.73 21 CFR 101.74 21 CFR 101.75 21 CFR 101.76 21 CFR 101.77 21 CFR 101.78 21 CFR 101.79 21 CFR 101.80 21 CFR 101.81 21 CFR 101.82 21 CFR 101.83
CFR: Code of Federal Regulations
Table 10.5 Currently authorized FDAMA health claims as of March 2007 Health claim
Docket reference
Whole grain foods and the risk of heart disease and certain cancers Potassium and the risk of high blood pressure and stroke Nutrient content claim (good source) of choline Fluoridated water and the risk of dental caries or tooth decay Saturated fat, cholesterol and trans fat and the risk of heart disease
99P-2209 and 03Q-0547 00Q-1582 01Q-0352 2006Q-0418 2006Q-0458
Education Act (DSHEA) of 1994 allow health claims on food or supplement labels describing the role of a substance in disease risk reduction. The FDA authorizes these claims based on the totality of publicly available scientific evidence and using significant scientific agreement (SSA) criteria to determine the validity of the substance/disease relationship. A list of current (as of March 2007) FDA approved SSA health claims are presented in Table 10.4. 2. Claims based on authoritative statement: The FDA Modernization Act (FDAMA) of 1997 also allows health claims based on an authoritative statement issued by a scientific body of the US Government bearing a public health protection responsibility, such as The National Institutes of Health (NIH), The Centers for Disease Control (CDC) or The National Academy of Science (NAS). However, FDAMA claims are not available for dietary supplements. Table 10.5 lists the health claims that are currently (as of March 2007) approved under the FDAMA process. 3. Qualified health claims: Consumer Health Information for Better Nutrition Initiative of FDA (2003) provides the use of health claims (qualified health claims (QHC)) for foods or dietary supplements where the scientific evidence to support a substance/disease relationship is still emerging and has not developed enough to meet the SSA standard. These claims have to include qualifying
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Table 10.6 Qualified health claims as of March 2007 Permitted qualified health claims
Docket reference
0.8 mg folic acid and the risk of neural tube birth defects* B Vitamins (B6, B12 and folic acid) and the risk of vascular disease* Selenium and the risk of cancer* Phosphatidylserine and the risk of cognitive dysfunction and dementia* Antioxidant vitamins (Vitamin C and E) and the risk of cancer* Nuts and the risk of heart disease Walnuts and the risk of heart disease Omega-3 fatty acids (EPA and DHA) and the risk of coronary heart disease Monounsaturated fatty acids from olive oil and the risk of coronary heart disease Green tea and the risk of cancer Calcium and the risk of colorectal cancer* Calcium and the risk of hypertension* Chromium picolinate and the risk of insulin resistance or type II diabetes* Tomatoes and/or tomato sauce and the risk of prostate, ovarian, gastric and pancreatic cancer Unsaturated fatty acids from canola oil and the risk of coronary heart disease Corn oil and corn oil-containing products and a reduced risk of heart disease
91N-100H 99P-3029 02P-0457 02P-0413 91N-0101 02P-0505 02P-0292 2004Q-0401 2003Q-0559 2004Q-0083 2004Q-0097 2004Q-0098 2004Q-0144 2004Q-0201 2006Q-0091 2006P-0243
*Approved only for the dietary supplements
language as part of the claim indicating that the evidence supporting the claim is limited. In July 2003, the FDA provided interim guidelines outlining the petition process and the evidence-based ranking system to evaluate the scientific data concerning the claim. Since July 2003, the FDA has authorized several qualified health xlaims for foods and dietary supplements. Table 10.6 shows all the approved qualified health claims to date (as of March 2007). Health claims in general relate to disease risk reduction, but do not quantify the degree of risk reduction. Health claims language always uses ‘may’or ‘might’ to express the substance and disease relationship. All FDA approved health claims are generic and not for the exclusive use of the petitioner. These claims are available to any conventional food or dietary supplement product that meets the SSA or FDAMA claims criteria or the QHC enforcement discretion conditions specified by the FDA. Additionally, the foods bearing the health claims must contain 10% or more of the DV for one or more of the six nutrients (vitamin A, vitamin C, iron, calcium, protein or fiber) without fortification. Dietary supplements are exempt from this requirement. Foods bearing the health claims must also contain less than the 13 g, 4 g, 60 mg, 480 mg of fat, saturated fat, cholesterol and sodium, respectively, the disqualifying nutrients 21 CFR § 101.14 (6).
Dietary Guidance Statements The FDA also allowed dietary guidance statements on food labels to encourage good nutrition among consumers as a part of the Consumer Health Information for Better Nutrition Initiative (7). These statements address the role of dietary patterns
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or of general categories of foods (e.g. fruits and vegetables) in health and are not considered health claims. Although dietary guidance statements are not subject to FDA review and authorization, these must be truthful and non-misleading. The FDA recently offered a dietary guidance statement for fruits and vegetables: ‘Diets rich in fruits and vegetables may reduce the risk of some types of cancer and other chronic diseases’ (8).
Factual Statements There are several other claims/factual statements that are often used by the manufacturers. Some of the common examples are provided below. Many of these may not have strong scientific support or regulatory guidance and therefore the regulatory agencies may view them as misleading to consumers. Legal counsel should be consulted prior to making any claims not clearly defined in the regulations. 1. Net carbs: Net carbs is a way of representing the amount of carbohydrate not contributing significantly towards energy or blood sugar. The net carbs number is often calculated by subtracting fiber and/or sugar alcohol from total carbohydrate. The net carbs calculation is generally presented next to the claim. The FDA has not provided any guidance on how to calculate or make net carb claims. 2. ‘Zero’ g trans fat or 0 g trans fat: This is a factual statement. In absence of any guidance from the FDA about ‘trans fat free’, this statement is becoming a common claim of expressing that the product does not have any significant amount of trans fat. 3. Whole grain goodness: This is a statement indicating that the product contains whole grain and therefore may provide the health benefits that are associated with whole grain. 4. Loaded with nutrition/complete nutritious food: It suggests that the product contains nutrients. 5. Glycemic index (GI): This is measured as a rise in the blood sugar following ingestion of a food and is representative of the quality of carbohydrate in the food. Usually foods with a glycemic index of 55 or less are considered as low GI foods. 6. Other common factual statements are: ‘as much calcium as a glass of milk’, ‘contains same amount of vitamin C as a glass of orange juice’ and ‘as much fiber as in an apple’.
Nutritional Claims Display on Packages Manufacturers use a variety of ways to communicate the nutritional attributes and health advantages of their products: 1. Attribute on the principle display panel as a burst. 2. List of attributes in a check box style on the side panel. 3. Goodness corner to highlight the attributes.
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References 141
4. Complete back panel to display the nutritional attributes and their associated functional/health benefits. 5. Company/brand’s website. 6. Sales literature and other materials available at the point of purchase (grocery store/health food store). According to a Food Label Package Survey conducted by the FDA (9), 49.7% of the FDA regulated products sold during 2000–2001 had nutrient content claims, 6.2% had structure/function claims and 4.4% had health claims on food labels.
References 1. Frazao E. (1995). The American diet: health and economic consequences. USDA/ ERS, AIB-711. 2. Moshfegh A, Goldman J, Cleveland L. (2005). What we eat in America, NHANES 2001–2002: usual nutrient intakes from food compared to dietary reference intakes. USDA, ARS. 3. FDA. (2004). Code of Federal Regulation, Title 21, Part 101 Food Labeling, http://www.access.gpo.gov/nara/cfr/waisidx04/21cfr10104.html 4. Nutrition Labeling and Education Act of 1990. (1990). Public Law 101–535, 1990. 5. FDA. (2002). Guidance for Industry, Structure Function Claims – Small Entity Compliance Guide, http://www.cfsan.fda.gov/~dms/sclmguid.html 6. CFSAN. (2003). Claims that can be made for conventional foods and dietary supplements, http://www.cfsan.fda.gov/~dms/hclaims.html 7. FDA. (2003). Consumer Health Information for Better Nutrition Initiative, http:// www.cfsan.fda.gov/~dms/nuttftoc.html 8. CFSAN. (2003). Dietary guidance message about fruits and vegetables, http://www. cfsan.fda.gov/~dms/lab-dg.html 9. LeGault L, Brandt MB, McCabe N, Adler C, Brown A-M, Brecher S. (2004). 2000– 2001 Food label and package survey: an update on prevalence of nutrition labeling and claims on processed, packaged foods. J Am Diet Assoc 104, 952–958. 10. Dietary Supplement Health and Education Act of 1994. (1994). Public Law 103–417. 11. FDA Modernization Act of 1997. (1997). http://www.cfsan.fda.gov/~dms/labfdama. html
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