701 1 '7‘ - regulations.gov

Randy C. Papadellis President & Chief Executive Officer

Ocean Spray Cranberries, Inc. One Ocean Spray Drive Lakeville-Middleboro, MA 02349 p (508) 923.3228 1(508) 946.7714

August 1, 2014

The Honorable Margaret Hamburg Division of Dockets Management (HFA — 305)

Food and Drug Administration 5360 Fishers Lane, Rm. 601 Rockville, MD 20852

701 11 "'7‘

Re: Comments to Proposed Rulemaking; Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Docket No. FDA — 2012-N-1210; RIN 0910-AF22

Dear Commissioner Hamburg:

On behalf of Ocean Spray Cranberries, Inc. and our grower-owners, I submit these comments to FDA's Proposed Rule on Food Labeling: Revision of the Nutrition and Supplement Facts Labels, Docket No. FDA-2012- N-1210 ("Proposed Rule"). Ocean Spray is an agricultural cooperative consisting of over 700 cranberry and

grapefruit grower-owners who have helped preserve the family farming way of life in rural areas of our country for generations. Founded in 1930, we have a long history of providing a wide variety of nutritious

cranberry beverage and food products to consumers throughout the United States and the world. Our grower-

owners are extremely proud of the history and heritage of cranberries and the nutritious products produced from the fruit grown on their farms.

SUMMARY

We applaud FDA's effort to improve the health of Americans by revising certain information on the nutrition label for consumers through the Proposed Rule. As a general matter, Ocean Spray supports the proposed revisions where they call for information that is clear and will assist consumers in making healthy dietary

choices. We likewise believe that consumers should be encouraged to make healthy dietary choices by being presented with food labels that display helpful information, conveyed in a manner they can comprehend.

However, we believe that FDA's proposal to require a declaration of "added sugar" as a separate item on the Nutrition Facts panel does not meet this criteria with regard to products containing cranberries. Cranberries are nutrient-dense, but are one of the only commonly consumed fruits that require sweetening to be palatable. As such, the cranberry industry stands virtually alone as producers of healthy fruit products that will be unintentionally harmed by the Proposed Rule.

Cranberries are unique. Their healthful properties were first recognized by Native Americans hundreds of years

ago, and today's research confirms that cranberries are a nutrient-dense fruit that can deliver valuable health benefits to help consumers meet recommended fruit intake levels and maintain a healthy diet. Cranberries are rich in polyphenols, they provide well-documented urinary tract health benefits, and emerging research

suggests that they also provide heart health properties. Yet, cranberries (unlike grapes, apples and oranges) are naturally low in sugar, giving them a distinctively tart, astringent and even unpalatable taste. As such, consumers enjoy the benefits of cranberry products that are sweetened to similar levels of naturally occurring sugar contained in comparable fruit juices and dried fruit products. This sweetening for palatability does not diminish the healthful properties of cranberry products, a fact that has been acknowledged by USDA

Because of their need to be sweetened for palatability, healthy and nutrient-dense cranberry products will be unfairly characterized by a required declaration of "added sugars" on the Nutrition Facts panel. A cranberry product containing the same amount of sugar as a comparable fruit product with endogenous sugar will show a significantly larger "added sugar" value, even though the total sugar content for the two foods may be nearly identical. Because consumers have been led to believe that "added sugar" signifies that a product is unhealthy, the Proposed Rule will mislead them to think that the cranberry product is a less nutritious choice than a product made from another fruit, even those with more total sugar. Without some sort of accommodation in the Proposed Rule, the "added sugar" declaration will have the unintended consequence of driving consumers away from the cranberry's dense nutrients, broad array of health benefits, and overall positive contribution to their diets. The ability to utilize cranberries as a tool to help address public health issues (such as the challenges posed by urinary tract infections) would be critically diluted. Rather than assisting consumers in maintaining healthy dietary practices, the proposed "added sugar" declaration poses a substantial risk of confusing them in a manner that could negatively impact public health.

Another unintended result of the Proposed Rule is that it will negatively impact the U.S. cranberry industry. If cranberry products are wrongly viewed as "unhealthy" because of the negative connotations that come with their declared "added sugar" values, cranberry consumption will decrease and the viability of our nation's cranberry farms, along with their multi-generational farming families and the rural communities they support, will be put in jeopardy.

USDA recently addressed these critical concerns regarding cranberry products by granting a similar exemption in connection with the availability of cranberry products for sale in our nation's schools. We believe like action here by FDA is equally warranted because an exemption for certain cranberry products will provide consumers with accurate and fair information about their nutritional value in a manner that does not risk misleading them to think those products compare unfavorably to other fruit products with similar or greater quantities of total sugar.

For these reasons, if the declaration of "added sugars" is mandated in the final rule, Ocean Spray and its grower-owners ask that FDA provide for an exemption to accommodate certain products made using fruits that, like cranberries, are nutrient-dense but have very low natural sugar and are not typically consumed in their raw, unpalatable state.

1 Interim Rule, National School Lunch Program and School Breakfast Program: Nutrition Standards for All Foods Sold in School as Required by the Healthy Hunger-Free Kids Act of 2010, Federal Register, Vol. 78 No. 125, June 28, 2013 ("USDA Nutrition Standards").

of 16

CRANBERRY PRODUCTS ARE NUTRITIOUS & DELIVER UNIQUE HEALTH BENEFITS

Cranberries and cranberry products help Americans meet their fruit intake recommendations and deliver valuable health benefits to consumers. Compared to other commonly consumed fruits, cranberries are rich in polyphenols, specifically flavonoids. 2 Their positive impact on urinary tract health — an important public health challenge — is well known and well documented. In addition, emerging research suggests that cranberries provide health benefits in other areas, such as heart health and gastrointestinal health. Because of their unique ability to deliver a range of health benefits, including benefits that help mitigate public health concerns, cranberries are precisely the sort of food that the FDA should seek to encourage consumers to consider when constructing diets containing nutrient-dense foods. Cranberries' healthful properties include the following:

(A) Cranberries Help Americans Meet Their Recommended Daily Fruit Needs.

Cranberries can play an important role in helping Americans meet their recommended daily fruit needs. As a threshold matter, Americans should be encouraged to eat more fruit, an important food group, and for which most consumers do not meet their recommended intake. The 2010 Dietary Guidelines for Americans makes clear that Americans should increase their fruit intake and choose foods that provide more dietary fiber (a "nutrient of concern in American diets"). 3 Encouraging consumption of cranberry products can help achieve this goal: for example, a 1/2 cup of dried cranberries contains at least 10% of the daily value of dietary fiber.

Fruit itself is a preferred means of delivering health benefits of the nutrients they contain. According to the IOM, evolving understanding of plant foods (such as cranberries) highlights three key takeaways: first, plant foods are compositionally complex; second, the health benefits of plant foods appear closely related to their compositional complexity, not to their individual components; and third, the levels of vitamins and minerals in foods do not necessarily correlate well with the other classes of beneficial components!' As the DGAC has noted, "[fruits and vegetables] contain not only the essential vitamins and minerals that are often targeted in nutrient supplement pills, but also hundreds of naturally-occurring phytonutrients and other substances, including carotenoids, flavonoids, isoflavones, and protease inhibitors that may protect against cancer, heart disease, osteoporosis, and other chronic health conditions."' Critically, 10M stated: "These points reinforce the need for nutrition standards to look beyond the criteria of nutrient upper limits (for sugars, fat, saturated fat, etc.), and to place at least equal emphasis on the health benefits of fruits, vegetables, and whole grains."' By focusing only on curtailing "added sugar," without an accommodation that takes into account the positive impact that consumption of fruits like cranberries brings to the American diet, FDA would be making precisely the mistake that 10M has cautioned against.

2 Bhagwat, et al., USDA Database for the Flavonoid Content of Selected Foods, Release 3.0, 2011, US Dep't of Agric., Agricultural Research Service Nutrient Data Laboratory.

3 U.S. Dep't of Agric. & U.S. Dep't of Health and Human Servs. Dietary Guidelines for Americans, 2010. 7th Ed., Washington, DC: U.S. Government Printing Office, Dec. 2010, p. 34 ("2010 DGAC").

4 IOM (Institute of Medicine). 2007. Nutrition Standards for Foods in Schools: Leading the Way Toward Healthier Youth. Washington, DC: Nat'l Academies Press. at Box 2.1, p. 41.

5 2010 DGAC at Section 2, Part D, p. 125.

6 IOM, supra note 4.

of 16

FRUIT / SERVING SIZE (g )

TOTAL PHENOLS PER SERVING (ng)

CRANBERRI ES 1/2 cup (5S)

APPLE 1 ermdiurn (138)

CHERRIES 1/2 cup (72)

WATERMELON 1113 1 large wedge. 2 cups dived (226)

BLUEBERRIES IUI 1/2 cup (70)

BANANA 174 '- 1 medium) (126)

GREEN GRAPES 155 1 /2 cu p (1110)

ille)ii„

Ili 1 filliallIf71 (1 66) PF_AR

*a RED GRAPES 1/2 ..p 03o)

0 • 4114. ' Aft STRAWBERRIES

B medium (147)

M. 411.4.

(B) Cranberries Have Abundant Polyphenols, Including Unique Proanthocvanidins.

Research has shown that cranberry products have a wide range of positive nutritional benefits due to their high content of polyphenols, including their unique proanthocyanidins ("PACs"). PACs are a natural compound that reduces bacterial adhesion to cells, and may also positively impact immune health.' In fact, cranberries contain the highest amount of polyphenols and PACs among commonly consumed fruits. (See Table 1 and Table 2). 8

Table 1: Polyphenol content of commonly consumed fruits.

7 Nantz et al., Consumption of cranberry polyphenols enhances human y5-T cell proliferation and reduces the number of symptoms associated with colds and influenza: a randomized, placebo-controlled intervention study, Nutr J. 2013 Dec 13; 12:161; Pierre JF et al. Cranberry proanthocyanidins improve intestinal sIgA during elemental enteral nutrition, JPEN J Parenter Enteral Nutr. 2014 Jan, 38(1):107-14.

8 Table 1: Vinson, Su, Zubik, Bose, et al., Phenol antioxidant quantity and quality in foods: fruits, J. Agric. Food Chem., 2001 Nov, 49(11)5315-21; Table 2: Gu, et al., J. Nutr. 2004 Mar, 134(3):613-7.

of 16

Cranberry is #1 in PACs Among Common Fruits

i 11 md Plum Culivaled Seawbeey Red Green Red ReMbulY WebberlY

Iluebeny leyobery Delicious Grape &ape

APIde

Sauce: Jound ci Winn, 134: 613-617, 200k reseach =ducted by USDA

27.0

I.

Table 2: Proanthocyanidin content of commonly consumed fruits.

(C) 'Cranberries' PACs Positively Impacts Urinary Tract Health & May Help Reduce Antibiotic Use.

The unique PACs found in cranberry products provide significant health benefits in the areas of urinary tract health and antibiotic resistance. Bacterial adhesion to bladder cells is a factor in urinary tract infections ("UTIs"), which are considered a significant public health challenge in the United States. Urinary tract infections are the second most common bacterial infection that results in more than 9.7 million physician visits annually in this country. 9 The recurrence rate of UTIs in women is up to 30%, and in children, the prevalence rate is about 7%, with a recurrent rate of about 12-30%. Chronic UTIs are also a serious problem. 10 UTIs are recognized by WHO, and other bodies, as a significant public health challenge that should be addressed expeditiously due to their contribution to antibiotic resistance. n

Against this backdrop, it is critical to recognize that consuming cranberry products helps improve urinary tract health, and reduces the risk of UTIs, by causing the bacteria that result in UTIs to become unable to adhere to bladder cell walls. The positive impact cranberries have on urinary tract health extends to women who suffer from recurrent UTIs. 12 Results from three recent pediatric trials support that consumption of cranberry-

9 Medical Expenditure Panel Survey (MEPS), September 2012, Agency for Healthcare Res. and Quality, Rockville, MD, available at: htto://www.ahria.Rov/research/datameps/index.html.

10 . . Griebling, Urologic diseases in America project: trends in resource use for urinary tract infections in women, J. Urol. 2005 Apr; 173(4):1281-7; Greenhow, et al., The changing epidemiology of serious bacterial infections in young infants, Pediatr. Infect Dis. J. 2014 Jun, 33(6):595-9; Shim, et al., The risk factors of recurrent urinary tract infection in infants with normal urinary systems, Pediatr. Nephrol. 2009 Feb, 24(2):309-12; Nuutinen, et al., Recurrence and follow-up after urinary tract infection under the age of 1 year, Pediatr. Nephrol. 2001 Jan, 16(1):69-72.

11 Antimicrobial Resistance: Global report on surveillance 2014, World Health Organization, April 2014, available at: http://aDos.whoint/iris/bitstream/10665/112642/1/9789241564748 eng.oclf.

12 Wang, et al., Cranberry-containing products for prevention of urinary tract infections in susceptible populations: a systematic review and meta-analysis of randomized controlled trials, Arch Intern. Med., 2012 Jul 9, 172(13):988-96.

of 16

containing products protects against UTIs in among our nation's children.' 3 Recent consensus reports and peer reviewed articles by several global health researchers confirm that cranberries can be important as a nutritional approach to help maintain urinary tract health. 14 Facilitating the consumption of cranberry products capable of delivering the benefits of a healthy urinary tract should be encouraged wherever possible.

Prevention of UTIs via the improved urinary tract health associated with cranberry consumption also contributes positively to managing antibiotic resistance, which is likewise a public health concern, by helping to reduce antibiotic use. 15 A recent WHO Global Surveillance report on antimicrobial resistance recognized that very high rates of antibiotic resistance have been observed in bacteria that cause common community acquired infections associated with health-care and similar settings (e.g. urinary tract infection, pneumonia) in all WHO regions. 16 The high proportion of resistance reported for E. coil and K. pneumoniae to third generation cephalosporins, which are used to treat urinary tract and blood stream infections, means that treatment of severe infections that are likely to be caused by these bacteria must rely on carbapenems, the last-resort to treat severe community and hospital acquired infections. The Center for Disease Control published a similar antibiotic resistance report in July 2013, which noted that UTIs are the second most common infection leading to an antibiotic prescription in nursing homes, at nearly 33%. 17

Consumption of cranberry products may help overcome the emerging problems of antibiotic resistance. For example, FDA's own list of qualifying resistant pathogens of public health concern, which it promulgated just two months ago (June 5, 2014) includes Enterobacteriaceae (e.g., Klebsiella pneumoniae), Enterococcus species, and Helicobacter pylori among those pathogens that pose particular risk of antibiotic resistance.' 8 Importantly, these are pathogens that have been found to be impacted by cranberry compounds. 19 Thus, whereas treatment of UTIs with antibiotics has the potential to contribute to the problem of antibiotic resistance, maintenance of a healthy urinary tract through consuming cranberry products can mitigate growing resistance of those pathogens to antibiotics by reducing our population's reliance on those antibiotics used to treat UTIs.

13 Salo, et al., Cranberry juice for the prevention of recurrences of urinary tract infections in children: a randomized

placebo-controlled trial, Clin. Infect. Dis. 2012 Feb 1; 54(3):340-6; Afshar, et al., Cranberry juice for the prevention of pediatric urinary tract infection: a randomized controlled trial, J. Urol. 2012 Oct, 188(4 Suppl.):1584-7; Ferrara, et al., Cranberry juice for the prevention of recurrent urinary tract infections: a randomized controlled trial in children, Scand. J. Urol. Nephrol. 2009; 43(5):369-72.

14 Blumberg, et al., Cranberries and their bioactive constituents in human health, Adv. Nutr. 2013 Nov 6, 4(6):618-32; Gardner, The health properties of cranberry juice, Nutr. Bulletin, 2014, 39: 223-230.

15 Supra note 9.

16 WHO, supra note 11.

17 Benoit, et al., Factors Associated with Antimicrobial Use in Nursing Homes: A Multilevel Model, J. Am. Geriatr. Soc. 2008 Nov, 56(11):2039-44.

18 Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act, 79 FR 32464, 21 CFR Part 317, Docket No. FDA-2012-N-1037, June 5, 2014.

19 Gupta, et al., Inhibition of adherence of multi-drug resistant E. coli by proanthocyanidin, Urol. Res. 2012 Apr, 40(2):143- 50; Shmuely, et al., Cranberry components for the therapy of infectious disease, Curr. Opin. Biotech. 2012 Apr, 23(2):148- 52.

of 16

(D) Cranberries May Have the Capability to Improve Heart Health.

Emerging clinical research also supports the fact that cranberry polyphenols are important bioactives in the

diet for improving heart health, as reported by an international group of scientists! ° Recent clinical studies

completed at the USDA Human Nutrition Research Center and Oklahoma State University show that subjects

drinking one/two servings of a light cranberry juice beverage have significantly reduced C - reactive protein

and diastolic blood pressure in one study and reduced oxidized LDL in another!' In addition recent peer-

reviewed studies show that cranberry juice consumers are more likely to have normal weight and significantly

more likely to have lower waist-to-hip circumference and C-reactive protein, all important indicators of heart

health!'

CRANBERRIES HAVE LITTLE NATURAL SUGAR AND REQUIRE SWEETENING, WHICH DOES NOT DIMINISH THEIR MANY HEALTH BENEFITS

Unlike grapes, apples and oranges, cranberries are naturally low in sugar. Cranberries have a uniquely tart,

astringent and even unpalatable taste as shown by the sugar (brix)-to-acid ratio in Table 2 below. Due to the high brix/acid ratio of cranberries, some sugar is required for this particular fruit and fruit juice to be

considered palatable by most consumers. As such, consumers enjoy the benefits of cranberry products that

are sweetened to similar levels of naturally occurring sugar contained in comparable fruit juices and dried fruit products. (See Table 3 and Table 4).

20 Blumberg, et al., supra note 14.

21 Novotny, et al., Low Calorie Cranberry Juice Reduces Risk Factors of Cardiovascular Disease in Adults, Circulation, 2012,

126:21 Supplement A19732; Novotny, et al., Low Calorie Cranberry Juice Lowers Blood Pressure in Healthy Adults, Hypertension 2012, 60:3 Mtg Abstr. A299; Basu, et al., Low-energy cranberry juice decreases lipid oxidation and increases plasma antioxidant capacity in women with metabolic syndrome, Nutr Res. 2011 Mar, 31(3):190 - 6.

22 Duffey, et al., Adult cranberry beverage consumers have healthier macronutrient intakes and measures of body

composition compared to non-consumers: National Health and Nutrition Examination Survey (NHANES) 2005-2008, Nutrients, 2013 Dec 4; 5(12):4938-49.

of 16

120

100

:2 60

20

Grapefruit Cranberry Juice Juice

Lemon Juice

CJC Grape Juice

Apple Juice

Orange Juice

Table 3: Brix-to-acid ratios of common fruit juices. 23

The Proposed Rule's aim to reduce added sugar consumption is directed at limiting excess calories from added sugars, with the consumption of sugary beverages with empty calories as its primary target. However, adding a modest amount of sugar to cranberry products does not diminish the health benefits of the cranberry that those products deliver, as shown by the high polyphenol content of cranberry juice in comparison to other fruit juices. This is not only true for cranberry juice cocktail (See Table 4A), but also dried cranberries, which contain more polyphenols per serving than raisins (See Table 4B). In fact, a majority of peer-reviewed studies that the health benefits of cranberries referenced in this Comment were conducted using sweetened cranberry products.

Table 4A: Nutritional Profile of cranberry juice cocktail to comparable 100% Juices. 24

Juice Calories per 240 ml

% Calories from added sugar

Total Sugar (g) Polyphenols (uM)

Cranberry Juice Cocktail

110 88 28 81

100% apple 112 0 28 65

100% white grape 156 0 39 14

100% orange juice 90 0 22 20

23 Table 3 adapted from: Leahy, Roderick, Brilliant, et al., The Cranberry — Promising Health Benefits, Old and New, Nutr.

Today 2001 at 36(5):254-265 and Ocean Spray laboratory data. Note: "CJC" means cranberry juice cocktail.

24 Adapted from Mullen, et al., Evaluation of Phenolic Compounds in Commercial Fruit Juices and Fruit Drinks, J. Agric.

Food Chem. 2007,55 (8), p. 3148-3157; Vinson, et al., supra note 8.

of 16

Table 4B: Nutritional Profile of dried cranberries to comparable dried fruit.

Dried Fruit Calories per 40 g (1/4 cup)

% Calories from added sugar

Total Sugar (g) Fiber (g) Polyphenols (mg)

Dried Cranberries 130 92% 26-29 3 177

Raisins 130 0% 26-29 2

150

There is no question that cranberry products remain nutrient-rich even after sweetening. The DGAC

concluded in 2010 that the best use of added sugar is to increase the palatability of nutrient-dense foods. 25 As

FDA acknowledges in the Proposed Rule, "small amounts of added-sugars can increase the palatability of nutrient-dense foods," and that such foods are "appropriate in a balanced diet." 26 Sweetened cranberry

products achieve this goal.

FDA'S TREATMENT OF "ADDED SUGARS" IN THE PROPOSED RULE IS SCIENTIFICALLY AND FUNCTIONALLY FLAWED WITH REGARD TO CRANBERRY PRODUCTS

(A) The "Added Sugars" in Cranberry Products Are No Different from Naturally Occurring Sugars in

Other Fruit Products.

In its own commentary on the proposed rule, FDA acknowledges the broad scientific consensus with regard to sugar: there is no functional difference between "added" and "naturally occurring" sugars because "added

sugars are not chemically different from natural sugars." 27 The 2010 DGAC report notes that "the body's response to sugars does not depend on whether they are naturally present in food or added to foods." 28 That

same report found that randomized clinical trials show that added sugars are not different from other calories

in increasing energy intake or body weight. 29

Simply put, our bodies do not distinguish between naturally-occurring sugar and added sugar; both provide

energy at 4 kcal/g and the body's conversion of sugar to energy is indifferent with regard to the source of that sugar. Therefore, one type of sugar is not preferable to the other: when cranberry juice cocktail is sweetened

25 2010 DGAC, at p. 46.

26 Proposed Rule at 11905.

27 Id . (We continue to recognize the lack of a physiological distinction between added and naturally occurring sugars" and

noting no technologically feasible analytical method capable of distinguishing between natural occurring sugars and

added sugars).

28 2010 DGAC, at Ch. 3.

29 Id.

of 16

to contain the same volume of total sugar as apple juice, FDA should not treat the sugar in cranberry products differently. 3°

(B) The "Added Sugars" in Cranberry Products Do Not Negatively Impact Health.

We agree with and echo FDA's conclusion that the intake of "added sugars" does not relate to any chronic disease or health condition. 3 ' FDA correctly notes that:

"U.S. consensus reports have determined that inadequate evidence exists to support the direct contribution of added sugars to obesity or heart disease ... neither the 2010 DGA nor the IOM macronutrient report concluded that added sugars consumption from all dietary sources, in itself, increases obesity. In fact, the 2010 DGA states that added sugars do not contribute to weight gain more than any other source of calories." 32

The results of a large meta-analysis commissioned by the World Health Organization examined a link between "added sugar" and body weight and concluded that changes in body weight are due to excess calories and not due to added sugar. As quoted in the paper: "Among free living people involving ad libitum diets, intake of free sugars or sugar sweetened beverages is a determinant of body weight. The changes in body fatness that occurs with modifying intakes seems to be mediated via changes in energy intakes, since isoenergetic exchange of sugars with other carbohydrates was not associated with weight change." 33 Likewise, the Academy of Nutrition and Dietetics' Position Paper on the Total Diet Approach to Healthy Eating states:" It strengthens the position that the total dietary pattern should be emphasized, rather than an overly restrictive reliance on specific food components in a diet " 34

Consistent with this concept, consensus reports note it is not plausible to set a scientifically supported quantitative intake recommendation for "added sugars" from which to derive a Daily Recommend Value. For example, the IOM DRI Report on Energy states that data from the Third National Health and Nutrition Examination Survey shows the median intake of added sugars ranged widely from 10 to 30 tsp./day for adults, which is equivalent to 40 to 120 grams/day of sugars. 35 Based on data from CFSII, the mean intake of "added sugars" in the U.S. population aged two and older is 82 grams, accounting for 15.8 % of the total energy intake,

30 We are aware that other commenters have expressed concern that FDA may lack the statutory authority to treat

"added sugars" as distinct from endogenous sugars and require its appearance on the Nutrition Facts panel because "added sugars" is not a nutrient within the meaning of Section 403(q) of the Food Drug and Cosmetic Act. Because of the unique impact that the Proposed Rule may have as to nutritious cranberry products, we acknowledge and echo those concerns.


32 Id.

33 Morenga, et al., Dietary sugars and body weight: systematic review and meta-analyses of randomised controlled trials

and cohort studies, BMJ 2013, 345:e7492

34 Freeland-Graves, et al., Position of the academy of nutrition and dietetics: total diet approach to healthy eating, J. Acad. Nutr. Diet. 2013 Feb, 113(2):307-17.

35 Institute of Medicine (2005), Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), Washington, D.C., Nat'l Acad. Press.

of 16

while fats contribute about 20%. 36 Based on this information, the IOM determined that there is no clear association between increased intake of added sugars, like those included in cranberry products, and Body Mass Index, and concluded that this data "cannot be used to set an upper limit for either added or total sugars. pi 37

The USDA Food Patterns, which provide recommended amounts of foods from each food group that individuals should consume in order to meet their nutrient needs within a specific calorie level, specify that the maximum amount of calories from solid fats and added sugars that can be consumed at the 2,000 calorie level while staying within calorie limits is 258 calories. 38 The solid fats and added sugars limit at each calorie level in the USDA Food Patterns is determined by calculation through food pattern modeling rather than on any biomarker of risk of disease or other public health endpoint. Thus, FDA does not have a scientifically supported quantitative intake recommendation for added sugars, such as those included in cranberry products, on which a DRV for added sugars can be derived.

It follows that modest amounts of sugars added to cranberry products do not negatively impact the overall health benefits they deliver to consumers.

(C) FDA's Definition of "Added Sugars" Should Not Include "Fruit Juice From Concentrate"

Even with the exemption for cranberry products requested in this Comment, we believe the definition of "added sugars" proposed by FDA requires clarification, as it is overbroad in its treatment of fruit juice from concentrate. The proposed definition includes "naturally occurring sugars that are isolated from whole food and concentrated so that sugar is the primary component (e.g., fruit juice concentrates)." 39 This proposed definition could be read to expand the currently understood treatment of fruit juice from concentrate under FDA's "no added sugar" rule for nutrient content claims, as it would represent a departure from FDA's current treatment of fruit juice from concentrate. FDA made clear in its rule on nutrient content claims for "no sugar added" that "the addition of water to a juice concentrate to produce a single strength juice would not preclude the use of a `no sugar added' claim." 49

The proposed definition would require virtually all beverages that contain fruit juice concentrate — including juice from concentrate in 100% juice and juice drinks, as well as blends — to declare that the naturally occurring sugars in their product be listed as "added sugars." A 100% fruit juice made from concentrate, reformulated to its original single-strength brix, would see its "added sugars" value equivalent to its total sugars value, while that same fruit juice made from expressed fruit would have zero "added sugars." The result would be disparate treatment between two products with the same health benefits simply because they are produced through different methods.

36 Guthrie, et al., Food sources of added sweeteners in the diets of Americans, J. Am. Diet Assoc. 2000 Jan, 100(1):43-51 ("Guthrie").

37 id.

38 USDA Food Patterns, U.S. Dep't of Agric. Center for Nutr. Policy and Promotion, Sept. 2011.


4° Food Labeling: Nutrient Content Claims, Final Rule, 21 CFR Parts 5 and 101; Federal Register Vol. 58, No. 3, Jan. 6, 1993, at n. 91.

of 16

Moreover, there is no scientific or nutritional justification for this difference in treatment of expressed versus 'from concentrate' juice. When fruit juice is concentrated, its water content is evaporated, thereby concentrating the sugar solids and other nutrients in the expressed juice into a smaller volume. To make juice from concentrate, the process involves putting back in the exact amount of water taken out during concentrating, thereby restoring it to its single-strength brix level. There are no sugars at all in the reconstituted juice that do not come from the fruits themselves, and the juice is no different in sugar content than a like quantity of expressed juice. With regard to cranberry products, the unique health benefits delivered in fruit juice made from concentrate are still present because the phytonutrients are not lost when then juice is concentrate and reconstituted. There is simply no rational basis for FDA to compel an "added sugars" declaration on juice from concentrate in 100% juice and juice drinks, and similar blends, where it does not do so for the same beverage made from expressed juice.'"

FDA SHOULD CONSIDER THE UNINTENDED CONSEQUENCES OF ITS PROPOSED RULE AS APPLIED TO CRANBERRIES

We suggest that FDA has not fully considered the unintended consequences that the Proposed Rule will have on fruit products, such as cranberry, for which some sweetening is necessary for consumers to enjoy the products and include as part of their recommended fruit intake. We request that the Proposed Rule be revised to provide an appropriate exemption for qualified cranberry products because (1) the "added sugars" declaration is likely to increase consumer confusion regarding the healthfulness of cranberry products; and (2) the Proposed Rule will harm America's cranberry farmers.

(A) The "Added Sugars" Declaration Is Likely to Confuse Consumers With Regard to the Relative Health Benefits of Cranberry Products.

FDA's statutory authority to require the proposed "added sugars" declaration makes clear that FDA may require this information on the Nutrition Facts Panel (1) if the information will "assist consumers in maintaining healthy dietary practices;" 42 and (2) if the information will be "conveyed in a manner that enables the public to readily observe and comprehend the information and to understand its relative significance in the context of a total daily diet."43 The Proposed Rule fails that standard with respect to cranberry products: the presence of an "added sugars" line will not help the average consumer understand the relative health of cranberry products in their diet. Rather, it will mislead them to think such products are unhealthy, thereby discouraging consumption.

For example, an April 2014 consumer study demonstrates that an "added sugars" declaration leaves consumers more confused about the products they choose to consume." The study's authors found that using the current Nutrition Facts panel, only 5% of consumers inaccurately identified the amount of sugar in a cereal label, whereas, when "added sugar" was included on the label, their inaccurate responses increased to

41 An additional discrepancy in FDA's definition of "added sugars" warrants mention here: while FDA has chosen to

include "fruit juice concentrates" in its definition, it has not included vegetable juice concentrates, which likewise contain sugars. FDA's omission of vegetable juice concentrate demonstrates the inconsistent and somewhat arbitrary nature of the definition it has chosen.

42 Food Drug & Cosmetic Act (FD&C Act), 21 U.S.C. § 403(q)(1).

43 Id. at § 343 n.

44 Bertino M, et al., Added-sugar labeling: implications for consumers, FASEB J. April 2014, 28:630.11.

of 16

36%. Moreover, when presented with two labels and asked to pick the healthier option, over one-third chose a food with lower "added sugar," even though it contained higher calories, fat, and saturated fat.

These results are alarming, and make clear that consumers already wrongfully view "added sugars" as a warning symbol signifying that a food is inherently unhealthy. That belief is clearly incorrect with regard to cranberry products. With respect to cranberries, the Proposed Rule will foster the false conception that the "added sugars" in cranberry products make those products unhealthy, and will drive consumers away from receiving the unique health benefits cranberries deliver.

Moreover, the "added sugars" declaration does not meet the stated goal of the Proposed Rule, which is to convey "information necessary to meet [DGAC] recommendations to construct diets containing nutrient-dense foods."45 The proposed declaration fails in this regard because it does not convey any information that will allow a consumer to differentiate between a nutrient-dense and a non- nutrient-dense food. The Proposed Rule does not provide consumers with any means to differentiate between foods that will contribute phytonutrients to their diet (such as cranberry products), from foods with empty calories.

FDA's Proposed Rule does not mention any scientific evidence to support that the declaration of "added sugars" will lead to changes in food choices related to unhealthy food categories, without impacting other food categories that are recommended for consumption (i.e. fruits such as cranberries). FDA's stated goal is to provide consumers with information to help them "construct diets containing nutrient-dense foods," 46 however, the scientific community has not agreed upon any quantitative definition of "nutrient density," especially in the case of fruits and foods with bioactive food components like phytonutrients. The Dietary Guidelines 2010 definition of "nutrient-dense" states that nutrient-dense foods provide vitamins, minerals, and other substances that may have positive health effects, with relatively few calories. Cranberry products, juice beverages and dried fruits, have similar or lower calories and sugar, and similar or higher phytonutrients than other fruit products with endogenous sugar.

Without an exemption or accommodation for cranberry products, consumers may be misled into believing that cranberry products are not healthy, may ignore the fruit's unique contribution to their diet, thereby reducing delivery of cranberries' unique PACs and their associated health benefits that help address public health concerns.47 This result would be in direct contradiction to FDA's goals.


46 Id.

47 We understand that other commenters have voiced concern that the required "added sugars" declaration in the Proposed Rule runs afoul of the First Amendment rights of food manufacturers. We share this concern as it applies to cranberry products. While FDA's authority to regulate food labeling allows it to impose certain restrictions on speech, compelling the declaration of "added sugars" on the Nutrition Facts panel of cranberry products may fail First Amendment scrutiny because it does not directly respond to, nor materially alleviate, the problem of "decrease[d] intake of nutrient-rich foods in the diet," which is the harm identified by FDA. Edenfield v. Fane, 507 U.S. 761, 770-71 (1993) ("a governmental body seeking to sustain a restriction on commercial speech must demonstrate that the harms it recites are real and that its restriction will in fact alleviate them to a material degree"). FDA's goal is not served by the proposed restriction on speech in the labels of cranberry products because (i) those products are nutrient-rich, and (ii) consumers do not understand the meaning of "added sugars" in the context of a nutrient-rich cranberry product. Rather than encouraging them to take in nutrient-rich cranberries, the Proposed Rule is likely to have the opposite effect.

of 16

(B) The "Added Sugars" Declaration Will Have a Tangible Negative Economic Impact on America's Cranberry Farmers.

America's cranberry farmers will be an unintended casualty if the Proposed Rule is promulgated as written. Because they are the only fruit product that requires sweetening to be made palatable, cranberry products are put at a comparative disadvantage to other fruits, even though the total sugars and total calories of the

products are comparable to or less than fruit products with endogenous sugars.

Not only will consumers be less likely to consume cranberry products because of the misperception that "added sugars" render the products unhealthy, state and local governments looking to further discourage the consumption of nutrient-poor sugar-sweetened products may seek to implement taxes based on the level of

added sugars declared on a product's Nutrition Facts panel. Without an exemption here, cranberry products

would likely face such a tax. A tax imposed on cranberry products despite their many health benefits would exacerbate the unfair and unintended impact of the Proposed Rule on the cranberry industry and further

threaten the viability of cranberry growers and their farms.

America's cranberry farms have a long history in this country. They are predominantly comprised of small, multi-generational family farms that economically support small pockets of rural communities. Despite their typical small size, America's cranberry farms are economically important: a forthcoming independent study

concludes that between 2009 and 2012, the cranberry industry in the United States was responsible for an

annual average of $3.55 billion in value-added output, and for 11,610 full-time jobs. The Proposed Rule risks putting these farmers in economic peril by unfairly hurting sales of cranberry products made from their crops.48 It comes at a time when the industry is wrestling with a serious cranberry surplus that has severely depressed cranberry prices for many growers across the United States. If the Proposed Rule is promulgated without an accommodation for the cranberry products these farming families rely on, their continued viability

will be in severe jeopardy, and the economic impact may reverberate throughout their local rural communities.

USDA AND OTHERS HAVE GRANTED REGULATORY EXEMPTIONS FOR CRANBERRY PRODUCTS

An exemption to the proposed "added sugars" declaration for cranberry products is further supported by the fact that, during the current Presidential administration, other federal agencies, including USDA, have already

approved and promulgated similar exemptions on the same rationale.

For example, in June 2013, USDA promulgated new "Nutrition Standards for All Foods Sold in School" in

connection with its responsibilities for the National School Lunch Program and School Breakfast Program ("School Nutrition Standards"). 49 USDA's School Nutrition Standards establish guidelines for foods that may be

48 Cranberries are a predominately North American crop. In recent years, the U.S. cranberry industry has increasingly

relied on exports of its cranberries to international markets to grow demand. For example, Ocean Spray is the 2014 winner of the President's "E" Star Award, which is awarded by the U.S. Department of Commerce and is the highest

recognition a U.S. entity can receive for significant contributions to America's exports. Other commenters have expressed

concern that the Proposed Rule may run afoul of the United States' obligations under the WTO Agreement on Technical

Barriers to Trade (in particular, the obligation to ensure that "technical regulations do not create unnecessary obstacles to international trade ...."). See Comments from the Australian Government on the Government of the United States of America's "Food Labeling: Revision of the Nutrition and Supplement Facts Labels". As a leading exporter of America's cranberries, we echo those concerns and believe that FDA should consider whether the "added sugars" declaration poses

any technical barrier to trade that could harm the cranberry industry.

49 USDA Nutr. Standards at 39077, 39086.

of 16

sold as "competitive foods" in our nation's school cafeterias and vending machines before and after school, including a cap on the amount of sugar that may be in such products. Importantly, in its School Nutrition Standards, USDA recognized that cranberry products should be available to school children. The standard approved by USDA requires that food items have 35% or less of their weight derived from total sugars to be sold in schools, with a general restriction on foods with added sugars. However, USDA created a specific exemption to the standard:

"Dried whole fruits, or pieces, with nutritive sweeteners that are required for processing and/or palatability purposes (i.e. cranberries, tart cherries, or blueberries) are exempt from the sugar standard." 5°

In exempting dried cranberries from the School Nutrition Standards, USDA recognized that encouraging the consumption of this unique fruit, with all its attendant health benefits, would serve the public good. Concerns regarding sugar content should not outweigh the overall health profile of the food, and in recognizing this fact, USDA correctly determined that cranberry products should not be unfairly penalized simply because they require sugar to achieve palatability.

In further recognition of the health benefits of cranberry products, for the 2014 school year, USDA added dried cranberries to its "Foods Available List," making these products available to America's schoolchildren under the National School Lunch Program for the purposes of improving school nutrition. 51

In similar fashion, the European Union has recognized the need for special treatment of unique cranberries because they are low in endogenous sugar and require sweetening to overcome their tart and astringent taste. Council Directive 2001/112/EC of 20 December 2001, relating to fruit juices and certain similar products intended for human consumption (Annex IV) specifies a category of fruit nectar made from "fruits with acidic juice unpalatable in the natural state," including cranberries. 52 Pursuant to this EU Directive, for a product containing at least 30% cranberries (by volume of the finished product) may contain added sugar and still be labeled a "fruit nectar." This Directive by the EU appropriately recognizes that cranberries and other naturally tart, nutrient-dense fruits require sweetening for palatability so consumers can increase their recommended daily fruit intake and enjoy the many health benefits of the cranberry.

51 The continued availability of cranberry products under the National School Lunch Program and other federal food procurement programs may become a further unintended consequence of the Proposed Rule, as such programs could eventually face pressure to make policy changes requiring that they no longer purchase products containing "added sugars," even where those products — like the cranberry products at issue here — are nutritious ones that will benefit consumers.

52 Council Directive 2001/112/EC of 20 December 2001 at 61 and Annex 4.

of 16

FDA SHOULD ALLOW CERTAIN CRANBERRY PRODUCTS TO BE EXEMPTED FROM THE PROPOSED "ADDED SUGARS" DECLARATION

Cranberries are unique among commonly consumed fruits in that they must be sweetened in order for consumers to enjoy the health benefits that they deliver. Americans should be encouraged to consume

cranberry products that provide those health benefits — including benefits that address public health concerns such as preventing urinary tract infections, mitigating the problem of antibiotic resistance, and helping to

promote heart health — as part of their diets. Under the Proposed Rule, because of the public misconception that "added sugars" are different from endogenous sugars, cranberry products will be perceived as

"unhealthy," despite the fact that they are rich in polyphenols and unique cranberry PACs. Consequently, we believe the proposed "added sugars" declaration will result in the unintended and unfair consequence of

discouraging consumers from enjoying the health benefits of cranberry products.

For the reasons summarized here and detailed above, we respectfully request that if FDA includes an "added sugars" requirement on the Nutrition Facts panel in the final rule, it should allow a specific category of cranberry products that meet certain reasonable criteria to be exempt. We believe that a reasonable and appropriate exemption that is similar to the one that has already been adopted by USDA takes into account that cranberry products are unique in their need for sweetening to achieve palatability to deliver their health benefits.

The specific form of this exemption would apply only to cranberry juice products and dried cranberry products that have been sweetened to levels no greater than the levels of endogenous sugars found in comparable

products. We envision an accommodation on the label of these qualifying cranberry products that would allow for an asterisk in lieu of the added sugars declaration, and an accompanying phrase explaining to the

consumer that cranberry products must be sweetened to achieve palatability.

To be clear, while the two most widely consumed products in the industry — cranberry juice cocktails and dried

cranberries — with their associated health benefits, could qualify for the exemption, there are many industry products that we anticipate will fall outside of an appropriate exemption due to their specific formulation and

cranberry content. We are not asserting that these products (which constitute a majority of cranberry-

containing SKUs) should be entitled to an exemption from the added sugars declaration.

We are confident that such an exemption will not only guard against dissuading consumers from including

healthy cranberry products in their diets, but that it will fulfill FDA's mandate to "provide information regarding the nutritional value of [cranberry products] that will assist consumers in maintaining healthy dietary

practices." 53

Thank you in advance for your consideration of our concerns. Please do not hesitate to let us know if we can

provide any additional information on this important issue.

Sincerely, OCEAN SPRAY CRANBERRIES, INC.

0/7),

Randy C. Papadellis President & Chief Executive Officer

53 FD&C Act, at § 403(q)(1).

of 16

JUDY MCEACHERN 0.0 LBS LTR 508-946-7823 OCEAN SPRAY CRANBERRIES, INC. 1 OCEAN SPRAY DRIVE LAKEVILLE MA 02347

SHIP TO: THE HONORABLE MARGARET HAMBURG FOOD AND DRUG ADMINISTRATION DIVISION OF DOCKETS MANAGEMENT 5360 FISHERS LANE, ROOM 601

ROCKVILLE MD 20852

1 OF 1

..,....„.........., .,„ . ...,.. , ,...:,.$. ,. •„. • A • ....F .<4:• < . } <4 V. ..1.• • ••••

$:).. <::‘ • :.• i .• •1 t 1 • 'IAA. : • ' 17.71.:c ?4.%•

.:•• V 4 . • ...V .+ : .• . • . • :•. .* • ) / • • •. 1.

MI) 2 0 '7

1111111111

9 - '7 8

1111 UPS NEXT TRACKING #: 1Z 014

DAY AIR 608 01 9/84 6394 1

1 1 11 1 I I I 1 BILLING: P/P

Cost/Profit/Order#: 900169 GL Code #: 6311007

CS 16.5.32. WNT1E100 54.0A 07/2014 111,1

https:// ww

w.carn

pusship.ups.corn/cshi p/creat e?ActionO

ri ginPair=d

efault

701 1 '7‘ - regulations.gov

Documents