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`SHEEHAN & ASSOCIATES, P.C.
`Spencer Sheehan
`505 Northern Blvd., Suite 311
`Great Neck, NY 11021
`Telephone: (516) 303-0552
`Facsimile: (516) 234-7800
`spencer@spencersheehan.com
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`-and-
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`REESE LLP
`Michael R. Reese
`100 West 93rd Street, 16th Floor
`New York, NY 10025
`Telephone: (212) 643-0500
`Facsimile: (212) 253-4272
`mreese@reesellp.com
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`United States District Court
`Southern District of New York
`
`Quincy Steele Jimmy Arriola, individually
`and on behalf of all others similarly situated,
`
`1:19-cv-09227
`
`Plaintiffs
`
`
`Class Action Complaint
`
`- against -
`
`Wegmans Food Markets, Inc.,
`
`Defendant
`
`
`
`Plaintiff by attorneys alleges upon information and belief, except for allegations pertaining
`
`to plaintiff, which are based on personal knowledge:
`
`1. Wegmans Food Markets, Inc. (“defendant”) manufactures, distributes, markets,
`
`labels and sells ice cream products purporting to contain vanilla ice cream under the Wegmans
`
`brand (“Products”).
`
`2.
`
`The Products are available to consumers from defendant’s approximately 90 stores
`
`in states from Virginia to Massachusetts, and directly from defendant’s website.
`
`1
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 2 of 41
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`3.
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`The Products are sold in containers of 1.5 quarts and 1.0 pints cartons and represented
`
`as containing vanilla ice cream on the labels, in point-of-sale marketing, store display ads and print
`
`circulars and promotions, websites, television and/or radio ads.
`
`4.
`
`The Products include approximately eighty (80) flavors across three (3) distinct
`
`Product Lines – Regular, Premium and Organic.
`
`5. Within the Regular Product Line, defendant sells standard 10% milkfat ice cream
`
`and versions of ice cream modified by express nutrient content claims.
`
`6. No fewer than twenty-two (22), or 27.5%, of the Products purport to contain types
`
`of vanilla ice cream, some of which are indicated below.1
`
`Product Name
`
`Statement of Identity
`
`Product Line
`
`Chocolate Chip
`
`Cookies & Cream
`
`Vanilla Ice Cream with Chocolate
`Flakes
`
`Vanilla Ice Cream with Chocolate
`Flavored Crème Filled Cookie Pieces
`
`French Vanilla
`
`French Vanilla
`
`Lactose Free* Vanilla
`
`Lactose Free* Vanilla Ice Cream
`
`Regular
`
`Regular
`
`Regular
`
`Regular
`
`Light* Cappuccino Chip
`
`Coffee Ice Cream with Vanilla Swirls &
`Mocha Chips
`
`Regular; Light
`
`Light* Cookies & Cream
`
`Vanilla Ice Cream with Cookie Pieces
`
`Regular; Light
`
`Light* French Vanilla
`
`Light* French Vanilla Ice Cream
`
`Regular; Light
`
`Light* Peanut Butter Swirl
`
`Light* Pecan Praline
`
`Light* Raspberry Truffle
`
`Vanilla Ice Cream with Real Peanut
`Butter Swirls
`
`Vanilla Ice Cream with Ribbons of
`Caramel & Praline Pecan Pieces
`
`Vanilla Ice Cream with Ribbons of
`Natural Raspberry & Chocolate
`Flavored Flakes
`
`Regular; Light
`
`Regular; Light
`
`Regular; Light
`
`Light* Vanilla
`
`Light* Vanilla Ice Cream
`
`Regular; Light
`
`
`1 21 C.F.R. § 135.110(f)(6) (applying identical labeling for vanilla ice cream when combined with other flavors, i.e.,
`Neapolitan).
`
`2
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`
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 3 of 41
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`Neapolitan
`
`Chocolate, Strawberry and Vanilla Ice
`Creams.
`
`Regular
`
`No Sugar Added Vanilla Light
`
`Vanilla Light Ice Cream
`
`Regular; Light; No
`Sugar Added
`
`Nutter Batter Premium
`
`Peanut Chocolate Stampede
`
`Root Beer Float
`
`Scrapin’ the Bowl
`
`Vanilla
`
`Vanilla
`
`Vanilla Ice Cream with Peanut Butter
`Dough, Caramel & Peanut Butter Swirls
`
`Vanilla Ice Cream with Peanut Butter &
`Fudge Swirls, Fudge Covered Peanuts,
`Fudge Covered Pretzels & Praline
`Peanuts
`
`Vanilla Ice Cream with Root Beer
`Flavored Swirls
`
`Vanilla & Chocolate Swirled Ice Cream
`with Chunks of Cookie Dough &
`Brownie Dough Pieces
`
`Premium
`
`Regular
`
`Regular
`
`Premium
`
`Vanilla Ice Cream
`
`Organic; Premium
`
`Vanilla Ice Cream
`
`Premium
`
`Vanilla & Chocolate Twist
`
`Chocolate Ice Cream Swirled with
`Vanilla Ice Cream
`
`Organic; Premium
`
`Vanilla and Chocolate
`
`Vanilla and Chocolate Ice Cream
`
`Vanilla Orange
`
`Vanilla Ice Cream Swirled with Orange
`Sherbet
`
`Regular
`
`Regular
`
`I. Ice Cream Products
`
`7.
`
`8.
`
`Ice cream is a year-round treat enjoyed by 96% of Americans.2
`
`Its popularity is attributed “to the perfect combination of elements – sugar, fat, frozen
`
`water, and air – that make up the mouthwatering concoction.”3
`
`9.
`
`Ice cream is defined by a minimum of 10 percent milkfat, weighing no less than 4.5
`
`pounds to the gallon and containing less than 1.4 % egg yolk solids.4
`
`
`2 Arwa Mahdawi, The big scoop: America's favorite ice-cream flavor, revealed, The Guardian, July 11, 2018
`3 Vox Creative, The Reason You Love Ice Cream So Much Is Simple: Science, Eater.com, October 12, 2017.
`4 21 C.F.R. § 135.110(a)(2) (“Ice cream and frozen custard.”).
`
`3
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`
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 4 of 41
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`10. When ice cream has 1.4% or more egg yolk solids as part of its base, it is referred to
`
`as “french ice cream.”5
`
`11. According to ice cream lore, Thomas Jefferson may have discovered vanilla ice
`
`cream when a bottle of vanilla extract accidentally spilled into the frozen milk and cream dessert
`
`he was preparing during the summer he wrote our Constitution.6
`
`II. Vanilla is Perennial Favorite Ice Cream Flavor
`
`12. Vanilla is the consistent number one flavor for 28% of consumers, confirmed two
`
`groups who would know – the International Dairy Foods Association (IDFA) (ice cream
`
`producers) and National Ice Cream Retailers Association (ice cream parlors).
`
`13. The reasons for vanilla’s staying power are “not only because it is creamy and
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`delicious, but also because of its ability to enhance so many other desserts and treats.”7
`
`14. By some estimates, approximately two-thirds of “all ice cream eaten is either vanilla
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`or vanilla with something stirred into it, like chocolate chips.”8
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`15. The applications of vanilla ice cream include its centerpiece between chocolate
`
`wafers (“sandwich”), enrobed in chocolate on a stick (“bar”), topping a warm slice of fresh-baked
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`pie (“à la Mode”), drizzled with hot fudge and sprinkled with crushed nuts and topped by a
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`maraschino cherry (“sundae”) or dunked in a cold frothy glass of root beer (“float”).9
`
`
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`5 21 C.F.R. § 135.110(f)(1).
`6 Thomas Jefferson’s Handwritten Vanilla Ice Cream Recipe, Open Culture, July 13, 2014; Thomas Jefferson’s Vanilla
`Ice Cream, Taste of Home, June-July 2012; Thomas Jefferson’s Original Vanilla Ice Cream Recipe, Jefferson Papers,
`Library of Congress; Anna Berkes, “Ice Cream” in Thomas Jefferson Encyclopedia, Thomas Jefferson Foundation,
`Inc., Monticello.org, June 28, 2013
`7Press Release, IDFA, Vanilla Reigns Supreme; Chocolate Flavors Dominate in Top Five Ice Cream Favorites Among
`Americans, July 1, 2018
`8Bill Daley (the other one), Which vanilla ice cream is the cream of the crop? We taste test 12 top brands, Chicago
`Tribune, July 18, 2018
`9 The True Wonders of Vanilla Ice Cream, FrozenDessertSupplies.com.
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`4
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 5 of 41
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`III. Vanilla is Constantly Subject to Efforts at Imitation Due to High Demand
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`16. The tropical orchid commonly known as “vanilla” does not develop its prized flavor
`
`on its own.
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`17. By law, vanilla refers to the “the total sapid and odorous principles extractable from
`
`one-unit weight of vanilla beans.”10
`
`18. Shortly after the passage of the Pure Food and Drugs Act of 1906, E. M. Chace,
`
`Assistant Chief of the Foods Division of the U.S. Department of Agriculture’s Bureau of
`
`Chemistry, noted “There is at least three times as much vanilla consumed [in the United States] as
`
`all other flavors together.”11
`
`19. This demand could not be met by the natural sources of vanilla, leading
`
`manufacturers to devise methods to imitate vanilla’s flavor and appearance.
`
`20. Though the Pure Food and Drugs Act was enacted to “protect consumer health and
`
`prevent commercial fraud,” this was but one episode in the perpetual struggle against those who
`
`have sought profit through sale of imitation and lower quality commodities, dressed up as the
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`genuine articles.12
`
`21. Daily headlines tell a story of a “resurgent” global threat of “food fraud” – from olive
`
`oil made from cottonseeds to the horsemeat scandal in the European Union.13
`
`
`
`10 21 C.F.R. §169.3(c)
`11 E. M. Chace, “The Manufacture of Flavoring Extracts,” Yearbook of the United States Department of Agriculture
`1908 (Washington, DC: Government Printing Office, 1909) pp.333–42, 333 quoted in Nadia Berenstein, "Making a
`global sensation: Vanilla flavor, synthetic chemistry, and the meanings of purity," History of Science 54.4 (2016):
`399-424 at 399.
`12 Berenstein, 412; some of the earliest recorded examples of food fraud include unscrupulous Roman merchants who
`sweetened wine with lead.
`13 Jenny Eagle, ‘Today’s complex, fragmented, global food supply chains have led to an increase in food fraud’,
`FoodNavigator.com, Feb. 20, 2019; M. Dourado et al., Do we really know what’s in our plate?. Annals of Medicine,
`51(sup1), 179-179 (May 2019); Aline Wisniewski et al., "How to tackle food fraud in official food control authorities
`in Germany." Journal of Consumer Protection and Food Safety: 1-10. June 11, 2019.
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`5
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 6 of 41
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`22. While “food fraud” has no agreed-upon definition, its typologies encompass an ever-
`
`expanding, often overlapping range of techniques with one common goal: giving consumers less
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`than what they bargained for.
`
`23. Vanilla is considered a “high-risk [for food fraud] product because of the multiple
`
`market impact factors such as natural disasters in the source regions, unstable production, wide
`
`variability of quality and value of vanilla flavorings,” second only to saffron in price.14
`
`24. The efforts at imitating vanilla offers a lens to the types of food fraud regularly
`
`employed across the spectrum of valuable commodities.15
`
`Type of Food Fraud
`
`Application to Vanilla
`
`➢ Cheating on analytical tests
`
`• Manipulation of the carbon isotope ratios to
`
`by containing markers
`
`produce synthetic vanillin with similar carbon
`
`specifically tested for
`
`isotope composition to natural vanilla
`
`➢ Cheating by giving
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`• Ground vanilla beans and/or seeds to provide visual
`
`consumers the impression
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`appeal as “specks” so consumer thinks they are a
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`the food or ingredient is
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`result of the product containing real vanilla bean,
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`present in greater amounts
`
`when the ground beans have been exhausted of
`
`and/or higher quality form
`
`flavor, and any vanilla flavor tasted may not even
`
`than it actually contains
`
`be due to the presence of real vanilla
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`➢ Substitution or Replacement
`
`• Tonka beans, which are banned from entry to the
`
`a food product/ingredient
`
`United States, instead of vanilla beans
`
`with an alternate food
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`• Coumarin, phytochemical found in Tonka beans, to
`
`product/ingredient of lower
`
`increase the vanilla flavor perception
`
`quality
`
`➢ Coloring agents to produce a
`
`• Caramel
`
`in vanilla extracts
`
`to darken
`
`the
`
`
`14 Société Générale de Surveillance SA, (“SGS “), Authenticity Testing of Vanilla Flavors – Alignment Between
`Source Material, Claims and Regulation, May 2019.
`15 Kathleen Wybourn, DNV GL, Understanding Food Fraud and Mitigation Strategies, PowerPoint Presentation, Mar.
`16, 2016.
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`6
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 7 of 41
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`more attractive color
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`substance’s color additives like caramel to enhance
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`the hue of an imitation vanilla so it more closely
`
`resembles real vanilla16
`
`• Annatto and turmeric in dairy products purporting
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`to be flavored with vanilla, to darken the color to
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`better resemble the hue of rich, yellow butter
`
`➢ Addition of less expensive
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`• Synthetically produced ethyl vanillin, derived from
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`substitute ingredient to
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`wood pulp, tree bark or coal tar
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`mimic flavor of more
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`valuable component
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`➢ Ingredient list deception17
`
`• Subtle, yet deliberate misidentification and
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`obfuscation of a product’s components and
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`qualities as they appear on the ingredient list –
`
`“ground vanilla beans” as containing actual vanilla
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`flavor when they are devoid of any naturally
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`occurring vanilla flavor
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`• “Vanilla With Other Natural Flavor” sold by flavor
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`suppliers to manufacturers, which contains vanillin
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`as part of the “WONF,” in violation of vanilla-
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`vanillin regulations; manufacturers then deceive
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`consumers by labeling ingredient “natural flavor”
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`➢ Diluting/Extending
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`• Combination with flavoring substances such as
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`propenyl guaethol (“Vanitrope”), a “flavoring agent
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`[, also] unconnected to vanilla beans or vanillin, but
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`unmistakably producing the sensation of vanilla”18
`
`
`16 Renée Johnson, “Food fraud and economically motivated adulteration of food and food ingredients." Congressional
`Research Service R43358, January 10, 2014.
`17 Recent example of this would be “evaporated cane juice” as a more healthful sounding term to consumers to identify
`sugar
`18 Berenstein, 423.
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`7
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 8 of 41
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`• “Spiking” or “fortification” of vanilla through
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`addition of natural flavors including vanillin, which
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`simulates vanilla taste but obtained from tree bark
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`➢ Compounding – “to mix
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`• “Flavor Compounding Is a Skilled Art and Science
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`flavor materials together at
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`Designed to Produce a Flavor Perception That
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`a special ratio in which
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`Seems to be Authentic or at Least Derived from a
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`they [sic] compliment each
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`Natural Source”20
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`other to give the desirable
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`• 2018: According to the head of “taste solutions” at
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`aroma and taste.”19
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`global conglomerate Kerry, “The challenge is to
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`find a vanilla flavor that matches the taste of pure
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`vanilla natural extracts.”21
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`• The solution? “[G]et creative” and “build a
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`compounded vanilla flavor with other natural
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`flavors,” Mr. Curtis said. “This solution can provide
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`the same vanilla taste expectation while requiring a
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`smaller quantity of vanilla beans. The result is a
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`greater consistency in pricing, availability and
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`quality.”
`
`• 1911: The “public should clearly understand” that
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`flavor combinations
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`such as “vanilla and
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`vanillin…vanilla flavor compound,” etc., are not
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`“vanilla
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`[extract] no matter what claims,
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`explanations or formulas are given on the label.”22
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`IV. What Consumers Expect from Ice Cream Labeling
`
`25. To prevent deception of consumers, the labeling of ice cream is divided into three
`
`
`19 Chee-Teck Tan, "Physical Chemistry in Flavor Products Preparation: An Overview" in Flavor Technology, ACS
`Symposium Series, Vol. 610 1995. 1-17.
`20 Charles Zapsalis et al., Food chemistry and nutritional biochemistry. Wiley, 1985, p. 611.
`21 Donna Berry, Understanding the limitations of natural flavors, BakingBusiness.com, Jan. 16, 2018.
`22 Kansas State Board of Health, Bulletin, Vol. 7, 1911, p. 168.
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`8
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 9 of 41
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`categories which differ based on factors including (1) the source(s) of the characterizing flavor,
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`(2) the flavor which predominates, (3) the amount of each flavor component and (4) the percent of
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`the total flavor component represented by a flavor component.23
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`26. For ice cream, any flavor not derived from the characterizing flavor is considered an
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`artificial flavor.
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`A. Category 1 Ice Cream Products
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`27. For decades, consumers have expected products containing vanilla ice cream to be
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`exclusively flavored by real vanilla derived from the vanilla plant and contain a sufficient amount
`
`of vanilla to characterize the food.
`
`28. This requirement is contained at 21 C.F.R. §135.110(f)(2)(i), which states that where
`
`an ice cream contains no artificial flavor, the name on the principal display panel or panels of the
`
`label shall be accompanied by the common or usual name of the characterizing flavor, e.g.,
`
`“vanilla,” in letters not less than one-half the height of the letters used in the words “ice cream.”
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`29. Because ice cream is a standardized food and the vanilla ingredients are subject to
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`their own standards, the designation of the vanilla flavoring is controlled by 21 U.S.C. §343(g):
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`A food shall be deemed to be misbranded –
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`(g) Representation as to definition and standard of identity
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`If it purports to be or is represented as a food for which a definition and standard of
`identity has been prescribed by regulations as provided by section 341 of this title,
`unless (1) it conforms to such definition and standard, and (2) its label bears the
`name of the food specified in the definition and standard, and, insofar as may be
`required by such regulations, the common names of optional ingredients (other than
`spices, flavoring, and coloring) present in such food.
`
`30. This means that where an ice cream characterized by a vanilla and does not contain
`
`
`23 21 C.F.R. § 135.110(f)(2)(i)-(iii); 21 C.F.R. § 135.110(f)(3)-(5).
`
`9
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 10 of 41
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`artificial flavor, its ingredient list is required to bear “the common names of optional ingredients
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`(other than spices, flavoring, and coloring) present in such food.”24
`
`31. For vanilla ice cream, the common names of the flavorings include Vanilla Extract,
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`Concentrated Vanilla Extract, Vanilla Flavoring and Concentrated Vanilla Flavoring, specified in
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`the regulations for vanilla ingredients. See 21 C.F.R. §§ 169.175 to 169.178.
`
`B. Category 2 Ice Cream
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`32.
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`If an ice cream contains a natural characterizing flavor (i.e., vanilla) and an artificial
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`flavor simulating it, and if the natural flavor predominates, a non-misleading label would be
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`expressed in the following form:
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`[“characterizing flavor”] + [“flavored”] + [“ice cream”] → “Vanilla Flavored Ice
`Cream” or “Peach Flavored Ice Cream.”25 (“Category 2”).
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`33. Under these assumptions, 21 C.F.R. §135.110(f)(2)(ii) is applicable:
`
`C. Category 3 Ice Cream
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`34.
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`If an ice cream contains a natural characterizing flavor and an artificial flavor
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`simulating it, and if the artificial flavor predominates, or if only artificial flavor is used, a non-
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`misleading label would be expressed in the following form:
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`[“artificial” or “artificially flavored”] + [“characterizing flavor”] + [“ice cream”]
`→ “Artificially Flavored Vanilla Ice Cream” or “Artificially Flavored Strawberry
`Ice Cream.”26 (“Category 3”).
`
`V. The Vanilla Ice Creams or Products Containing Vanilla Ice Cream Varieties are Misleading
`
`35. The Products’ principal display panels all indicate they contain vanilla ice cream as
`
`
`24 21 U.S.C. § 343(g)(2) read with 21 C.F.R. § 135.110(f)(2)(i) and 21 C.F.R. §§ 169.175 – 169.178.
`25 21 C.F.R. § 135.110(f)(2)(ii).
`26 21 C.F.R. § 135.110(f)(2)(iii).
`
`10
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 11 of 41
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`part of their product name or statement of identity.
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`36. The representations of the “vanilla” in the name “vanilla ice cream” are unqualified
`
`and the labels and packaging do not disclose the addition of non-vanilla flavors as part of vanilla
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`ice cream.
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`37. The Regular and/or Premium Vanilla Ice Cream Products are misleading because
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`they do not contain the amount, type and percentage of vanilla as a component of the flavoring in
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`the product which is required and consistent with consumer expectations.
`
`A. Ingredient Lists Reveal Products Contain Flavoring Not from Vanilla
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`38. The front label statements of “vanilla ice cream” are understood by consumers to
`
`identify a product where the characterizing flavor is vanilla and supplied to the Products only from
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`the vanilla plant.
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`39. The Products’ vanilla ice cream is not flavored only by vanilla but contains flavors
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`derived from non-vanilla sources, which is misleading to consumers.
`
`40. This is revealed through the ingredient lists indicating the Products contain “natural
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`flavors” as indicated in the sections below corresponding to the different product lines.
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`41. The Products’ flavor components are identical across the Products purporting to be
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`vanilla ice cream varieties.
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`VI. Regular Products’ Representations are Misleading
`
`42. For the purpose of this section, “Regular” will exclude those Products in the Regular
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`Product Line that are modified by an express nutrient content claim.
`
`43. The Regular Products give consumers the impression that vanilla is the sole flavor
`
`source due to one or more of the statements or representations on the front label.
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`11
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 12 of 41
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`• “vanilla ice cream” as part of the statement of identity;27
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`• “No Artificial Colors, Flavors or Preservatives;”
`
`• Scoops of ice cream which have orange and/or yellow hue.
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`
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`44. The above Vanilla Ice Cream Product is also misleading because the front label states
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`“Made with Milk, Cream and Natural Vanilla Flavor.”
`
`45. The Product’s ingredient list discloses the presence of “Natural Flavor,” which
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`means that the “Natural Vanilla Flavor” is part of the “Natural Flavor.”
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`46. Consumers are misled by a material omission – failing to disclose that the flavoring
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`component is not only comprised of “Natural Vanilla Flavor.
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`47. The Premium Products contain a vignette of the vanilla flower.
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`27 Category I.
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`12
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`
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`48. The Regular and Premium Products are not flavored only by vanilla but contain
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`flavors derived from non-vanilla sources, which is misleading to consumers.
`
`49. This is revealed through the ingredient lists indicating the Regular and Premium
`
`Products contain “Natural Flavor” for the Vanilla Ice Cream and Organic Vanilla Ice Cream,
`
`below.28
`
`Front Label
`
`Ingredient List
`
`Ingredients: Milk, Cream, Corn Syrup,
`Liquid Sugar, Skim Milk, Buttermilk,
`Milkfat, Whey, Natural Flavor, Mono- and
`Diglycerides, Guar Gum, Cellulose Gum,
`Carrageenan, Dextrose, Annatto (color).
`
`
`
`
`28 The flavor is listed as “Natural Flavor” for all varieties of Regular and Premium items purporting to contain vanilla
`ice cream.
`
`13
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 14 of 41
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`Ingredients: Organic Cream, Organic Skim
`Milk, Organic Sugar, Organic Egg Yolks,
`Natural Flavor.
`
`
`
`
`
`50. The Products contain “Natural Flavor” as the flavoring ingredient.
`
`51. “Natural Flavor” means the Products contain flavor not derived from vanilla beans,
`
`which is inconsistent with an ice cream flavor represented by an unqualified “Vanilla.”29
`
`VII. Products Labeled as or with Vanilla Ice Cream Modified by Express Nutrient Content Claims30
`
`A. Differences between Standard Vanilla Ice Cream and Version Modified by Express
`
`Nutrient Content Claims
`
`i. Allowance Made for Variations in Fat, Sugar and Calories in Ice Cream
`
`52. Until the early 1990s, any product with “ice cream” (or a standardized food) in its
`
`name had to meet requirements set in its standards of identity which required a dairy product with
`
`“not less than 10 percent milkfat, nor less than 10 percent nonfat milk solids.”31
`
`53. Around this time, express nutrient content claims were introduced, which meant
`
`29 21 C.F.R. § 135.110(f)(2)(ii).
`30 21 CFR § 130.10 – Requirements for foods named by use of a nutrient content claim and a standardized term.
`31 21 C.F.R. § 135.110(a)(2).
`
`
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`14
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 15 of 41
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`companies could make “direct statement[s] about the level (or range) of a nutrient in a food, e.g.,
`
`‘low sodium’ or ‘contains 100 calories,’” milkfat or sugar.32
`
`54.
`
`In all other respects, the product has to maintain conformity to the standard so
`
`consumers will not expect a product to taste and/or perform in a certain way when that product
`
`departs in significant and/or material ways from what they are accustomed to receiving.
`
`55. For example, instead of requiring ice cream to have 10% milkfat, “lowfat ice cream”
`
`could contain a maximum of 3 grams of total fat per serving (½ cup) and “nonfat ice cream” could
`
`contain less than 0.5 grams of total fat per serving.33
`
`56. The following table contains variations of ice cream with express nutrient content
`
`claims.
`
`Nutrient Content Claim + Ice Cream34
`
`Difference between Modified
`and Standardized Ice Cream
`
`Reduced Fat Ice Cream
`
`product35
`
`• 25% less fat than a reference
`
`Light Ice Cream
`
`No Sugar Added Ice Cream
`
`Low Fat Ice Cream
`
`• 50% reduction in total fat
`from the reference product, or one-third
`reduction in calories if fewer than 50% of the
`calories are from fat36
`
`• No amount of sugars or
`ingredient that contains sugars is added during
`processing or packaging;
`• The food does not contain an
`ingredient containing added sugars37
`
`• Not more than 3 g of total fat
`
`per serving38
`
`
`
`32 21 C.F.R. § 101.13(b)(1).
`33 21 21 C.F.R. § 130.10(a).
`34 21 C.F.R. § 130.10(e) (“Nomenclature. The name of a substitute food that complies with all parts of this regulation
`is the appropriate expressed nutrient content claim and the applicable standardized term.”)
`35 21 C.F.R. § 101.62(b)(4)
`36 21 C.F.R. § 101.56
`37 21 C.F.R. § 101.60(c)(2)
`38 21 C.F.R. § 101.62(b)(2)
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`15
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 16 of 41
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`Nonfat or Fat Free Ice Cream
`
`serving39
`
`• Less than 0.5 g of fat per
`
`ii.
`
`Performance Characteristics
`
`57. Modified versions of standardized foods were permitted to deviate from the standard
`
`with respect to performance characteristics like moisture content, food solids content requirements,
`
`or processing conditions.
`
`iii.
`
`Ingredient Deviations
`
`58.
`
`In modified foods, the ingredients were required to be those permitted by the
`
`particular standard, subject to certain exceptions.40
`
`59.
`
`If an ingredient or component was specifically required by the standard, it could not
`
`be replaced or exchanged with a similar ingredient from another source unless the standard allows
`
`it, i.e., vegetable oil shall not replace milkfat in light sour cream).41
`
`60.
`
`If a standard prohibited an ingredient, that ingredient could not be added in a
`
`modified version of the food.42
`
`61. All ingredients required by a standard have to still be present in a significant amount
`
`in a modified version of the food, viz, at least that amount that is required to achieve the technical
`
`effect of that ingredient in the food.43
`
`B. The Products’ Representations are Misleading
`
`62. The Products represented as Modified Versions of the Standardized Vanilla Ice
`
`
`
`39 21 C.F.R. § 101.62(b)(1)
`40 21 C.F.R. § 130.10(d)(1).
`41 21 C.F.R. § 130.10(d)(2).
`42 21 C.F.R. § 130.10(d)(3).
`43 21 C.F.R. § 130.10(d)(4).
`
`16
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 17 of 41
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`Creams are misleading
`
`63. Two examples of Modified Ice Cream Products are represented below, the Light
`
`Vanilla Ice Cream No Sugar Added Light Vanilla Ice Cream.
`
`Front Label
`
`Ingredient List
`
`Ingredients: Milk, Skim Milk,
`Buttermilk, Corn Syrup, Liquid
`Sugar, Cream, Microcrystalline
`Cellulose (Celluslose Gel), Mono-
`and Diglycerides, Cellulose Gum,
`Guar Gum, Locust Bean Gum,
`Carrageenan,
`Maltodextrin,
`Milkfat, Whey, Natural Flavor,
`Dextrose, Annatto (color), Vitamin
`A Palmitate.
`
`Ingredients: Milk, Skim Milk,
`Buttermilk, Erythritol, Maltodextri,
`Cream, Mono- and Diglycerides,
`Cellulose Gel, Cellulose Gum,
`Locust Bean Gum, Carrageenan,
`Natural Flavor, Annatto (color),
`Rebaudioside A (Stevia Extract),
`Vitamin A Palmitate, Vitamin D.
`
`
`
`
`
`64. The Products contain “Natural Flavor” as the flavoring ingredient.
`
`65.
`
` “Natural Flavor” means the Products contain flavor not derived from vanilla beans,
`
`which is inconsistent with an ice cream flavor represented by an unqualified “Vanilla.”44
`
`66. Vanilla ice cream modified by an express nutrient content claim requires that the
`
`44 21 C.F.R. § 135.110(f)(2)(ii).
`
`
`
`17
`
`
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 18 of 41
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`flavor is derived exclusively from the characterizing flavor, vanilla, and in sufficient amounts to
`
`characterize the product – it is a required ingredient in a Category 1 vanilla ice cream.
`
`67. The standard for vanilla ice cream does not permit the Products to replace or
`
`substitute the flavors obtained from a non-vanilla source for flavors obtained from the vanilla plant,
`
`i.e., vanilla flavoring or vanilla extract. See 21 C.F.R. § 130.10(d)(2).45
`
`68. Vanilla ice cream modified by express nutrient content claim does not permit non-
`
`vanilla bean derived flavors in a Category 1 vanilla ice cream where there is an unqualified
`
`representation the food is flavored by the characterizing flavor. See 21 C.F.R. § 130.10(d)(3).46
`
`69. The prohibited ingredient or ingredient component in the Products is the non-vanilla
`
`part of the “Natural Flavor.”
`
`70. Because “Natural Flavor” is not permitted by the standard, it is by definition used in
`
`excess of levels provided for by the standard.
`
`71. Even if “Natural Flavor” was permitted in a Category 1 vanilla ice cream, the
`
`Products’ labels would still be misleading because the ingredient lists do not identify the “Natural
`
`Flavors” with an asterisk, such as “*Ingredient(s) not in regular vanilla light ice cream” or
`
`“*Ingredient(s) in excess of amount permitted in regular vanilla light ice cream.”47
`
`
`45 21 C.F.R. § 130.10(d)(2) (“An ingredient or component of an ingredient that is specifically required by the standard
`(i.e., a mandatory ingredient) as defined in parts 131 through 169 of this chapter, shall not be replaced or exchanged
`with a similar ingredient from another source unless the standard, as defined in parts 131 through 169 of this chapter,
`provides for the addition of such ingredient (e.g., vegetable oil shall not replace milkfat in light sour cream); 21 C.F.R.
`§ 135.110(f)(2)(i)
`46 21 C.F.R. § 130.10(d)(3) (“An ingredient or component of an ingredient that is specifically prohibited by the
`standard as defined in parts 131 through 169 of this chapter, shall not be added to a substitute food under this section.”);
`21 C.F.R. § 135.110(f)(2)(i)
`47 21 C.F.R. § 130.10(f)(2) (“Ingredients not provided for, and ingredients used in excess of those levels provided
`for, by the standard as defined in parts 131 through 169 of this chapter, shall be identified as such with an asterisk in
`the ingredient statement, except that ingredients added to restore nutrients to the product as required in paragraph (b)
`of this section shall not be identified with an asterisk. The statement “*Ingredient(s) not in regular ___” (fill in name
`of the traditional standardized food) or “*Ingredient(s) in excess of amount permitted in regular ___” (fill in name of
`the traditional standardized food) or both as appropriate shall immediately follow the ingredient statement in the same
`type size.); 21 C.F.R. § 135.110(f)(2)(i).
`
`18
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`Case 1:19-cv-09227 Document 1 Filed 10/04/19 Page 19 of 41
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`C. Express Nutrient Content Claim Does Not Relate to Flavoring Used in Ice Creams
`
`72. The only authorized deviations from the standard by express nutrient content claims
`
`are those that (1) are necessary to make the nutrient content claim, (2) to ensure that the food meets
`
`the performance characteristics of the traditional standardized food and (3) to ensure the food is
`
`not nutritionally inferior to the traditional standardized food.
`
`73. The allowed modifications to standardized foods related to direct statements about
`
`the level or range of a nutrient in the food such as fat, sugar and calories, as opposed to the amount
`
`and composition of the flavoring.
`
`74. Modification of a food by an express nutrient content claim does not provide
`
`justification or authority for deviating from the vanilla flavor requirement of a Category 1 ice
`
`cream because:
`
`• The nutrient content claims modify the term “ice cream” by adjusting the
`
`nutrient composition of the Products;
`
`•
`
`the modified products are called “vanilla light ice cream” and not “light
`
`vanilla ice cream,”48
`
`• Vanilla and its flavorings are not nutrients, but flavorings;
`
`• Vanilla extract and vanilla flavorings are insignificant sources of calories
`
`and contributors to fat and sugar content and other nutrients which are
`
`subject to express nutrient content claims; and
`
`• Simple enough to designate an ice cream with the term “vanilla flavored”
`
`or a similar variation, the amount, t