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DEFENDANT’S MOTION TO DISMISS AMENDED CONSOLIDATED COMPLAINT, NO. 5:10-CV-00502-RS
Gibson, Dunn &
Crutcher LLP
GIBSON, DUNN & CRUTCHER LLP
Daniel W. Nelson (pro hac vice)
DNelson@gibsondunn.com
Andrew S. Tulumello (pro hac vice)
ATulumello@gibsondunn.com
Scott P. Martin (pro hac vice)
SMartin@gibsondunn.com
1050 Connecticut Avenue, N.W.
Washington, D.C. 20036
Telephone: 202-955-8500
Facsimile: 202-530-4238
Christopher Chorba (SBN 216692)
CChorba@gibsondunn.com
333 South Grand Avenue
Los Angeles, CA 90071
Telephone: 213-229-7000
Facsimile: 213-229-7520
Counsel for Defendant The Quaker Oats Company
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF CALIFORNIA
SAN FRANCISCO DIVISION
VICTOR GUTTMANN, KELLEY BRUNO,
SONYA YRENE, and REBECCA YUMUL,
on behalf of themselves and all others similarly
situated,
Plaintiffs,
v.
THE QUAKER OATS COMPANY,
Defendant.
CASE NO.: 5:10-CV-00502-RS
DEFENDANT THE QUAKER OATS
COMPANY’S NOTICE OF MOTION
AND MOTION TO DISMISS
AMENDED CONSOLIDATED
COMPLAINT
Hearing Date: January 12, 2012
Time: 1:30 p.m.
Place: Courtroom 3, 17th Floor
Judge: Honorable Richard Seeborg
Action Filed: February 3, 2010
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DEFENDANT’S MOTION TO DISMISS AMENDED CONSOLIDATED COMPLAINT, NO. 5:10-CV-00502-RS
Gibson, Dunn &
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TO PLAINTIFFS AND THEIR ATTORNEYS OF RECORD:
PLEASE TAKE NOTICE THAT on January 12, 2012, at 1:30 p.m., or as soon thereafter as it
may be heard, in Courtroom 3, 17th Floor, of this Court, located at 450 Golden Gate Avenue, San
Francisco, CA 94102, Defendant The Quaker Oats Company (“Quaker”) will and hereby does move
this Court pursuant to Federal Rule of Civil Procedure 12(b)(6) for an order dismissing the Amended
Consolidated Complaint filed against it on August 19, 2011.
Quaker makes this motion because the allegations in the Amended Consolidated Complaint
fail to state a claim upon which relief can be granted, and because the labeling statements at issue are
either preempted by federal law and/or constitute non-actionable puffery.
Quaker seeks dismissal of the Amended Consolidated Complaint without leave to amend and
entry of judgment in favor of Quaker. This Motion is based on this Notice of Motion, the attached
Memorandum of Points and Authorities, the accompanying Request for Judicial Notice (“RJN”), the
pleadings and papers on file herein, and such other matters as may be presented to the Court at the
time of the hearing.
Dated: October 14, 2011 GIBSON, DUNN & CRUTCHER LLP
By: /s/ Christopher Chorba
Christopher Chorba
Counsel for Defendant
The Quaker Oats Company
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TABLE OF CONTENTS
Page
I. INTRODUCTION AND SUMMARY OF ARGUMENT ......................................................... 1
II. STATEMENT OF THE ISSUES TO BE DECIDED ................................................................. 2
III. SUMMARY OF ALLEGED FACTS AND RELEVANT REGULATIONS ............................ 2
IV. THE LEGAL STANDARDS GOVERNING THIS MOTION .................................................. 7
V. ARGUMENT .............................................................................................................................. 8
A. Plaintiffs’ Allegations Do Not State A Plausible Claim For Relief. ............................... 8
B. Federal Law Preempts Plaintiffs’ Claims. .................................................................... 11
C. Plaintiffs’ Remaining Claims Attempt To Challenge Non-Actionable Puffery. .......... 18
VI. CONCLUSION ......................................................................................................................... 21
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TABLE OF AUTHORITIES
Page
Cases
Ackerman v. Coca-Cola Co.,
No. 09-0395, 2010 WL 2925955 (S.D.N.Y. July 21, 2010) ...................................................... 18, 20
Anunziato v. eMachines, Inc.,
402 F. Supp. 2d 1133 (C.D. Cal. 2005) ........................................................................................... 22
Ashcroft v. Iqbal,
129 S. Ct. 1937 (2009) ............................................................................................................. 2, 8, 17
Bank of Am. v. City & County of S.F.,
309 F.3d 551 (9th Cir. 2002) ........................................................................................................... 13
Bates v. Dow Agrosciences LLC,
544 U.S. 431 (2005) ......................................................................................................................... 13
Bell Atl. Corp. v. Twombly,
550 U.S. 544 (2007) ....................................................................................................................... 2, 8
Buckman Co. v. Plaintiffs’ Legal Comm.,
531 U.S. 341 (2001) ................................................................................................................... 13, 19
Chacanaca v. Quaker Oats Co.,
752 F. Supp. 2d 1111 (N.D. Cal. 2010) .................................................................................... passim
Cipollone v. Liggett Group Inc.,
505 U.S. 504 (1992) ......................................................................................................................... 13
Consumer Advocates v. Echostart Satellite Corp.,
113 Cal. App. 4th 1351 (2003) ........................................................................................................ 22
Cook, Perkiss & Liehe, Inc. v. N. Ca. Collections Serv. Inc.,
911 F.2d 242 (9th Cir. 1990) ............................................................................................... 21, 23, 24
Dvora v. General Mills, Inc.,
No. 11-1074, 2011 WL 1897349 (C.D. Cal. May 16, 2011) ........................................................... 21
Edmunson v. Proctor & Gamble Co.,
No. 10-cv-2256, 2011 WL 1897625 (S.D. Cal. May 17, 2011) ...................................................... 23
Fraker v. KFC Corp.,
No. 06-cv-01284, 2007 WL 1296571 (S.D. Cal. Apr. 30, 2007) ...................................................... 6
Hillborough County v. Automated Med. Labs., Inc.,
471 U.S. 707 (1985) ......................................................................................................................... 13
In re Epogen & Aranesp Off-Label Mktg. & Sales Practices Litig.,
No. MDL 08-1934, 2009 WL 1703285 (C.D. Cal. June 17, 2009) ................................................. 19
In re Sony Grand Wega KDF-E A10/A20 Series Rear Projection HDTV Television Litig.,
758 F. Supp. 2d 1077 (S.D. Cal. 2010) ............................................................................................ 22
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In re XM Satellite Radio Holdings Sec. Litig.,
479 F. Supp. 2d 165 (D.D.C. 2007) ................................................................................................. 24
K&N Eng’g, Inc. v. Spectre Performance,
No. 09-1900, 2011 WL 4387094 (S.D. Cal. Sept. 20, 2011)........................................................... 24
McKinnis v. Kellogg USA,
No. 07-2611, 2007 WL 4766060 (C.D. Cal. Sept. 19, 2007) .......................................................... 21
Monroe Emps. Ret. Sys. v. Bridgestone Corp.,
399 F.3d 651 (6th Cir. 2005) ........................................................................................................... 23
Mylan Labs., Inc. v. Matkari,
7 F.3d 1130 (4th Cir. 1993) ............................................................................................................. 19
Newcal Indus., Inc. v. Ikon Office Solution,
513 F.3d 1038 (9th Cir. 2008) ......................................................................................................... 23
Pelobello v. Quaker Oats Co.,
No. 3:11-CV-00093-RS ..................................................................................................................... 4
Peviani v. Hostess Brands, Inc.
750 F. Supp. 2d 1111 (C.D. Cal. 2010) ........................................................................................... 12
Southland Sod Farms v. Stover Seed Co.,
108 F.3d 1134 (9th Cir. 1997) ......................................................................................................... 22
Starr v. Baca,
652 F.3d 1202 (9th Cir. 2011) ........................................................................................................... 8
Tylka v. Gerber Products Co.,
No. 96-1647, 1999 WL 495126 (N.D. Ill. July 1, 1999) ................................................................... 4
Whiting v. AARP,
701 F. Supp. 2d 21 (D.D.C. 2010) ................................................................................................... 24
Yrene v. Quaker Oats Co.,
No. 5:10-CV-5389-RS ....................................................................................................................... 4
Yumul v. Quaker Oats Co.,
No. 5:10-CV-5538-RS ....................................................................................................................... 4
Constitutional Provisions
U.S. Const. art. VI, cl. 2 ....................................................................................................................... 11
Statutes
21 U.S.C. § 301 et seq. ........................................................................................................................... 6
21 U.S.C. § 321(g)(1) ........................................................................................................................... 19
21 U.S.C. § 321(g)(1)(B) ..................................................................................................................... 18
21 U.S.C. § 331(a) ................................................................................................................................. 6
21 U.S.C. § 337(a) ................................................................................................................... 13, 17, 19
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21 U.S.C. § 341-1(a)(5) ....................................................................................................................... 13
21 U.S.C. § 343 ...................................................................................................................................... 6
21 U.S.C. § 343(a)(1) ............................................................................................................................. 6
21 U.S.C. § 343(q)(1) ............................................................................................................................. 6
21 U.S.C. § 343(r)(1)(A)–(B) ................................................................................................................ 7
21 U.S.C. § 343(r)(1)(B) ...................................................................................................................... 19
21 U.S.C. § 343(r)(3)(C) ............................................................................................................ 8, 15, 16
21 U.S.C. § 343(r)(3)(D) .................................................................................................................. 8, 17
21 U.S.C. § 343(r)(3)(D)(ii) ................................................................................................................. 17
21 U.S.C. § 343-1(a)(4) ....................................................................................................................... 13
21 U.S.C. § 343-1(a)(5) ................................................................................................................... 2, 18
Cal. Bus. & Prof. Code § 17200 et seq. ................................................................................................. 5
Cal. Bus. & Prof. Code § 17500 et seq. ................................................................................................. 5
Cal. Civ. Code § 1750 et seq. ................................................................................................................. 5
Cal. Health & Safety Code § 114377(d) .............................................................................................. 11
Regulations
21 C.F.R. § 101.13 ................................................................................................................................. 7
21 C.F.R. § 101.14 ................................................................................................................................. 7
21 C.F.R. § 101.14(a)(1) .................................................................................................................. 7, 15
21 C.F.R. § 101.14(a)(4) ...................................................................................................................... 10
21 C.F.R. § 101.22 ............................................................................................................................... 20
21 C.F.R. § 101.65(2)(2) ........................................................................................................................ 8
21 C.F.R. § 101.65(c)(2) ...................................................................................................................... 20
21 C.F.R. § 101.81 ............................................................................................................................... 18
21 C.F.R. § 101.81(c)(2)(i) .................................................................................................................... 7
21 C.F.R. § 101.81(d)(2) .................................................................................................................. 7, 18
21 C.F.R. § 101.9 ................................................................................................................................... 6
21 C.F.R. § 101.9(c)(2)(ii) ............................................................................................................... 7, 14
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21 C.F.R. § 101.9(f)(1) .................................................................................................................... 7, 14
21 C.F.R. § 170.3(i) ......................................................................................................................... 9, 11
21 C.F.R. § 170.30(a) ............................................................................................................................. 9
21 C.F.R. § 170.30(g) ............................................................................................................................ 9
Rules
Fed. R. Civ. P. 12(b)(6) .......................................................................................................................... 7
Other Authorities
Baltimore Health Code § 6-507(a)(2) .................................................................................................. 11
Food and Nutrition Bd., Inst. of Med., Dietary Reference Intakes for Energy, Carbohydrates,
Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (2005) ......................................... 11
Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health
Claims,
68 Fed. Reg. 41,434 (July 11, 2003) ............................................................................................ 6, 10
Guidance for Industry: A Labeling Guide for Restaurants and Other Retail Establishments Selling
Away-From-Home Foods (Apr. 2008), available at http://www.fda.gov/Food/
GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabeling
Nutrition/ucm053455.htm ............................................................................................................... 15
H.R. Rep. 101-538 (1990), reprinted in 1990 U.S.C.C.A.N. 3336 ....................................................... 6
Montgomery County Bd. Health Res. 16-134(a)(2) ............................................................................ 11
New York City Health Code § 81.08(b) .............................................................................................. 11
Philadelphia Health Code § 6-307(2) ................................................................................................... 11
Requirements for Foods Named by Use of a Nutrient Content Claim,
58 Fed. Reg. 44,020 (Aug. 18, 1993) ........................................................................................ 10, 14
Select Comm. on GRAS Substances, Report No. 70 ............................................................................. 9
Stamford Municipal Code § 132-24.1(b) ............................................................................................. 11
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DEFENDANT’S MOTION TO DISMISS AMENDED CONSOLIDATED COMPLAINT, NO. 5:10-CV-00502-RS
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I. INTRODUCTION AND SUMMARY OF ARGUMENT
All of Plaintiffs’ consumer protection and false advertising claims against The Quaker Oats
Company (“Quaker”) are based on the implausible allegation that trans fat is “toxic to human health”
and that there is “no safe level” of trans fat consumption. The United States Food and Drug
Administration (“FDA”) disagrees with Plaintiffs’ theory. After careful review, the FDA has
determined that partially hydrogenated vegetable oils (“PHVOs”)—the source of the trans fats at
issue here—are recognized as safe under federal law for use as a food additive. As a result, the
responsible agency charged by Congress with regulating this field has already thoroughly evaluated
and rejected the key scientific premises underlying Plaintiffs’ lawsuit. Indeed, the FDA has
concluded that the amounts of trans fat allegedly present in Quaker’s products—less than 0.5 grams
per serving—are nutritionally insignificant and mandates that such amounts be reported as zero.
Because all of Plaintiffs’ claims about allegedly false and misleading marketing are based on the
assumption that trans fat is unsafe at any level—a conclusion that is implausible because it is directly
contrary to the considered judgment of the expert administrative agency—the Amended Consolidated
Complaint should be dismissed.
In addition to the facial implausibility of Plaintiffs’ theory, the Federal Food, Drug, and
Cosmetic Act (“FDCA”) expressly preempts many of their claims. This law preempts any attempt to
impose state-law labeling requirements that are “not identical” to those prescribed by federal law.
Yet several statements challenged by Plaintiffs as false or misleading—that Quaker’s products “ad[d]
a dietarily insignificant amount of trans fat,” are “heart healthy,” “hel[p] reduce cholesterol,” and
contain “[a]ll the nutrition of a bowl of oatmeal”—are specifically permitted by the FDA. By
attempting to impose state-law liability for federally approved statements, Plaintiffs are asking this
Court to impose labeling requirements for Quaker that are “not identical” to—indeed, that are flatly
inconsistent with—the federal standard. As this Court already ruled, “[e]ssentially, plaintiffs’ claim
asks this Court to ascribe disqualifying status to trans fats where the Agency has at least so far
declined to do so.” Chacanaca v. Quaker Oats Co., 752 F. Supp. 2d 1111, 1122 (N.D. Cal. 2010).
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After two opportunities to amend their pleadings, Plaintiffs’ core theory remains the same, but it is
expressly preempted by the FDCA.
Finally, Plaintiffs assert that labeling statements on newly challenged product labels, such as
“wholesome, great tasting goodness in every bowl” and Quaker’s assertions regarding its products’
“quality,” are misleading because they imply the general “healthiness” of Quaker’s products. But
generalized, unverifiable assertions of product superiority are unlikely to mislead consumers as a
matter of law and cannot support a consumer-fraud claim. From Quaker’s perspective, its products
are, indeed, “quality” and “wholesome, great tasting goodness,” but the puffery doctrine does not
permit Plaintiffs to base this putative class action lawsuit on such claims.
Plaintiffs’ claims rest on implausible factual assertions and are either preempted by federal
law or seek to challenge only non-actionable puffery. For these reasons, the Court should dismiss the
Amended Consolidated Complaint with prejudice.
II. STATEMENT OF THE ISSUES TO BE DECIDED
1. Failure to Show a Plausible Claim for Relief: Whether Plaintiffs fail to state a
plausible claim for relief under Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949–50 (2009), and Bell Atl.
Corp. v. Twombly, 550 U.S. 544, 555–58 (2007).
2. Preemption: Whether Plaintiffs’ claims regarding statements such as “adds a
dietarily insignificant amount of trans fat,” “heart healthy,” “helps reduce cholesterol,” and “[a]ll the
nutrition of a bowl of oatmeal,” as well as images that include oats, nuts, fruits, and brown sugar, are
preempted by the FDCA because they seek to impose requirements for product labeling that are “not
identical” to those mandated by federal law. 21 U.S.C. § 343-1(a)(5).
3. Non-Actionable Puffery: Whether Plaintiffs’ claims regarding “wholesome,
great-tasting goodness in every bowl,” “quality,” “help you feel your best,” and “smart choices made
easy,” taken in context, are non-actionable puffery.
III. SUMMARY OF ALLEGED FACTS AND RELEVANT REGULATIONS
A. Procedural History and Plaintiffs’ Amended Consolidated Complaint. Plaintiffs Victor
Guttmann and Robert Chacanaca’s initial complaint in this action challenged statements and images
on Quaker Chewy Granola Bars as false and misleading because the products contained trans fat.
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See, e.g., Dkt. Entry 1 ¶ 6. Specifically, these plaintiffs asserted that “the trans fat content of Quaker
Chewy granola bars renders them unfit for human consumption,” and they challenged labeling
statements that the granola bars contained “0 grams trans fat,” were a “good source” for calcium and
fiber, were made with whole grain oats but lacked high fructose corn syrup (HFCS), were
“wholesome” and “smart choices made easy,” and came with pictures of healthy children, oats, and
nuts. See id. ¶¶ 57–61.
On October 14, 2010, this Court granted in part and denied in part Quaker’s motion for
judgment on the pleadings. See Chacanaca, 752 F. Supp. 2d at 1127. The Court held that the
FDCA preempted the challenges to the “0 grams trans fat,” “good source,” and HFCS statements. Id.
at 1119–23 (holding that the FDCA expressly preempts lawsuits under state law predicated on
nutrient content claims seeking to impose any requirement “in the label or labeling of food that is not
identical to the requirement[s]” of the FDCA). The Court cited the FDA’s requirement that amounts
of trans fat alleged to be present in Quaker Chewy Granola bars—less than 0.5 grams per serving—
be reported on the side panel “Nutritional Facts” box as zero grams because it constituted a
“nutritionally insignificant amoun[t].” Id. at 1116. For this reason, federal law preempted Plaintiffs’
challenge to the “0 grams trans fat” label.
Similarly, the Court found that federal law preempted Plaintiffs’ claims related to statements
asserting the presence of whole grain oats, the absence of HFCS, and that the products are a “good
source” of calcium because FDA regulations do not establish that trans fat is so unhealthy that
products containing the nutrient may not make unrelated health claims: “As a matter of federal law,
then, the presence of trans fats alone is not a ‘disqualifying’ nutrient which would prevent Quaker
Oats from emphasizing whatever other health benefits are available from the Bars’ other ingredients
or because it lacks certain ingredients.” 752 F. Supp. 2d at 1122.
Next, the Court determined that, “at this juncture” and “on this motion,” it could not
determine whether the statements “wholesome” and “smart choices made easy,” and the graphic
depictions on Quaker boxes, were non-actionable puffery. 752 F. Supp. 2d at 1125–26. It reasoned
that, depending on the context, a statement like “wholesome” may not be puffery, and distinguished
other cases where “wholesome” had been found to be puffery based on the larger context and
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packaging. Id. at 1125 (“The use of the word ‘wholesome,’ however, was only part of the phrase
deemed puffery in Tylka [v. Gerber Products Co., No. 96-1647, 1999 WL 495126, at *2 (N.D. Ill.
July 1, 1999)].”) The Court based its conclusion that these claims should be permitted to proceed on
accepting Plaintiffs’ allegation that trans fats are not safe in any amount. See id. at 1115
(“[Plaintiffs] insist in their Complaint that trans fats are not safe for human consumption in any
amount.”); id. at 1126 (“Taking plaintiffs’ allegation that trans fats are not safe in any amount as true
. . . .”).
After this Court ruled on the motion, three additional suits containing similar allegations were
filed against Quaker in this District.1 On June 24, 2011, interim class counsel filed a Consolidated
Complaint. See Dkt. Entry 95.2 This Consolidated Complaint added allegations regarding additional
products (Instant Quaker Oatmeal and Quaker Oatmeal to Go Bars) and challenged additional
labeling statements that were allegedly deceptive. Quaker filed a motion to dismiss on July 29, 2011,
see Dkt. Entry 98, but rather than respond to the motion to dismiss, Plaintiffs filed an Amended
Consolidated Complaint on August 19, 2011, see Dkt. Entry 102.
Plaintiffs’ Amended Consolidated Complaint alleges that they are repeat purchasers of
Quaker Instant Oatmeal, Quaker Chewy Granola Bars, and Quaker Oatmeal to Go Bars. See Dkt.
Entry 102 (“Am. Compl.”) ¶ 4. Plaintiffs allege that, in purchasing these products, they were
“seeking, for themselves and their families, products of particular qualities.” Id. ¶ 115. In pursuit of
this goal, Plaintiffs assert that they read and relied on statements written on Quaker’s packaging,
including the statement that ingredients in these products add trace amounts of trans fat. See id.
¶ 116 & App’x A. This allegation contradicts Plaintiffs Guttmann and Chacanaca’s initial complaint,
which alleged that they were unaware of the presence of trans fat. See Dkt. Entry 1 ¶¶ 75, 88.
Plaintiffs now claim that Quaker’s products did not meet their standards because, unbeknownst to
them, trans fat is harmful. See, e.g, Am. Compl. ¶¶ 126–127.
1 See Yrene v. Quaker Oats Co., No. 5:10-CV-5389-RS; Yumul v. Quaker Oats Co., No. 5:10-CV-
5538-RS; Pelobello v. Quaker Oats Co., No. 3:11-CV-00093-RS.
2 The initial Consolidated Complaint did not identify Robert Chacanaca, an originally named
plaintiff in this action, as a plaintiff. See Dkt. Entry 95. Similarly, Mr. Chacanaca is not
identified as a plaintiff in the Amended Consolidated Complaint.
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Plaintiffs further allege that they were misled into buying Quaker’s products by the following
supposedly false and misleading statements and images on Quaker’s product labels: (1) “Smart
Choices Made Easy” (Am. Compl. ¶¶ 70–77); (2) “heart-healthy” (id. ¶¶ 82, 85–94); (3) “quality”
(id. ¶ 95); (4) “part of a heart healthy diet” (id. ¶¶ 99, 108–112); (5) “help your family fuel their busy
days” (id. ¶ 78); (6) “wholesome, great tasting goodness in every bowl” (id. ¶ 95 & Ex. B); (7) a
“wholesome way to keep your family going” (id. ¶ 69 & Ex. A); (8) “adds a dietarily insignificant
amount of trans fat” (id. ¶¶ 79–80, 96–97, 113–114); (9) will “help you feel your best” (id. ¶ 99);
(10) “Helps Reduce Cholesterol!” (id. ¶¶ 99, 102–107); (11) the Quaker Oatmeal to Go Bars contain
“All the Nutrition of a Bowl of Instant Oatmeal” (id. ¶ 99); and (12) graphical depictions of hearts,
oats, nuts, natural brown sugar, and children in soccer uniforms (id. ¶¶ 78, 82, 95). Plaintiffs claim
that these statements and images are false and misleading because the products contained PHVOs,
which, in turn, contain trans fat. See id. ¶ 4. They also allege that Quaker’s products are unhealthy
because they contain “highly refined sugar and simple starches.” Id. ¶¶ 71–72, 78, 82, 95, 101.
Based on these purportedly false and misleading statements, Plaintiffs assert causes of action for
alleged violations of (1) California’s Unfair Competition Law (“UCL”), Cal. Bus. & Prof. Code
§ 17200 et seq. (Counts 1 and 2); (2) violations of California’s False Advertising Law (“FAL”), Cal.
Bus. & Prof. Code § 17500 et seq. (Count 3); and (3) violations of California’s Consumer Legal
Remedies Act (“CLRA”), Cal. Civ. Code § 1750 et seq. (Counts 4 and 5). Am. Compl. ¶¶ 142–176.
In an effort to address the arguments raised in Quaker’s previous motion to dismiss, Plaintiffs now
acknowledge the federal statutes and FDA regulations governing many of the claims at issue and
attempt to assert violations of those provisions. See id. ¶¶ 86–93, 106–107, 109–111.
B. Regulatory Background. The FDA has long regulated food labeling under the FDCA. See
21 U.S.C. § 301 et seq. Enacted in 1938, the FDCA prohibits the misbranding of food. See id.
§ 331(a). Congress passed the Nutrition Labeling and Education Act in 1990 to “clarify and to
strengthen the [FDA’s] legal authority to require nutrition labeling on foods, and to establish the
circumstances under which claims may be made about nutrients in foods.” H.R. Rep. 101-538, at 7
(1990), reprinted in 1990 U.S.C.C.A.N. 3336, 3337. Together, these provisions establish “a
comprehensive regulatory scheme of branding and labeling of food products.” Fraker v. KFC Corp.,
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No. 06-cv-01284, 2007 WL 1296571, at *4 (S.D. Cal. Apr. 30, 2007).
The term “misbranded” as it relates to food is defined by various provisions of 21 U.S.C.
§ 343 and accompanying FDA regulations. In general, food is misbranded if “its labeling is false or
misleading in any particular.” 21 U.S.C. § 343(a)(1). Section 343 also imposes specific
requirements on the information contained on food labels. Under Section 343(q), food labels must
bear “nutrition information” that indicates the level of particular nutrients present per serving of the
food. See id. § 343(q)(1). Food labels disclose this information in a “Nutrition Facts” box. See 21
C.F.R. § 101.9.
Since 2006, FDA regulations have required food labels to disclose nutrient information for
trans fat. See Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and
Health Claims, 68 Fed. Reg. 41,434 (July 11, 2003); see also 21 C.F.R. § 101.9(c)(2)(ii). These
regulations require the trans fat content to be “expressed as grams per serving to the nearest 0.5 (1/2)-
gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving
contains less than 0.5 gram, the content, when declared, shall be expressed as zero.” 21 C.F.R.
§ 101.9(c)(2)(ii). The FDA defines as an “insignificant amount” any nutrient present “in an amount
that allows a declaration of zero in nutrition labeling.” Id. § 101.9(f)(1).
Section 343(r) imposes requirements for voluntary statements made on food labeling that,
“expressly or by implication,” “characterizes the level of any nutrient . . . of the food” (i.e., a
“nutrient content claim”), or “characterizes the relationship of any nutrient . . . to a disease or a
health-related condition” (i.e., a “health claim”). 21 U.S.C. § 343(r)(1)(A)–(B); see also 21 C.F.R.
§ 101.13 (“Nutrient content claims—general principles”); id. § 101.14 (“Health claims: general
requirements”). In addition to written statements, the definition of “health claims” includes “symbols
(e.g., a heart symbol), or vignettes.” Id. § 101.14(a)(1).
The FDA has adopted regulations governing certain approved nutrient content and health
claims, which expressly permit the health claims made on Quaker’s labeling. First, the FDA permits
food labels for products that meet specific FDA nutritional standards to make health claims
“associating diets that are low in saturated fat and cholesterol and that include soluble fiber from
certain foods with reduced risk of heart disease.” 21 C.F.R. § 101.81(c)(2)(i). This statement may
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include information that the “reduced risk of heart disease is through the intermediate link of”
cholesterol. Id. § 101.81(d)(2). Second, the FDA permits food labels to compare its nutrient contents
with that of other food by reference, such as by claiming that a product has “as much fiber as an
apple.” 21 C.F.R. § 101.65(2)(2). Plaintiffs have not refuted—and cannot refute—that the Quaker
products carrying these types of claims meet the FDA’s nutritional standards for making these
claims.
Even where the FDA has not authorized a particular health claim by regulation, the FDCA
permits companies to provide the FDA with notice of a proposed claim regarding a particular
nutrient, along with scientific literature discussing the relationship between that nutrient and the
health-related condition at issue. See 21 U.S.C. § 343(r)(3)(C). After submission of such a notice,
manufacturers are authorized to include the claim on their food labels unless the FDA issues a
regulation prohibiting it, determines that the submission was inadequate, or successfully pursues an
enforcement proceeding that the submission requirements were not satisfied. See id. § 343(r)(3)(D).
IV. THE LEGAL STANDARDS GOVERNING THIS MOTION
To survive a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6), Plaintiffs’
complaint must “contain sufficient factual matter, accepted as true, to ‘state a claim for relief that is
plausible on its face.’” Iqbal, 129 S. Ct. at 1949 (quoting Twombly, 550 U.S. at 570). To meet the
plausibility standard, a complaint must contain facts from which the court can draw a “reasonable
inference” that the defendant is liable for the alleged misconduct. Id. Although the Court must
accept factual allegations as true for purposes of a motion to dismiss, this tenet is “inapplicable to
legal conclusions.” Id. After stripping away the “conclusory statements” in the complaint, the
remaining factual allegations must do more than “create a suspicion of a legally cognizable right of
action”; they must “raise a right to relief above the speculative level.” Id. In making this
determination, the Court must “draw on its judicial experience and common sense.” Id. at 1950.
This analysis provides an important gatekeeper function, because Plaintiffs’ claims must be
sufficiently plausible such “that it is not unfair to require the opposing party to be subjected to the
expense of discovery and continued litigation.” Starr v. Baca, 652 F.3d 1202, 1216 (9th Cir. 2011).
Here, Plaintiffs’ allegations fall far short of stating a plausible entitlement to relief.
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V. ARGUMENT
A. Plaintiffs’ Allegations Do Not State A Plausible Claim For Relief.
All of Plaintiffs’ claims depend on their core theory that trans fat is “toxic,” Am. Compl. ¶ 4,
and unsafe for human consumption in any amount, see id. ¶ 60 (asserting that there is “‘no safe level’
of trans fat intake”). This allegation is implausible in light of the FDA regulations, municipal
ordinances, and other materials before the Court. Plaintiffs’ claims should therefore be dismissed.
The FDA has carefully reviewed similar arguments, and it has decided that the scientific
evidence does not support Plaintiffs’ conclusion. The agency has long listed PHVOs—the source of
trans fat at issue here, see Am. Compl. ¶ 26—in its database of food additives that are “generally
recognized as safe” (“GRAS”). See Select Comm. on GRAS Substances, Report No. 70, available at
www.accessdata.fda.gov/scripts/fcn/fcnDetailNavigation.cfm?rpt=scogsListing&id=154 (last updated
Oct. 31, 2006). The GRAS designation “may be based only on the views of experts qualified by
scientific training and experience to evaluate the safety of substances directly or indirectly added to
food.” 21 C.F.R. § 170.30(a). Listing a food additive as GRAS means there is “reasonable certainty
in the minds of competent scientists that the substance is not harmful under its intended conditions of
use,” id. § 170.3(i), and that manufacturers are permitted to include the additive in their products
without first obtaining FDA approval, see, e.g., id. § 170.30(g).
Moreover, as this Court has already acknowledged, the FDA requires companies to list the
amounts of trans fat allegedly present in Quaker’s products at issue in this litigation—less than 0.5
grams per serving—as 0 grams. See Chacanaca, 725 F. Supp. 2d at 1121 (citing 21 C.F.R.
§ 101.9(c)(2)(ii)). The FDA enacted this requirement because, in its view, less than 0.5 grams of
trans fats “means the same thing” as “nutritionally insignificant amounts.” Id.; see also, e.g.,
Requirements for Foods Named by Use of a Nutrient Content Claim, 58 Fed. Reg. 44,020, 44,024
(Aug. 18, 1993) (noting that “nutritionally trivial” amounts of given nutrients are “declared as zero on
the nutrition label”). Consistent with this view, the FDA permits companies to assert in their labeling
that PHVOs add a “dietarily insignificant amount of trans fat,” so long as the product would
otherwise be entitled to report its trans fat values as zero grams. See RJN Ex. 1. (Letter from Felicia
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B. Satchell, Director, Food Label and Standards Staff, FDA, to Richard S. Silverman (Mar. 18,
2004)).
Indeed, the FDA specifically considered—and rejected—a rule that would have banned food
purveyors from making unqualified health claims about its products that contain trans fat. See
21 C.F.R. § 101.14(a)(4). Pursuant to FDA regulations, if a food product contains certain nutrients
above specified levels, then the food is disqualified from making any claims characterizing the food’s
effect on a health-related condition (i.e., health claims). The FDA carefully evaluated a proposed rule
setting disqualifying levels for trans fat—but it ultimately withdrew the proposal because it could not
support such a rule with “scientifically-based definitions and levels” of trans fat. See, e.g., 68 Fed.
Reg. 41,434, 41,465 (July 11, 2003).3
As the foregoing indicates, the FDA has concluded that the presence of trans fat in food—in
amounts less than 0.5 grams per serving—does not make the use of the nutrient content and health
claims they have authorized false or misleading. Perhaps recognizing that the FDA’s conclusion
raises serious plausibility problems for their allegations, Plaintiffs instead turn to state and local
regulations regarding trans fat. See Am. Compl. ¶¶ 63–64. But these regulations are entirely
consistent with the FDA’s view. Indeed, every example of purported “bans” cited in the complaint—
including under California law—contains an exception for foods with less than 0.5 grams of trans fat
per serving. See Cal. Health & Safety Code § 114377(d) (equating less than 0.5 grams trans fat per
serving with no trans fat); New York City Health Code § 81.08(b) (same); Philadelphia Health Code
§ 6-307(2) (same); Baltimore Health Code § 6-507(a)(2) (same); Montgomery County Bd. Health
Res. 16-134(a)(2) (same); Stamford Municipal Code § 132-24.1(b) (same).
Plaintiffs also rely on a handful of studies that, they claim, suggest that trans fat at any level is
unhealthy. It is hardly clear that this is correct,4 but again the FDA has reviewed and analyzed the
3 As explained below, the FDA has set certain disqualifying levels of trans fat for some specific
health claims. See, e.g., infra at pp. 14. There is, however, no general disqualifying level of
trans fat. See Chacanaca, 725 F. Supp. 2d at 1121. Plaintiffs have not alleged that the amount of
trans fat in Quaker’s products would put it in out of compliance with the requirements for these
specific claims.
4 Even one of the studies cited by Plaintiffs, for instance, establishes that there are no adverse
health effects associated with consumption of small amounts of trans fat. See Food and Nutrition
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relevant scientific research and it has specifically concluded that trans fat quantities of less than
0.5 grams per serving are indistinguishable from zero for nutritional purposes. Although Plaintiffs
repeatedly insist that trans fats are harmful in any quantity, the FDA’s regulatory regime and relevant
statutory sources illustrate the implausibility of this assertion.
Plaintiffs’ further allegations that Quaker’s products are unhealthy because they contain
“highly refined sugar and simple starches” (Am. Compl. ¶ 71) are similarly implausible. These
threadbare allegations are never developed in the complaint; Plaintiffs do not allege that they were
deceived about the sugar content of Quaker’s products, or that they were unaware of the health
effects of sugar consumption. Even if they had done so, any such allegations would be implausible—
and, indeed, flatly inconsistent with claims some of these very same plaintiffs have asserted in other
recent lawsuits. For example, in Peviani v. Hostess Brands, Inc., Plaintiff Guttmann alleged that he
was a consumer of Hostess Products such as Cinnamon Streusel Coffee Cakes, Twinkie Bites Golden
Sponge Cake with Creamy Filling, Chocolate Cake with Creamy Filling, Lemon Golden Cake with
Creamy Filling, Strawberry Cake with Cream Cheese Icing and Creamy Filling, and Carrot Cake
with Cream Cheese Icing and Creamy Filling. 750 F. Supp. 2d 1111, 1113 n.1 (C.D. Cal. 2010). Yet
in this action, Guttmann claims that he was harmed by buying products laden with sugar when he was
actually looking for “products made with natural, healthy ingredients.” Am. Compl. ¶ 115. These
contradictory allegations make clear why Plaintiffs have not alleged—and could not plausibly
allege—that they were misled about the sugar content of Quaker’s products.5
Bd., Inst. of Med., Dietary Reference Intakes for Energy, Carbohydrates, Fiber, Fat, Fatty Acids,
Cholesterol, Protein, and Amino Acids 835 (2005) (“There are no known risks of chronic disease
from consuming low intakes of saturated fatty acids, trans fatty acids, or cholesterol.”), cited in
Am. Compl. ¶ 60 & n.33. This is consistent with the FDA’s view that there is “reasonable
certainty in the minds of competent scientists” that small amounts of trans fat are “not harmful.”
21 C.F.R. § 170.3(i).
5 Other inconsistencies further undermine the plausibility of Plaintiffs’ allegations. Plaintiffs
assert that they were deceived as to the allegedly unhealthy nature of the trans fat content in
Quaker’s products. See Am. Compl. ¶ 117. But in stark contrast to their prior pleadings,
Plaintiffs no longer allege they were unaware that the products contained trans fat. See Dkt.
Entry 1 ¶¶ 75, 88 (alleging that Plaintiffs were deceived into believing that Quaker’s products
contained “‘no’ . . . trans fat”). Instead, they now admit that they “read and relied upon” the
statement that products contained trans fat. Am. Compl. ¶¶ 79, 96, 113, 116, App’x A. Plaintiffs
are simply shifting theories in the hopes that they will eventually find a viable claim.
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B. Federal Law Preempts Plaintiffs’ Claims.
Alternatively, the FDA’s extensive regulations preempt Plaintiffs’ claims. The FDA has
established extensive standards for food labeling, and many of the statements challenged by Plaintiffs
as violations of state law—that Quaker’s products “ad[d] a dietarily insignificant amount of trans
fat,” are “heart healthy,” “hel[p] reduce cholesterol,” and contain “[a]ll the nutrition of a bowl of
oatmeal”—are governed by these standards. Because Congress preempted state law in this area,
Plaintiffs’ challenges to these statements must fail.6
Under the Supremacy Clause, “the Laws of the United States . . . shall be the supreme law of
the land,” U.S. Const. art. VI, cl. 2, and preempt all state laws to the contrary, see, e.g., Bank of Am.
v. City & County of S.F., 309 F.3d 551, 557–58 (9th Cir. 2002). There is no private right of action to
enforce the FDCA or FDA regulations. See 21 U.S.C. § 337(a); see also Buckman Co. v. Plaintiffs’
Legal Comm., 531 U.S. 341, 349 n.5 (2001). Plaintiffs have therefore attempted to plead their
challenges to Quaker’s labeling under California law. However, the FDCA, as amended by the
Nutritional Labeling and Education Act, contains a broad preemption provision: As relevant here,
the statute preempts “any requirement for the labeling of food that is not identical” to federal
requirements for nutrition information, nutrient content, and health-related claims. 21 U.S.C. § 343-
1(a)(4); see id. § 341-1(a)(5). The term “requirements” “sweeps broadly,” Cipollone v. Liggett
Group Inc., 505 U.S. 504, 521 (1992), and includes “positive enactments, such as statutes and
regulations, [as well as] common-law duties” and judge-made rules, Bates v. Dow Agrosciences LLC,
544 U.S. 431, 449 (2005); see also Hillborough County v. Automated Med. Labs., Inc., 471 U.S. 707,
713 (1985) (same).
As this Court has already concluded, the FDCA expressly prevents Plaintiffs from seeking to
impose requirements in addition to those mandated by federal statutes and regulations. See
Chacanaca, 752 F. Supp. 2d at 1114. This ruling forecloses several of Plaintiffs’ allegations.
1. “Adds a dietarily insignificant amount of trans fat.” This statement accompanies the
Ingredients List item for the PHVOs present in Quaker Chewy Granola Bars, Quaker Instant
6 As discussed below, the remaining statements should be dismissed because they challenge only
non-actionable puffery. See infra pp. 19–21.
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Oatmeal, and Quaker Oatmeal To Go bars. Am. Compl. ¶¶ 79–80, 96–97, 113–14. According to
Plaintiffs, the statement is false and misleading in “light of the pernicious effects of even small
amounts of trans fat” and because the statement implies endorsement by the FDA. Id. ¶¶ 80, 97, 114.
These claims are preempted for the same reason this Court has already rejected other
allegations in the original complaint: The FDA considers trans fat content of less than 0.5 grams per
serving to be an “insignificant amount.” FDA regulations provide that, “[i]f a serving contains less
than 0.5 gram [of trans fat], the content, when declared, shall be declared as zero.” 21 C.F.R.
§ 101.9(c)(2)(ii). The same regulation defines an “‘insignificant amount’” of a particular nutrient, in
turn, as “that amount that allows a declaration of zero in nutrition labeling.” Id. § 101.9(f)(1). Thus,
as this Court has concluded, amounts of trans fat less than 0.5 grams per serving are deemed by the
FDA to be nutritionally insignificant. See Chacanaca, 752 F. Supp. 2d at 1117 (citing Requirements
for Foods Named by Use of a Nutrient Content Claim, 58 Fed. Reg. 44,020, 44,024 (Aug. 18, 1993)).
Similarly, the Court should reject Plaintiffs’ assertion that the “dietarily insignificant”
statements falsely imply endorsement by the FDA. In addition to the FDA regulations that explicitly
define less than 0.5 grams of trans fat per serving as an “insignificant amount,” the FDA has also
expressly endorsed the very statement at issue here: It has concluded that, where a food’s labeling
declares “0 g trans fat,” the manufacturer may “voluntarily identif[y] ingredients that are generally
understood by consumers to contain trans fat . . . with an asterisk that refers to a statement below the
list of ingredients which states ‘adds a trivial (or negligible or dietarily insignificant) amount of trans
fat.’” RJN Ex. 1 (Letter from Felicia B. Satchell, Director, Food Label and Standards Staff, FDA, to
Richard S. Silverman (Mar. 18, 2004)) (emphasis added). This is precisely what Quaker did:
Because PHVOs are “generally understood by consumers to contain trans fat,” but Quaker’s products
nonetheless contain “0 g trans fat” as determined by FDA regulations, Quaker included the FDA-
permitted statement that the PHVOs “ad[d] a . . . dietarily insignificant . . . amount of trans fat.”
Contrary to Plaintiffs’ assertions, therefore, the challenged statements have expressly been permitted
by the FDA in this context.
2. “Heart Healthy”/Images of Hearts. Plaintiffs allege that the label of Quaker Instant
Oatmeal is false and misleading because it states, on the front panel, “Heart Healthy” surrounded by a
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“prominent image of a heart.” Am. Compl. ¶ 82. This statement and image appears directly above
an asterisk stating “See side panel for information about the relationship between whole grains and
heart disease.” Id. ¶ 83. The side panel of the packaging states, in turn, “*diets rich in whole grain
oats and other plant foods and low in saturated fat and cholesterol may help reduce the risk of heart
disease.” Id. ¶ 84. Under FDA regulations, statements and images such as these are considered
“implied health claims” governed by the FDCA. 21 C.F.R. § 101.14(a)(1) (“Implied health claims
include those statements, symbols, vignettes, or other forms of communications that suggest . . . that
a relationship exists between the presence or level of a substance in the food and a disease or health-
related condition”); Guidance for Industry: A Labeling Guide for Restaurants and Other Retail
Establishments Selling Away-From-Home Foods (Apr. 2008) at Nos. 40–41, 45–46, 55, 60
(explaining that the statement “heart healthy” and heart images on food labeling are regulated by the
FDA as an implied health claim), available at http://www.fda.gov/Food/
GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm05345
5.htm. Plaintiffs’ challenges to these health claims are preempted for several reasons.
First, as even Plaintiffs concede, the Heart Healthy statements and images are “authorized
pursuant to 21 U.S.C. § 343(r)(3)(C).” Am. Compl. ¶ 85. Section 343(r)(3)(C) permits companies to
submit to the FDA notice of a proposed health claim, along with scientific literature discussing the
relationship between the proposed claim and the health-related condition at issue; after 120 days,
companies are entitled to use the claim unless FDA disapproves. In 2003, Kraft Foods submitted a
notification for the precise language at issue here. See RJN Ex. 2 (Letter from Jean E. Spence, Senior
Vice President, Research and Development, Kraft Foods, to Division of Nutrition Programs and
Labeling, FDA (Aug. 8, 2003)) (“Kraft Letter”) (attaching report titled “Notification of Health Claim
Based on Authoritative Statement: Whole Grain Foods and Heart Disease”).7 The Kraft Letter alone
7 After engaging in discussions with the FDA about the proposed claim, Kraft submitted additional
letters on November 3 and 26 and attached revised reports. See RJN Ex. 3 (Letter from Sheryl A.
Marcouiller, Senior Food Law Counsel, Kraft Foods, to Julie Scrimpf, Division of Nutrition
Programs and Labeling, FDA (Nov. 3, 2003)); RJN Ex. 4 (Letter from Sheryl A. Marcouiller,
Senior Food Law Counsel, Kraft Foods, to Julie Scrimpf, Division of Nutrition Programs and
Labeling, FDA (Nov. 26, 2003)). These subsequent submissions do not alter Quaker’s ability to
make the “Heart Healthy” claim.
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would be sufficient to permit Quaker to use the health claim challenged by Plaintiffs unless the FDA
disapproved that claim, which it did not. But in this case, the FDA specifically considered and
approved use of the statement. See Health Claim Notification for Whole Grain Foods with Moderate
Fat Content (Dec. 9, 2003), available at http://www.fda.gov/Food/LabelingNutrition/LabelClaims/
FDAModernizationActFDAMAClaims/ucm073634.htm. The FDA issued detailed guidance to
determine when the presence of trans fat might bar a label from containing the health claims at
issue—it required that the food contain “0.5 gram or less trans fat” per reference amount customarily
consumed. See id.
Plaintiffs do not—and cannot—allege that Quaker Instant Oatmeal is not in compliance with
this guidance. Their arguments are therefore a direct attack on the FDA’s approval of the very health
claims at issue here. To recognize those claims would add a state-law requirement in addition to
those imposed by the FDCA in contravention of the express preemption clause in Section 343-1.
Second, Plaintiffs’ attempts to circumvent the preemptive effect of Section 343(r)(3)(C) are
meritless. For example, they allege that: (a) the Kraft submission did not present a “balanced
representation of the scientific literature”; (b) Quaker may only make such a claim if its Instant
Oatmeal “does not contain, as determined by the Secretary by regulation, any nutrient in an amount
which increases” risk of disease or other health-related condition; (c) the statements fail to be
“complete, truthful, and not misleading”; and (d) the statements are interrupted by “intervening
material.” Am. Compl. ¶¶ 87–94. Plaintiffs provide no factual support for these legal conclusions,
and therefore the Court need not accept them for purposes of a motion to dismiss. See Iqbal, 129
S. Ct. at 1949–50 (“the tenet that a court must accept as true all of the allegations contained in a
complaint is inapplicable to legal conclusions”).
More importantly, the decision to permit the health claims at issue here is vested by Congress
in the FDA, and the agency has considered and rejected the same arguments now advanced by
Plaintiffs. See Health Claim Notification for Whole Grain Foods with Moderate Fat Content (Dec. 9,
2003), available at http://www.fda.gov/Food/LabelingNutrition/LabelClaims/
FDAModernizationActFDAMAClaims/ucm073634.htm. Once the FDA receives notice of the
proposed health claim and the time period elapses, manufacturers are authorized to make the claim
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until the FDA issues a regulation prohibiting it, determines that the submission was inadequate, or
successfully pursues an enforcement proceeding that the submission requirements were not satisfied.
See 21 U.S.C. § 343(r)(3)(D). The FDA has not issued any such regulation, and a private litigant
may not bring an enforcement proceeding to overturn the health claim. See 21 U.S.C.
§ 343(r)(3)(D)(ii); see also id. § 337(a). Until one of these events occurs, Quaker is authorized to
make this health claim, and any state law requirement that would impose liability for the claim is
preempted.
Third, Plaintiffs separately allege that “‘Heart Healthy’ messaging and imaging” on Oatmeal
To Go bars is false and misleading. Am. Compl. ¶¶ 108–112. The sole reason Plaintiffs allege that
the statement is misleading is that the bars contain trans fat and refined sugars and starches. This
Court has already rejected the argument that the presence of trans fat “would prevent Quaker Oats
from emphasizing whatever other health benefits are available from” other ingredients in its products.
Chacanaca, 752 F. Supp. 2d at 1122. It did so because FDA regulations provide a list of nutrients
and amounts that “disqualify” a product label from bearing health claims—none of which is trans fat.
See id. This Court’s reasoning applies with equal force to the presence of refined sugars and starches,
because those ingredients also have not been recognized as disqualifying by the FDA. Plaintiffs’
claims based on heart healthy messages and images are preempted. Ackerman v. Coca-Cola Co.,
No. 09-0395, 2010 WL 2925955, at *8 (S.D.N.Y. July 21, 2010) (“[A]ny claim under state law solely
premised on the notion that vitaminwater’s high sugar content made its health or implied nutrient
content claims misleading is preempted by the FDA’s express decision to not recognize sugar as a
disqualifying nutrient.”).
3. “Helps Reduce Cholesterol.” Plaintiffs’ challenge the labeling of Quaker’s Oatmeal To
Go Bars because it contains the statements “As part of a heart healthy diet, the soluble fiber in
Quaker Oatmeal Helps Reduce Cholesterol!*” and “Get your heart healthy oats in a variety of ways.”
Am. Compl. ¶¶ 99–112. Just below these statements appears an asterisk referencing the cholesterol
statement, which is accompanied by the statement “3 grams of soluble fiber from oatmeal daily in a
diet low in saturated fat and cholesterol may reduce the risk of heart disease. Quaker Old Fashioned
Oats provide 2g per serving. Quaker Instant Oatmeal, Oatmeal Squares, and Oatmeal to Go bars
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provide 1g per serving.” Id. Ex. C. According to Plaintiffs, these statements are false and misleading
because the presence of trans fat, as well as highly refined sugars and starches, “damage the heart and
increase the risk and severity of type 2 diabetes.” Id. ¶ 101. These claims, too, are expressly
preempted.
Plaintiffs admit that FDA regulations authorize a health claim associating soluble fiber from
whole grain oats with a reduced risk of coronary heart disease. See Am. Compl. ¶ 106 (citing
21 C.F.R. § 101.81). This regulation allows the label to contain “optional information” that the
“reduced risk of heart disease is through the intermediate link of” cholesterol. 21 C.F.R.
§ 101.81(d)(2). The FDA has expressly permitted Quaker to make the statement challenged here, and
thus Plaintiffs’ claim would impose a requirement “not identical” to federal law. See 21 U.S.C.
§ 343-1(a)(5).
In an attempt to escape this conclusion, Plaintiffs assert that the link between Oatmeal To Go
bars and lowering cholesterol is a “therapeutic claim” that renders the product “a drug within the
meaning of 21 U.S.C. § 321(g)(1)(B).” Am. Compl. ¶ 102. But Plaintiffs do not explain how
Quaker’s inclusion of an FDA-approved health claim could simultaneously function as a therapeutic
claim transforming oatmeal into an unapproved drug. To the contrary, the statutory provision
invoked by Plaintiffs, which defines the term “drug” under the FDCA, provides that a food “is not a
drug solely because the label or the labeling” of the food contains a health-related claim under 21
U.S.C. § 343(r)(1)(B). See id. 21 U.S.C. § 321(g)(1). For this reason, Plaintiffs’ claim that Quaker
Oatmeal To Go bars are a “misbranded unapproved new drug” fails.8
8 In any event, Plaintiffs’ unapproved-drug argument is not an assertion that Quaker has violated
any labeling provision of the FDCA but instead that it has violated separate provisions of the
FDCA governing approval of new drugs. But “the FDCA leaves no doubt that it is the Federal
Government rather than private litigants who are authorized to file suit for noncompliance” with
those provisions. Buckman, 531 U.S. at 349 n.5; see also 21 U.S.C. § 337(a) (“[A]ll such
proceedings for the enforcement, or to restrain violations, of this Act . . . shall be by and in the
name of the United States.”). Thus, when a plaintiff’s “misrepresentation” claims are “nothing
more than a proxy” for allegations of regulatory violations, the complaint must be dismissed with
prejudice. See In re Epogen & Aranesp Off-Label Mktg. & Sales Practices Litig., No. MDL 08-
1934, 2009 WL 1703285, at *5 (C.D. Cal. June 17, 2009) (rejecting claims for implied
misrepresentations of safety and effectiveness where the only “standard of proof of efficacy that
plaintiffs point to is FDA approval,” e.g., allegations that the product “has not been proven to be
effective in the treatment of [a particular disease] as the FDA has not approved it for such use”);
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4. “All the nutrition of a bowl of oatmeal.” Plaintiffs also fault the labels of Oatmeal To Go
Bars because they contain the phrase “All the nutrition of a bowl of instant oatmeal” on its side panel,
near a depiction of a bowl of oatmeal. See Am. Compl. ¶ 99 & Ex. C. Plaintiffs assert that this
statement is “not complete, not truthful, and highly misleading.” Id. ¶ 99 (emphases omitted). As
with their other claims, the only support for these legal conclusions is that Oatmeal To Go Bars
contain trans fat. Id. This claim, however, is preempted by federal law.
The statement that a food “contains as much” nutrition as another food is an implied nutrient
content claim governed by express FDA regulations. See, e.g., 21 C.F.R. § 101.65(c)(2). Under
these regulations, the phrase “‘contains . . . as much [nutrient] as a [food]’ may be used on the label
or in the labeling of foods,” so long as the two foods contain equivalent nutrients. Id. No FDA
regulation or requirement applicable to this provision disqualifies Quaker from making an implied
nutrient content claim because the products being referenced contain trans fat; the FDA has expressly
decided not to recognize trans fat as a disqualifying nutrient. See supra p. 9; see also Chacanaca,
752 F. Supp. 2d at 1122. Accordingly, any attempt to ascribe disqualifying status to the presence of
trans fat is “inconsistent with [the FDCA] and its regulations,” and is therefore preempted.
Chacanaca, 752 F. Supp. 2d at 1122; see Ackerman, 2010 WL 2925955, at *8.
5. Images of Oats, Nuts, Fruits, and Brown Sugar. Plaintiffs also allege that images of oats,
nuts, fruits, and natural brown sugar on the label for Quaker Chewy Granola9 bars and Instant
Oatmeal are misleading because they falsely imply that the products are consistent with a healthy
lifestyle. These claims, too, would impose labeling requirements that depart from federal law, and
they are therefore preempted.
see also Mylan Labs., Inc. v. Matkari, 7 F.3d 1130, 1139 (4th Cir. 1993) (dismissing a federal
false advertising claim under the Lanham Act as an attempt to evade the prohibition on private
enforcement of the FDCA “by ingenious pleading.”).
9 This Court has already ruled that claims based on “photographic depictions of oats, nuts, and
children in soccer uniforms, the inclusion of a ‘smart choices made easy’ decal, and the general
descriptor ‘wholesome’” on Quaker Chewy Granola bars labels were not preempted because the
“NLEA does not regulate ‘front of the box’ symbols.” Chacanaca, 752 F. Supp. 2d at 1123.
That ruling did not extend to Plaintiffs’ new claims regarding Quaker Instant Oatmeal and, in any
event, did not consider the grounds for preemption asserted herein. See id.
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The FDA has promulgated specific standards for labels that depict or characterize the flavors
present in a food. See 21 C.F.R. § 101.22. This regulation applies to labels that make “any direct or
indirect representations with respect to the primary recognizable flavor(s), by word, vignette, e.g.,
depiction of a fruit, or other means.” Id. § 101.22(i) (emphasis added). The images of oats, nuts,
fruits, and brown sugar challenged by Plaintiffs are paradigmatic examples of depictions identifying
the flavors of the Quaker products. See, e.g., Dvora v. General Mills, Inc., No. 11-1074, 2011 WL
1897349, at *5–6 (C.D. Cal. May 16, 2011) (holding that California consumer deception and false
advertising claims predicated on depictions of blueberries are preempted by 21 C.F.R. § 101.22(i));
McKinnis v. Kellogg USA, No. 07-2611, 2007 WL 4766060, at *4 (C.D. Cal. Sept. 19, 2007) (holding
that depictions of fruit were permissible under 21 C.F.R. § 101.22(i), even though the product
contained none of those fruits). Plaintiffs have not alleged that Quaker violated these federal
requirements, and they cannot do so because the products actually contain the ingredients depicted.
See Am. Compl. Ex. A, B. Their claims predicated on these images are therefore preempted. See
Dvora, 2011 WL 1897349, at *6.
C. Plaintiffs’ Remaining Claims Attempt To Challenge Non-Actionable Puffery.
The remaining statements challenged by Plaintiffs—“quality,” “wholesome, great tasting
goodness in every bowl,” “help you feel your best,” and “smart choices made easy”—are non-
actionable puffery. “General assertions of superiority,” as opposed to factual assertions, are deemed
“puffery” that is unlikely to deceive as a matter of law. Cook, Perkiss & Liehe, Inc. v. N. Ca.
Collections Serv. Inc., 911 F.2d 242, 246 (9th Cir. 1990). Plaintiffs’ remaining challenged statements
fall into this category of non-actionable puffery.10
10 In its earlier ruling, this Court determined that “at this juncture” and “on this motion” it could not
determine that the term “wholesome,” standing alone, the “smart choices made easy” decal, and
the photographic depictions of oats, nuts, and children in soccer uniforms were non-actionable
puffery. Chacanaca, 752 F. Supp. 2d at 1126. At that time the Plaintiffs had not challenged any
of Quaker’s product labels for bearing the word “quality.” The Court’s ruling with respect to the
term “wholesome” was limited to Quaker Chewy Granola Bars, and considered the term in
isolation, while it distinguished cases considering the term in context. Quaker’s arguments in this
motion relate to a newly challenged product (Quaker Instant Oatmeal) and provide the necessary
additional context to their earlier argument relating to Quaker Chewy Granola Bars. See
Southland Sod Farms v. Stover Seed Co., 108 F.3d 1134, 1139 (9th Cir. 1997) (“When evaluating
whether an advertising claim . . . the claim must always be analyzed in full context.”).
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1. “Quality.” Plaintiff challenges as false and misleading Quaker’s statement that its product
is “quality.” This argument runs counter to a long line of California cases holding that assertions of
quality are not actionable. See, e.g., In re Sony Grand Wega KDF-E A10/A20 Series Rear Projection
HDTV Television Litig., 758 F. Supp. 2d 1077, 1089 (S.D. Cal. 2010) (“generalized and vague
statements of product superiority such as ‘superb, uncompromising quality’ . . . are non-actionable
puffery” (internal quotation marks omitted)); Anunziato v. eMachines, Inc., 402 F. Supp. 2d 1133,
1140 (C.D. Cal. 2005) (“The Court finds that the word ‘quality’ is non-actionable puffery.”);
Consumer Advocates v. Echostar Satellite Corp., 113 Cal. App. 4th 1351, 1361 (2003) (“‘Crystal
clear’ and ‘CD quality’ are not factual representations that a given standard is met. Instead, they are
boasts, all-but-meaningless superlatives.”). As these cases squarely hold, calling a product “quality”
is not the kind of objective, factual assertion that may be the predicate for liability under consumer
protection laws. Plaintiffs’ claims based on assertion of quality should therefore be rejected.
2. “Wholesome, great tasting goodness in every bowl.” In an apparent attempt to wrench the
word completely out of context, Plaintiffs assert that the word “wholesome,” on its own, is
misleading. Am. Compl. ¶¶ 69, 95. Taken in context, however, that characterization of Quaker’s
products conveys only “generalized and vague statements of product superiority.” In re Sony Grand
Wega, 758 F. Supp. 2d at 1089.
The “wholesome” statements appear on the labels of Quaker Chewy Granola Bars and Quaker
Instant Oatmeal. See Am. Compl. ¶¶ 69, 95 & Exs. 1–2. The label for Chewy Granola Bars says, in
context, “Made with the goodness of whole grain Quaker® oats and yummy ingredients like peanut
butter or chocolate chips, they’re a great tasting, wholesome way to help keep your family going.”
Am. Compl. Ex. 1. The full statement on the Instant Oatmeal label states, “With wholesome, great-
tasting goodness in every bowl, our instant oatmeal is sure to give everyone in your family something
to smile about!” See Am. Compl. Ex. B.
Viewed in the full context in which they appear, these statements are analytically identical to
assertions of high quality. Quaker’s references to its “wholesome” products are surrounded by
assertions that the products are “great-tasting goodness,” made with “yummy ingredients,” and are
“something to smile about.” These statements are “generalized assertions of superiority,” Cook, 911
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F.2d at 246, and they make clear that the packaging uses “wholesome” in the same way. The
assertion that Quaker’s products are “wholesome” is thus “extremely unlikely to induce consumer
reliance,” Newcal Indus., Inc. v. Ikon Office Solution, 513 F.3d 1038, 1053 (9th Cir. 2008), and
accordingly non-actionable.
3. “Help you feel your best.” The label of Quaker Oatmeal To Go Bars contains the phrase
“Great taste with extra fiber to help you feel your best!” See Am. Compl. ¶ 99 & Ex. C. Plaintiffs
allege this statement is “not complete, not truthful, and highly misleading” solely because the bars
contain trans fat. Id. at ¶ 99. This statement is precisely the kind of “general assertion of
superiority” that courts have consistently found to be non-actionable puffery, because the statement is
not a “factual assertion” upon which a consumer could reasonably rely. See Cook, 911 F.2d at 247.
Indeed, numerous courts have dismissed claims relying on similar assertions (“best”) because those
assertions can only be viewed as puffery. See, e.g., Edmunson v. Proctor & Gamble Co., No. 10-cv-
2256, 2011 WL 1897625, at *6 (S.D. Cal. May 17, 2011) (“statements related to obtaining ‘best
results’ . . . are non-actionable puffery”); see also Monroe Emps. Ret. Sys. v. Bridgestone Corp., 399
F.3d 651, 671 (6th Cir. 2005) (statement that products were “the best” are non-actionable puffery);
Cook, F.2d at 246 (statements such as “best technology” are non-actionable puffery); K&N Eng’g,
Inc. v. Spectre Performance, No. 09-1900, 2011 WL 4387094, at *15 (S.D. Cal. Sept. 20, 2011).
Here, the assertion that a food will “help you feel your best” is a “highly subjective” “general
assertion” that cannot be interpreted as a factual claim. Cook, F.2d at 246. It is therefore non-
actionable puffery.
4. “Smart Choices Made Easy.” Finally, Plaintiffs challenge the phrase “smart choices made
easy” as it appears on the labels of Quaker Chewy Granola bars because, they claim, it suggests that
the product is “a good decision for one’s health.” Am. Compl. ¶ 70. Calling a product a “smart
choice”—similar to calling it “quality”—is a subjective and unverifiable opinion. See Whiting v.
AARP, 701 F. Supp. 2d 21, 30 n.7 (D.D.C. 2010) (statement that a product is “a smart option” is “too
general and subjective in nature to be considered [a] misrepresentation”), aff’d, 637 F.3d 355 (D.C.
Cir. 2011); In re XM Satellite Radio Holdings Sec. Litig., 479 F. Supp. 2d 165, 180 (D.D.C. 2007)
(“generalized positive statements about . . . ‘smart’ . . . growth are vague and incapable of objective
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verification” and are therefore puffery). For this reason, the references to “smart choices” on
Quaker’s packaging constitute non-actionable puffery.
VI. CONCLUSION
Plaintiffs’ claims rest on the implausible assertion that trans fat is “toxic” and cannot be
safely consumed at any level—an assertion that is completely foreclosed by the FDA’s many
contrary pronouncements on the issue. Their claims also are either preempted by federal law or seek
to challenge only non-actionable puffery. For these reasons, the Court should dismiss the Amended
Consolidated Complaint with prejudice.
Respectfully submitted,
Dated: October 14, 2011 GIBSON, DUNN & CRUTCHER LLP
By: /s/ Christopher Chorba
Christopher Chorba
Counsel for Defendant
The Quaker Oats Company
101164562.16
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