2013 Decisions

Opinions of the United

States Court of Appeals

for the Third Circuit

5-9-2013

Thomas Young v. Johnson & Johnson

Precedential or Non-Precedential: Non-Precedential

Docket No. 12-2475

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Recommended Citation

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NOT PRECEDENTIAL

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

_____________

No. 12-2475

_____________

THOMAS YOUNG, on behalf of himself and all others similarly situated,

 Appellant

v.

JOHNSON & JOHNSON, a New Jersey Corporation

_______________

On Appeal from the United States District Court

for the District of New Jersey

(D.C. No. 3-11-cv-04580)

District Judge: Hon. Joel A. Pisano

_______________

Argued

April 23, 2013

Before: SLOVITER, JORDAN and NYGAARD, Circuit Judges.

(Filed: May 9, 2013)

_______________

Jared H. Beck, Esq. [ARGUED]

Beck & Lee

66 West Flagler Street, Suite 1000

Miami, Fl 33130

Kim E. Richman, Esq.

Reese Richman

875 Avenue of the Americas – 18th Fl.

New York, NY 10001
2

Richard P. Rinaldo, Esq.

1767 Morris Avenue, Suite205

Union, NJ 07083

 Counsel for Appellant

Charles J. Falletta, Esq.

Jeffrey J. Greenbaum , Esq. [ARGUED]

Sills, Cummis & Gross

One Riverfront Plaza

Newark, NJ 07102

 Counsel for Appellee

Richard A. Samp, Esq.

Washington Legal Foundation

2009 Massachusetts Avenue, NW

Washington, DC 20036

 Counsel for Amicus

_______________

OPINION OF THE COURT

_______________

JORDAN, Circuit Judge.

Thomas Young appeals the dismissal of his class action complaint against Johnson 

& Johnson (“J&J”) asserting various state law causes of action based on allegedly 

deceptive labeling of certain J&J products. For the following reasons, we will affirm. 

I. Background

J&J manufactures Benecol® Regular Spread and Benecol®Light Spread 

butter/margarine substitutes (collectively “Benecol”). In two locations on the outside of 

the Benecol label1and one on the inside of the label, it states that Benecol contains “NO 

 

1

The Benecol label wraps around and is separate from the container holding the 

actual spread. Representations and disclaimers located on the inside of the Benecol label 

are not visible until the label is removed from the product. 
3

TRANS FAT.” (App. at 47-48.) The “Nutrition Facts” box, which is also on the outside 

of the label, notes the “Amount/Serving” of “Trans Fat” as “0g.” (Id. at 47.) Directly 

above the Nutrition Facts box on the outside of the label is the statement “No Trans Fatty 

Acids.” (Id.) 

The label also states in large letters immediately below the Benecol name in two 

locations on the outside and once on the inside that the product is “Proven to Reduce 

Cholesterol.” (App. at 47-48.) The outside of the label provides the basis for that claim, 

stating, in relevant part, that “[p]roducts containing 0.7 g or more of plant stanol esters 

per serving eaten twice a day with meals for a daily intake of at least 1.4 g may reduce 

the risk of heart disease as part of a diet low in saturated fat and cholesterol.” (App. at 

47-48.) The outside of the label also states that “[e]ach serving contains 0.85 g of Plant 

Stanol Esters (0.5 g plant stanols)” and that “Plant Stanol Esters[’] proven ability to lower 

cholesterol is supported by over 25 studies, including one in the New England Journal of 

Medicine.” (App. at 47-48 (emphasis in original).) The inside of the label further claims 

that Benecol “offers you a great way to reduce your cholesterol” because it “[r]educes 

‘bad’ (LDL) cholesterol,” “[r]educes total cholesterol,” and “[b]locks cholesterol from 

being absorbed into your body.” (App. at 47, 49.)

Young asserts that Benecol’s representations concerning its trans fat content and 

cholesterol-lowering capability are false and misleading because Benecol contains small 

amounts of trans fats (also referred to as “partially hydrogenated oil”) that may be 

detrimental to heart health. He further alleges that he paid a premium price for Benecol,

in reliance on its false and misleading nutrient content and health claims. 
4

Young filed a five-count complaint in the United States District Court for the 

District of New Jersey asserting claims for violations of the New Jersey Consumer Fraud 

Act, N.J. Stat. Ann. § 56:8-1, et seq., and the New York General Business Law § 349 (on 

behalf of a putative New York subclass), breach of express warranties and of the implied 

covenant of merchantability, and unjust enrichment. The District Court granted J&J’s 

motion to dismiss, concluding that Young had not adequately pled an injury-in-fact and 

therefore lacked standing, and that his claims were expressly preempted by the Food, 

Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., as amended by the Nutrition 

Labeling and Education Act (“NLEA”), 21 U.S.C. § 343-1.

This timely appeal followed.

II. Discussion2

The NLEA expressly preempts any state-imposed requirement for nutrition 

labeling of food, or with respect to nutritional or health-related claims, “that is not 

identical to the requirement” set forth in the relevant provisions of the Act. 21 U.S.C. 

§ 343-1(a)(4), (a)(5). Young asserts that his state law causes of action based on J&J’s 

alleged misrepresentations about Benecol are not preempted because they seek to impose 

 

2

The District Court had jurisdiction pursuant to the Class Action Fairness Act, 28 

U.S.C. § 1332(d). We have jurisdiction under 28 U.S.C. § 1291. “To survive a motion to 

dismiss [under Rule 12(b)(6)], a complaint must contain sufficient factual matter, 

accepted as true, to state a claim to relief that is plausible on its face.” Sheridan v. NGK 

Metals Corp., 609 F.3d 239, 263 n.27 (3d Cir. 2010) (quoting Ashcroft v. Iqbal, 556 U.S. 

662, 678 (2009)) (internal quotation marks omitted). “A claim has facial plausibility 

when the plaintiff pleads factual content that allows the court to draw the reasonable 

inference that the defendant is liable for the misconduct alleged.” Id. (quoting Iqbal, 556 

U.S. at 678) (internal quotation marks omitted). 
5

requirements that are identical to those set forth in the NLEA.

3

 His arguments

correspond to the two groups of claims made on the Benecol package: (1) that the 

product does not contain trans fats (the “Trans Fat Claims”); and (2) that it is proven to 

reduce cholesterol because it contains beneficial plant stanol esters (the “Cholesterol 

Claims”). We discuss preemption as it pertains to each of those sets of claims 

separately.4

A. Trans Fat Claims

The essence of Young’s argument regarding the Trans Fat Claims is that, although 

the regulations authorize Benecol to claim that it contains “0g of Trans Fat Per Serving,” 

they do not expressly permit a claim of “NO TRANS FAT” for the product as a whole. 

Thus, Young contends that he “seeks to prohibit false and misleading nutrient content 

 

3

The District Court did not reach Young’s alternative theories of liability based on 

breach of express and implied warranties and unjust enrichment. He does not press those 

theories on appeal, and we do not address them.

4

The District Court also concluded that Young lacked standing because he had not 

pled a sufficient injury-in-fact. We note that cases from the District of New Jersey have 

found that plaintiffs have standing to sue under New Jersey’s Consumer Fraud Act 

(“CFA”) when they have alleged financial injuries based on their purchase of a product 

that did not have the attributes it claimed. See, e.g., Lieberson v. Johnson & Johnson 

Consumer Cos., Inc., 865 F. Supp. 2d 529, 537 (D.N.J. 2011) (finding standing under the 

CFA based on consumer’s assertion that she would not have purchased the product but 

for its claim that it would help her baby to sleep better); Green v. Green Mountain Coffee 

Roasters, Inc., 279 F.R.D. 275, 280 (D.N.J. 2011) (finding standing under the CFA based 

on consumer’s allegation that he purchased a coffee maker based on allegedly false 

representation that it would brew a programmed quantity of coffee); Zebersky v. Bed Bath 

& Beyond, Inc., No. 06-1735, 2006 WL 3454993, at *2 (D.N.J. Nov. 29, 2006) 

(concluding that a consumer “alleged an injury in fact sufficient to withstand [a] motion 

[to dismiss]” under the CFA because she alleged “that the goods purchased were of 

inferior quality to what was represented by defendants”). Though tenuous, Young’s 

standing under the specific facts of this case is sufficient for us to consider the merits. 
6

claims regarding trans fat content per product. Prohibition of such statements is not 

inconsistent with the FDA’s regulation allowing nutrient content claims about trans fat 

per serving.” (Appellant’s Opening Br. at 25 (emphasis in original).)

The FDA nutrition information regulation that covers trans fat content generally 

requires “[a] statement of the number of grams of trans fat in a serving,” but further 

provides that “[i]f the serving contains less than 0.5 gram [of trans fat], the content, when 

declared, shall be expressed as zero.” 21 C.F.R. § 101.9(c)(2)(ii). The regulation also 

says that such amounts are deemed to be “insignificant amounts” for purposes of the 

“declaration of nutrition information.” Id. § 101.9(f)(1). Benecol contains less than 0.5 

grams of trans fat per serving, and therefore properly discloses that it contains “0g of 

trans fat” per serving in the Nutrition Facts box.

While FDA regulations do not specifically say a product can advertise itself as 

containing “NO TRANS FAT” when it has an insignificant amount, they do allow

“nutrient content claim[s],” id. § 101.13(b), such as claims that a product contains “no 

fat” or “no saturated fat,” without reference to a per-serving limitation, provided that the 

product indeed contains less than 0.5 grams per serving, id. § 101.62(b)(1), (c)(1). And 

more broadly, FDA regulations permit the label to contain a “statement about the amount 

or percentage of a nutrient” if it is “not false or misleading.” Id. § 101.13(i)(3). 

The FDA has long recognized the potential for a discrepancy between required 

disclosure of “zero grams per serving” and an accurate nutrient content claim that the 

product is not, in fact “free” of the nutrient in question. Because “[s]uch declarations 

could be confusing to consumers, and this consequence is unintended[,] ... the 
7

determination of whether a product is free of a nutrient [is] based on the value of the 

nutrient ... per labeled serving.” 58 Fed. Reg. 44025 (Aug. 18, 1993). In the interest of 

clarity and consistency with the nutritional information, FDA regulations therefore 

authorize nutrient content claims based on per serving amounts, even if those claims are 

not entirely accurate on a per product basis. For example, the regulations authorize 

nutrient content claims that a food is “calorie free” if it contains less than 5 calories per 

serving, 21 C.F.R. § 101.60(b)(1); that a food is “sodium free” if it contains less than 5 

milligrams of sodium per serving, id. § 101.61(b)(1); and that a food contains “no fat” or 

“no saturated fat” if it contains less than 0.5 grams per serving, id. § 101.62(b)(1), (c)(1). 

Consequently, the “NO TRANS FAT” claim on the Benecol label is not “misleading” as 

that term is used in 21 C.F.R. § 1.13(i)(3), and is authorized under that provision, even if 

a “no trans fat” claim is not expressly contemplated by the regulations.5

Nutrient content claim regulations promulgated under the NLEA thus authorize 

the Trans Fat Claims, based on the per serving amount of trans fats that the product 

contains. Because Young seeks to bar that disclosure under state law, in effect enforcing 

 

5

Three other courts that have recently reached the same conclusion. See Carrea v. 

Dreyer’s Grand Ice Cream, Inc., 475 F. App’x 113, 115 (9th Cir. 2010) (concluding that

“0g Trans Fat ... is an express nutrient content claim that the [FDA] not only permits, but 

further instructs should mirror the Nutrition Facts panel” (citations omitted)); Chacanaca 

v. Quaker Oats Co., 752 F. Supp. 2d 1111, 1121 (N.D. Cal. 2010) (concluding that

“‘nutritionally insignificant amounts’ of less than 0.5 grams trans fats means the same 

thing, according to [FDA] regulations, as ‘0 grams,’” and that “the use of the latter 

language in a[] ... nutrient content claim would not be misleading within the meaning of 

[the FDCA] or any of its regulations”); Reid v. Johnson & Johnson, No. 11-cv-01310-LBLM, 2012 WL 4108114, at *10 (S.D. Cal. Sept. 18, 2012) (concluding that FDA 

regulations authorize the “no Trans Fat” and “No Trans Fatty Acids” claims on the 

Benecol label because “[m]aking a distinction between ‘No Trans Fat’ and ‘0 grams trans 

fat’ is unreasonable”). 
8

state law requirements that are not identical to the NLEA, his action is expressly 

preempted as it relates to those claims.

B. Cholesterol Claims

Young contends that the FDCA does not preempt his action with respect to the 

Cholesterol Claims because he seeks to enforce state law requirements that are identical 

to regulations prohibiting false and misleading health claims. Young argues that the 

District Court failed to distinguish between “Defendant’s false claim that Benecol as a 

whole is ‘Proven to Reduce Cholesterol’ [and] the FDA-approved claim that plant 

sterol/stanol esters are ‘Proven to Reduce Cholesterol.’” (Appellant’s Opening Br. at 26.) 

Two interrelated FDA regulations, 21 C.F.R. §§ 101.14 and 101.83, govern the 

Benecol Cholesterol Claims. J&J’s claim that the product is “Proven to Reduce 

Cholesterol” is a “health claim” subject to 21 C.F.R. § 101.14 because it is based on the 

fact that the product includes particular amounts of plant stanol esters, and therefore 

“characterizes the relationship of a[] substance to a disease or health-related condition.” 

Id. § 101.14(a). Food labeling may not include a health claim, whether express or 

implied, unless the claim is “specifically provided for” in 21 C.F.R. §§ 101.70-83, and 

the claim “conforms to all general provisions of [§ 101.14].” Id. § 101.14(e)(1), (e)(2). 

The general provisions of § 101.14 require, inter alia, that health claims must be 

“complete, truthful, and not misleading.” Id. § 101.14(d)(2)(iii). The Benecol

Cholesterol Claims also come under 21 C.F.R. § 101.83, which specifically provides for 

health claims “which summarize the relationship between diets that include plant 
9

sterol/stanol esters and the risk of [heart disease] and the significance of the relationship.” 

Id. § 101.83(d)(3). 

Young argues that J&J’s claim that its product (rather than the plant stanol esters 

the product contains) is “Proven to Reduce Cholesterol” is not “specifically provided for” 

in §§ 101.70-101.83 (as required by § 101.14(e)), and that it violates § 101.14(d) because 

it is false and misleading. The first argument is directly contradicted by § 101.83, which 

permits a food product to make a health claim based on plant stanol esters if “the food 

product ... contain[s] ... [a]t least 1.7 g of plant stanol esters ... per reference amount 

customarily consumed of the food products eligible to bear the health claims, specifically 

spreads ... .” 21 C.F.R. § 101.83(c)(2)(iii)(A)(2) (emphasis added).6 Thus, “[t]he 

regulations state the minimum amount of plant stanol esters that a product must contain 

before it can bear health claims, but[] ... do not require that products show that they 

effectively reduce cholesterol as formulated.” Reid v. Johnson & Johnson, No. 11-cv01310-L-BLM, 2012 WL 4108114, at *9 (S.D. Cal. Sept. 18, 2012) (internal quotation 

marks omitted). 

Young’s second argument, that the “Proven to Reduce Cholesterol” claim is false 

and misleading, rests on the assertion that the claim is expressed with reference to the 

product itself rather than to the plant stanol esters it contains, and that the product 

 

6

In 2003, the FDA reduced the amount of plant stanol esters required for a food to 

make the health claims listed in 21 C.F.R. § 101.83 to 0.4 grams per serving, and a total

daily intake of 0.8 grams, but the regulation was not revised to reflect that change. 

Benecol contains more than those required amounts, and Young does not appear to 

challenge Benecol’s ability to make cholesterol-lowering claims based on the amount of 

plant stanol esters it contains.
10

contains harmful trans fats. Both of those facts are irrelevant. It is of no consequence

that the claim may be read as referring to the product rather than to the plant stanol esters 

it contains because the regulations expressly authorize the product to make the health 

claim. See 21 C.F.R. § 101.83(c)(2)(iii)(A) (describing the “[n]ature of the food eligible 

to bear the claim” in terms of the amount of plant stanol esters that the “food product 

shall contain”). Also, the regulations set forth a “model health claim” that speaks in 

terms of “[f]oods containing” and “servings of foods containing” the specified amounts 

of plant stanol esters. Id. § 101.83(e)(2)(i), (e)(2)(ii). Likewise, the fact that Benecol 

contains small amounts of trans fats does not render its Cholesterol Claims false and

misleading because the Cholesterol Claims are authorized by the regulations based solely 

on the product’s plant stanol ester content, without reference to other nutrients such as 

trans fats. Id. § 101.83(c)(2)(iii)(A)(2). 

In summary, J&J is permitted to make heart health claims that relate to Benecol

based on the product’s plant stanol esters content. The Cholesterol Claims are authorized 

by FDA regulations and are not false or misleading. Because Young’s state law action 

seeks to impose standards that are not identical to those set forth in the regulations, it is

expressly preempted by the NLEA as it relates to those claims. 
11

III. Conclusion

The District Court therefore properly dismissed Young’s complaint because all of 

his theories of liability are expressly preempted.7 We will therefore affirm the District 

Court’s ruling.

 

7 Young also argues that the District Court abused its discretion when it dismissed 

his complaint with prejudice, effectively denying him leave to amend. “Under [Federal 

Rule of Civil Procedure] 15(a), futility of amendment is a sufficient basis to deny leave to 

amend.” Great W. Mining & Mineral Co. v. Fox Rothschild LLP, 615 F.3d 159, 175 (3d 

Cir. 2010). “Futility means that the complaint, as amended, would fail to state a claim 

upon which relief could be granted.” In re Merck & Co. Sec., Inc., Derivative & ERISA 

Litig., 493 F.3d 393, 400 (3d Cir. 2007) (internal quotation marks omitted). Therefore, a 

court need not grant leave to amend if “the amendment would not cure the deficiency.” 

Shane v. Fauver, 213 F.3d 113, 115 (3d Cir. 2000). In this case, the District Court 

dismissed Young’s complaint because his claims are expressly preempted. That is a 

determination of law, not fact. See Roth v. Norfalco LLC, 651 F.3d 367, 374 (3d Cir. 

2011) (noting that a district court’s “preemption ... determinations were based on 

questions of law”). Any attempt by Young to amend the factual allegations in his 

complaint would not have saved it as a matter of law, and the District Court did not abuse 

its discretion when it dismissed the complaint with prejudice.