Hughes v. Ester C Co.

• Decision Date: 27 March 2015
• Docket Number: No. 12–CV–0041 PKCGRB.,12–CV–0041 PKCGRB.
• Citation: 99 F.Supp.3d 278
• Parties: Patrick HUGHES and Nafise Nina Hodjat, individually and on behalf of all others similarly situated, Plaintiffs, v. The ESTER C COMPANY, NBTY, Inc., and Naturesmart, LLC, Defendants.
• Court: U.S. District Court — Eastern District of New York

99 F.Supp.3d 278

Patrick HUGHES and Nafise Nina Hodjat, individually and on behalf of all others similarly situated, Plaintiffs

v.The ESTER C COMPANY, NBTY, Inc., and Naturesmart, LLC, Defendants.

No. 12–CV–0041 PKCGRB.

United States District Court, E.D. New York.

Signed March 27, 2015.

Kim Richman, Michael Robert Reese, Reese Richman LLP, New York, NY, Alvin C. Paulson, Kevin T. Hoerner, Becker, Paulson, Hoerner & Thompson, P.C., Belleville, IL, Jeffrey A. Leon, Quantum Legal LLC, Zachary A. Jacobs, Complex Litigation Group LLC, Highland Park, IL, Patrick J. Sheehan, Whatley Drake & Kallas LLC, Boston, MA, for Plaintiffs.

Michelle Waller Cohen, Steven Alan Zalesin, Jonah Moses Knobler, Patterson Belknap Webb & Tyler LLP, New York, NY, for Defendants.

MEMORANDUM & ORDER

PAMELA K. CHEN, District Judge:

Plaintiffs Patrick Hughes and Nafise Nina Hodjat (together, “Plaintiffs”) initiated this putative consumer class action on behalf of themselves and proposed classes of individuals who bought vitamin C

dietary supplements sold by The Ester C Company, NBTY, Inc., and Naturesmart LLC (collectively, “Defendants”) under the name “Ester–C.” Plaintiffs assert claims under California and Missouri statutes and New York common law, alleging that Defendants deceptively packaged and marketed Ester–C products through false or misleading representations that Ester–C products are a form of immune system support that would decrease the likelihood of getting or remaining ill, and that Ester–C is a superior source of vitamin C. Defendants have filed a motion for partial summary judgment arguing that Plaintiffs' state law claims regarding Ester–C's “Immune Support” statements are preempted by federal law. (Dkt. 66.)¹ For the reasons set forth below, Defendants' motion is denied.

BACKGROUND

The Court presumes the parties' familiarity with the factual allegations in the Amended Complaint, which are also detailed in the Court's prior order denying Defendants' motion to dismiss. Hughes v. Ester C Co., 930 F.Supp.2d 439 (E.D.N.Y.2013).²

Briefly, the Ester–C dietary supplements at issue in this action contain high doses of vitamin C

in the form of calcium ascorbate. (Dkt. 70 (“Def. St.”) ¶ 1.) According to Plaintiffs, misrepresentations in Ester–C's packaging and marketing create a reasonable expectation with purchasers that Ester–C provides a form of immune system defense that protects users from illnesses, and decreases one's likelihood of getting or remaining ill. (Dkt. 13 (“Am. Compl.”) ¶¶ 2, 25; Dkt. 71 (“Pl. Mem.”) at 2.) There is no dispute that the label for each of Ester–C's products prominently features an emblem with the words “Immune Support,” including variants such as “immune system support.” (Am. Compl. ¶ 17; Dkt. 67 (“Def. Mem.”) at 2–3). Equally undisputed is that labels on Ester–C products do not expressly mention the words “cold,” “flu” or other diseases. (Def. Mem. at 4; see Pl. Mem. 2–3.)

Plaintiffs allege that Ester–C product labels also feature false or misleading statements that: (1) Ester–C “provides your body with the immune and antioxidant support it needs to help keep you healthy and strong during times of seasonal change and the stresses of daily living”; (2) supports “Antioxidant Health”; and (3) provides “24 Hour Immune Support.” (Am. Compl. ¶¶ 2, 17.) Plaintiffs' Amended Complaint further alleges that Defendants' marketing and advertising underscore these misleading representations. (Id. ¶¶ 19–24.) The Ester–C website, for instance, recommends taking Ester–C as one way to help stay healthy during winter months. (Id. ¶ 20.) In addition, Plaintiffs allege that Defendants falsely portray Ester–C as the “Better Vitamin C

.” (Id. ¶ 17.)

In their summary judgment motion, Defendants argue that Plaintiffs' challenge to Ester–C's “immune support” statement is preempted by federal law because Congress and the Food and Drug Administration (“FDA”) have directly addressed which statements manufacturers may, and may not, make in nutritional supplement

labeling. (Def. Mem. at 1.) Specifically, Defendants contend that “as a matter of federal law, the statement ‘immune support’ does not imply disease treatment or prevention.” (Id. (emphasis in original).) Indeed, Defendants' motion “is strictly limited to the statement of ‘Immune Support’[,]” and “does not seek to preclude Plaintiffs' attack on any other statement on Ester–C packaging.” (Dkt. 72 (“Reply”) at 2; see Def. Mem. at 3 n. 2 (noting that comparative claims that Ester–C is “better” are not at issue).)

DISCUSSION

I. Legal Standard

Summary judgment is proper only when, construing the evidence in the light most favorable to the non-movant, “there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” FRCP 56(a) ; see also Redd v. N.Y. Div. of Parole, 678 F.3d 166, 174 (2d Cir.2012). A dispute is “genuine” when “the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A fact is material when it “might affect the outcome of the suit under the governing law.” Id. Because Plaintiffs, as the non-moving party, have the “burden of proof at trial” on their claims, Defendants' ability to satisfy this standard as to any “essential element” of a claim “necessarily renders all other facts immaterial,” Celotex Corp. v. Catrett, 477 U.S. 317, 322–23, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986), and entitles Defendants to summary judgment.

In determining whether there are genuine disputes of material fact, the court must “resolve all ambiguities and draw all permissible factual inferences in favor of the party against whom summary judgment is sought.” Terry v. Ashcroft, 336 F.3d 128, 137 (2d Cir.2003) (citation and quotation omitted). The non-moving party cannot avoid summary judgment simply by relying “on conclusory allegations or unsubstantiated speculation.” Jeffreys v. City of New York, 426 F.3d 549, 554 (2d Cir.2005) (quotations and citations omitted). That party must offer “some hard evidence showing that its version of the events is not wholly fanciful.” Miner v. Clinton Cnty., New York, 541 F.3d 464, 471 (2d Cir.2008) (quotations and citation omitted).

II. Federal Regulatory Context

The federal Food, Drug, and Cosmetic Act (the “FDCA”), enacted in 1938, “empowers the [FDA] to (a) protect the public health by ensuring that ‘foods are safe, wholesome, sanitary, and properly labeled,’ 21 U.S.C. § 393(b)(2)(A) ; (b) promulgate regulations pursuant to this authority; and (c) enforce its regulations through administrative proceedings[,] [s ]ee 21 C.F.R. § 7.1 et seq. ” Jovel v. i-Health, Inc., 12 CV 5614, 2013 WL 5437065, at *3 (E.D.N.Y. Sept. 27, 2013). In 1990, Congress amended the FDCA by enacting the Nutrition Labeling and Education Act (the “NLEA”), codified, as amended, at 21 U.S.C. §§ 301, 321, 337, 343, 371. “The NLEA was passed 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 the nutrients in foods.’ ” Nutritional Health Alliance v. Shalala, 144 F.3d 220 (2d Cir.1998) (citing H.R.Rep. No. 101–538, at 7 (1990)).³

Defendants' motion focuses on a section of the NLEA “establish[ing] standards with respect to dietary supplements” that was added by Congress in 1994 through the passage of the Dietary Supplement Health and Education Act (“DSHEA”), Pub.L. No. 103–417, 108 Stat. 4325 ; see Jovel, 2013 WL 5437065, at *4 (DSHEA “created a new regime for the FDA's regulation of dietary supplements”). The term dietary supplements are defined in the DSHEA to include vitamins. 21 U.S.C. § 321(ff).⁴ The DSHEA allows dietary supplement labeling to include, among other types of statements, a statement that “describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans” (“structure/function claims”). Id. at § 343(r)(6)(A).⁵ Such structure/function claims do not require FDA pre-approval. Instead, companies that make structure/function claims must provide notice to the FDA within thirty days of first use of the claim, have “substantiation that such statement is truthful and not misleading,” and include a disclaimer on the label stating that the FDA has not evaluated the claim and that the product is not intended to “diagnose, treat, cure or prevent any disease.” Id. at § 343(r)(6)(B)-(C) ; see 21 C.F.R. § 101.93. Section 343(r)(6) expressly prohibits claims that dietary supplements can “diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases” (“disease claim”). 21 U.S.C. § 343(r)(6) ; see id. at §§ 343(r)(1)(B) and (r)(5)(D) (requiring prior authorization to make claims on a dietary supplement label that “characterize the relationship of any nutrient ... to a disease or a health-related condition”). Additionally, a dietary supplement may be misbranded where “its labeling is false or misleading in any particular.” Id. at § 343(a)(1).

In 2000, the FDA promulgated a regulation regarding the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body. 65 Fed.Reg. 1000–01 ; 21 C.F.R. § 101.93. The regulation established criteria for determining when a dietary supplement claim is an acceptable structure/function claim or a prohibited disease claim. 65 Fed.Reg. 1000–01 at 10001, I.B; see 21 C.F.R. § 101.93(f) (“[p]ermitted structure/function statements”) and § 101.93(g) (listing criteria for “disease claims”). The FDA warned that the rule is not “intended to establish whether any particular structure/function claim is appropriate for any specific product,” and that “an otherwise acceptable structure/function claim might nevertheless be false or misleading for other reasons.” 65 Fed.Reg. 1000–01 at 10001.

In proposing and responding to public comment on the criteria for disease claims, the...