ORDER DENYING MOTION TO DISMISS AND STRIKE
On June 25, 2015, Defendant Pharma-Care US, Inc. filed a motion to dismiss and
Background
This case is a putative nationwide consumer class action regarding Defendant’s over-the-counter product IntenseX. Plaintiff filed the initial complaint on April 3, 2015.- (Doc. No. 1.) He filed the operative first amended complaint (“FAC”) on June 11, 2015. (Doc. No. 9.) This Court has jurisdiction under the Class Action Fairness Act, 28 U.S.C. § 1332(d)(2). (Id. ¶ 1.)
Plaintiff seeks to litigate on behalf of all persons in' the United States who bought IntenseX primarily for personal, family, or household use and not for resale since January 1, 2004. (Id. ¶87.) He alleges causes of action for unlawful, unfair, and fraudulent business practices under California’s Unfair Competition Law (“UCL”), Cal. Bus. & Prof. Code § 17200 et seq.; violation of California’s False Advertising Law (“FAL”), Cal. Bus. & Prof. Code § 17500 et seq.; violation of California’s Consumer Legal Remedies Act (“CLRA”), Cal. Civ. Code § 1750 et seq.; breach of express warranty; breach of the implied warranty of merchantability; and violation of the federal Magnuson-Moss Warranty Act (“MMWA”), 15 U.S.C. § 2301 et seq. (FAC ¶¶ 99-146.)
According to Plaintiff, the name “Inten-seX” implies that the product will enable intense sex. (Id, ¶ 22.) The label contains the following statements: “Sexual Power and Performance,” “IntenseX is designed to intensify your endurance, stamina, and sexual performance,” “This fast acting formula quickly dissolves in the body releasing an energy packed blend of potent herbal extracts,” “Achieve peak performance to maximize the experience when you want it most,” “Laboratory Quality Tested,” “Proprietary Stamina Blend,” and “Produced using the highest manufacturing standards.” (Id. ¶¶ 23-25, 77.) The ingredients are calcium, guaraña, muirá puama, catuaba, ginkgo biloba, avena sativa, cor-dyceps, ashwaganda, tribulus terrestris, American ginseng, Korean ginseng, ginger, cinnamon, nutmeg, and cayenne. (Id. ¶ 28.)
The IntenseX website features pictures of amorous couples and claims the product “WORKS SO FAST YOU MAY NOT MAKE IT HOME,” and the “FAST ACTING FORMULA ... is the. only formula that works within minutes giving you the powerful energy you need to make a ‘long lasting
Plaintiff alleges that he bought IntenseX for $9.99 about fourteen months ago in California.. (Id. ¶ 75.) When deciding to buy the product, he relied on the label and believed IntenseX had powerful aphrodisiac qualities that would improve his sexual power and performance. (Id. ¶¶ 77-78.) But the product did not deliver the promised benefits. (Id. ¶ 79.) Moreover, he asserts, there is no evidence that the ingredients provide the claimed benefits, and consuming random herbs and extracts is potentially dangerous, which is an unfair and unreasonable risk considering that the product provides no benefits. (Id. ¶¶ 45, 79.)
Plaintiff supports his claims with several reports. According to New York Univer-
Plaintiff makes three core claims about IntenseX. First, he claims that IntenseX is misbranded because the product label and website make “disease” claims that cause reasonable consumers to believe the product can treat premature ejaculation, erectile dysfunction, and diminished libido. (Id. ¶¶ 63.) Hence, plaintiff claims, Inten-seX violates FDA regulation 21 C.F.R. § 101.93, which regulates the claims manufacturers can make on supplement labels, as well as California’s Sherman Food, Drug, and Cosmetic Law (“Sherman Law”), Cal, Health & Safety Code § 109875 et seq., which incorporates the FDA’s labeling regulations. (Id. ¶¶ 63-66, 102-03.) In turn, Plaintiff alleges that these violations are “unlawful” conduct within the meaning of the UCL. (Id. ¶¶ 101-03.)
Second, Plaintiff claims that IntenseX is misbranded because it is marketed for use as. an aphrodisiac. (Id. ¶¶ 58-62, 102.) The FDA has determined that any product that is promoted for use as an aphrodisiac is a “new drug” that requires premarket approval. See 21 C.F.R. § 310.528(b). Because Defendant does not have new-drug approval for IntenseX, Plaintiff asserts, the product is misbranded, in violation of FDA regulations, the Sherman Law, and the unlawful prong of the UCL. (FAC ¶¶ 101-03.)
. Third, Plaintiff alleges that the IntenseX labeling and advertising is false and misleading because IntenseX is incapable of delivering the áphrodisiac and sexual-health benefits it promises. (Id. ¶¶ 26-57.) He. claims that the-product is thus mis-branded under the Food, Drug, and Cosmetic Act (“FPCA”), the labeling violates California false-advertising laws and the Sherman Law, and these violations are unlawful conduct under the UCL. (Id. ¶¶ 101-03.) ..
Plaintiff seeks an order compelling Defendant to conduct a corrective advertising campaign and .destroy all misleading advertising materials, labels, and product; disgorgement; restitution; interest; attorney fees and costs; and actual and punitive damages. (Id. ¶¶ A-I.)
Discussion
A. Request for Judicial Notice
Defendant requests, judicial notice of scans of several items: (1) reproductions of the IntenseX label; (2) the FDA’s Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body, 65 Fed.Reg; 1000 (Jan. 6, 2000); and (3) three publications Plaintiff relied upon and cited in the FAC. (Doc. No. 11-2 & Exhs. A-E.) Plaintiff does not oppose the request;
The contents of the Federal Register are noticeable as a matter of law. See 44 U.S.C. § 1507 (“The contents of the Federal .Register shall be judicially no-ticed____”); Bayview Hunters Point Cmty. Advocates v. Metro. Transp. Comm’n,
The Court will not take judicial notice of the publications Plaintiff relied on and cited in the complaint, but will consider them under the doctrine of incorporation by reference. “Even if a document is-not attached to a complaint, it may be incorporated by reference into a complaint if the plaintiff refers extensively to the document or the document forms the basis of the plaintiffs claim.” United States v. Ritchie,
B. Motion to Dismiss
A motion to- dismiss under Federal Rule of Civil Procedure 12(b)(6) tests the legal sufficiency of the pleadings and allows a court to -dismiss a complaint if the plaintiff has failed to state a claim upon which relief can be granted. See Navarro v. Block,
Defendant contends that all of Plaintiffs claims must be dismissed under these standards. The Court addresses each of its arguments in turn.
1. Express Preemption
Defendant contends that Plaintiffs state-law claims are all expressly preempted by the Pood, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., as amended by the Nutrition Labeling and Education Act of 1990 (“NLEA”). (Doc. No. 11-1 at 14-15.) The FDCA sets guidelines for when food is misbranded. See 21 U.S.C. § 343. Subsection 343(a)(1) provides that food is misbranded if the “labeling is false or misleading in any particular.” Subsection § 343(r)(6), provides that dietary supplement labels can make so-called “structure/function” claims, but not “disease” claims. A structure/function claim is a statement that
claims a benefit related to a classic nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a dietary nutrient or dietary ingredient.
Id. § 343(r)(6)(A). A disease claim is a representation that a product can “diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.” Id. § 343(r)(6)i. If a product makes a disease claim, it is subject to regulation ás a drug. See 21 C.F.R. § 101.93(f).
The FDCA contains an express preemption provision that preempts state-law food-labeling requirements that are “not identical to the requirements of section 343(r).” 21 U.S.C. § 343-1(a)(5). This provision applies to supplements because supplements are deemed to be “food” for purposes of the FDCA. 21 U.S.C. § 321(ff). Under this framework, state-law claims are preempted only “where application of state laws would impose more or inconsistent burdens on manufacturers than the burdens imposed by the FDCA.” Gallagher v. Bayer AG,
Defendant contends that Plaintiffs state-law claims are expressly preempted because the FDA has determined that statements like the ones on the IntenseX label are acceptable structure/function claims. (Doc. No. 11-1 at 15.) Defendant relies on guidance the FDA issued with the final regulation interpreting, the distinction between structure/function claims and disease claims, 21 C.F.R. § 101.93(f)-(g). The guidance explains that “ ‘arouses or increases, sexual desire and improves sexual performance’ is an acceptable structure/function claim because it does not imply treatment of a disease.” 65 Fed.Reg. 1000, 1030 (Jan. 6, 2000). But “improves performance, staying power, and sexual potency” and “builds virility and sexual potency” are disease claims because they use the . term “potency,” which implies treatment of impotence. Id.
This regulation preempts Plaintiffs theory that the IntenseX label makes impermissible disease claims.' Among ' other things, the label promises “Sexual Power and Performance,” that IntenseX is “designed to intensify your endurance, stamina, and sexual performance,” and that it will enable users to “[ajchieve peak performance to maximize, the experience when
But Plaintiff also identifies statements on the IntenseX website that are disease claims. For example, the website states: “Empirical evidence suggests tribulus may help impotence in men and diminished libido in both sexes.” (EAC ¶ 57.) This statement is a disease claim because it “implies treatment of impotence, a disease.” 65 Fed.Reg. at 1030. Plaintiff asserts that these statements violate 21 C.F.R. § 101.93, the Sherman Law, and the unlawful prong of the UCL. (Id. ¶¶ 63, 65-67, 102.) The Sherman Law incorporates FDA regulations and adopts them as the laws of California. See Cal. Health & Safety Code § 110100(a) (“All food labeling regulations ... adopted pursuant to the federal act ... shall be the food labeling regulations of this state.”). Claims under the Sherman Law are not expressly preempted because the Sherman Law incorporates and parallels federal law. See Hesano v. Iovate Health Sciences, Inc.,
Plaintiffs other theories are also not expressly preempted. His second theory is that IntenseX is misbranded because it is marketed as an aphrodisiac, so that it is a “new drug” that is subject to the premarket approval process. (FAC ¶¶ 58-62.) In 21 C.F.R. § 310.528, the FDA determined: “Any product that bears labeling claims that it will arouse or increase sexual desire, or that it will improve sexual performance, is an aphrodisiac drug” that must be approved as a new drug before it is marketed. Like Plaintiffs theory regarding the website, this theory is not expressly preempted because Plaintiff alleges a violation of FDA regulations, a parallel violation of the Sherman Law, and a resulting violation of the unlawful prong of the UCL. (FAC ¶¶ 101-03.)
Plaintiffs third theory is that the IntenseX label is false and misleading because IntenseX does not and cannot provide the promised benefits. Because the label is false and misleading, Plaintiff asserts, it violates 21 U.S.C. § 343(a) of the FDCA and the unlawful and fraudulent prongs of the UCL. (FAC ¶¶ 102, 109.) This theory is not preempted because state false-advertising laws are consistent with the FDCA’s prohibition on false and misleading labeling and they are unrelated to the labeling requirements of § 343(r)(6). See Gallagher,
The rule is neither intended to establish whether any particular structure/function claim is appropriate for any specific product, nor whether the claim would be permitted under other provisions of the act.. Like the labeling of any other FDA-regulated product, the labeling of dietary supplements must comply with all applicable requirements of the actand regulations. For example, an otherwise acceptable strueture/function claim might nevertheless be false or misleading for other reasons, causing the product to be misbranded under [§ 343] of the act.
65 Fed.Reg. at 1001. Thus, Plaintiffs claims premised on the theory that the IntenseX labeling is false and misleading are also not expressly preempted.
2. Implied Preemption
Next, Defendant proposes that Plaintiffs claims are impliedly preempted under 21 U.S.C. § 337(a). (Doc. No. 11-1 at 15-18.) Section 337(a) provides that “all ... proceedings for the enforcement, or to restrain violations of the [FDCA] shall be by and in the name of the United States.” In a case involving medical devices, the Supreme Court held that § 337(a) impliedly preempted state-law fraud-on-the-FDA claims. See Buckman Co. v. Plaintiffs’ Legal Comm.,
Defendant contends that the rule from Buekman applies here. It relies on several medical-device cases, which are inappo-site, and Fraker v. KFC Corp.,
Since then, district courts have routinely rejected arguments that state-law UCL, FAL, and CLRA food-labeling claims and related claims under the Sherman Law are impliedly preempted under § 337(a) and Buckman. See Vassigh v. Bai Brands, LLC,
3. Lack of Substantiation
Next, Defendant proposes that Plaintiffs claims fail because he alleges
Plaintiff alleges only a lack of substantiation at points. For example, he alleges that “there is as yet no real evidence” that herbs offer any benefits for increasing sexual performance or desire, and there are “nó reliable scientific studies” establishing that ginkgo biloba improves sexual function. (FAC ¶¶ 32-33.) But Plaintiff also alleges falsity. For example, he alleges that several studies have shown that ginkgo biloba has no effect on improving sexual function, and that avena sativa, guaraña, ginger, nutmeg, cinnamon, and cayenne also do not improve - sexual function. ■ (Id. ¶¶ 34-35, 38-43.) Further, the FDA has determined that “labeling claims for aphrodisiacs for [over-the-counter] use are either false, misleading, or unsupported by scientific data.” 21 C.F.R. § 310.528(a).
Defendant argues that Plaintiff has pleaded himself out of court, since the materials he relies on refer to studies that found that ginkgo biloba and ginseng had positive effects on sexual function.
4. Plausibility
Next, Defendant contends that Plaintiffs’s UCL, FAL, and CLRA claims are not plausible because no reasonable consumer could be deceived by the representations on the IntenseX label. (Doc. No. 11-1 at 22-24.) Claims under the UCL, FAL, and CLRA are governed by the “reasonable consumer” test. Williams v. Gerber Prods. Co.,
5. Particularity
Next, Defendant argues that Plaintiffs UCL, FAL, and CLRA claims must be dismissed because they are insufficiently particular under Federal Rule of Civil Procedure 9(b). (Doc. No. 11-1 at 25-26.) Under Rule 9(b), a plaintiff must plead fraud with particularity. “Aver-ments of fraud must be accompanied by the who, what, when where, and how of the misconduct charged.” Vess v. Ciba-Geigy
6.Breach of Express Warranty
Defendant contends that Plaintiffs claim for breach of express warranty fails because Plaintiff has not alleged the elements of a claim. (Doc. No. 11-1 at 26-27.) To plead a claim for breach of express warranty, the plaintiff must allege the exact terms of the warranty, reasonable reliance, and that a breach of the warranty proximately caused his injury. See Williams v. Beechnut Nutrition Corp.,
Plaintiff has- adequately pleaded the elements of a claim for breach of express warranty. He identifies the specific statements made on the IntenseX packaging that promised increased sexual power and performance; he alleges that he and putative class members reasonably relied on those statements; and he alleges that the product did not and cannot provide the promised effects. (FAC ¶¶ 22-26, 77, 126-28.) Defendant has not shown that this claim must be' dismissed for any other reason, so its motion to dismiss this claim is denied.
7. Breach of Implied Warranty
Defendant argues that Plaintiffs claim for breach of the implied warranty of merchantability must be dismissed because Plaintiff does not allege that IntenseX was unfit for its ordinary use. (Doc. No. 11 — 1 at 27-28.) The implied warranty of merchantability “is breached when the goods do not conform to the promises or affirmations contained on the container or label or are not fit for the ordinary purposes for which the goods are used.” Martinez v. Metabolife Int’l, Inc.,
8. Magnuson-Moss Warranty Act
Defendant asserts that Plaintiffs Magnuson-Moss' Warranty Act (“MMWA”) claim fails because product descriptions are not warranties and the In-tenseX labeling is regulated by the FDCA, making the MMWA inapplicable. (Doc. No. 11-1 at 28-29.) The MMWA regulates warranties on consumer goods. It applies to written warranties, which are defined as a written affirmation that “relates to the nature of the material or workmanship and affirms or promises that such
The MMWA is expressly “inapplicable to any written waiTanty the making or content of which is otherwise governed by Federal Law.” 15 U.S.C. § 2311(d). But the next sentence provides: “If only a portion of a written warranty is so governed by Federal law, the remaining portion shall be subject to this chapter.” Id. Some courts have dismissed MMWA claims in product labeling actions based on the first sentence, with little analysis and no mention of the second sentence. See, e.g., Bates v. Gen. Nutrition Centers, Inc.,
Plaintiff borrows the state-law warranty claims, (FAC ¶ 139), which are adequately pleaded, and he asserts that the product is ineffective, contrary to the representations on the label, (id. ¶ 142). As a result, the complaint states a claim under both applications of the MMWA. Plaintiff will have to prove that the product does not work and is “defective” within the meaning of the MMWA, and Defendant is free to claim that the label made no warranty within the meaning of the MMWA. See Dorsey,
9. Claims Under the UCL
Defendant asserts that Plaintiff has failed to plead any UCL violation. (Doc. No. 11-1 at 29-30.) But Plaintiffs theories that the IntenseX labeling violates FDA regulations, the Sherman Law, and the unlawful prong of the UCL survive Defendant’s challenges. Plaintiffs false-advertising theory under the fraudulent prong of the UCL also survive. Defendant contends that Plaintiff has not adequately alleged a violation of the unfair prong because he did not identify the established public policy the label violates and he has not pleaded facts to suggest that Defendant’s conduct was immoral, oppressive, or substantially injurious to. consumers. (Doc. No. 11-1 at 29-30.) But Plaintiff alleges that the IntenseX labeling “offends public policy by seeking to profit from consumers’ vulnerability to false or
10. CLRA Claim
Defendant contends that Plaintiffs CLRA claim must be dismissed because he did not file an affidavit showing that this action was commenced in the proper county. (Doc. No. 11-1 at 18 n.9.) The CLRA requires plaintiffs to file an affidavit with the complaint showing that the action was commenced in the correct county. See Cal. Civ.Code § 1780(d). The correct county is “the county in which the person against whom it is brought resides, has his or her principal place of business, or is doing business, or in the county where the transaction or any substantial portion thereof occurred.” Id. If a plaintiff does not file the required affidavit; the statute directs the court to dismiss the action without prejudice. See id.
Plaintiff argues that this requirement is procedural, so that it does not apply to CLRA claims filed in federal court. Under the facts of this case, the Court agrees. Additionally, this appears to be the proper county, as Plaintiff alleges that Defendant conducts business in this district, has an office in this district, and the subsidiary responsible for selling and marketing In-tenseX is located in San Diego. (FAC ¶¶ 2-3.)
11. Injunctive Relief
Last, Defendant contends that Plaintiff does not have standing to seek injunctive relief-because he does not allege that he will purchase IntenseX ■ again. (Doc. No. 11-1 at 30-31.) To establish standing, the plaintiff must show that he suffered an injury in fact, the injury is “fairly traceable” to the defendant’s conduct, and the injury is likely to be redressed by a favorable decision. Lujan v. Defenders of Wildlife,
District courts are split as to whether plaintiffs in product-labeling actions have standing to seek -injunctive relief, since consumers who know the truth cannot claim any .future reliance on the purportedly misleading labeling. See In re 5-hour ENERGY Marketing & Sales Practices Litig.,
Plaintiff has standing to pursue his claims, and Defendant does not contend otherwise. Defendant’s request to shave off one remedy does not require dismissal of his claims. For now, the Court declines to dismiss Plaintiffs requests for injunc-tive relief.
Defendant moves to strike Plaintiffs allegations regarding punitive damages, Plaintiffs proposed class definition, and the statements on the IntenseX website. (Doc. No. 11-1 at 18 n.8, 31-32.) Federal Rule of Civil Procedure 12(f) provides that courts “may strike from any pleading an insufficient defense or any redundant, immaterial, impertinent, or scandalous mat-' ter.” ' ■ Courts ordinarily grant motions to strike only when the matter to be stricken clearly has no possible bearing on the litigation. See Ollier v. Sweetwater Union High Sch. Dist.,
Defendant contends that Plaintiff has not properly pleaded punitive damages. (Doc. No. 11-1 at 31.) Defendant relies on California Civil Code § 3294(b), which provides, for corporate punitive damages’liability, that an “officer, director, or managing agent of the corporation” must have consciously disregarded, authorized, or ratified each act of “oppression, fraud, of malice.”' See also White v. Ultramar, Inc.,
Conclusion
The Court denies Defendant’s motion to dismiss and strike, (Doc. No. 11). Many of the issues raised are better suited for summary judgment. Defendant must answer no later than. October 14, 2015.
IT IS SO ORDERED!
Notes
. These materials were the subject of Defendant's unopposed request for judicial notice. (Doc. No. 11-2, Exhs.C-E.)