Franz v. Beiersdorf, Inc. et al

MOTION to Dismiss for Failure to State a Claim Plaintiff's Second Amended Complaint

S.D. Cal.October 24, 2016

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 DEFENDANT’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S SECOND AMENDED COMPLAINT CASE NO. 3:14-CV-2241-LAB-RBB Alycia A. Degen (SBN 211350) adegen@sidley.com 555 West Fifth Street, Suite 4000 Los Angeles, California 90013 Telephone: (213) 896-6000 Facsimile: (213) 896-6600 Kara L. McCall (Pro Hac Vice) kmccall@sidley.com Elizabeth M. Chiarello (Pro Hac Vice) echiarello@sidley.com SIDLEY AUSTIN LLP One South Dearborn Chicago, Illinois 60603 Telephone: (312) 853-7000 Facsimile: (312) 853-7036 Attorneys for Defendant UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF CALIFORNIA ASHLEY FRANZ, On Behalf of Herself and All Others Similarly Situated, Plaintiff, vs. BEIERSDORF, INC. a Delaware Corporation Defendant. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Case No. 3:14-cv-02241-LAB-RBB DEFENDANT’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S SECOND AMENDED COMPLAINT Judge: Hon. Larry A. Burns Date: December 5, 2016 Time: 11:30 a.m. Place: Courtroom 14A (14th Fl.) *Oral Argument Requested DEMAND FOR JURY TRIAL Case 3:14-cv-02241-LAB-AGS Document 47 Filed 10/24/16 Page 1 of 4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 1 DEFENDANT’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S SECOND AMENDED COMPLAINT CASE NO. 3:14-CV-2241-LAB-RBB TO PLAINTIFF AND HER ATTORNEYS OF RECORD: PLEASE TAKE NOTICE that on December 5, 2016 at 11:30 a.m., or as soon thereafter as counsel may be heard, in Courtroom 14A of the above-entitled court, located at 333 West Broadway, San Diego, California 92101, Defendant Beiersdorf, Inc. (“Beiersdorf”) will and hereby does move to dismiss the Second Amended Complaint (“SAC”) [D.E. 46] filed by Plaintiff Ashley Franz (“Plaintiff”) pursuant to Federal Rules of Civil Procedure 8, 9(b), and 12(b)(6). The motion is made on the following grounds: (1) Plaintiff’s SAC does not meet the requirements of Federal Rules of Civil Procedure 8, 9 and 12. Plaintiff alleges that Defendant violated the Federal Food, Drug, and Cosmetic Act (“FDCA”) and California’s Sherman Act by selling its NIVEA Skin Firming Hydration Body Lotion (the “Lotion”) without an FDA- approved New Drug Application. SAC, [D.E. 46] at ¶ 31. The basis of Plaintiff’s Complaint is her assertion that Defendant’s skin firming representations about the Lotion “resulted in its being deemed a drug under FDA regulations.” Id. However, Plaintiff’s Complaint provides no support for this claim that would move it from possible to plausible, as required under Ashcroft v. Iqbal, 129 S.Ct. 1937 (2009) and Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007). Indeed, FDA’s stated positions and the case law actually undermine her claim. Thus, Plaintiff’s SAC fails to state a claim under Rules 8, 9 and 12 and must be dismissed. (2) Pursuant to Judge Burns’ Standing Order in Civil Cases, § 4(f), Defendant requests oral argument on this motion. The motion is based on this notice of motion, the memorandum of points and authorities, all other papers and pleadings on file, and the argument of counsel at the hearing of this motion. Case 3:14-cv-02241-LAB-AGS Document 47 Filed 10/24/16 Page 2 of 4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 2 DEFENDANT’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S SECOND AMENDED COMPLAINT CASE NO. 3:14-CV-2241-LAB-RBB Dated: October 24, 2016 SIDLEY AUSTIN LLP By: /s/ Alycia A. Degen Alycia A. Degen SIDLEY AUSTIN LLP 555 West Fifth Street Los Angeles, CA 90013 (213) 896-6682 (213) 896-6600 (fax) adegen@sidley.com Kara L. McCall (Pro Hac Vice) kmccall@sidley.com Elizabeth M. Chiarello (Pro Hac Vice) echiarello@sidley.com SIDLEY AUSTIN LLP 1 S. Dearborn Street Chicago, IL 60603 (312) 853-7000 (312) 853-7036 (fax) Attorneys for Defendant Case 3:14-cv-02241-LAB-AGS Document 47 Filed 10/24/16 Page 3 of 4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 3 DEFENDANT’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S SECOND AMENDED COMPLAINT CASE NO. 3:14-CV-2241-LAB-RBB CERTIFICATE OF SERVICE VIA CM/ECF SYSTEM The undersigned certifies that on October 24, 2016, a true and correct copy of the following document was electronically filed and served on all counsel of record who are deemed to have consented to electronic service via the Court’s CM-ECF system: DEFENDANT’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFF’S SECOND AMENDED COMPLAINT Pursuant to the CM/ECF system, registration as a CM/ECF user constitutes consent to electronic service through the Court’s transmission facilities. Any other counsel of record will be served by electronic mail and U.S. mail. _/s/ Alycia Degen Alycia Degen Counsel for Defendant Case 3:14-cv-02241-LAB-AGS Document 47 Filed 10/24/16 Page 4 of 4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 DEFENDANT’S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION TO DISMISS PLAINTIFF’S SECOND AMENDED COMPLAINT - CASE NO. 3:14-CV-02241-LAB-RBB Alycia A. Degen (SBN 211350) adegen@sidley.com SIDLEY AUSTIN LLP 555 California Street, 20th Floor San Francisco, CA 94104 Telephone: (415) 772-1200 Facsimile: (415) 772-7400 Kara L. McCall (Pro Hac Vice) kmccall@sidley.com Elizabeth M. Chiarello (Pro Hac Vice) echiarello@sidley.com SIDLEY AUSTIN LLP 1 S. Dearborn Street Chicago, IL 60603 Telephone: (312) 853-7000 Facsimile: (312) 853-7036 Attorneys for Defendant UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF CALIFORNIA ASHLEY FRANZ, On Behalf of Herself and All Others Similarly Situated, Plaintiff, v. BEIERSDORF, INC. a Delaware Corporation, Defendant. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Case No. 3:14-cv-02241-LAB-RBB DEFENDANT’S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION TO DISMISS PLAINTIFF’S SECOND AMENDED COMPLAINT Judge: Hon. Larry A. Burns Date: December 5, 2016 Time: 11:30 a.m. Place: Courtroom 14A (14th Fl.) *Oral Argument Requested DEMAND FOR JURY TRIAL Case 3:14-cv-02241-LAB-AGS Document 47-1 Filed 10/24/16 Page 1 of 11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 i DEFENDANT’S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION TO DISMISS PLAINTIFF’S CORRECTED FIRST AMENDED COMPLAINT - CASE NO. 3:14-CV-02241-LAB-RBB TABLE OF CONTENTS Page BACKGROUND ........................................................................................................... 1 I. PLAINTIFF’S SECOND AMENDED COMPLAINT DOES NOT SATISFY RULES 8 OR 9(b). .................................................................................. 3 A. Legal Standard ..................................................................................................... 3 B. Plaintiff Fails To Plausibly Allege That The Lotion Is A Drug .......................... 4 1. FDA Guidance Does Not Move Plaintiff’s Claim From Possible To Plausible .................................................................................................... 4 2. Case Law Does Not Move Plaintiff’s Claim From Possible To Plausible. ........................................................................................................ 7 CONCLUSION .............................................................................................................. 8 Case 3:14-cv-02241-LAB-AGS Document 47-1 Filed 10/24/16 Page 2 of 11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 1 DEFENDANT’S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION TO DISMISS PLAINTIFF’S CORRECTED FIRST AMENDED COMPLAINT - CASE NO. 3:14-CV-02241-LAB-RBB Plaintiff’s Second Amended Complaint is based solely on the premise that Defendant’s NIVEA Skin Firming Hydration Body Lotion with CoQ10 Plus (the “Lotion”) is a drug. According to Plaintiff, because the Lotion label makes statements about improving firmness and tightening the skin’s surface, the Lotion is not only a cosmetic (as it is currently sold), but also a drug that is “misbranded” and “illegal” because it has not been approved by the U.S. Food and Drug Administration (“FDA”) (Second Amended Complaint (“SAC”) [Dkt. 46] at ¶¶ 2-3). In particular, the SAC challenges the label statements that the Lotion “improves skin firmness within 2 weeks,” and that the Lotion is “proven to firm and tighten skin’s surface in as little as two weeks” (collectively referred to as the “skin-firming representations”) (id. at ¶¶ 2, 10). Because Plaintiff has no factual or legal support whatsoever for her theory, and therefore fails to establish the required plausibility for her claims, this Court should dismiss the SAC in its entirety. BACKGROUND On November 13, 2014, Plaintiff filed her Corrected First Amended Complaint (“FAC”) [Dkt. 19], which made two claims: (1) the Lotion’s skin-firming representations were false and misleading because they were not supported by “reliable scientific evidence” (which Plaintiff defined as published, randomized, placebo-controlled, clinical trials subject to peer review) (id. at ¶¶ 13-26, Count II (violation of the Consumer Legal Remedies Act)); and (2) the Lotion is not only a cosmetic but also a drug, which cannot be sold without an FDA-approved New Drug Application (“NDA”) (id. at ¶¶ 27-38, Count I (Violation of Business & Professions Code, UCL)). Plaintiff sought monetary and injunctive relief on behalf of a multi- state class (id. at ¶ 46 and p. 20). Defendant filed a Motion to Dismiss the FAC, on the grounds that (1) Plaintiff had not sufficiently alleged an actionable misrepresentation; and (2) the UCL cosmetic/drug classification claim should be dismissed or stayed based on the primary jurisdiction doctrine [Dkt. 22]. The Court agreed with Defendant, finding, first, that Case 3:14-cv-02241-LAB-AGS Document 47-1 Filed 10/24/16 Page 3 of 11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 2 DEFENDANT’S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION TO DISMISS PLAINTIFF’S CORRECTED FIRST AMENDED COMPLAINT - CASE NO. 3:14-CV-02241-LAB-RBB Plaintiff failed to state a cognizable claim for misrepresentation because she alleged only that the skin-firming representations lacked substantiation, not that they were actually false (Order [Dkt. 34] at 4-5). The Court granted Plaintiff leave to re-plead her misrepresentation claim if she could adequately allege actual falsity (id. at 9). The Court also agreed that the FDA had primary jurisdiction to determine whether the Lotion was a drug or a cosmetic (id. at 7). Plaintiff did not re-plead her misrepresentation claim. As to her cosmetic/drug classification claim, on September 16, 2015, Plaintiff filed a “Citizen Petition” with the FDA asking the FDA to commence the warning letter process with regard to the Lotion on the ground that it is a drug that requires approval of an NDA, or, alternatively, inform Plaintiff that it did not intend to take any action regarding the Lotion (see Plaintiff’s Supplemental Report Regarding Order Staying Plaintiff’s UCL Claims and Request for Telephonic Status Conference [Dkt. 37]). On March 14, 2016, Plaintiff received notification from the FDA indicating that it did not intend to take action regarding the Lotion [Dkt. 37, 37-1], and further noting that enforcement action is decided on a case-by-case basis and is within the discretion of the agency [id.]. On October 3, 2016, in light of the FDA’s notification, this Court granted Plaintiff’s motion for leave to file her Second Amended Complaint [Dkt. 45]. In her Second Amended Complaint, Plaintiff has dropped all allegations other than the allegation that the Lotion is an unapproved drug. Without citing any guidance or statement from the FDA concluding that skin-firming statements make the Lotion not only a cosmetic but also a drug, Plaintiff alleges that Defendant violated the Federal Food, Drug, and Cosmetic Act (“FDCA”) and California’s Sherman Act by selling the Lotion without obtaining an approved NDA. Although she made different reliance allegations in her earlier Complaint,1 she now claims that 1 In her Corrected First Amended Complaint (“FAC”), Plaintiff claimed that she purchased the Lotion “in reliance on Defendant’s skin firming representations” and paid a “substantial premium” because of those representations (FAC [Dkt. 19] at ¶ 11). In the FAC, she did not allege, as she does now, that she would not have purchased the product had she known that it was an unapproved drug. Case 3:14-cv-02241-LAB-AGS Document 47-1 Filed 10/24/16 Page 4 of 11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 3 DEFENDANT’S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION TO DISMISS PLAINTIFF’S CORRECTED FIRST AMENDED COMPLAINT - CASE NO. 3:14-CV-02241-LAB-RBB she would not have purchased the Lotion (which she purchased for $10 at a San Diego CVS) had she known it was an “illegal and misbranded drug” (SAC ¶ 7). Plaintiff asserts only one count: an Unfair Competition Law (“UCL”) claim based on the “unlawful” prong of that statute (id. ¶¶ 28-36). Plaintiff seeks damages on behalf of a California class of consumers who purchased the Lotion (id. ¶¶ 21, 33-34, p. 9). I. PLAINTIFF’S SECOND AMENDED COMPLAINT DOES NOT SATISFY RULES 8 OR 9(b). A. Legal Standard “To survive a motion to dismiss [under Rule 12(b)(6)], a complaint must contain sufficient factual matter to ‘state a claim to relief that is plausible on its face.’” Sateriale v. R.J. Reynolds Tobacco Co., 697 F.3d 777, 784 (9th Cir. 2012) (emphasis added) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)). Plausibility requires that the allegations, taken as true, be “enough to raise a right to relief above the speculative level.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 559 (2007); Fed. R. Civ. P. 8. That standard “asks for more than a sheer possibility that a defendant has acted unlawfully.” Ashcroft v. Iqbal, 129 S.Ct. 1937, 1949 (2009) (quoting Twombly, 550 U.S. at 556); see also Iqbal, 556 U.S. at 678 (“Nor does a complaint suffice if it tenders “naked assertion[s]” devoid of “further factual enhancement.”) (internal quotation marks omitted). “Mere conclusory statements in a complaint and ‘formulaic recitation[s] of the elements of a cause of action’ are not sufficient.” Chavez v. U.S., 683 F.3d 1102, 1108 (9th Cir. 2012) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007)). “Thus, a court discounts conclusory statements, which are not entitled to the presumption of truth, before determining whether a claim is plausible.” Chavez, 683 F.3d at 1108; Timmons v. Linvatec Corp., 263 F.R.D. 582, 584 (C.D. Cal. 2010). Where “the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct,” the complaint should be dismissed. Iqbal, 556 U.S. at 679 (emphasis added). Case 3:14-cv-02241-LAB-AGS Document 47-1 Filed 10/24/16 Page 5 of 11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 4 DEFENDANT’S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION TO DISMISS PLAINTIFF’S CORRECTED FIRST AMENDED COMPLAINT - CASE NO. 3:14-CV-02241-LAB-RBB B. Plaintiff Fails To Plausibly Allege That The Lotion Is A Drug. Plaintiff does not dispute that the Lotion is a cosmetic (SAC ¶ 12). Plaintiff alleges that the Lotion is also a drug (id. ¶17). Plaintiff, however, provides no support that would move this claim - the entire basis of her Complaint - from possible to plausible, as required under Iqbal and Twombly. Indeed, FDA’s stated positions and the case law actually undermine her claim. 1. FDA Guidance Does Not Move Plaintiff’s Claim From Possible To Plausible. Plaintiff has cited to no guidance or regulation from the FDA (or any regulatory agency) concluding that “firming” claims such as ones made on the label of the Lotion are drug claims. The fact that the FDA has found products intended “to remove wrinkles or increase the skin’s production of collagen” to be drugs (SAC, ¶ 16), says nothing about the Lotion, which makes no representations about wrinkles or increasing production of collagen. See Hutt, et al., Food and Drug Law, 4th ed. 2014, 114-15 (“ a product that claims to improve or maintain temporarily the appearance or the feel of the skin” is a cosmetic, not a drugs) (quoting Letter From John M. Taylor, FDA Associate Commissioner for Regulatory Affairs, to Various Attorneys Representing the Cosmetic Industry, Nov. 19, 1987 (“Taylor Letter”), and explaining that the “letter represents the agency’s view of the line between separating cosmetics from cosmetic drugs to the current day”). The Taylor Letter states that “claims that a product ‘counteracts,’ ‘retards,’ or ‘controls’ aging or the aging process, as well as claims that a product will ‘rejuvenate,’ ‘repair,’ or ‘renew’ the skin are drug claims because they can be fairly understood as claims that a function of the body, or that the structure of the body, will be affected by the product.” Id. The Taylor Letter goes on to note, however, in no uncertain terms, that “a product that claims to moisturize or soften the skin is a cosmetic.” Id. This interpretation has been most recently reiterated in FDA’s guidance for Alpha Hydroxy Acids (“AHA”) used in both cosmetics and drugs. See Request for Case 3:14-cv-02241-LAB-AGS Document 47-1 Filed 10/24/16 Page 6 of 11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 5 DEFENDANT’S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION TO DISMISS PLAINTIFF’S CORRECTED FIRST AMENDED COMPLAINT - CASE NO. 3:14-CV-02241-LAB-RBB Judicial Notice (“RJN”), Exhibit A (Alpha Hydroxy Acids, available at http://www.fda.gov/cosmetics/productsingredients/ingredients/ucm107940.htm (last visited Oct. 21, 2016)). In that guidance, FDA notes that AHAs are cosmetics when intended for “smoothing fine lines and surface wrinkles, improving skin texture and tone, unblocking and cleansing pores, and improving skin condition,” but are considered drugs when marketed for “treating acne, removing scars, and lightening discolorations.” Id. It is clear that the FDA’s interpretation of the FDCA is starkly at odds with Plaintiff’s theory. Plaintiff’s theory appears to be that a skin-firming claim is a claim to affect the structure of function of the body, and therefore a product making a firming claim is a drug. But the FDA has clearly stated that a product that moisturizes or softens the skin (which also affects the structure or function of the body) is a cosmetic, so the very product that the FDA says is a cosmetic would be a drug if Plaintiff’s theory were correct. The theory underlying Plaintiff’s SAC cannot be correct. To be sure, Plaintiff cites to one 2012 Warning Letter sent by the FDA to Avon, but that Warning Letter was concerned with Avon’s use of “wrinkle” claims - which have no relation to the language used on the label of the Lotion. See RJN Ex. B. The FDA issued the Warning Letter to Avon because its products were making claims such as: • “The at-home answer to wrinkle-filling injections. Start rebuilding collagen in just 48 hours.” • “4D WRINKLE-REVERSE TECHNOLOGY IS DESIGNED TO: Rebuild collagen to help plump out lines and wrinkles. Stimulate elastin to help improve elasticity and resilience. Regenerate hydroproteins to help visibly minimize creasing.” • “Formulated to boost shock-absorbing proteins to help strength skin’s support layers.” Case 3:14-cv-02241-LAB-AGS Document 47-1 Filed 10/24/16 Page 7 of 11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 6 DEFENDANT’S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION TO DISMISS PLAINTIFF’S CORRECTED FIRST AMENDED COMPLAINT - CASE NO. 3:14-CV-02241-LAB-RBB • “Improve fine & deep wrinkles up to 50%. Immediately plumps out wrinkles and fine lines. Within 48 hours begins boosting collagen production.” • “Designed to boost Activitn, ANEW’s Activinol Technoloyg helps reactivitate skin’s repair process to recreate fresh skin & help dramatically reverse vsisible wrinkles.” • “Help tighten the connections between skin’s layers.” • “Formulated with pomegranate and fennel extracts to help boost production of collagen and elastin.” Id. The Lotion is distinguishable from these products because it is a firming lotion-it does not purport to remove wrinkles, improve elasticity and resilience, or boost collagen production. The only “skin firming” statement that Avon made was “Our effective lifting treatment is formulated to fortify damaged tissue with new collagen. In just 3 days, see tighter, firmer, more lifted skin.” This statement is much more aggressive than the Lotion’s skin-firming representations in that it is accompanied by a claim about “fortify[ing] damaged tissue with new collagen.” In short, the one document Plaintiff puts forth to support her theory -the FDA warning letter to Avon - has nothing to do with this case. Moreover, Plaintiff has not alleged that FDA has issued a monograph or guidance regarding the classification of products that make skin-firming claims like those made on the Lotion. To the contrary, the FDA advised that a product is not a drug if it claims “to make lines and wrinkles less noticeable” (See RJN Ex. C, FDA, Wrinkle Treatments and Other Anti-Aging Products, available at http://www.fda.gov/Cosmetics/ProductsIngredients/Products /ucm388826.htm (updated July 2, 2014) (emphasis added)), but is a drug if it claims to “remove wrinkles or increase the skin’s production of collagen,” id. (emphasis added). Plaintiff provides absolutely no support for her claims other than her own speculation Case 3:14-cv-02241-LAB-AGS Document 47-1 Filed 10/24/16 Page 8 of 11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 7 DEFENDANT’S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION TO DISMISS PLAINTIFF’S CORRECTED FIRST AMENDED COMPLAINT - CASE NO. 3:14-CV-02241-LAB-RBB as to how FDA might view the statements. Because her speculation cannot take her claim from possible to plausible, it must be dismissed. 2. Case Law Does Not Move Plaintiff’s Claim From Possible To Plausible. Plaintiff does not cite to any case law concluding that “firming” claims such as the ones made on the label of the Lotion are drug claims. To the contrary, at least one District Court has found that claims of skin firming and tightening (along with additional claims that the Lotion does not make) are clearly intended to be understood as cosmetic claims related to “altering the appearance,” and are not representations “that the product will affect the structure of the body in some medical-or drug-type fashion.” U.S. v. An Article . . . “Helene Curtis Magic Secret,” 331 F. Supp. 912, 917 (D. Md. 1971). In Helene Curtis, the court confronted a product called Magic Secret making the following claims: “pure protein,” “smoothes away wrinkles in minutes, keeps them way for hours,” “dramatic power to smooth away crowsfeet, puffy undereye circles, laugh, frown, and throat lines in just minutes,” “see how smooth and young looking your skin can become,” “skin should respond fully to Magic Secret’s dramatic action,” “does indeed firm the skin to smoother, younger-looking loveliness,” “astringent sensation . . . indicating that the lotion is gently firming and toning your skin,” “tightening and moisturizing tired skin,” and “skin quickly responds to Magic Secret’s dramatic astringent activity.” 331 F. Supp. at 915. Even in light of these claims - which were much more aggressive than the claims Plaintiff is challenging here - the court held that Magic Secret was a cosmetic and not a drug because “even the ‘ignorant, unthinking and credulous’ consumer would not be led . . . to believe that ‘Magic Secret” would do other than alter their appearance.” Id. at 917. Here, by comparison, Defendant is alleged to have made only one of the many claims made about the Magic Secret, and it cannot be said that the ignorant, unthinking, and credulous consumer in 2012 (when Franz said she Case 3:14-cv-02241-LAB-AGS Document 47-1 Filed 10/24/16 Page 9 of 11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 8 DEFENDANT’S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION TO DISMISS PLAINTIFF’S CORRECTED FIRST AMENDED COMPLAINT - CASE NO. 3:14-CV-02241-LAB-RBB bought the product) would plausibly believe the Lotion would do anything other than alter the appearance of skin. Indeed, taking Plaintiff’s allegations as true, it appears that even she believed the Lotion was a cosmetic when she bought it. She alleges that, had she known it was a drug, she would not have bought it (SAC ¶ 7), which implies that even she understood the product to be making cosmetic claims. CONCLUSION For the foregoing reasons, Defendant requests that the Court dismiss Plaintiff’s Corrected First Amended Complaint pursuant to Fed. R. Civ. P. 8 and 12(b)(6). Dated: October 24, 2016 SIDLEY AUSTIN LLP By: /s/ Alycia A. Degen Alycia A. Degen SIDLEY AUSTIN LLP 555 West Fifth Street Los Angeles, CA 90013 (213) 896-6682 (213) 896-6600 (fax) adegen@sidley.com Kara L. McCall (Pro Hac Vice) kmccall@sidley.com Elizabeth M. Chiarello (Pro Hac Vice) echiarello@sidley.com SIDLEY AUSTIN LLP 1 S. Dearborn Street Chicago, IL 60603 (312) 853-7000 (312) 853-7036 (fax) Attorneys for Defendant Case 3:14-cv-02241-LAB-AGS Document 47-1 Filed 10/24/16 Page 10 of 11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 9 DEFENDANT’S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION TO DISMISS PLAINTIFF’S CORRECTED FIRST AMENDED COMPLAINT - CASE NO. 3:14-CV-02241-LAB-RBB CERTIFICATE OF SERVICE VIA CM/ECF SYSTEM The undersigned certifies that on October 24, 2016, a true and correct copy of the following document was electronically filed and served on all counsel of record who are deemed to have consented to electronic service via the Court’s CM-ECF system: DEFENDANT’S MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION TO DISMISS PLAINTIFF’S SECOND AMENDED COMPLAINT Pursuant to the CM/ECF system, registration as a CM/ECF user constitutes consent to electronic service through the Court’s transmission facilities. Any other counsel of record will be served by electronic mail and U.S. mail. _/s/ Alycia Degen__ _ Alycia Degen Counsel for Defendant Case 3:14-cv-02241-LAB-AGS Document 47-1 Filed 10/24/16 Page 11 of 11 REQUEST FOR JUDICIAL NOTICE -3:14-cv-02241-LAB-RBB 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Alycia A. Degen (SBN 211350) adegen@sidley.com SIDLEY AUSTIN LLP 555 California Street, 20th Floor San Francisco, CA 94104 Telephone: (415) 772-1200 Facsimile: (415) 772-7400 Kara L. McCall (Pro Hac Vice) kmccall@sidley.com Elizabeth M. Chiarello (Pro Hac Vice) echiarello@sidley.com SIDLEY AUSTIN LLP 1 S. Dearborn Street Chicago, IL 60603 Telephone: (312) 853-7000 Facsimile: (312) 853-7036 Attorneys for Defendant UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF CALIFORNIA ASHLEY FRANZ, On Behalf of Herself and All Others Similarly Situated, Plaintiff, v. BEIERSDORF, INC. a Delaware Corporation, Defendant. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Case No. 3:14-cv-02241-LAB-RBB REQUEST FOR JUDICIAL NOTICE IN SUPPORT OF MOTION TO DISMISS PLAINTIFF’S SECOND AMENDED COMPLAINT Judge: Hon. Larry A. Burns Date: December 5, 2016 Time: 11:30 a.m. Place: Courtroom 14A (14th Fl.) Case 3:14-cv-02241-LAB-AGS Document 47-2 Filed 10/24/16 Page 1 of 6 1 REQUEST FOR JUDICIAL NOTICE -3:14-cv-02241-LAB-RBB 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD: PLEASE TAKE NOTICE that on December 5, 2016 at 11:30 a.m., or as soon thereafter as counsel may be heard, in Courtroom 14A of the above-entitled Court, located at 333 West Broadway, San Diego, CA 92101, Defendant Beiersdorf, Inc. (“Beiersdorf”) will and hereby does request that the Court take judicial notice of documents published by the U.S. Food and Drug Administration (“FDA”), attached as exhibits A-C to this Request. This Request is being submitted in support of Beiersdorf’s Motion to Dismiss Plaintiff’s Second Amended Complaint and is based on this Notice and Request, the Memorandum of Points and Authorities attached hereto, all the papers, records, and pleadings on file in this action, and such other evidence as may be presented at the hearing on Defendant’s Motion to Dismiss. Dated: October 24, 2016 SIDLEY AUSTIN LLP By: /s/ Alycia A. Degen Alycia A. Degen SIDLEY AUSTIN LLP 555 West Fifth Street Los Angeles, CA 90013 (213) 896-6682 (213) 896-6600 (fax) adegen@sidley.com Kara L. McCall (Pro Hac Vice) kmccall@sidley.com Elizabeth M. Chiarello (Pro Hac Vice) echiarello@sidley.com SIDLEY AUSTIN LLP 1 S. Dearborn Street Chicago, IL 60603 (312) 853-7000 (312) 853-7036 (fax) Attorneys for Defendant Case 3:14-cv-02241-LAB-AGS Document 47-2 Filed 10/24/16 Page 2 of 6 1 REQUEST FOR JUDICIAL NOTICE -3:14-cv-02241-LAB-RBB 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 MEMORANDUM OF POINTS AND AUTHORITIES Pursuant to Federal Rule of Evidence 201, and in connection with its concurrently filed Motion to Dismiss Plaintiff’s Second Amended Complaint (“SAC”), Defendant Beiersdorf, Inc. (“Beiersdorf”) respectfully requests that the Court take judicial notice of the following documents, which are referenced in Defendant’s Memorandum of Points and Authorities in Support of its Motion to Dismiss (“Def. Mem.”) at 5-7 and publicly available on the website of the FDA: • Attached hereto as Exhibit A is a true and correct copy of U.S. Food & Drug Administration (“FDA”), Alpha Hydroxy Acids, available at http://www.fda.gov/cosmetics/productsingredients/ingredients/ucm107940.htm (last visited Oct. 21, 2016). • Attached hereto as Exhibit B is a true and correct copy of a letter from M. Roosevelt (FDA) to A. Jung (Avon) dated Oct. 5, 2012, available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm323738.htm (last visited Oct. 21, 2016). This document is also referenced in Plaintiff’s SAC at ¶16. • Attached hereto as Exhibit C is a true and correct copy of FDA, Wrinkle Treatments and Other Anti-Aging Products, available at http://www.fda.gov/Cosmetics/ProductsIngredients/Products /ucm388826.htm (updated July 2, 2014) (last visited Oct. 21, 2016). Federal Rule of Evidence 201(b) authorizes the Court to take judicial notice of facts that are “not subject to reasonable dispute” because they “can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.” Fed. R. Evid. 201(b). Pursuant to this Rule, courts routinely take judicial notice of documents that appear on FDA’s website without converting motions to dismiss into motions for summary judgment. See, e.g., Gustavson v. Wrigley Sales Co., 961 F. Supp. 2d 1100, 1113 n.1 (N.D. Cal. 2013) (“[A] court may take judicial notice of . . . matters of public record,” including documents “available on the FDA’s website”); Eidson v. Medtronic, Inc., 981 F. Supp. 2d 868, 878-79 (N.D. Cal. 2013) (taking judicial notice of documents Case 3:14-cv-02241-LAB-AGS Document 47-2 Filed 10/24/16 Page 3 of 6 2 REQUEST FOR JUDICIAL NOTICE -3:14-cv-02241-LAB-RBB 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 that “appear on the FDA’s public website”); Modglin v. DJO Global Inc., 48 F. Supp. 3d 1362, 1381 (C.D. Cal. 2014) (taking judicial notice of documents from FDA’s website, because “[u]nder Rule 201, the court can take judicial notice of public records and government documents available from reliable sources on the Internet, such as websites by government agencies”) (internal quotations omitted); Erickson v. Boston Scientific Corp., 846 F. Supp. 2d 1085, 1088-89 (C.D. Cal. 2011) (taking judicial notice of documents that are “published by the Food and Drug Administration (“FDA”) and are located . . . on the FDA’s online database.”).1 Additionally, under the “incorporation by reference” doctrine, a district court may consider, on a motion to dismiss, “documents whose contents are alleged in a complaint and whose authenticity no party questions, but which are not physically attached to the [plaintiff’s] pleading.” Gustavson, 961 F. Supp. 2d at 1113 n.1 (taking judicial notice of packaging labels referenced and quoted in the complaint). Accordingly, Defendant respectfully requests that the Court take judicial notice of the FDA materials referenced above and in its Memorandum of Points and Authorities in Support of its Motion to Dismiss, and consider these documents in connection with Defendant’s concurrently filed Motion to Dismiss Plaintiff’s Second Amended Complaint. 1 Courts throughout the country have likewise taken judicial notice of public FDA records. See, e.g., Reeves v. PharmaJet, Inc., 846 F. Supp. 2d 791, 794 n.1 (N.D. Ohio 2012); Desabio v. Howmedica Osteonics Corp., 817 F. Supp. 2d 197, 201 n.3 (W.D.N.Y. 2011); In re Wellbutrin SR/Zyban Antitrust Litg., 281 F. Supp. 2d 751, 754 n.2 (E.D. Pa. 2003); see also Tillman v. Smith & Nephew, Inc., No. 12 C 4977, 2012 WL 6681698, at *1-2 (N.D. Ill. Nov. 1, 2012); Ali v. Allergan USA, Inc., No. 1:12-CV-115, 2012 WL 3692396, at *1 (E.D. Va. Aug. 23, 2012); Funk v. Stryker Corp., 673 F. Supp. 2d 522 (S.D. Tex. 2009), aff’d, 631 F.3d 777 (5th Cir. 2011); Tierney v. AGA Med. Corp., No. 4:11CV3098, 2011 WL 7400469, at *1 n.9 (D. Neb. Nov. 18, 2011). Case 3:14-cv-02241-LAB-AGS Document 47-2 Filed 10/24/16 Page 4 of 6 3 REQUEST FOR JUDICIAL NOTICE -3:14-cv-02241-LAB-RBB 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Dated: October 24, 2016 SIDLEY AUSTIN LLP By: /s/ Alycia A. Degen Alycia A. Degen SIDLEY AUSTIN LLP 555 West Fifth Street Los Angeles, CA 90013 (213) 896-6682 (213) 896-6600 (fax) adegen@sidley.com Kara L. McCall (Pro Hac Vice) kmccall@sidley.com Elizabeth M. Chiarello (Pro Hac Vice) echiarello@sidley.com SIDLEY AUSTIN LLP 1 S. Dearborn Street Chicago, IL 60603 (312) 853-7000 (312) 853-7036 (fax) Attorneys for Defendant Case 3:14-cv-02241-LAB-AGS Document 47-2 Filed 10/24/16 Page 5 of 6 4 REQUEST FOR JUDICIAL NOTICE -3:14-cv-02241-LAB-RBB 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 CERTIFICATE OF SERVICE VIA CM/ECF SYSTEM The undersigned certifies that on October 24, 2016, a true and correct copy of the following document was electronically filed and served on all counsel of record who are deemed to have consented to electronic service via the Court’s CM-ECF system: REQUEST FOR JUDICIAL NOTICE IN SUPPORT OF MOTION TO DISMISS PLAINTIFF’S SECOND AMENDED COMPLAINT Pursuant to the CM/ECF system, registration as a CM/ECF user constitutes consent to electronic service through the Court’s transmission facilities. Any other counsel of record will be served by electronic mail and U.S. mail. /s/ Alycia A. Degen _ Alycia A. Degen Counsel for Defendant Case 3:14-cv-02241-LAB-AGS Document 47-2 Filed 10/24/16 Page 6 of 6 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 TABLE OF EXHIBITS 217867549 TABLE OF EXHIBITS [Submitted In Support Of Defendant’s Memorandum Of Points And Authorities In Support of Defendant’s Motion to Dismiss Second Amended Complaint] EXHIBIT DESCRIPTION PAGES Exhibit A FDA Alpha Hydroxy Acids Article 1-4 Exhibit B Letter from M. Roosevelt (FDA) to A. Jung (Avon) dated Oct. 5, 2012 5-6 Exhibit C FDA Wrinkle Treatments and Other Anti-aging Products Article 7-8 Case 3:14-cv-02241-LAB-AGS Document 47-3 Filed 10/24/16 Page 1 of 1 EXHIBIT A Case 3:14-cv-02241-LAB-AGS Document 47-4 Filed 10/24/16 Page 1 of 5 10/21/2016 Ingredients > Alpha Hydroxy Acids http://www.fda.gov/cosmetics/productsingredients/ingredients/ucm107940.htm 1/4 Alpha Hydroxy Acids See also: Guidance for Industry: Labeling for Cosmetics Containing Alpha Hydroxy Acids (/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm090816.htm) The following information is intended to answer questions about alpha hydroxy acids, also known as AHAs, which are often used as ingredients in cosmetic and drug products applied to the skin. Why are AHAs used in some cosmetics? How do AHAs work? What about products that contain AHAs and are marketed with therapeutic claims? Has FDA received reports of adverse events related to AHAs? Has FDA conducted research on the safety of AHAs? How can AHAs be used safely? How can I know if a product contains AHAs? Why are AHAs used in some cosmetics? Products containing AHAs are marketed for a variety of purposes, such as smoothing fine lines and surface wrinkles, improving skin texture and tone, unblocking and cleansing pores, and improving skin condition in general. Sometimes AHAs are used in cosmetics for other purposes, such as to adjust the pH (the degree of acidity or alkalinity). How do AHAs work? AHA-containing products cause exfoliation, or shedding of the surface skin. The extent of exfoliation depends on the type and concentration of the AHA, its pH, and other ingredients in the product. What about products that contain AHAs and are marketed with therapeutic claims? Some products containing AHAs have been marketed for uses such as treating acne, removing scars, and lightening discolorations. Among these are some products marketed as "skin peelers," which may contain relatively high concentrations of AHAs or other acids and are designed to remove the outer layer of the skin. Products that are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body are drugs under the law (Federal Food, Drug, and Cosmetic Act, Sec. 201(g)). For example, products intended for use as acne treatments or skin lighteners are considered drugs. For more on this subject, see Is It a Cosmetic, a Drug, or Both? (or Is It Soap?) (/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm). EXHIBIT A Page 1 Case 3:14-cv-02241-LAB-AGS Document 47-4 Filed 10/24/16 Page 2 of 5 10/21/2016 Ingredients > Alpha Hydroxy Acids http://www.fda.gov/cosmetics/productsingredients/ingredients/ucm107940.htm 2/4 Has FDA received reports of adverse events related to AHAs? FDA received a total of 114 adverse dermatologic experience reports for AHA-containing skin care products between 1992 and February 2004, with the maximum number in 1994. The reported adverse experiences included burning (45), dermatitis or rash (35), swelling (29), pigmentary changes (15), blisters or welts (14), skin peeling (13), itching (12), irritation or tenderness (8), chemical burns (6), and increased sunburn (3). The frequency of such reports for skin exfoliating products that contain AHAs has been considerably lower in subsequent years. The more serious adverse reactions appear to occur most often with products that cause the greatest degree of exfoliation, such as "skin peelers." Has FDA conducted research on the safety of AHAs? Yes. These studies (1) compared the effect of AHAs, topically applied in a cream, on the sensitivity of human skin to ultraviolet (UV) radiation with the effect of the same cream containing no AHAs, (2) measured how fast the skin returns to normal after use of the AHA-containing cream is discontinued, and (3) investigated whether AHAs enhance UV-induced damage to DNA in the skin (Kays Kaidbey, Betsy Sutherland, Paula Bennett, Wayne G. Wamer, Curtis Barton, Donna Dennis, and Andrija Kornhauser, Topical glycolic acid enhances photodamage by ultraviolet light, Photodermatology, Photoimmunology and Photomedicine, vol. 19 (2003), issue 1, pages 21-27). These studies confirmed previous industry studies indicating that applying AHAs to the skin results in increased UV sensitivity. After four weeks of AHA application, volunteers' sensitivity to skin reddening produced by UV increased by 18 percent. Similarly, the volunteers' sensitivity to UV-induced cellular damage doubled, on average, with considerable differences among individuals. However, the studies also indicated that this increase in sensitivity is reversible and does not last long after discontinuing use of the AHA cream. One week after the treatments were halted, researchers found no significant differences in UV sensitivity among the various skin sites. The studies did not identify exactly how AHAs bring about the increased UV sensitivity, although the effects did not appear to involve dramatic increases in UV-induced damage to DNA in the skin. Previous FDA studies have indicated that a cosmetic-type cream base caused an AHA to penetrate more deeply into the skin when compared to an AHA solution without the usual cosmetic ingredients. However, further studies will be needed to learn how much, if at all, those cosmetic-type ingredients influence the AHA-related effects on UV sensitivity. FDA also has collaborated with the National Toxicology Program (http://ntp.niehs.nih.gov/) (NTP) to assess the safety of the long-term use of AHAs. This study determined that glycolic acid did not affect photocarcinogenesis (the development of cancer cells associated with exposure to light) in mice, and that salicyclic acid had a photoprotective effect (protected against the effects of light) in mice. The complete results of this study are available in the NTP Technical Report on the Photocarcinogenesis Study of Glycolic Acid and Salicylic Acid (CAS Nos. 79-14-1 and 69-72-7) in SKH-1 Mice (Available in PDF (1.9MB)) (http://ntp.niehs.nih.gov/files/524_web1.pdf). FDA continues to review available data on AHAs to address the potential for this increased skin sensitivity to the sun. How can AHAs be used safely? EXHIBIT A Page 2 Case 3:14-cv-02241-LAB-AGS Document 47-4 Filed 10/24/16 Page 3 of 5 10/21/2016 Ingredients > Alpha Hydroxy Acids http://www.fda.gov/cosmetics/productsingredients/ingredients/ucm107940.htm 3/4 It is important to follow directions carefully and heed any warning statements on the label when using any cosmetic product. If you are using AHAs, it is advisable to use sun protection. In January 2005, FDA issued Guidance for Industry: Labeling of Cosmetics Containing Alpha Hydroxy Acids as Ingredients (/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm090816.htm). The purpose of this guidance is to educate consumers about the potential for increased skin sensitivity to the sun from the topical use of cosmetics containing AHAs and to educate manufacturers to help ensure that their labeling for these products is not false or misleading. FDA recommends that the labeling of a cosmetic product that contains an AHA as an ingredient and that is topically applied to the skin or mucous membrane, such as the lips, bear a statement that conveys the following information: Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards. Based on industry-sponsored studies, the Cosmetic Ingredient Review (CIR) Expert Panel - the industry's self- regulatory body for reviewing the safety of cosmetic ingredients - concluded that products containing the AHAs glycolic and lactic acid are safe for use by consumers if: The AHA concentration is 10 percent or less. The final product has a pH of 3.5 or greater. The final product is formulated in such a way that it protects the skin from increased sun sensitivity or its package directions tell consumers to use daily protection from the sun. How can I know if a cosmetic product contains AHAs? Under the authority of the Fair Packaging and Labeling Act (/RegulatoryInformation/Legislation/ucm148722.htm) (FPLA), FDA requires an ingredient declaration on cosmetic products sold at the retail level to consumers. However, because the FPLA does not apply to products used exclusively by professionals - for example, in salons - the requirement for an ingredient declaration does not apply to these products. The most common AHAs in cosmetic products are glycolic acid and lactic acid. Among others are citric acid, hydroxycaprylic acid, and hydroxycapric acid. Resources for You Guidance for Industry: Labeling for Cosmetics Containing Alpha Hydroxy Acids (/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm090816.htm) Your Guide to Reporting Problems to FDA (/ForConsumers/ConsumerUpdates/ucm095859.htm) More in Ingredients (/Cosmetics/ProductsIngredients/Ingredients/default.htm) EXHIBIT A Page 3 Case 3:14-cv-02241-LAB-AGS Document 47-4 Filed 10/24/16 Page 4 of 5 10/21/2016 Ingredients > Alpha Hydroxy Acids http://www.fda.gov/cosmetics/productsingredients/ingredients/ucm107940.htm 4/4 Alpha Hydroxy Acids (/Cosmetics/ProductsIngredients/Ingredients/ucm107940.htm) Beta Hydroxy Acids (/Cosmetics/ProductsIngredients/Ingredients/ucm107943.htm) Diethanolamine (/Cosmetics/ProductsIngredients/Ingredients/ucm109655.htm) Fragrances in Cosmetics (/Cosmetics/ProductsIngredients/Ingredients/ucm388821.htm) Parabens in Cosmetics (/Cosmetics/ProductsIngredients/Ingredients/ucm128042.htm) Phthalates (/Cosmetics/ProductsIngredients/Ingredients/ucm128250.htm) Talc (/Cosmetics/ProductsIngredients/Ingredients/ucm293184.htm) EXHIBIT A Page 4 Case 3:14-cv-02241-LAB-AGS Document 47-4 Filed 10/24/16 Page 5 of 5 EXHIBIT B Case 3:14-cv-02241-LAB-AGS Document 47-5 Filed 10/24/16 Page 1 of 3 10/21/2016 2012 > Avon Products, Inc. (U.S. Headquarters) 10/5/12 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm323738.htm 1/2 Avon Products, Inc. (U.S. Headquarters) 10/5/12 Department of Health and Human Services Public Health Service Food and Drug Administration College Park, MD 20740 October 5, 2012 WARNING LETTER VIA CERTIFIED MAIL Ms. Andrea Jung Chairman and Chief Executive Officer Avon Products, Inc. Global Headquarters 1345 Avenue of the Americas New York, NY 10105 Re: 262337 Dear Ms. Jung: This is to advise you that the Food and Drug Administration (FDA) reviewed your web site at the Internet address http://www.avon.com in August 2012. Based on this review, your products Anew Clinical Advanced Wrinkle Corrector, Anew Reversalist Night Renewal Cream, Anew Reversalist Renewal Serum, Anew Clinical Thermafirm Face Lifting Cream, and Solutions Liquid Bra Toning Gel appear to be intended for uses that cause these products to be drugs under section 201(g)(1) (C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(C)]. The claims on your web site indicate that these products are intended to affect the structure or any function of the human body, rendering them drugs under the Act. The marketing of these products with claims evidencing these intended uses violates the Act. Examples of some of the claims observed on your web site include: Anew Clinical Advanced Wrinkle Corrector: “The at-home answer to wrinkle-filling injections. Start rebuilding collagen in just 48 hours.” “4D WRINKLE-REVERSE TECHNOLOGY IS DESIGNED TO: Rebuild collagen to help plump out lines and wrinkles. Stimulate elastin to help improve elasticity and resilience. Regenerate hydroproteins to help visibly minimize creasing.” “Formulated to boost shock-absorbing proteins to help strengthen skin's support layers.” “Improve fine & deep wrinkles up to 50%. Immediately plumps out wrinkles and fine lines. Within 48 hours begins boosting collagen production.” Anew Reversalist Night Renewal Cream & Anew Reversalist Renewal Serum “[W]rinkles are a result of micro-injuries to the skin, so AVON studied how skin heals. As part of the repair process, the body produces Activin . . . . [E]xhaustive research, testing & review have resulted in an unprecedented discovery by AVON scientists: how to activate this key repair molecule. . . . Designed to boost Activin, ANEW’s Activinol Technology helps reactivate skin’s repair process to recreate fresh skin & help dramatically reverse visible wrinkles.” Anew Clinical Thermafirm Face Lifting Cream “Our effective lifting treatment is formulated to fortify damaged tissue with new collagen. In just 3 days, see tighter, firmer, more lifted skin.” “[H]elp tighten the connections between skin's layers.” Solutions Liquid Bra Toning Gel “Formulated with pomegranate and fennel extracts to help boost production of collagen and elastin.” Your products are not generally recognized among qualified experts as safe and effective for the above referenced uses and, therefore, the products are new drugs as defined in section 201(p) of the Act [21 U.S.C. § 321(p)]. Under section 505(a) of the Act [21 U.S.C. § 355(a)], a new drug may not be legally marketed in the U.S. without prior approval from FDA in the form of an approved New Drug Application (NDA). A description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm1. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993. This letter is not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act. We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products. Please notify this office in writing within 15 working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be implemented. Please direct your written reply to Kathleen Lewis, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement (HFS-608), 5100 Paint Branch Parkway, College Park, Maryland 20740-3835. Inspections, Compliance, Enforcement, and Criminal Investigations Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters 2012 EXHIBIT B Page 5 Case 3:14-cv-02241-LAB-AGS Document 47-5 Filed 10/24/16 Page 2 of 3 10/21/2016 2012 > Avon Products, Inc. (U.S. Headquarters) 10/5/12 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm323738.htm 2/2 Sincerely, /S/ Michael W. Roosevelt Acting Director Office of Compliance Center for Food Safety and Applied Nutrition Page Last Updated: 10/13/2012 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Nondiscrimination Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive Links on this page: 1. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm EXHIBIT B Page 6 Case 3:14-cv-02241-LAB-AGS Document 47-5 Filed 10/24/16 Page 3 of 3 EXHIBIT C Case 3:14-cv-02241-LAB-AGS Document 47-6 Filed 10/24/16 Page 1 of 3 10/21/2016 Products > Wrinkle Treatments and Other Anti-aging Products http://www.fda.gov/Cosmetics/ProductsIngredients/Products%20/ucm388826.htm 1/2 Wrinkle Treatments and Other Anti-aging Products Soaps & Lotions Main Page (/Cosmetics/ProductsIngredients/Products/ucm388824.htm) Some products are marketed with claims that they will make people look younger. But are these products cosmetics? It depends. Products intended to make people more attractive are generally cosmetics. For example, moisturizing is a cosmetic claim. So, if a product is intended to make lines and wrinkles less noticeable, simply by moisturizing the skin, it’s a cosmetic. Similarly, makeup or “primers” intended to make the signs of aging less noticeable just by hiding them are also cosmetics. But, products intended to affect the structure or function of the body, such as the skin, are drugs (http://www.fda.gov/Drugs/default.htm), or sometimes medical devices (http://www.fda.gov/MedicalDevices/default.htm), even if they affect the appearance. So, if a product is intended, for example, to remove wrinkles or increase the skin’s production of collagen, it’s a drug or a medical device. Under the law, cosmetics must be safe when consumers use them according to product labeling, or the way in which the products are customarily used. But the law does not require cosmetics to be approved by FDA before they go on the market. Drugs, however, must have FDA approval for both safety and effectiveness before they go on the market. Similarly, medical devices must go through FDA’s clearance process. FDA is concerned about drug claims made for products marketed as cosmetics, such as skin care products with anti- wrinkle or anti-aging claims that involve supposed effects on the structure or function of the skin. Where to learn more: Consumer Updates Are Some Cosmetics Promising Too Much? (/ForConsumers/ConsumerUpdates/ucm439270.htm) Regulation and Enforcement Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) (/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm): To learn about the legal differences between cosmetics and drugs "Cosmeceutical (/Cosmetics/Labeling/Claims/ucm127064.htm)": To learn about this marketing term Import Alert #66-38: Skin Care Products Labeled as Anti-Aging Creams (http://www.accessdata.fda.gov/cms_ia/importalert_188.html): Information to help import inspectors identify anti-aging products with unapproved drug claims and keep them off the U.S. market EXHIBIT C Page 7 Case 3:14-cv-02241-LAB-AGS Document 47-6 Filed 10/24/16 Page 2 of 3 10/21/2016 Products > Wrinkle Treatments and Other Anti-aging Products http://www.fda.gov/Cosmetics/ProductsIngredients/Products%20/ucm388826.htm 2/2 Warning Letters Address Drug Claims for Products Marketed as Cosmetics: For examples of anti-aging claims that are considered drug claims (/Cosmetics/ComplianceEnforcement/WarningLetters/ucm081086.htm) Warning Letters Highlight Differences Between Cosmetics and Medical Devices (/Cosmetics/ComplianceEnforcement/WarningLetters/ucm081141.htm) Federal Trade Commission Action on L’Oréal Anti-aging Claims for Génifique and Youth Code (http://www.ftc.gov/news-events/press-releases/2014/06/loreal-settles-ftc-charges-alleging-deceptive- advertising-anti) Products and Ingredients Alpha Hydroxy Acids (/Cosmetics/ProductsIngredients/Ingredients/ucm107940.htm) and Beta Hydroxy Acids (/Cosmetics/ProductsIngredients/Ingredients/ucm107943.htm) (AHAs and BHAs) and Cosmetics: To learn how products may be cosmetics if they contain these ingredients at low concentrations, or drugs if the concentrations are higher Mercury Poisoning Linked to Skin Products (/ForConsumers/ConsumerUpdates/ucm294849.htm): Consumer Update Soaps and Lotions (/Cosmetics/ProductsIngredients/Products/ucm388824.htm): For information on skin care products Outside of FDA Federal Trade Commission (http://www.ftc.gov/): The government agency that regulates advertising claims Aromatherapy (/Cosmetics/ProductsIngredients/Products/ucm127054.htm) Disposable Wipes (/Cosmetics/ProductsIngredients/Products/ucm441465.htm) Hair Products (/Cosmetics/ProductsIngredients/Products/ucm127988.htm) Makeup (/Cosmetics/ProductsIngredients/Products/ucm134054.htm) Nail Care Products (/Cosmetics/ProductsIngredients/Products/ucm127068.htm) Soaps & Lotions (/Cosmetics/ProductsIngredients/Products/ucm388824.htm) Tanning Products (/Cosmetics/ProductsIngredients/Products/ucm134059.htm) Tattoos & Permanent Makeup: Guide to Resources (/Cosmetics/ProductsIngredients/Products/ucm107327.htm) More in Products (/Cosmetics/ProductsIngredients/Products/default.htm) EXHIBIT C Page 8 Case 3:14-cv-02241-LAB-AGS Document 47-6 Filed 10/24/16 Page 3 of 3