258 F. Supp. 3d 312
S.D.N.Y.2017Background
- Colgate sells Colgate Optic White and Optic White Platinum toothpastes marketed with claims like “Goes Beyond Surface Stain Removal to Deeply Whiten” and “Deeply Whitens More Than 3 Shades.” Both contain 1% hydrogen peroxide.
- Plaintiff Lori Canale alleges the 1% peroxide in toothpaste cannot penetrate to whiten intrinsic stains or “deeply whiten” because concentration and contact time are insufficient; she bought the product relying on the claims and asserts injury from lack of promised whitening.
- Plaintiff challenges product labels and two TV commercials that depict deep whitening and penetration below the tooth surface; she cites scientific literature and NAD (National Advertising Division) recommendations that Colgate lacked sufficient evidence to support intrinsic-whitening claims.
- NAD twice advised Colgate to stop implying peroxide in Optic White provides intrinsic/deep whitening; Colgate did not comply and the NAD referred the matter to the FTC; the FTC opened an ongoing investigation.
- Plaintiff brings putative class claims for breach of express warranty (nationwide class excluding several states) and New York GBL §§ 349, 350 (New York purchasers), alleging false and misleading labeling/advertising.
- Colgate moved to dismiss or stay the case, arguing (1) state-law claims are expressly preempted by the FDCA and related FDA monographs/decisions and (2) the primary jurisdiction doctrine requires deference to the FTC; the court denied dismissal but stayed the case pending the FTC investigation.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Express preemption under FDCA (21 U.S.C. §§ 379r, 379s) | Canale’s state-law claims merely duplicate FDCA’s prohibition on false or misleading labeling and therefore are not preempted | Colgate: FDCA/OTC monograph regime and FDA actions specifically regulate these products; non-identical state requirements are preempted | Court: No express preemption — FDA materials cited do not address peroxide intrinsic-whitening claims; state claims mirror FDCA’s general false/misleading prohibition and survive preemption challenge |
| Primary jurisdiction (deference to FTC) | Canale: Court can adjudicate consumer-advertising claims; agency input not necessary to evaluate deception | Colgate: FTC is investigating same claims; agency expertise and risk of inconsistent rulings counsel deferral or dismissal | Court: Applied Ellis factors and found primary jurisdiction appropriate; stayed the case (not dismissed) pending FTC resolution, with six-month status updates |
| Applicability of FDA monograph/agency materials to preemption analysis | Canale: Anticaries monograph and FDA citizen-petition denial do not regulate whitening claims at issue | Colgate: Monograph, prior drafts, and FDA correspondence show federal regulation of dental products and justify preemption | Court: Anticaries Monograph addresses anticaries active ingredients, not whitening claims; FDA denial of ADA petition did not regulate whitening representations — materials do not preempt Plaintiff’s claims |
| Pleading standard under Rule 12(b)(6) (plausibility) | Canale: Complaint pleads facts (advertising, purchases, scientific citations, NAD/FTC history) sufficient to state plausible claims | Colgate: Allegations are insufficient or preempted; primary jurisdiction/agency should decide first | Court: Complaint meets plausibility standard; dismissal denied, but case stayed under primary jurisdiction doctrine |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (plausibility standard for pleadings)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (plausibility standard and pleading requirements)
- Wyeth v. Levine, 555 U.S. 555 (presumption against preemption where not expressly stated)
- Chamber of Commerce v. Whiting, 563 U.S. 582 (focus on plain statutory text in express preemption analysis)
- Ellis v. Tribune Television Co., 443 F.3d 71 (2d Cir. 2006) (primary jurisdiction factors and doctrine explanation)
- NRDC, Inc. v. U.S. Food & Drug Admin., 710 F.3d 71 (2d Cir. 2013) (monograph/OTC drug approval framework)