Pom Wonderful continues to be so. Last year it produced a terrific 9th Circuit opinion reinforcing that only the United States, not private plaintiffs, can enforce the FDCA and FDA regulations. See Pom Wonderful LLC v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012). And so the FDCA and its regulations barred plaintiff’s Lanham Act claims. We blogged about it here, and at the end of the year it made our Top Ten List. But that opinion, addressing two federal statutes, didn’t technically involve preemption. Well, the latest decision from the trial court does.
On remand, the Pom Wonderful trial court had to consider whether the FDCA preempts plaintiff’s state law claims under California’s Unfair Competition Law and False Advertising law. Pom Wonderful LLC v. Coca-Cola Co., 2013 U.S. Dist. LEXIS 33501 (C.D. Cal. Feb. 13, 2013). And, wonderfully, it does.
First, a refresher on the preemption provision to the “F” portion of the FDCA:
[N]o State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce . . . any requirement for the labeling of food… that is not identical to the requirement of such section.
21 U.S.C. § 343-1(a)(5). So it’s pretty simple. If the state law isn’t identical, it’s preempted.
That left the plaintiff in Pom Wonderful with a big problem. It was suing about the defendant’s naming and labeling of its juice product. But the FDA has regulations addressing those very things, and the defendant apparently didn’t violate any of them. So, it seems that any state law claim would be imposing a different or additional requirement to those imposed by the FDA. In other words, not identical.
So plaintiff came up with one heck of an argument: defendant may have complied with FDA regulations, but it didn’t comply with the FDCA. 2013 U.S. Dist. LEXIS 33501, at *9. If you’re saying, “What you talkin’ ‘bout Willis”?, you’re not alone. With this argument, plaintiff wants to do even more than improperly interpret and enforce the provisions of the FDCA as a private litigant. It wants to marginalize the FDA too: its regulations don’t matter, only the terms of FDCA do. One of the many problems with this argument, though, is that the FDA issues its regulations because the terms of the FDCA gave it the authority to do so:
[H]ere the FDA properly authorizes certain conduct pursuant to certain sections of the FDCA, such conduct must also be seen as being in compliance with the statute itself. To hold otherwise would be to undermine FDA’s authority to implement the FDCA.
Id. at *10. In other words, plaintiff couldn’t impose liability on the defendant despite its compliance with the FDA’s regulations on naming and labeling:
[The preemption provision] is a much broader preclusion of state law than one merely preempting contradictory state law would be, and it necessarily must cover situations where parties use state law not to overturn FDA regulations but to impose liability in spite of them. The Court therefore sees no basis for drawing the distinction Plaintiff seeks to establish here.
Id. at 11-12. In short, preempted.
But the opinion continues on, becoming even more wonderful. You see, the court held that California has a safe-harbor for company conduct that the legislature has permitted or considered and chosen not to prohibit:
If the Legislature has permitted certain conduct or considered a situation and concluded no action should lie, courts may not override that determination.
Id. at *14 (citing Cel-Tech Comms., Inc. v. Los Angeles Cellular Tel. Co., 20 Cal. 4th 163, 182, 83 Cal. Rptr. 2d 548, 973 P.2d 527 (1999). That’s a good rule. This safe-harbor applies “equally to action by the California legislature and action by the U.S. Congress.” Id. at *15. And, since Congress gave the FDA authority to issue regulations and make determinations about food, and the FDA has done so as to the naming and labeling of juice, the defendant’s conduct – which does not violate those regulations – comes within the safe harbor:
Here, Congress has explicitly allowed labeling that is not misleading, and granted FDA the authority to make such a determination. Defendant has complied with the relevant FDA regulations, and so, per the discussion above, is also compliant by extension with the FDCA. The Court therefore finds that California’s Safe Harbor Statute provides a separate and independent basis for granting the Motion.
Id. This appears to be the first time that we’ve addressed this safe harbor from California. We like it. It’s wonderful.