We like Velveeta, frozen yogurt, and Pringles—just never all at the same time. Anyone who has ever encountered or consumed these products knows that the creamy orange substance known as Velveeta is not cheese, but is a “pasteurized prepared cheese product.” We all know that frozen yogurt is not ice cream. Pringles are not potato chips. They are “potato crisps,” not to be confused with the potato “crisps” that our readers in the U.K. purchase at the shop. (“Crisps” in the U.K. would qualify as “chips” in the U.S., but the Brits already use the word “chips” to refer to French fries, which may or may not have anything to do with British-French relations, but we digress.)
Why do these foods suffer from identity crises?
Because the FDA says so. The rules are known as food “standards of identity,” and in them the FDA sets forth the criteria that foods must meet to bear certain monikers. Velveeta, Pringles, and frozen yogurt do not meet the identity standards to be called the foods that they aspire to be, so their sellers cannot use those names on their labels. William Shakespeare wrote that a rose by any other name would smell as sweet. The FDA would not agree. You can call a chip a Pringle, but in the regulators’ minds, those are two different things, even if they smell somewhat the same.
The tie-in to the Drug and Device Law Blog is federal preemption, because the FDA’s identity standards are federal laws that have strong preemptive impact over state laws imposing different requirements. In Nemphos v. Nestle Waters N. Am., Inc., No. 13-2146, 2015 U.S. App. Lexis 275 (4th Cir. Jan. 8, 2015), the product at issue was bottled water. The plaintiff alleged that the bottled water, infant formula, and baby food that her baby consumed contained fluoride, resulting in a condition known as dental fluorosis. Id. at **1-2. According to the plaintiff, the food sellers failed to warn about the risks of dental fluorosis and engaged in misleading marketing in connection with their fluoride-containing product. Id. at **4-5.
The district court dismissed the bottled water claims as preempted by federal law, and the Fourth Circuit affirmed. The Nutrition Labeling and Education Act gives the FDA authority to oversee food labeling, and the statute has an express preemption clause that forbids states from establishing any requirement that “is not identical to” the federal requirements in five areas of food labeling, including standards of identity. The only exception, oddly, is maple syrup (which actually is good when combined with frozen yogurt and a few nuts). Id. at **9-10. This express preemption language of course is similar to the “different from or in addition to” language that we often cite from the Medical Device Amendments and is even closer to the “not identical with” language from the express preemption provision for over-the-counter drugs.
As it turns out, “bottled water” is a food regulated by the FDA, and the regulatory standard of identity classifies fluoride as an optional ingredient with limits described in the standard. If the fluoride exceeds the specified levels, the label must say “Contains Excess Fluoride.” Id. at **15-16. Because the plaintiffs were attempting to impose additional warnings regarding fluoride (and it was undisputed that the fluoride in the defendants’ water was within the allowable limits), those claims were preempted because they sought to impose state requirements “not identical to” the federal requirements. Id. at **20-27.
The Fourth Circuit’s well-developed discussion of the policy behind express preemption caught our interest. The Fourth Circuit first observes that “[a] system engineered to ensure national uniformity must exclude some local disuniformities. . . . [By calling for preemption], [t]he Act struck a necessary balance between the two fonts of regulatory authority – between uniform federal labeling standards and potentially more stringent laws in individuals states.” Id. at **8-9.
This is the essence of federal preemption—the establishment and maintenance of uniform national standards where uniformity is desirable. What are some examples? Well, pulling two out of the blue, let’s say medical devices and pharmaceutical products, where some level of risk is inherent in the products and where the applicable regulations must strike a balance. Uniform standards promote that end, while making essential products available to those who need them and creating a predictable regulatory environment for manufacturer and sellers.
The Fourth Circuit explained it this way:
In each of the areas selected for preemption, such as the standard of identity . . . , the NLEA sought to ensure a nationally uniform regulatory system, rather than a fifty-state patchwork.
. . . .
To allow a nonidentical state requirement to contravene the FDA’s approach in this area would undermine the NLEA’s preemption framework. Without this system of preemption, a manufacturer might be whipsawed by federal regulations delineating permissible labeling and state-law claims of impermissibility. In the five areas designated by the NLEA, preemption shields manufacturers from that predicament.
Id. at *21, *26. “Whipsawed”? That word has not appeared in the Drug and Device Law Blog, at least not for several years, which is surprising because getting pulled in one direction by federal regulations and in another by state-law tort claims is a frequent concern in our practices. The Fourth Circuit put a nice point on it, one that we may return to at some point down the road.
To bring the case to a close, the district court also dismissed the infant formula and baby food claims under TwIqbal—without leave to amend because plaintiff had already been allowed three attempts to plead. As the Fourth Circuit said,
The complaint is studded with highly general and conclusory statements that could be adapted to many different products at many different times. It says little about the contents of the infant formula and baby food products in particular, except merely that they contain some amount of fluoride. We are left essentially with a “naked assertion” of liability that lacks the “further factual enhancement” demanded by Rule 8(a)(2).
Id. at *28 (citing Twombly). Substitute “pharmaceutical product” or “medical device” for “infant formula and baby food,” and you have a description of complaints that we see most every day, with boilerplate allegations of product “defects” without sufficient facts to back it up. We commend the district court for rejecting such facile claims and the Fourth Circuit for holding firm, though we wonder why it took three versions of the complaint to reach this conclusion.
As the NFL playoffs continue to unfold, maybe we will hunker down this Sunday with a can of Pringles and a block of Velveeta, minus the frozen yogurt. We’ll also quench our thirst with multiple bottles of water, confident in the fact that “water” means “water.” Because the FDA says so.