Source: https://www.druganddevicelawblog.com/2013/02/a-honey-of-litigation.html
Timestamp: 2020-08-15 19:15:24
Document Index: 673338522

Matched Legal Cases: ['§ 343', '§343', '§343', '§ 343', '§343', '§343', '§343']

A Honey of A Litigation | Drug & Device Law
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Let’s start with what’s the same in all five cases. The federal law. First, the NLEA contains an express preemption provision:
21 U.S.C. § 343-1(a)(3). In other words, “when confronted with conflicting state labeling requirements, federal law controls how a food must be labeled.” Ross, 2013 U.S. Dist. LEXIS 6181 at *28. Replace “food” with “drug” and we sure like the sound of that.
Section 343(i) applies to foods for which the FDA has not otherwise provided a specific regulatory definition or “standard of identity” – such as honey. So, any state laws imposing requirements on honey must be identical to §343(i) which provides that “a food shall be deemed to be misbranded “[u]nless its label bears the common or usual name of the food.” Brod, 2012 U.S. Dist LEXIS 129391 at *21. See Regan, 2013 U.S. Dist. LEXIS 13166 at *6 (“[W]hen, as here, there is no federal standard of identity, the label must bear the common or usual name of the food.”). Therefore, to comply with federal law, honey has to be called honey. None of the plaintiffs in any of the honey cases were able to dispute (although they did try) that the common name for honey is honey. Id. at *22-24 (citing Webster’s and Random House dictionary definitions, as well as prior regulations establishing grades of honey); Overton, 2012 U.S. Dist. LEXIS 185697 at *21-23 (looking to National Honey Board for common definition of honey: “Honey is honey, it’s just that simple.”). And, in none of the accepted definitions was the presence of pollen a requirement to consider something honey. Regan 2013 U.S. Dist. LEXIS 13166 at *17 (citing another National Honey Board publication: “Honey without pollen is still honey nutritionally and in flavor . . . The truth is that honey is made by honey bees from nectar of flower and plants, not pollen.”).
What’s the problem with that? Well, some states’ laws – like California, Wisconsin and Florida – prohibit, except where unavoidable, the removal of pollen from honey and go on to prohibit the sale of honey as honey if it doesn’t comply with that law. Id. at *24. “Thus, while federal law requires Sue Bee Clover Honey to be labeled with its common name, “honey,” California law prohibits it.” Id. at *25. The Brod court summed it up nicely:
Given that the Court finds that thecommon or usual name of a product that has had its pollen avoidably removed is honey, and that California [law] disallows such a product to be labeled honey, it imposes a requirement which is not imposed by federal law, and is therefore not identical to federal law. Consequently, the California [law] is preempted by the NLEA and Plaintiff’s state law claims based on a violation of [that] California [law] are also preempted.
Overton, at *25.
By the time we get to the most recent California decision, Ross, plaintiffs decided to try a different tactic. Instead of simply arguing that the defendant wasn’t allowed to call its pollen-free honey “honey” under California law, they also contended that “both federal and state law impose a duty on Sioux Honey to disclose the fact that all pollen had been removed from Sue Bee Honey.” Ross, 2013 U.S. Dist. LEXIS 6181 at *5. Go back and look at the federal and state law above – can you find a duty to disclose the pollen content of honey? We couldn’t either. Neither could the court.
As to state law, the Ross plaintiffs seem to hang their hat on a statement by the court in Brod:
The Court notes that its finding of preemption does not imply that California is powerless to act in this arena. For instance, if California required disclosure on its labels that the honey was e.g., “filtered” or “pollen free,” that would appear not to conflict expressly with [NELA]. California simply cannot . . .ban the use of the label “honey” for products which are commonly and usually called honey.
Brod at *25-26. We don’t necessarily agree and we’ll address that shortly. But, even so, just because the court found that there may be a circumstance in which California could impose some requirements on the labeling of honey that would not be preempted doesn’t mean that they have. See Ross at *35-39 (“While the law appears to prohibit the sale of [pollen-free] honey, it does not purport to impose a labeling requirement when such honey is sold.”). We stand behind any decision that refuses to create and impose labeling obligations that simply don’t exist.
But what about their federal law claim? Here, the Ross plaintiffs focus on the regulations concerning how to discern the “common or usual name” of a food, which provide that the common name should include “characterizing components” of the food. Id. at *29-30. But, the FDA regulations don’t offer any further definition of a characterizing component and plaintiffs didn’t “cite a single state or federal statute or regulation, case authority, legal treatise, dictionary definition, food industry publication, or any other source” identifying pollen as a “characterizing component of pollen.” Id. at *31. Now, we think the court need not have even entertained the substance of these claims – which brings us to Regan.
The Regan court reached the same conclusion as the California courts: “Wisconsin’s labeling requirement is preempted because it is not identical to the NLEA’s labeling requirement.” Id. at *10-11. But, the Wisconsin decision has two additional findings that we like.
First, with respect to the Brod court’s statement that perhaps some honey labeling requirements (pollen-free language) would be permissible, the Regan court disagrees, holding that “such a requirement would be preempted because it is not identical to the federal requirement.” Id. at *11 n5. We like the Regan court’s black and white take on this issue. Either the laws are identical or not; if not then preemption. Identical doesn’t mean similar, or less than, or slightly different – it means exactly alike in every detail. If the laws are different, they aren’t identical.
The second thing we like about Regan is the way it got rid of plaintiffs’ federal law claims – essentially the same as those brought in Ross. No FDCA private right of action. “[A] private party cannot attempt to enforce the FDCA under the guise of state law claims.” Id. at *16. Simple, straightforward and consistent with the pharmaceutical decisions.
So, what happened in Florida? The Guerrero court had a different interpretation of 21 U.S.C. §343(i). All of the other courts held that § 343(i) governs food for which the FDA has not established a standard of identity – meaning if no federal standard, the manufacturer is required to use the food’s common name. Guerrero adopts plaintiffs’ argument that §343(i) only applies “in the absence of any standard of identity, state or federal.” Guerrero, 2012 U.S. Dist. LEXIS 125055 at *33 (emphasis added). Therefore, concludes the court, since Florida has adopted a standard of identity for honey, §343(i) is inapplicable and “the Florida Honey Standard does not conflict because there is no federal standard of identity for honey.” Id. at *35. Both Regan and Overton explicitly reject this finding:
Regan at *13.
If the phrase “standard of identity” referred to both federally-created and state-created standards of identity, then state-created standards of identity would trump Federal Section 343(i)(1)’s requirement that a food be labeled by its “common or usual name,” even if a federal regulation establishes a “common or usual name” for the food.
Overton at *15-16. We’re not sure how the Guerrero court missed this or how they so easily got around express preemption. But, the suggestion of this decision is that pollen-free honey, marketed throughout the country as “honey” in accordance with 21 U.S.C. §343(i), cannot be so marketed in the state of Florida. This would seem to allow Florida to skirt federal labeling requirements. A definite no-no. Now the good news is that the Guerrero case was dismissed for failure to adequately plead under TwIqbal, but with leave to amend.
Well, that’s a lot of sweet stuff (with one sour lump). Like we said at the beginning, when a litigation creates this much favorable preemption law, we think it’s important to know about, so we’ll keep an eye on the honey litigation while you go watch the Bee Movie – who doesn’t want to see animated Ray Liotta.
Tags: California, Florida, Food, Wisconsin