[Drug and Device Law] Preemption: Oregon Has Not Gone Bananas

Can you get sued over a picture of a banana?  It seems the answer might depend on where you live and probably not in Oregon.  That is one takeaway from a good preemption case that came out of the District of Oregon last week, Henry v. Gerber Products Co., No. 3:15-cv-02201, 2016 U.S. Dist. LEXIS (D. Or. Apr. 18, 2016).  In Henry, a concerned mother sued because the baby "Puffs" she purchased depicted a banana on the label, but contained only "natural banana flavor."  Not actual bananas.  Never mind that label stated the product's ingredients truthfully and clearly in black and white.  Never mind that if a parent wants his or her toddler to snack on bananas, he or she could purchase, you know, bananas.  For whatever reason, this parent preferred banana puffs, with bright yellow bananas on the label.  And it resulted in a federal lawsuit. 

How did we get here?  Like most every other state, Oregon has an Unfair Trade Practices Act that prohibits product sellers from representing that their products have "particular characteristics, ingredients, benefits, or qualities that they do not have."  See Or. Rev. Stat. § 646.608(1)(e).  A right and just law when applied properly, to be sure. 

It becomes interesting, however, when talking about food because federal law is extraordinarily specific in regulating food labels.  Surely you read our guest post on the FDA's regulation of non-functional slack-fill (whatever that is) and its impact on product packaging.  Or our post on food "standards of identity" which dictate what food sellers can and cannot call their products.  You probably also knew that a food label's Nutrition Facts have to appear in a certain place on the package, unless the package has less than 40 square inches of surface area, except when the packaging includes a cellophane window, which does not count as available surface area, unless the window is itself used as a label (such as with a sticker), in which case the window does count as available surface area, and provided that the manufacturer has not applied for special allowance to affix something to the packaging that might obscure the Facts, such as a straw.  See 21 C.F.R. § 101.9.  You get the idea—the FDA has put a lot of thought into the uniform regulation of food labels.

The tie in to drugs and medical devices is preemption.  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 labeling on ingredients and flavorings.  21 U.S.C. § 343-1(a)(2) & (3).  In Henry, the plaintiff alleged that the banana puff manufacturer led customers to believe that the puffs actually contained "the prominently depicted fruits," e.g., bananas, which allegedly violated Oregon's UTPA.  2016 U.S. Dist. Lexis 52638, at *18. 

But, as it turns out, the FDA's regulations provide that it is perfectly okay to represent a food's flavor with a picture of a fruit, even where the food contains only "natural flavor" and not the actual fruit.  The manufacturer just has to say so on the label in a mind-bogglingly particular way.  (We won't quote the regulation here; you'll have to read the opinion to get its flavor, but trust us, its detail is exceptional.)  The banana puffs manufacturer complied to a tee, which led it to argue justifiably that the plaintiff's Oregon law claims sought to impose requirements that were "not identical to" federal requirements.  Id. at **12-13. 

That means federal preemption, and the district court agreed: 

The gravamen of Henry's complaint is that "[the manufacturer's] marketing and labeling of Puffs lead consumer to believe that Puff's actually contain the prominently depicted fruits or vegetables for which each variety is named."

. . . .

[However, the] law, as applied to the situation presented to this Court, is clear:  "FDA regulations permit illustrations of fruit on product labels to indicate that product's 'characterizing flavor,' even where the product contains no ingredients derived from the depicted fruit."  []  Henry's state law claims under the UTPA are, therefore preempted. 

Id. at **18-19 (citations omitted).  This is a pretty straightforward application of express preemption, but there are two points that we think make this order particularly interesting. 

First, in its discussion of preemption law, the district court invoked the "presumption against preemption," under which it would "start with the assumption that the historic police powers of the State were not to be superseded by [federal law] unless that was the clear and manifest purpose of Congress."  Id. at *13 (citing Medtronic v. Lohr, 518 U.S. 470 (1996)).  Don't get Bexis started on the presumption against preemption.  (See, for example, here)  The presumption (or assumption) is a false concept, a makeweight invoked when consistent with a no-preemption result.  In Henry, the express preemption was so clear that the "presumption" did not matter.  The district court found preemption regardless.

Second, the district court distinguished the case from another from its neighbor to the south, the Golden State.  You see, the Nutrition Labeling and Education Act has a catch-all, which prohibits food labeling that is "false or misleading in any particular."  21 U.S.C. § 343(a).  Because the preemption provision does not expressly cover the catch-all, the plaintiff argued that any claim under the catch-all was not preempted, citing an order from the Central District of California, Zupnik v. Tropicana Products Inc., No. 09-cv-6130 (C.D. Cal. Feb. 1, 2010). 

The district court rejected this argument as overly simplistic.  Just because a label allegedly falls within a catch-all for "false or misleading" labeling does not mean that it all of a sudden falls outside the FDA's more specific regulations, which permit exactly that labeling.  As the district court put it, "[W]here the challenged conduct is expressly required or permitted by FDA regulations, the claims fall within the core of the preemption provision because they would 'impose different requirements on precisely those aspects . . . that the FDA had approved.'"  Id. at *20 (citations omitted).  Moreover, where the FDA regulations permit particular labeling, that labeling is not considered "false or misleading" under federal law by definition.  Id.  According to the Henry judge, the Zupnik order from California was an outlier and "quite perfunctory" in an area of the law that was complex and nuanced.  As Californians, we say "ouch."  But setting our native pride aside, we have to say that we agree. 

Food litigation may continue in California, but manufacturers should continue to push back with preemption and its lesser sibling, primary jurisdiction.  Preemption carried the day in Oregon, and it should continue to do so. 

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