[Drug and Device Law] Going The Distance To Limit Preemption
Anybody who watched the Mayweather-Pacquiao fight knows that a long fight does not necessarily make for an exciting fight. Thirty-six minutes of “action” can actually contain very little action. The exceedingly long decision of the court in Grocery Manufacturers Assoc. v. Sorrell, No. 5:14-cv-117, 2015 U.S. Dist. LEXIS 56147 (D. Vt. Apr. 27, 2015), has little to keep our DDL-centric attention—its discussion of preemption based on various federal statutes, including the FDCA. As the court forcefully rejected most preemption arguments raised by trade groups whose members were likely to be affected by Vermont’s labeling rules for foods derived in whole or in part from genetic engineering, we are reminded of another dynamic from the “Fight of the Century.” Watching live, with the volume up, a viewer might have been swayed by the cheering of the decidedly pro-Pacquiao crowd into thinking Pacquiao was doing damage during many of the too-infrequent exchanges of punches. However, almost invariably, the slow-motion replay between rounds showed Pacquiao’s blows had been deflected and followed by a Mayweather punch to the face, the latter almost too quick to see in real time. Similarly—or at least as similarly as pugilistic analogy allows—the court’s analysis of preemption relied on borrowing concepts from one type of preemption and applying them to another without saying what it was doing.
As our resident state historian cum travel brochure maker (and boxing afficianado) has noted here and here, Vermont has been known to do its own thing. That has included enacting peculiar statutes that unconstitutionally impinge on national commerce. Based upon its judgment that the various federal statutes and regulations—and the pendency of federal legislation—did not do enough to inform consumers of the existence of ingredients created through some degree of genetic engineering in products they might purchase, the Vermont legislature enacted Act 120. It contained two provisions challenged in the GMA case, one requiring packaging or site-of-sale displays disclosing the presence of ingredients derived from genetic engineering in products for sale and one prohibiting labeling or advertising describing the product as “natural” in one way or another. (We will skip the discussion of how much genetic engineering counts, given that humans have been eating “genetically engineered” food ever since our ancestors started selectively mating captured aurochs or zebu and have known that this was a manipulation of genetics at least since Gregor Mendel started playing with peas in his abbey.) The legislature could not say that foods with one or more genetically engineered ingredients were less safe than those without, but cared that polls showed Vermonters wanted to know about the presence of such ingredients so they can make “informed decisions” and not be “confus[ed] and dece[ived]” by claims of “natural” products. Before Act 120 even took effect, a multi-faceted constitutional challenge was brought. The decision we are discussing results from the Vermont AG’s motion to dismiss and the plaintiff’s motion for preliminary injunction. If you want to read about the Commerce Clause or First Amendment issues with Act 120, knock yourself out, but we will not discuss them here.
There is a veritable alphabet soup of federal laws covering aspects of how food is described, with the familiar Food, Drug and Cosmetic Act (“FDCA”), Nutrition Labeling and Education Act (“NLEA”), Federal Meat Inspection Act (“FMIA”), and Poultry Products Inspection Act (“PPIA”) discussed in GMA (with PPA, FIFRA and OFPA mentioned in a footnote for flavor). There is not yet a federal law that provides comprehensive treatment of the issue of labeling of food with genetically modified ingredients, and the guidances on the subject from FDA are non-binding. 2015 U.S. Dist. LEXIS 56147, **53-54. With this framework, there was no contention that field preemption applied and barred states from regulating these issues at all. Yet, the GMA started with the dreaded “presumption against preemption,” which derives from field preemption and has no place in the discussion of the express preemption and implied/conflict preemption arguments raised by the plaintiffs. Id. at *48. As we have said many times—like here, here and way back here—the resort to the presumption in Levine (which started in Vermont state court) and in many other bad express and implied preemption decisions tends to be a clear signal of where things are going. Here, it predicted most of the outcome. The first round of analysis concerned whether the express preemption provisions in the NLEA preclude Act 120’s disclosure requirement. By their terms, the provisions prohibit states from requiring food labeling that is “not identical” to the NLEA’s own mandatory requirements. Id. at *52. The GMA court says an additional condition for preemption, beyond the state requirement being “not identical,” is that the NLEA requirement “is clearly entitled to preemptive effect,” citing the express preemption provisions in the NLEA. Id. at *53. While we are not specialists in food law, we do not see any source for engrafting this condition based on a statute that reads “no 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” and gives five types of requirements for food, food labeling, or food nutrition labeling that might apply when “not identical” to specified parts of the NLEA. Again calling on the “duty to accept the reading [of the state act] that disfavors preemption”—properly applicable only to field preemption—the court interpreted “not identical” in a counter-intuitive way:
[I]n order for preemption to apply, the FDCA [as amended by the NLEA] must require the labeling information at issue; the NLEA must indicate that the mandatory federal labeling requirement is entitled to preemptive effect; and Act 120’s GE disclosure requirement must govern this same information.
Id. at *58. Because Act 120 specified that it did not require the term “genetically engineered” to go before the food’s “common name” or with specific ingredients, the plaintiff “failed to establish that Act 120’s GE disclosure requirement is ‘not identical’ to any mandatory labeling requirement of the FDCA.” Id. at *62. In other words, the state act’s disclosure requirement was nimble enough to duck express preemption from the NLEA, even though the NLEA did not mandate any such disclosure. Next up was whether it was Act 120’s disclosure requirements conflicts with the FDCA requirement of not labeling food in a false and misleading manner. The court gives some attention to two ways that could happen. The first is if it would be impossible for a seller to simultaneously comply with both acts. Despite the undertone of Act 120 that disclosing genetically engineered ingredients is important because it suggests something about safety, there is no conflict with the FDCA because such a disclosure does not convey anything, explicitly or implicitly, about lack of safety. Id. at *65. The second is if Act 120 stood as an obstacle to federal agencies enforcing federal law. Beyond a White House policy statement on a “Coordinated Framework for Regulation of Biotechnology” that was addressed in part to genetically engineered food but was rejected as non-binding and not legislative, there was a recognition of Congressional intent to have the FDCA and NLEA promote “national uniformity in certain aspects of food labeling, so that the food industry can market its products efficiently in all 50 States in a cost-effective manner.” Id. at *66 (citation omitted). While a law that would require a state-specific label—with the possibility that other states might require something different—might seem like a pretty clear obstacle to the Congressional intent here, the court found otherwise. Added to the third call to the presumption against preemption were two other principles not appropriate to implied preemption: (1) the “purpose of Congress is the ultimate touchstone in every pre-emption case” based on Lohr, an express preemption case; and (2) “in areas of traditional state regulation, [the court] assume[s] that a federal statute has not supplanted state law unless Congress has made such an intention clear and manifest” based on Bates, a field preemption case. Id. at **67-68. With these principles recited and not much more, the court “must presume that Act 120’s GE disclosure requirement can coexist with federal regulations.” Id. at *68 (internal quote and cite omitted).
That left a more narrow challenge for labeling involving certain meat and poultry items covered by the FMIA and PPIA. (A standing issue for the plaintiffs to raise such a challenge was rejected, but will linger.) Each of the Inspection Acts have mandatory labeling requirements and express preemption clauses that preclude state requirements that are “in addition to, or different than” what is in the Act (like the language in the Medical Device Amendments to the FDCA). Whereas “not identical” allowed some leeway, “in addition to, or different than” did not. Requiring disclosure of genetically modified “meat food products” or “poultry products” and restricting the use of the term “natural” in describing such products was expressly preempted, because the Inspection Acts have no such requirements or limits. While this part of plaintiff’s complaint survived dismissal, the court issued a split decision, failing to issue a preliminary injunction. This was so because the Vermont AG issued a “Final Rule” pursuant to Act 120 that interpreted the Act to not apply to FMIA and PPIA products, making “an enforcement action unlikely.” Keeping in mind that Act 120 has not yet gone into effect, the scope of its enforcement and how that might run afoul (or ameat?) of various federal food labeling requirements remains to be seen. We expect that there will be other decisions coming on this case, from this court and the Second Circuit. When they do, we do not expect the losing side to claim to have been hampered by a shoulder injury.--
Posted By Eric Alexander to Drug and Device Law at 5/08/2015 10:56:00 AM --
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