December 08, 2016
According to a recent opinion from the Southern District of California, consumers cannot dodge the word of Congress and the FDA by bringing state law challenges against food manufacturers for using partially hydrogenated oil in their products—at least for the time being. Hawkins v. Advancepierre Foods, Inc., No. 15-CV-2309-JAH (BLM), 2016 WL 6611099 (S.D. Cal. Nov. 8, 2016)
Defendant AdvancePierre Foods, Inc. manufactured and sold microwaveable sandwiches under the brand name Fast Bites. On October 14, 2015, plaintiff Shavonda Hawkins, a consumer who purchased Fast Bites “as many as a hundred times” since January 1, 2008, filed a putative class action lawsuit challenging defendant’s use of partially hydrogenated oil (“PHO”) in its microwaveable sandwiches. Id. at *1. Plaintiff asserted claims for unlawful and unfair business practices under California laws, nuisance, and implied warranty of merchantability and claimed to suffer both pecuniary and physical injuries. Plaintiff alleged that PHO is a source of artificial trans-fat for which there is “no safe level” because of PHO’s causal relationship with inflammation, cardiovascular heart disease, diabetes, cancer, Alzheimer’s disease, and cognitive damage. She also claimed that the defendant declined to use safe, economical alternatives to PHO in its microwaveable sandwiches. Id. Defendant moved to dismiss for failure to state a claim and based on federal preemption of plaintiff’s claims.
As explained in the court’s discussion of the relevant regulatory framework, the Federal Food, Drug & Cosmetic Act (“FDCA”) prohibits the introduction into interstate commerce of any food that is “adulterated.” 21 US.C. § 331(a). A food is adulterated “if it…contains…any food additive that is unsafe within the meaning of” 21 U.S.C. § 348. Id. § 342(a)(2)(C)(i). A food additive is deemed unsafe unless there is a regulation which prescribes the conditions under which the additive may be safely used and the additive is used in conformity with the regulation. Id. § 348(a)(2). However, the FDCA expressly exempts from the definition of “food additive” foods that meet certain conditions that entitle them to the status of “Generally Recognized as Safe” or “GRAS.” 21 C.F.R. § 170.30. Substances that are GRAS may be used in food without FDA approval. PHOs are not on the non-exhaustive list maintained by the FDA of foods that have been deemed GRAS. 21 C.F.R. § 170.30(d).
On June 17, 2015, the FDA issued a final determination on the use of PHO in food (“Final Determination.”). See Final Determination Regarding Partially Hydrogenated Oils, 80 Fed. Reg. 34650 (June 17, 2015). The FDA recognized that PHOs have a history of being considered GRAS by the food industry but announced that, based on current scientific evidence, there is no longer a consensus that PHOs are GRAS in human food. Based on this finding, the FDA set June 18, 2018 as a compliance date by which time food producers must have removed PHO from their food products or petitioned for and received approval to use PHO in their products. Id. at 34668. The three-year window was intended to minimize market disruptions by allowing the industry to phase out PHOs or seek FDA approval for their use. Id. at 34669. Several months after the FDA issued the Final Determination, Congress enacted the Consolidated Appropriations Act of 2016 (“CAA”). 2016 Pub. L. No. 114-113, § 754, 129 Stat. 2242, 2284 (2015). The CAA addressed the FDA’s Final Determination and stated that no PHOs shall be deemed unsafe and no foods containing PHOs deemed adulterated by virtue of containing a PHO until the Final Determination’s compliance date of June 18, 2018. Id. at Section 754.
Defendant argued that plaintiff’s claims were preempted because they directly conflicted with federal regulations and the CAA by attempting to make it “immediately unlawful” to market or sell food products containing trans fat. Hawkins, 2016 WL 6611099 at *5. Plaintiff contended that her claims were not preempted because the FDA’s Final Determination stated that PHOs are not GRAS and did not expressly permit manufacturers to use PHOs in their food products or declare that they were considered safe at present. Rather, plaintiff argued that the Final Determination’s compliance date represented only the date the FDA would begin enforcing a prohibition on the use of PHO in food. Id. The court rejected these arguments and agreed that plaintiff’s claims were barred under the doctrine of conflict preemption. The court emphasized that allowing plaintiff to proceed would contravene both the FDA’s and Congress’s purpose in issuing the Final Determination and passing section 754 of the CAA: “Because Plaintiff’s claims stand as a direct obstacle to the FDA’s objective to minimize market disruption by providing three years’ notice of the compliance date on use of PHO in food and Congress’s objective to bolster the FDA’s Final Determination through passage of section 754 of the 2016 CAA, Plaintiff’s remaining state claims are barred by conflict preemption.” Id. at *7.
Similarly, the court held that plaintiff failed to state a claim under the “unlawful prong” of section 17200 of California’s Unfair Competition Law (“UCL”), which prohibits “any unlawful, unfair or fraudulent business act or practice.” Id. at *4; Cal. Bus. & Prof. Code § 17200. Under this provision, violations of other laws are treated as “unlawful practices” that are independently actionable. Because the Final Determination, together with the CAA, makes clear that is not currently unlawful to use PHO in food products, the court rejected plaintiff’s argument that the defendant had violated numerous sections of the FDCA by using PHO in its microwavable sandwiches. Hawkins, 2016 WL 6611099 at *4. After its motion to dismiss was fully submitted, defendant filed two notices of supplemental authority: Backus v. Nestle USA, Inc., 167 F. Supp. 3d 1068 (N.D. Cal. 2016) and Backus v. ConAgra Foods, Inc., No. C 16-0454 WHA, 2016 WL 3844331 (N.D. Cal. July 15, 2016), which both held that current use of PHO in food products does not violate federal law or provide a basis for a claim of unlawful business practices under section 17200. The court found that the same result was warranted here.
Although regulation of health and safety is a field traditionally occupied by states, such that a presumption against preemption applied to the court’s analysis, the court’s “focus on Congress’s purpose and the goals and policies of the federal law” carried the day. The three-year window set by the FDA and solidified by federal statute was clearly intended as a grace period to give the industry an opportunity to exhaust current PHO-containing inventory and implement changes to eliminate PHOs without facing litigation. Despite the deliberate respite built into the federal regime, some consumers evidently thought it worthwhile to try their luck based on the theory that PHOs are unsafe now. Query whether a court would allow a PHO case to proceed prior to the June 18, 2018 compliance date under a different set of facts, such as if plaintiff alleged that PHOs were used in particularly excessive amounts or were added to a product that previously did not contain them. At least for now, it is safe to say that courts are properly declining to reward plaintiffs’ impatience in attempting to sidestep clear federal law.