Class Action and Product Insights for Your Business
March 30, 2016 - FDA

Cut the Fat . . . Just Not Yet: Court Rules that PHO Claims Are Preempted

Northern District of California Judge Maxine Chesney recently granted Nestlé’s motion to dismiss a challenge to partially hydrogenated oil (PHO) in Nestlé’s Coffee-mate® coffee-creamer products, finding plaintiff’s claims were preempted by federal regulations set to be implemented three years from enactment.  Backus v. Nestle USA, Inc., No. C-15-1963 MMC, 2016 WL 879673 (N.D. Cal. Mar. 8, 2016). The decision is a big win for Nestlé and may have broader implications for defendants facing “misbranding” allegations premised on evolving FDA standards.

Plaintiff’s PHO Challenge. Challenges to PHOs are not new; we’ve reported on them before. (See, e.g., “Court Stays Away from Trans Fat in General Mills Case.”) And plaintiff Troy Backus is a repeat player in PHO litigation:  We recently reported on the Ninth Circuit’s rejection of his appeal in another PHO case. (SeeNinth Circuit:  No Relief from Stay in General Mills’ Trans Fats Case Pending FDA Action.”)

Plaintiff’s challenge to Nestlé’s Coffee-mate® products is the same as the claims in the earlier cases: that PHO is an “‘illegal, dangerous additive’ for which there is ‘no safe level’ of consumption[.]”  Backus, 2016 WL 879673, at *1 (citation omitted). Plaintiff claimed Nestlé acted unlawfully by including PHO in its product, and misled consumers by claiming the product contain “0g Trans Fat.”

FDA’s PHO Position. On June 17, 2015, the FDA published a declaratory order finding “‘there is no longer a consensus among qualified experts’” that PHOs “are generally recognized as safe (GRAS) for any use in human food.” Id. at *3 (citing 80 Fed. Regs. 34650-01, 34650 (June 17, 2015)). FDA required discontinuation of PHO additives, but encouraged submissions of exemptions based on specific uses of the substance. Id. FDA set a compliance date of June 18, 2018, “‘to allow time for such petitions and their review.’” Id.

Congress thereafter enacted the Consolidated Appropriations Act, 2016 (H.R. 2029), which addressed PHOs. The statute confirmed that no PHO shall be deemed unsafe—or food containing such substance deemed adulterated—until the June 2018 compliance date set by the FDA. Id. (citing Pub. L. No. 114-113, § 754, 129 Stat. 2242, 2284 (2015).)

Court Says No to PHO Claims. The court rejected plaintiff’s claims. It found that, by seeking to make PHO illegal now, plaintiff’s claims “would effectively negate the FDA’s order setting a compliance date in 2018 and ‘stand[] as an obstacle to the accomplishment and execution of the full purposes and objectives’ of the FDA in adopting that order.”” Id. at *4 (citation omitted). Plaintiff’s characterization of PHOs as being “unsafe in any circumstance” was inaccurate. FDA simply found that there was no longer a consensus as to whether they are safe. Indeed, FDA confirmed it needed three years to review applications showing PHOs are safe in some circumstances.

Because Plaintiff’s attempt to retroactively apply FDA regulations undermined FDA’s goal in issuing the standards, his claims were preempted. The court dismissed plaintiff’s claims with prejudice.[1]

PHO Takeaway. A narrow reading of Backus may suggest it is limited to the facts: When the FDA and/or Congress enact regulations prohibiting the use of certain substances by a certain future date, a plaintiff cannot try to retroactively apply such regulations to punish use of the substance now. But a broader reading suggests Backus applies any time a plaintiff seeks to apply a new regulation to suggest a product did not comply in the past. Backus prohibits such hindsight. This decision is a solid win for companies defending against mislabeling claims that may change in the future.


[1] The court also held that plaintiff’s challenge to “0-Trans Fat” statement on the products’ front label was preempted. Federal regulations require that products containing less than .5 gram of trans fat list the amount as “zero” on the ingredient panel. FDA has expressed its preference that statements outside of a box match the inside. The court noted that other courts, including the Ninth Circuit, have accordingly found such claims preempted. Id. at *7. The Court agreed and dismissed these claims as well.