While the FDA’s recent determination that PHOs - a source of artificial trans fats - are not Generally Recognized as Safe (GRAS) appears to have emboldened plaintiff's attorneys targeting firms using PHOs, US district judge Thelton E. Henderson said the agency had also indicated that the use of PHOs is lawful until June 18, 2018.
In an order on a class action lawsuit* accusing Gen Mills of endangering consumers by using PHOs in its bakery mixes, Henderson said: "The FDA’s decision not to prohibit the sale of products containing PHOs until 2018 indicates that it was not and is not unlawful under federal law to sell them before that time.”
He also noted that the FDA had invited the industry to petition it to allow PHOs in certain applications.
Therefore, he said, it was appropriate to stay the case under the primary jurisdiction doctrine until the FDA had considered these petitions (so far, the GMA, of which Gen Mills is a member, has filed one such petition).
He added: “Whether small amounts of trans fats can lawfully be used as a food additive is a complicated question requiring agency expertise...
"The Court finds that this question, which is central to Backus’s claims in this case, is therefore properly left to the FDA’s determination under the primary jurisdiction doctrine.
“If the FDA finds that small amounts of trans fats are permissible as a food additive, this will significantly undermine Backus’s UCL [California’s unfair competition law] claims.”
Backus - who is represented by The Weston Firm - has filed a notice of appeal.
"The FDA’s decision not to prohibit the sale of products containing partially hydrogenated oils (PHOs) until 2018 indicates that it was not, and is not, unlawful under federal law to sell them before that time.” US district judge Thelton E. Henderson
PHO case vs Nissin Foods thrown out
Meanwhile, another PHO-related class action** filed by plaintiff Victor Guttmann against Nissin Foods USA has just been thrown out by US district judge William Alsup.
Guttmann - an avid label reader who has sued five different manufacturers over PHOs - could not reasonably allege he was unaware of the risks he was taking by consuming Nissin's products (which included PHOs on the ingredients list), argued Alsup.
He added: "In his deposition ... Guttmann admitted that he actually did inspect some product labels to determine whether they contained dangerous trans fat."
Therefore, observed the judge, "Guttmann was keenly aware of the alleged injury he might suffer by eating Nissin’s noodles, and he knew he could have avoided any such injury caused by Nissin by simply checking the product label."
Kristen Polovoy: The litigation exposure from the FDA's June 16 order is obvious
While the above orders might reassure some food manufacturers that are still using PHOs, the wording of the FDA's final determination was unfortunate, and has left manufacturers exposed to civil litigation, according to some legal experts.
In a recent blog post, for example, Kristen Polovoy of Montgomery, McCracken, Walker & Rhoads LLP, argued that, "The litigation exposure from the FDA's June 16 order is obvious, from both product liability and consumer fraud claim perspectives."
She added: "The FDA’s order does not contain an express preemption clause and does not contain any other protections against civil litigation during the three-year compliance period. The FDA’s position is that state or local laws banning or limiting PHOs would not likely conflict with the FDA’s new order or frustrate federal objectives."
Glenn Lammi: Wording of FDA final determination has 'emboldened aggrieved plaintiffs to sue more food companies'
Glenn Lammi, chief counsel in the legal studies division of the Washington Legal Foundation, also voiced his concerns in a recent blog post: "'Not GRAS' does not mean 'unsafe'. FDA, however, not only failed to make this clear in its PHO order, it didn’t affirm that until June 2018 (the deadline for phasing out artificial trans fat), the use of PHOs is lawful."
Such silence, he said, had "emboldened" aggrieved plaintiffs to "sue more food companies".
However, he welcomed judge Henderson's order, adding: "Judge Henderson’s decision will certainly be a positive development for targets of trans fat-oriented class actions if other judges in the Northern District of California find his reasoning persuasive and the result legally sound.”
Read more about the FDA's final determination on PHOs HERE.
*Troy Backus vs General Mills (3:15-cv-01964), Northern District of California.
**Victor Guttmann vs Nissin Foods (U.S.A.) Company Inc (3:15-cv-00567), Northern District of California.