Posted: 15 Mar 2016 06:44 PM PDT
By Ricardo Carvajal & JP Ellison –
In a decision of significance in the realm of food additive regulation, the U.S. District Court for the Northern District of California dismissed a lawsuit targeting coffee-creamer products containing partially hydrogenated oil (PHO) on preemption grounds. The complaint – one of several similar complaints targeting PHO-containing products – asserted nine causes of action under California law, some of which challenged the use of PHOs (the use-based causes of action), and others of which challenged a “0g Trans Fat” label declaration (the label-based causes of action). The court found the use-based causes of action preempted based on conflict preemption and the label-based causes of action expressly preempted.
With respect to the use-based causes of action, the Court noted that FDA had set a 3-year compliance date in its declaratory order revoking the GRAS status of PHOs (see our prior post here). That declaratory order cited a number factors in support of that compliance date, including the need to minimize market disruption, and to allow time for submission and review of food additive petitions, adjustments by small businesses, and development of supply chains for alternative oils. The Court also noted that the recently enacted Consolidated Appropriations Act included language stating that no food that contains a PHO shall be deemed adulterated by virtue of containing that PHO until the compliance date established by FDA. The Court held that Plaintiff’s claims “would impose an immediate prohibition on the use of PHOs in all foods under all circumstances” and thereby “’stand[ ] as an obstacle’ to the fulfillment of the FDA’s objectives, as embodied in its regulatory scheme setting a three-year compliance period, and conflict with Congress’s decision not to deem PHOs unsafe, or the food containing them adulterated” pending the compliance date.
With respect to the label-based causes of action, the Court found that the challenged trans fat claim was authorized by FDA regulations. Because Plaintiff’s claims “would impose a requirement that is not identical to the requirements imposed by those regulations,” the Court held that those claims are expressly preempted. This is the latest of several decisions finding preemption with respect to “0g trans fat” claims, but as noted by this Court, “no trans fat claims” have not fared as well.
In any future revocations of GRAS status, we expect this decision to be cited in defense of products marketed during any compliance period established by FDA. The Court’s rationale for finding conflict preemption, together with its observation that Congress “essentially ratified FDA’s Final Determination,” suggests that FDA compliance dates should be read to preempt claims of unlawfulness prior to such dates even in the absence of accompanying federal legislation.
In a decision of significance in the realm of food additive regulation, the U.S. District Court for the Northern District of California dismissed a lawsuit targeting coffee-creamer products containing partially hydrogenated oil (PHO) on preemption grounds. The complaint – one of several similar complaints targeting PHO-containing products – asserted nine causes of action under California law, some of which challenged the use of PHOs (the use-based causes of action), and others of which challenged a “0g Trans Fat” label declaration (the label-based causes of action). The court found the use-based causes of action preempted based on conflict preemption and the label-based causes of action expressly preempted.
With respect to the use-based causes of action, the Court noted that FDA had set a 3-year compliance date in its declaratory order revoking the GRAS status of PHOs (see our prior post here). That declaratory order cited a number factors in support of that compliance date, including the need to minimize market disruption, and to allow time for submission and review of food additive petitions, adjustments by small businesses, and development of supply chains for alternative oils. The Court also noted that the recently enacted Consolidated Appropriations Act included language stating that no food that contains a PHO shall be deemed adulterated by virtue of containing that PHO until the compliance date established by FDA. The Court held that Plaintiff’s claims “would impose an immediate prohibition on the use of PHOs in all foods under all circumstances” and thereby “’stand[ ] as an obstacle’ to the fulfillment of the FDA’s objectives, as embodied in its regulatory scheme setting a three-year compliance period, and conflict with Congress’s decision not to deem PHOs unsafe, or the food containing them adulterated” pending the compliance date.
With respect to the label-based causes of action, the Court found that the challenged trans fat claim was authorized by FDA regulations. Because Plaintiff’s claims “would impose a requirement that is not identical to the requirements imposed by those regulations,” the Court held that those claims are expressly preempted. This is the latest of several decisions finding preemption with respect to “0g trans fat” claims, but as noted by this Court, “no trans fat claims” have not fared as well.
In any future revocations of GRAS status, we expect this decision to be cited in defense of products marketed during any compliance period established by FDA. The Court’s rationale for finding conflict preemption, together with its observation that Congress “essentially ratified FDA’s Final Determination,” suggests that FDA compliance dates should be read to preempt claims of unlawfulness prior to such dates even in the absence of accompanying federal legislation.
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