Dachauer v. NBTY, Inc., No. 17-16242 (9th Cir. 2019)
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The Ninth Circuit affirmed the district court's grant of summary judgment for defendants, makers of vitamin E supplements, in an action alleging that the labels on the supplements violated California laws against false advertising. The panel held that section 343-1(a)(5) of the Federal Food, Drug, and Cosmetic Act (FDCA) expressly preempts state law requirements for claims about dietary supplements that differ from the FDCA's requirements. In this case, the panel held that section 343-1(a)(5) preempted most of plaintiff's claims.
The panel held that because the FDCA and California law have the same labeling requirement with respect to failing to disclose an increased risk of death, section 343-1(a)(5) did not preempt this part of plaintiff's action. The panel held that the record lacked evidence that vitamin E supplements were actually harmful, as opposed to simply useless at reducing all-cause mortality (which they did not claim to reduce). Therefore, there was no genuine issue of material fact as to whether defendants' immune-health structure/function claim was misleading.
Court Description: California Law / Federal Preemption. The panel affirmed the district court’s summary judgment in favor of makers of vitamin E supplements in a plaintiff/consumer’s action alleging that the labels on the supplements violated California laws against false advertising. For dietary supplements, the Federal Food, Drug, and Cosmetic Act (“FDCA”) distinguishes between “disease claims” and “structure/function claims” that manufacturers make about their products. A structure/function claim describes the role of a dietary ingredient, but may not claim to mitigate a specific disease. 21 U.S.C. § 343(r)(6). Although the FDCA requires manufacturers to have substantiation for their structure/function claims, California law does not allow private plaintiffs to demand substantiation for advertising claims. The panel held that § 343-1(a)(5) of the FDCA expressly preempts state-law requirements for claims about dietary supplements that differ from the FDCA’s requirements. The panel further held that, as applied here, § 343-1(a)(5) preempted most of plaintiff’s claims. Specifically, the panel held that § 343-1(a)(5) preempted plaintiff’s claims to the extent that he argued that defendants’ structure/function claims were false or misleading because their supplements did not prevent cardiovascular disease. The panel also held DACHAUER V. NBTY, INC. 3 that because the FDCA and California law have the same labeling requirement with respect to failing to disclose an increased risk of death, § 343-1(a)(5) did not preempt this particular aspect of plaintiff’s case. The panel held that the record lacked evidence that vitamin E supplements are actually harmful, as opposed to simply useless at reducing all-cause mortality (which they do not claim to reduce). The panel concluded that, on this record, plaintiff failed to meet his burden to create a genuine issue of material fact as to whether defendants’ immune- health structure/function claim was misleading.
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