## Facts

- NBTY, Inc. and Nature’s Bounty, Inc. manufactured and sold vitamin E dietary supplements.
- Product labels included “structure/function” statements such as “supports cardiovascular health” and “promotes immune health.”
- Paul Dachauer purchased a bottle and filed a putative class action under California’s Unfair Competition Law (UCL) and Consumers Legal Remedies Act (CLRA).
- He alleged the labels were false or misleading because vitamin E supplements (a) do not prevent cardiovascular disease and (b) do not reduce, and may increase, all-cause mortality; he also alleged the labels omitted the risk of increased mortality.
- Defendants moved for summary judgment, asserting FDCA preemption and lack of evidence of falsity or harm.
- The district court granted summary judgment for defendants; Dachauer appealed.

## Issues

1. Whether 21 U.S.C. § 343-1(a)(5) expressly preempts California UCL/CLRA claims that would impose labeling requirements for dietary-supplement structure/function claims that are not identical to federal requirements.
2. Whether a state-law theory that labels are misleading for failing to disclose an increased risk of all-cause mortality is preempted.
3. Whether the evidentiary record created a genuine dispute that the supplements, at labeled doses, increased all-cause mortality such that the omission theory could survive summary judgment.

## Decision

- The Ninth Circuit affirmed summary judgment for defendants.
- It held Dachauer’s challenges premised on requiring proof of disease prevention (or mortality reduction) were expressly preempted because they sought to impose non-identical state labeling requirements on federally regulated structure/function claims.
- It held the omission-based “failure to disclose increased mortality risk” theory was not preempted to the extent it paralleled the federal prohibition on misleading labeling.
- It nevertheless rejected the omission theory on the merits because Dachauer produced no evidence that vitamin E supplements were harmful at the doses recommended on the labels.

## Legal Principles

- The FDCA expressly preempts state-law labeling requirements for dietary supplements that are “not identical to” federal requirements governing, among other matters, structure/function claims. 21 U.S.C. § 343-1(a)(5).
- Structure/function claims may describe a nutrient’s role in maintaining normal body structure or function but may not claim to diagnose, mitigate, treat, cure, or prevent disease. 21 U.S.C. § 343(r)(6).
- A plaintiff may not use state consumer-protection law to convert a structure/function claim into a de facto disease-prevention or mortality-reduction claim by demanding proof beyond what federal law requires for such labeling.
- Private plaintiffs cannot prevail on a theory that a label is unlawful merely because the manufacturer allegedly lacked substantiation; the plaintiff must show the representation is actually false or misleading under the applicable state standard.
- A state-law claim based on omission of a material safety risk may avoid preemption when it mirrors the federal “not misleading” requirement, but it still requires evidence that the alleged risk exists for the product as used (including at labeled doses).

## Conclusion

The Ninth Circuit held that federal law preempted California claims that effectively demanded disease-prevention or mortality-reduction proof for dietary-supplement structure/function statements, and it affirmed summary judgment because the only potentially non-preempted omission theory failed for lack of evidence that the supplements were harmful at labeled dosages.


Dachauer v. NBTY, Inc., 913 F.3d 844 (9th Cir. 2019)