## Facts

- Nutraceutical Corporation and its subsidiary Solaray manufactured and sold dietary supplements containing ephedrine alkaloids (EDS), commonly marketed as “Ephedra.”
- After years of investigation, the FDA issued a 2004 final rule banning the sale of all EDS, concluding they present an “unreasonable risk of illness or injury” under DSHEA.
- The FDA relied on a record that included scientific studies, adverse event reports, and public comments.
- Using a risk–benefit framework, the FDA determined EDS posed significant health risks and that claimed benefits were not sufficiently established to justify those risks at any dosage level.
- Nutraceutical challenged the ban as applied to products recommending 10 mg/day or less, arguing DSHEA did not permit the FDA’s risk–benefit approach and that evidence did not show low-dose products posed an “unreasonable risk.”
- The district court granted summary judgment to Nutraceutical, enjoined enforcement against Nutraceutical’s ≤10 mg/day products, and remanded for further rulemaking.
- The federal defendants appealed.

## Issues

1. Whether DSHEA’s “unreasonable risk” standard permits (or requires) the FDA to use a risk–benefit analysis when determining adulteration under 21 U.S.C. § 342(f)(1)(A).
2. Whether the FDA proved by a preponderance of the evidence that EDS present an unreasonable risk of illness or injury, including at recommended daily doses of 10 mg or less, such that a complete ban is lawful and not arbitrary or capricious.

## Decision

- The Tenth Circuit reversed and remanded with instructions to enter judgment for the federal defendants.
- The court held DSHEA’s “unreasonable risk” standard allows and contemplates a risk–benefit analysis.
- The court held the FDA did not shift the burden of proof to Nutraceutical and that the agency met its burden by a preponderance of the evidence.
- The court upheld the FDA’s conclusion that no dosage level of EDS was shown to be acceptably safe for the market, rejecting a ≤10 mg/day carve-out.
- The court concluded the final rule reflected reasoned decisionmaking and was not arbitrary or capricious under the APA.

## Legal Principles

- Under DSHEA, determining whether a dietary supplement presents an “unreasonable risk of illness or injury” may require weighing identified risks against demonstrated benefits.
- The government bears the burden under DSHEA to show adulteration by a preponderance of the evidence.
- Courts generally defer to the FDA’s reasonable statutory interpretation and expert evaluation of complex scientific evidence when supported by an adequate administrative record.
- An agency may lawfully impose a complete ban where the record supports a finding of unreasonable risk across the product’s range of labeled conditions of use, including low-dose uses.

## Conclusion

The Tenth Circuit upheld the FDA’s nationwide ban on ephedrine-alkaloid dietary supplements, holding that DSHEA permits a risk–benefit analysis and that the FDA sufficiently proved EDS present an unreasonable risk at all doses, including products labeled for 10 mg/day or less.


Nutraceutical Corp. v. Von Eschenbach, 459 F.3d 1033 (10th Cir. 2006)