## Facts

- Before 1989, FDA regulations governing patient package inserts for oral contraceptives required a specific warning stating that estrogen had “been shown to cause cancer in animals,” supporting an inference of possible cancer risk in humans.
- In 1989, after notice-and-comment rulemaking, the FDA revised the oral-contraceptive labeling rules to require certain categories of information but stopped mandating specific wording, including the animal-carcinogen statement, so labeling content could be updated more quickly.
- Elizabeth L. Henley, an attorney proceeding pro se and acting on behalf of “One in Nine: Long Island Breast Cancer Action Coalition,” filed a citizen petition under 21 C.F.R. § 10.30.
- The petition asked FDA to amend oral-contraceptive warning-label requirements to include a warning advising women to limit their exposure to animal or human carcinogens—effectively seeking reinstatement of an animal-cancer-based warning.
- The FDA denied the petition, relying on post-1989 epidemiological studies involving women that, in the agency’s view, did not show an increased risk of cancer from oral contraceptive use.
- The FDA explained it continuously monitors scientific information about oral contraceptives and updates labeling recommendations through guidance to manufacturers rather than by locking specific phrases into regulations.
- Henley sued in the U.S. District Court for the Eastern District of New York under the Administrative Procedure Act (APA), claiming the denial was arbitrary, capricious, an abuse of discretion, and contrary to law; the district court granted summary judgment for the FDA.
- Henley appealed to the U.S. Court of Appeals for the Second Circuit.

## Issues

1. Whether the FDA acted arbitrarily, capriciously, abused its discretion, or acted contrary to law under APA § 706(2)(A) by denying Henley’s citizen petition seeking a carcinogen-focused warning requirement for oral-contraceptive patient inserts.
2. Whether the FDA permissibly relied on post-1989 human epidemiological evidence, rather than animal carcinogenicity findings, in deciding that the requested warning language should not be required.

## Decision

- The Second Circuit affirmed the district court’s grant of summary judgment for the FDA.
- The court held the FDA’s denial of Henley’s citizen petition was not arbitrary, capricious, an abuse of discretion, or contrary to law.
- The court concluded the FDA gave a reasoned explanation supported by the administrative record, including reliance on post-1989 human studies and the agency’s approach to updating labeling through guidance.
- The court declined to reweigh scientific evidence and deferred to the FDA’s technical judgments about what labeling warnings were warranted.

## Legal Principles

- Under APA § 706(2)(A), a court may set aside agency action only if it is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.
- An agency satisfies the APA when it considers the relevant material and provides a rational explanation connecting the record to its decision; courts do not substitute their judgment for the agency’s on scientific matters.
- A challenger cannot establish arbitrariness merely by disagreeing with how the agency weighed competing scientific data.
- The FDCA generally requires that drug labeling not be false or misleading and that warnings be adequate, but the specific content and phrasing of warnings are largely committed to FDA discretion when supported by the record.
- FDA may choose regulatory approaches that allow labeling to be updated through guidance rather than fixed regulatory text, so long as the approach is explained and consistent with the agency’s authority.

## Conclusion

*Henley v. Food and Drug Administration* holds that the FDA did not violate the APA by denying a citizen petition that sought to reinstate a cancer warning on oral-contraceptive inserts based on animal data, because the agency reasonably relied on post-1989 human studies showing no increased cancer risk and explained its policy of keeping labeling current through ongoing scientific review and guidance rather than mandated wording.


Henley v. Food and Drug Administration, 77 F.3d 616 (1996)