## Facts

- Public Citizen and individual consumers challenged FDA actions under the Color Additive Amendments of 1960, 21 U.S.C. § 376.
- The statute’s Delaney Clause bars FDA from listing as safe any color additive “found ... to induce cancer in man or animal.”
- FDA permanently listed two color additives (Orange No. 17 and Red No. 19) for specified uses even though animal studies indicated carcinogenicity.
- FDA relied on quantitative risk assessment to conclude the predicted human cancer risk from these dyes was extremely small and treated sufficiently low risk as de minimis for Delaney Clause purposes.
- FDA also repeatedly extended provisional listings for ten other color additives while additional safety evaluations continued.
- Public Citizen sought review of the final order listing Orange No. 17 and Red No. 19 and appealed a judgment upholding the provisional-listing extensions; the matters were consolidated in the D.C. Circuit.

## Issues

1. Whether the Delaney Clause permits an implied de minimis exception allowing FDA to list a color additive found to induce cancer in animals when estimated human risk is trivial.
2. Whether FDA lawfully extended provisional listings for ten color additives under the statutory conditions for postponement pending further evaluation.

## Decision

- The court set aside FDA’s permanent listings of Orange No. 17 and Red No. 19.
- The court held the Delaney Clause contains no implied de minimis exception once a color additive is found to induce cancer in humans or animals.
- The court upheld FDA’s extensions of the provisional listings for the ten other color additives because the statute expressly authorizes extensions when specified findings are made and carcinogenicity has not been found.

## Legal Principles

- Statutory text barring listing of “any” color additive “found ... to induce cancer in man or animal” establishes a categorical prohibition that forecloses agency-created de minimis thresholds.
- Where Congress draws a bright-line rule for carcinogenicity, an agency may not substitute a risk-balancing approach absent textual authorization.
- If a statute is unambiguous on a point, an agency interpretation contrary to the clear text is not entitled to deference.
- Provisional listings may be extended when FDA finds postponement for further evaluation is consistent with public health, evaluation is proceeding in good faith, completion will occur as soon as reasonably practicable, and the Delaney Clause has not been triggered by a finding of carcinogenicity.

## Conclusion

The D.C. Circuit required strict compliance with the Delaney Clause’s categorical bar against listing carcinogenic color additives, rejecting FDA’s de minimis risk policy, while permitting FDA to continue provisional listings when the statute’s express conditions for extension were satisfied and no carcinogenicity finding had yet been made.


Public Citizen v. Young, 831 F.2d 1108 (D.C. Cir. 1987)