## Facts

- The FDA issued regulations under the Color Additive Amendments of 1960 to the Federal Food, Drug, and Cosmetic Act governing certification of color additives used in products.
- One regulation provided that if a manufacturer refused FDA employees free access to manufacturing facilities and processes used to prepare color additives, the FDA Commissioner *may* immediately suspend certification service until corrective action occurred.
- Because certification was required before certain color additives could be used, suspension could temporarily prevent use of uncertified colors.
- A cosmetics trade association and numerous manufacturers and distributors sued the Secretary of Health, Education, and Welfare and the FDA Commissioner seeking declaratory and injunctive relief against multiple regulations, including the inspection-and-suspension rule.
- The district court allowed pre-enforcement review.
- The court of appeals allowed pre-enforcement review for some regulations but held review of the inspection-and-suspension rule improper at that time.
- The Supreme Court reviewed the ripeness of the pre-enforcement challenge to the inspection-and-suspension regulation.

## Issues

1. Whether a pre-enforcement suit challenging the FDA’s inspection-and-suspension regulation was ripe for judicial review under the Administrative Procedure Act and Declaratory Judgment Act.
2. Whether the regulation presented issues fit for immediate judicial decision and whether withholding review would impose sufficient present hardship on regulated parties.

## Decision

- The Supreme Court held that pre-enforcement judicial review of the inspection-and-suspension regulation was not appropriate because the dispute was not ripe.
- The Court concluded the issues were not fit for review because application of the regulation was contingent: it was unknown whether or when inspections would be demanded, on what justification, and how the regulatory scheme would be applied in practice.
- The Court found insufficient hardship from postponing review because the rule did not require immediate changes in the regulated parties’ primary conduct, and any suspension of certification could be challenged through administrative processes and later judicial review.
- The Court agreed that the FDCA did not itself preclude pre-enforcement review; the denial of review rested on ripeness, not statutory preclusion.
- The Court indicated that, given the limited immediate consequences, regulated parties should await concrete enforcement and pursue available administrative remedies before seeking judicial review.

## Legal Principles

- Ripeness for pre-enforcement challenges requires a two-part inquiry: (1) fitness of the issues for judicial resolution and (2) hardship to the parties from withholding court consideration.
- A regulation using discretionary, contingent enforcement mechanisms is less fit for review when its operation depends on uncertain future agency actions.
- Hardship is reduced when the challenged rule does not compel immediate changes to primary business conduct and when later administrative and judicial review is available after enforcement.
- The availability of pre-enforcement review under the APA and Declaratory Judgment Act may exist even when review is denied in a particular case because the challenge is unripe.

## Conclusion

The Court declined to decide the validity of the FDA’s inspection-and-suspension certification rule in advance of enforcement, holding that the challenge was premature under the fitness-and-hardship ripeness test, while confirming that the governing statute did not categorically bar pre-enforcement review.


Toilet Goods Ass'n v. Gardner, 387 U.S. 158 (1967)