## Facts

- Congress amended the Federal Food, Drug, and Cosmetic Act in 1960 to require premarket listing and conditions of use for “color additives,” deeming them unsafe unless used in conformity with an FDA regulation.
- The FDA issued implementing regulations that (1) treated some finished cosmetics as “color additives” when they directly imparted color, (2) imposed safety-related requirements on “diluents” used in color additive preparations, and (3) limited the statutory exemption for coal-tar hair dyes to situations where the statutory patch test warning scheme meaningfully addressed the risk.
- A cosmetics industry association and member companies sued federal officials responsible for FDA administration, seeking to invalidate these regulations as exceeding statutory authority.
- After earlier litigation concerning pre-enforcement review, the district court on the merits invalidated significant parts of the challenged regulations.
- The government appealed the merits judgment to the Second Circuit.

## Issues

1. Whether the FDA could treat certain finished cosmetic products as “color additives” subject to premarket clearance when their primary purpose is to impart color to the body.
2. Whether the FDA could regulate the safety of diluents used in color additive preparations under the Color Additive Amendments.
3. Whether the FDA could narrow the coal-tar hair dye exemption so it would not apply where the statutory patch test and warning scheme would not detect or guard against the relevant hazards.

## Decision

- The Second Circuit reversed most of the district court’s invalidation and sustained the core of the FDA regulations, subject to limiting constructions.
- The court upheld treating certain finished cosmetics as “color additives” where the product is used principally for coloring and the colorant component is not separately marketable.
- The court upheld FDA authority to require that diluents in color additive preparations be safe, while rejecting any reading that would automatically treat all cosmetic diluents as “color additives” outside that context.
- The court upheld FDA’s interpretation limiting the coal-tar hair dye exemption to risks of the sort addressed by the statutory warning and patch test, and allowing exclusion where that safeguard would not reveal the danger.

## Legal Principles

- In implementing a broad health-and-safety statute through rulemaking, an agency’s interpretation will be sustained if it is a reasonable reading of statutory text and purpose and is not clearly inconsistent with the statute.
- The Color Additive Amendments may reach products that function as coloring preparations, including certain finished cosmetics, when necessary to prevent evasion of premarket clearance.
- FDA may consider the safety of non-color components (such as diluents) when they are part of a color additive preparation and may affect the preparation’s toxic effects.
- A statutory exemption premised on a specific warning-and-test safeguard may be construed not to apply where that safeguard cannot meaningfully protect against the relevant hazards.

## Conclusion

The Second Circuit largely upheld FDA authority under the Color Additive Amendments to regulate coloring preparations in functional terms, including certain finished cosmetics and diluents used in color additive mixtures, and sustained FDA’s narrowing of the coal-tar hair dye exemption to situations where the statutory patch-test warning scheme addresses the risk.


Toilet Goods Ass’n v. Finch, 419 F.2d 21 (2d Cir. 1969)