## Facts

- Dyestuffs and Chemicals, Inc. manufactured coal-tar food colors, including FD&C Yellow Nos. 3 and 4, used mainly to color butter and oleomargarine.
- For about 40 years, FD&C Yellow Nos. 1–4 had been listed and their batches certified for food use under the Federal Food, Drug, and Cosmetic Act (FDCA).
- In January 1957, the Food and Drug Administration published a Federal Register notice proposing to amend color-certification regulations by removing FD&C Yellow Nos. 1–4 from the list approved for unrestricted use and invited written comments.
- After receiving submissions from interested parties (including an industry committee of which Dyestuffs was a member), the Commissioner issued a May 1957 order removing the four colors from the approved list on the ground they were not “harmless and suitable for use” within the meaning of 21 U.S.C. § 346(b).
- Dyestuffs petitioned for direct appellate review under 21 U.S.C. § 371(f), arguing the agency could not delist the colors without a trial-type evidentiary hearing and challenging the basis for the “not harmless” finding.

## Issues

1. Whether the FDCA required a formal, trial-type evidentiary hearing before the Secretary could delist coal-tar colors as not “harmless and suitable for use” under 21 U.S.C. § 346(b).
2. Whether the Secretary’s determination that FD&C Yellow Nos. 1–4 were not “harmless and suitable” was adequately supported and not arbitrary or capricious on judicial review.

## Decision

- The court denied the petition for review and sustained the order delisting FD&C Yellow Nos. 1–4.
- The court held the Secretary was not required to provide a trial-type evidentiary hearing; notice-and-comment procedures were sufficient for this generally applicable regulatory action.
- The court held the administrative record provided an adequate basis for the Secretary’s safety judgment, and the court would not reweigh technical and scientific evidence.

## Legal Principles

- Agency action that amends generally applicable color-certification regulations under 21 U.S.C. § 346(b) may proceed through informal rulemaking procedures absent an express statutory command for a formal evidentiary hearing.
- Written notice and an opportunity for interested parties to submit views and data can satisfy procedural requirements for this type of regulatory listing decision.
- The statutory requirement that listed colors be “harmless and suitable” is continuing; prior certification history does not bar the agency from revising listings when the scientific record no longer supports harmlessness.
- On review under 21 U.S.C. § 371(f), courts defer to the agency’s scientific and technical determinations and uphold them when supported by an adequate record and not arbitrary or capricious.

## Conclusion

The Eighth Circuit upheld the Secretary’s delisting of four coal-tar yellow food colors, ruling that the FDCA permitted notice-and-comment rulemaking without a trial-type hearing and that the agency’s determination of non-harmlessness was supported and entitled to judicial deference.


Dyestuffs & Chems., Inc. v. Flemming, 271 F.2d 281 (8th Cir. 1959)