## Facts

- Fmali Herb, Inc. was an importer of Chinese food products and sought to import foods containing herbs traditional in China that had never been widely used in the United States.
- One product Fmali wished to import was a jelly or honey-like product known as **renshenfengwangjiang**, which normally contains **schizandra seed**.
- Under FDCA § 201(s), 21 U.S.C. § 321(s), a substance added to food is a “food additive” unless it is generally recognized as safe; for substances used in food prior to January 1, 1958, safety may be shown through “scientific procedures” or “experience based on common use in food.”
- In 1974, the FDA issued 21 C.F.R. § 170.3(f), defining “common use in food” as “a substantial history of consumption of a substance by a significant number of consumers in the United States.”
- Applying that approach, the FDA indicated renshenfengwangjiang could be sold in the United States only if it did not contain schizandra seed, because schizandra seed lacked scientific testing and was not commonly used in the United States prior to 1958.
- The FDA refused to treat evidence of long and widespread use of schizandra seed in China as admissible to help establish safety through “common use in food.”
- Fmali filed a declaratory-judgment action seeking pre-enforcement review and a declaration that 21 C.F.R. § 170.3(f) was invalid because it improperly read a U.S.-only limitation into FDCA § 201(s).
- No facts were disputed; the parties filed cross-motions for summary judgment.
- The district court upheld the FDA’s position and dismissed the action. Fmali appealed.

## Issues

1. Whether Fmali’s pre-enforcement declaratory challenge to the FDA regulation was ripe and reviewable.
2. Whether 21 C.F.R. § 170.3(f) is an interpretive regulation (and, if so, what level of judicial weight it receives).
3. Whether the FDA permissibly interpreted FDCA § 201(s) by limiting “experience based on common use in food” to consumption in the United States, categorically excluding foreign consumption experience.

## Decision

- The Ninth Circuit held the case was ripe for pre-enforcement review and that the district court properly exercised jurisdiction under the declaratory-judgment posture.
- The Ninth Circuit treated 21 C.F.R. § 170.3(f) as an **interpretive** regulation because the statute did not specifically direct the FDA to define “common use in food.”
- Applying the standard for interpretive rules, the court concluded the FDA’s U.S.-only definition was not a sufficiently reasonable construction of FDCA § 201(s) because it did not fairly reflect the statutory language or the function of the pre-1958 “common use in food” proviso.
- The court reversed the district court’s declaration that the regulation was valid and remanded for further proceedings consistent with the holding that foreign experience cannot be excluded by definition from the “common use in food” inquiry.

## Legal Principles

- Pre-enforcement challenges to FDA regulations may be reviewable and ripe where the dispute is fit for judicial resolution and withholding review would impose hardship, consistent with Abbott Laboratories v. Gardner.
- When an agency issues an interpretive regulation construing statutory terms (rather than exercising delegated lawmaking power), the rule is given important but not controlling weight; a reviewing court asks whether the agency’s construction is sufficiently reasonable.
- Where statutory text is geographically neutral, an agency generally may not add a categorical “United States only” limitation absent support in the statute’s wording, structure, or function.
- FDCA § 201(s) provides two avenues for pre-1958 substances to show safety—scientific procedures or experience based on common use in food—and a regulation that makes the experience-based avenue unavailable for substances with extensive foreign use conflicts with that design.
- While the FDA may evaluate the reliability and relevance of evidence offered to show safety, it may not refuse to consider foreign consumption history as a matter of definition when the statute does not impose that bar.

## Conclusion

Fmali Herb, Inc. v. Heckler held that the FDA’s regulation defining “common use in food” as requiring a substantial history of consumption in the United States was an invalid interpretive construction of FDCA § 201(s), because the statute’s pre-1958 proviso does not limit “common use” to domestic experience; the Ninth Circuit therefore reversed the district court and required that foreign use experience be eligible for consideration in the “common use in food” analysis.


Fmali Herb, Inc. v. Heckler, 715 F.2d 1385 (1983)