## Facts

- Dr. Santokh Takhar, a California-licensed veterinarian, used and prescribed drugs for animals, including “extra-label” uses (uses not stated on an FDA-approved label).
- Extra-label use in animals was “technically illegal” under the FDCA, but the FDA historically exercised enforcement discretion through guidance.
- In 1984, the FDA issued Compliance Policy Guide (CPG) 7125.06 addressing extra-label use in food-producing animals, stating that illegal residues were no longer a prerequisite to enforcement and describing criteria and precautions (e.g., veterinarian-client-patient relationship, lack of approved alternatives, extended withdrawal times, and veterinarian labeling).
- In 1991, the FDA issued CPG 7125.35 addressing human-drug use in veterinary practice, incorporating criteria and precautions similar to CPG 7125.06 as enforcement guidance.
- In 1993, Takhar sued FDA officials seeking declaratory and injunctive relief, alleging the CPGs exceeded statutory authority and were invalid substantive rules adopted without APA notice-and-comment.
- The district court dismissed the case as not ripe and for lack of standing because Takhar had not been subjected to enforcement under the CPGs.

## Issues

1. Whether Takhar showed an Article III “injury in fact” sufficient for standing where he alleged only general interference with his practice and a speculative threat of enforcement.
2. Whether the challenge to the CPGs was ripe for judicial review absent a concrete enforcement action or developed factual context.
3. If justiciable, whether the CPGs exceeded FDA authority under the FDCA or required APA notice-and-comment as substantive rules.

## Decision

- The Ninth Circuit affirmed dismissal for lack of standing and lack of ripeness.
- The court held Takhar failed to show a concrete, particularized, actual or imminent injury because he had not been disciplined or threatened with enforcement and did not identify a specific course of conduct he was refraining from undertaking.
- The court held the claims were unripe because the CPGs were nonbinding enforcement guidelines and review would involve an abstract policy dispute without a specific application.
- Because the case was nonjusticiable, the court did not reach the merits of the FDCA or APA arguments.

## Legal Principles

- Article III standing requires a concrete and particularized injury that is actual or imminent, not conjectural or hypothetical.
- A generalized disagreement with agency policy, without enforcement action or a realistic danger of direct injury, is insufficient for pre-enforcement standing.
- Ripeness requires both fitness for judicial decision and hardship from withholding review; speculative future enforcement generally fails both.
- Nonbinding agency guidance that channels enforcement discretion, without independently imposing legal obligations, is less likely to be fit for pre-enforcement judicial review.

## Conclusion

The Ninth Circuit treated the FDA compliance policy guides as nonbinding enforcement guidance and held that, without a concrete injury or a developed dispute arising from an actual or imminent enforcement action, a pre-enforcement challenge lacked standing and was unripe.


Takhar v. Kessler, 76 F.3d 995 (9th Cir. 1996)