## Facts

- The United States, acting through the Food and Drug Administration (FDA), filed a civil enforcement action under the Federal Food, Drug, and Cosmetic Act (FDCA), seeking injunctive relief under 21 U.S.C. § 332(a).
- Tuente Livestock and the individual defendants operated as hog dealers: they bought live hogs from producers and sold them to slaughterhouses that would slaughter, process, and distribute pork for human consumption.
- The FDA accused defendants of delivering to slaughterhouses live swine whose edible tissues contained illegal residues of the animal drug sulfamethazine, which would render the resulting food adulterated under the FDCA.
- The complaint did not claim defendants themselves drugged or contaminated the hogs; instead, it alleged defendants failed to take steps to ensure the hogs were free of illegal drug residues at slaughter, including failing to obtain written assurances from producers.
- The government alleged defendants’ conduct amounted to introducing, or delivering for introduction, adulterated “food” into interstate commerce in violation of 21 U.S.C. § 331(a).
- Defendants moved to dismiss under Federal Rule of Civil Procedure 12(b)(6), arguing (i) live hogs are not “food” under the FDCA and (ii) their conduct as middlemen did not constitute introduction or delivery for introduction into interstate commerce.

## Issues

1. Whether live swine intended for slaughter can qualify as “food” under the FDCA’s definition in 21 U.S.C. § 321(f).
2. Whether hog dealers who buy live swine from producers and sell them to slaughterhouses can “introduce or deliver for introduction into interstate commerce” adulterated food under 21 U.S.C. § 331(a).
3. Whether the United States’ complaint stated a claim for injunctive relief sufficient to survive a Rule 12(b)(6) motion.

## Decision

- The court overruled defendants’ Rule 12(b)(6) motion to dismiss.
- The court held the FDCA’s definition of “food,” while broad, does not expressly resolve whether it covers live animals; given that ambiguity, the FDA’s long-standing interpretation treating live animals intended for human consumption as “food” was a permissible reading and could be used at the pleading stage.
- The court held defendants’ role as intermediaries in the chain of commerce could fall within § 331(a)’s prohibition on introducing or delivering adulterated food for introduction into interstate commerce.
- The court declared defendants’ motions to strike certain declarations (submitted in connection with the government’s preliminary-injunction request) moot in light of the ruling on the motion to dismiss.

## Legal Principles

- On a Rule 12(b)(6) motion, the court accepts well-pleaded factual allegations as true and dismisses only when the plaintiff can prove no set of facts that would entitle it to relief.
- When a statute administered by an agency is ambiguous on a point, courts may defer to the agency’s reasonable, long-used construction of the statute (Chevron deference).
- For FDCA enforcement, “food” may be read to include live animals held and sold for slaughter and ultimate human consumption.
- Section 331(a)’s ban on introducing or delivering adulterated food into interstate commerce can reach intermediaries who move regulated products along the commercial chain, not only the party that created the contamination.
- The FDCA’s written-guaranty defense structure indicates Congress anticipated that dealers and other middlemen could face § 331(a) liability and could protect themselves by obtaining qualifying guaranties.

## Conclusion

The district court allowed the United States’ FDCA injunction action to proceed, ruling that the FDA may treat live hogs intended for slaughter as “food” and that hog dealers who buy from producers and sell to slaughterhouses may be alleged to have delivered adulterated food for introduction into interstate commerce, making dismissal at the pleading stage improper.


United States v. Tuente Livestock, 888 F. Supp. 1416 (1995)