## Facts

- Federal and local law enforcement conducted a joint investigation into nitrous oxide sales at a rock concert at RFK Stadium in Washington, D.C., on June 9, 2001.
- An undercover officer allegedly paid defendants with pre-recorded funds and received balloons filled with nitrous oxide for inhalation.
- Defendants allegedly sold nitrous oxide in small, unlabeled balloons to concertgoers in a parking-lot setting for intoxicating effects.
- The United States charged defendants by informations and complaints with unlawful distribution of misbranded prescription drugs under the Federal Food, Drug, and Cosmetic Act (FDCA), invoking 21 U.S.C. §§ 331(a), 333(a)(1), 353(b)(1), and 352(f)(2).
- A Magistrate Judge dismissed the charges with prejudice, reasoning that the FDCA did not reach these private individuals and that the nitrous oxide, as sold, was not a “drug” for FDCA purposes.
- The government appealed the dismissal to the district court under Federal Rule of Criminal Procedure 58(g)(2)(B).

## Issues

1. Whether nitrous oxide distributed in balloons for inhalation could qualify as a “drug” under 21 U.S.C. § 321(g)(1) based on its intended use.
2. Whether the FDCA’s criminal prohibitions may be applied to private individuals selling nitrous oxide in a parking lot rather than to traditional regulated entities (e.g., manufacturers, pharmacists).
3. Whether the FDCA is unconstitutional as applied to these defendants, including on vagueness and nondelegation grounds.

## Decision

- The district court reversed the Magistrate Judge’s dismissal and reinstated the informations and complaints.
- The court held that nitrous oxide could fall within the FDCA’s definition of “drug” based on intended use inferred from the circumstances of sale and use.
- The court held that FDCA liability is not limited to licensed professionals or commercial drug firms; the statute reaches “any person” who commits prohibited acts involving drugs.
- The court rejected the as-applied constitutional challenges, concluding the statute provided adequate notice and contained sufficient legislative guidance for enforcement.

## Legal Principles

- “Intended use” under the FDCA may be proven by evidence beyond labeling, including the circumstances of distribution and the anticipated physiological effects.
- A substance may be a “drug” under 21 U.S.C. § 321(g)(1) if it is intended to affect the structure or function of the body.
- The FDCA’s prohibitions in 21 U.S.C. § 331 apply broadly to “any person,” permitting prosecution of individuals who distribute misbranded prescription drugs.
- A product treated as prescription-only under 21 U.S.C. § 353(b)(1) and distributed without adequate directions for use may be deemed misbranded under 21 U.S.C. § 352(f)(2).
- As applied here, the FDCA is not void for vagueness where statutory definitions and prohibitions provide fair notice of the charged conduct, and it does not violate nondelegation where Congress supplies an intelligible enforcement framework.

## Conclusion

The court reinstated FDCA criminal charges arising from nitrous oxide balloon sales at a concert, ruling that intended use can be inferred from surrounding facts, that private individuals may be prosecuted as “any person” under the Act, and that the statute is constitutional as applied.


United States v. Travia, 180 F. Supp. 2d 115 (D.D.C. 2001)