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

Rule:

Drugs are misbranded if they fail to bear adequate directions and warnings, 21 U.S.C.S. § 352(f), or if they are prescription drugs dispensed without a prescription, 21 U.S.C.S. § 353(b)(1).

Facts:

The government charged defendants with unlawful distribution of misbranded prescription drugs, in violation of the Food, Drug, and Cosmetic Act (FDCA), alleging that the defendants distributed nitrous oxide, commonly known as laughing gas, in the parking lot of a stadium where a rock concert was being held. Defendants contended that nitrous oxide was not a drug within the meaning of the FDCA, that the FDCA did not apply to the non-professional defendants, and that the criminal provisions of the FDCA were unconstitutionally vague. The government appealed the ruling of the magistrate judge of the United States District Court for the District of Columbia which dismissed the charges.

Issue:

1. Were the criminal provisions of the Food, Drug, and Cosmetic Act (FDCA) unconstitutionally vague? 
2. Was nitrous oxide a drug within the meaning of the FDCA?
3. Under the circumstances, could the defendants be prosecuted under the FDCA? 

Answer:

1) No. 2) Yes. 3) Yes.

Conclusion:

The district court held that the FDCA was constitutional and was properly applicable to the alleged conduct of defendants. Nitrous oxide was a drug within the statutory definition since defendants’ intent, as determined from the circumstances, was to sell a mind-altering article without a prescription; the nitrous oxide was thus a misbranded drug, even though defendants did not label or advertise their product. Further, the FDCA was expressly applicable to individuals, and there was no language in the statute which limited its application to professionals such as physicians, pharmacists, or commercial manufacturers. Finally, the FDCA was not vague since it provided sufficient notice that the introduction into interstate commerce of misbranded drugs was proscribed conduct. Accordingly, the ruling dismissing the charges against defendants was reversed, and the cases were reinstated.