## Facts

- Faraday Laboratories, Inc. manufactured and sold “OVA II,” an at-home pregnancy test kit shipped in interstate commerce.
- The kit was a set of chemicals and related materials intended to be used at home to run a “preliminary screening test” that would indicate the probability that a woman was pregnant.
- Each kit included bottles of liquid and other components, plus an insert with directions and warnings; the labeling included a poison warning referencing hydrochloric acid.
- The kit’s chemical components included sodium hydroxide and hydrochloric acid, both listed in the United States Pharmacopeia (USP).
- Acting through the Food and Drug Administration (FDA), the United States seized several thousand kits and filed an in rem forfeiture and condemnation action under the Federal Food, Drug, and Cosmetic Act (FDCA).
- The government alleged OVA II was a “drug” under 21 U.S.C. § 321(g)(1) and, because it lacked general recognition among qualified experts as safe and effective for its labeled use, was a “new drug” under 21 U.S.C. § 321(p) requiring an approved new drug application (NDA) before marketing under 21 U.S.C. § 355.
- Faraday appeared as claimant and sought summary judgment, arguing the kit was not a “drug” under any branch of the statutory definition and therefore was not subject to NDA requirements.
- The FDA argued that OVA II fell within the FDCA’s definition of “drug,” including because it was intended for diagnosis and because its ingredients were USP-recognized substances.
- After an earlier denial of cross-motions due to factual and legal uncertainties, the court requested additional clarification; the parties submitted a joint response and renewed cross-motions for summary judgment.

## Issues

1. Whether the OVA II at-home pregnancy test kit is a “drug” within the meaning of 21 U.S.C. § 321(g)(1), including as an article intended for use in diagnosis and/or as an article recognized in the USP.
2. If OVA II is a “drug,” whether it is a “new drug” under 21 U.S.C. § 321(p) that could not be introduced into interstate commerce without an approved NDA under 21 U.S.C. § 355.
3. Which party was entitled to summary judgment on forfeiture and condemnation of the seized kits.

## Decision

- The court held that OVA II is a “drug” within the meaning of the FDCA because it was marketed and labeled for use in diagnosing a condition (pregnancy).
- The court concluded that OVA II was a “new drug” because it was not generally recognized by qualified experts as safe and effective for its labeled at-home pregnancy screening use.
- The court granted summary judgment to the United States and denied Faraday’s renewed motion for summary judgment.
- The seized OVA II kits were subject to forfeiture and condemnation due to introduction into interstate commerce without an approved NDA.

## Legal Principles

- Whether an article is a “drug” under the FDCA turns largely on its intended use as shown by labeling, instructions, and marketing claims, not merely on whether it is ingested or applied to the body.
- The FDCA’s drug definition includes articles intended for use in diagnosis; an in vitro home test intended to determine whether a woman is pregnant can fall within § 321(g)(1)’s diagnostic category even though the test is performed outside the body.
- Listing of components in the USP may support “drug” status under § 321(g)(1)(A), but the court treated intended diagnostic use as sufficient to bring the kit within the statute without relying only on automatic USP incorporation.
- “New drug” status depends on whether qualified experts generally recognize the product, under its labeled conditions of use, as safe and effective; the analysis is tied to the product as marketed (including its instructions and home-use setting), not just to whether individual chemical ingredients are familiar.
- A product that is a “new drug” may not be marketed in interstate commerce without an FDA-approved NDA; failure to have an approved NDA supports condemnation in an FDCA forfeiture action.

## Conclusion

In *United States v. Article of Drug … Ova II*, the district court ruled that Faraday’s at-home pregnancy test kit was a “drug” because it was intended for diagnostic use, and it was a “new drug” because it lacked general recognition among qualified experts as safe and effective for the labeled home testing purpose; because the kits were distributed without an approved NDA, the government was entitled to summary judgment and condemnation of the seized articles.


United States v. Article of Drug … Ova II, 414 F. Supp. 660 (1975)