## Facts

- The United States brought an in rem libel under the Federal Food, Drug, and Cosmetic Act (FDCA) seeking seizure and condemnation of rubber prophylactic devices shipped in interstate commerce.
- The shipment at issue included about **43 1/2 gross** of “Xcello” brand devices and **112 1/2 gross** of “Silver-Tex” brand devices shipped from **Akron, Ohio** to a consignee in **Minneapolis, Minnesota**.
- The cartons were labeled “Prophylactics,” and the devices were sold as rubber articles intended to prevent transmission of venereal disease.
- The government alleged the articles were **adulterated** under **21 U.S.C. § 351(c)** because their quality fell below what they purported or were represented to possess, and **misbranded** under **21 U.S.C. § 352(a)** because the labeling was false or misleading.
- Government inspectors took two sets of samples from the shipment: a **pre-seizure** sample and a **post-seizure** sample.
- Testing showed some devices contained holes: **14 of 180** “Xcello” devices tested and **16 of 228** “Silver-Tex” devices tested contained holes (about **7.37%** of the tested units).
- Medical testimony indicated that prophylactic devices containing holes would not successfully prevent venereal disease transmission.
- The claimant challenged condemnation of the entire lot, arguing that only a small percentage of tested items were defective and that the government had not tested every article.

## Issues

1. Whether rubber prophylactic devices that contained holes were adulterated under 21 U.S.C. § 351(c) and misbranded under 21 U.S.C. § 352(a) when labeled “Prophylactics.”
2. Whether the FDCA permitted condemnation of the entire interstate shipment based on sample testing showing a portion of units were defective, rather than proof item-by-item.

## Decision

- The court held that the devices shown by testing to contain holes were **adulterated** under **21 U.S.C. § 351(c)** because their **quality** fell below what they purported or were represented to possess.
- The court held that those defective devices were **misbranded** under **21 U.S.C. § 352(a)** because labeling them “Prophylactics” was misleading when the defective items were not effective for disease prevention.
- The court rejected the argument that the government had to test every device and concluded that **representative sampling** could support an inference about the condition of the shipment.
- Based on the sampling results and the nature of the goods as a single commercial lot, the court ordered **condemnation of the entire shipment** under the FDCA’s seizure and condemnation provisions.

## Legal Principles

- Under **21 U.S.C. § 351(c)**, a device is adulterated if its strength differs from, or its purity or **quality** falls below, that which it purports or is represented to possess; “quality” can include functional performance for the use conveyed by the labeling and marketing.
- Under **21 U.S.C. § 352(a)**, a device is misbranded if its labeling is false or misleading in any particular; labeling a product “Prophylactics” conveys that it will function as protection against venereal disease, so defective units that cannot perform that function are misbranded.
- The government may rely on **sampling** in an FDCA condemnation case; it need not test each article if the sampling supports treating the seized property as a lot containing adulterated or misbranded articles.
- Where defective units are commingled in a shipment of devices sold for disease prevention, condemnation of the shipment may be ordered even if the defect rate shown by samples is less than a majority.

## Conclusion

The court concluded that rubber prophylactics labeled “Prophylactics” that contained holes were adulterated and misbranded under the FDCA, and it permitted condemnation of the entire interstate shipment based on representative sample testing showing defects that defeated the devices’ represented protective function.


United States v. 43 1/2 Gross Rubber Prophylactics Labeled in Part “Xcello's Prophylactics”, 65 F. Supp. 534 (1946)