## Facts

- The United States, on behalf of the FDA, filed an in rem condemnation action under the Federal Food, Drug, and Cosmetic Act (FDCA) against quantities of “Beacon Castile Shampoo.”
- The government alleged the shampoo was an adulterated cosmetic under 21 U.S.C. § 361(a) because it contained a poisonous or deleterious substance that “may render it injurious” to users under labeled or customary conditions of use.
- To show potential injury, the government offered evidence that a user would suffer temporary eye injury if the shampoo’s full-strength concentrate entered the eye.
- The manufacturer (as claimant) responded that the shampoo’s typical use is during showering, where the product is used with water and is commonly diluted in practice.
- The claimant argued that undiluted concentrate entering the eyes would be rare in ordinary use unless a consumer used the shampoo unusually close to the eyes.
- The dispute focused on whether the government’s full-strength eye-exposure scenario reflected “customary or usual” conditions of use and whether the government’s proof met the statutory standard for cosmetic adulteration.

## Issues

1. Whether “Beacon Castile Shampoo” was adulterated under 21 U.S.C. § 361(a) based on evidence that undiluted shampoo concentrate could cause temporary eye injury.
2. Whether undiluted shampoo concentrate contacting a user’s eyes is a “customary or usual” condition of use for shampoo under § 361(a).
3. Whether the government’s evidence of temporary injury from full-strength exposure was sufficient to justify condemnation in an FDCA in rem action.

## Decision

- The court ruled for the claimant and declined to condemn the shampoo.
- The court concluded that the government had not shown that the product “may render [it] injurious” to users under labeled directions or under conditions of use that are customary or usual.
- Evidence of temporary injury from full-strength concentrate reaching the eye did not establish adulteration where ordinary shower use made such undiluted eye exposure uncommon.

## Legal Principles

- Under 21 U.S.C. § 361(a), a cosmetic is adulterated if it contains a poisonous or deleterious substance that may render it injurious to users under labeled directions or under customary or usual conditions of use.
- The adulteration inquiry turns on how consumers normally use the product, not on rare or unusual exposure patterns that do not reflect customary use.
- In an FDCA condemnation action, the government must prove the statutory basis for adulteration and connect the claimed injury risk to customary or usual conditions of use.
- Evidence that a product can cause temporary injury under atypical, undiluted contact may be insufficient if customary use materially reduces the likelihood of that exposure.

## Conclusion

United States v. An Article of Cosmetic . . . “Beacon Castile Shampoo” treated FDCA cosmetic adulteration as a use-conditions inquiry: temporary eye injury from undiluted concentrate did not warrant condemnation where ordinary shower use typically dilutes the shampoo and makes full-strength eye contact uncommon.


United States v. An Article of Cosmetic . . . “Beacon Castile Shampoo”, 1969-1974 FDLI Jud. Rec. 160 (1974)