## Facts

- The United States, acting under the Federal Food, Drug, and Cosmetic Act (FDCA), brought an in rem seizure action against 216 bottles of a facial lotion labeled “Sudden Change,” manufactured by Hazel Bishop, Inc.
- “Sudden Change” was a clear, externally applied liquid lotion composed primarily of distilled water (over 84%) and bovine albumen (about 15%).
- When applied and allowed to dry, the product formed a film that temporarily (1) masked skin imperfections and (2) tightened the skin surface to make it look smoother and firmer; it washed off and was not shown to be absorbed or to change skin tissue.
- The product’s labeling and advertising included claims such as “Face Lift Without Surgery” and representations that it would “lift out puffs.”
- The government alleged the product was a “drug” under FDCA § 201(g)(1)(C), 21 U.S.C. § 321(g)(1)(C), as an article “intended to affect the structure” of the human body, based on its promotional claims.
- The claimant contended the product was a cosmetic with only temporary, mechanical, surface-level effects and that consumers would treat the advertising language as exaggeration rather than literal structural promises.

## Issues

1. Whether “Sudden Change” was a “drug” under 21 U.S.C. § 321(g)(1)(C) because, as marketed, it was “intended to affect the structure” of the human body.
2. Whether intent under § 321(g)(1)(C) is determined primarily from consumer-facing labeling and advertising rather than from pharmacological or physiological mechanisms.

## Decision

- The Second Circuit reversed the district court’s summary judgment for the claimant.
- The court held that “Sudden Change” was a “drug” within the meaning of 21 U.S.C. § 321(g)(1)(C) because its labeling and advertising showed an intent to affect bodily structure.
- The case was remanded for further proceedings consistent with the product’s classification as a drug.

## Legal Principles

- Under 21 U.S.C. § 321(g)(1)(C), an article is a “drug” if it is “intended to affect the structure or any function of the body.”
- “Intended use” may be established by objective evidence of labeling and promotional claims directed to consumers.
- A structural effect under § 321(g)(1)(C) need not be biochemical, physiological, or permanent; temporary or mechanically produced tightening or firming may qualify when marketed as structural change.
- Advertising statements that promise structural alteration (e.g., “face lift without surgery”) can support drug status even if the manufacturer characterizes the product as a cosmetic and even if the actual effect is limited.

## Conclusion

The Second Circuit concluded that a facial lotion marketed with claims suggesting a “face lift” and other structural changes falls within the FDCA’s definition of a “drug” because intended use is determined from labeling and advertising, and “structure” effects are not limited to permanent or physiological changes.


United States v. An Article . . . “Sudden Change”, 409 F.2d 734 (2d Cir. 1969)