United States v. Article . Consisting of 216
1969 U.S. App. LEXIS 12917, 409 F.2d 734 (1969)
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Rule of Law:
A product is regulated as a 'drug' under the Federal Food, Drug, and Cosmetic Act if its labeling or advertising makes claims that it is intended to affect the structure of the human body, regardless of the product's actual physical effects. Such claims are to be evaluated from the perspective of the 'ignorant, the unthinking and the credulous' consumer.
Facts:
- Hazel Bishop, Inc. manufactured and sold a cosmetic liquid lotion called 'Sudden Change.'
- The product, composed primarily of bovine albumen and water, worked by drying on the skin to form a temporary film.
- This film mechanically tightened the skin's surface, temporarily masking imperfections and smoothing wrinkles.
- The effects of the product were not permanent and could be removed by washing.
- The product's packaging, labeling, and advertising prominently featured claims such as 'Face Lift Without Surgery,' 'lifts, firms, tones slack skin,' and 'lifts the puffs under eyes.'
- Hazel Bishop, Inc. did not have an approved New Drug Application in effect for 'Sudden Change' and did not list the active ingredients on its label.
Procedural Posture:
- The United States filed a civil in rem action in the U.S. District Court for the Southern District of Florida to seize a shipment of 'Sudden Change'.
- The government alleged the product was an unapproved 'new drug' and was misbranded under the Federal Food, Drug, and Cosmetic Act.
- Hazel Bishop, Inc., the manufacturer, intervened as the claimant.
- On the claimant's motion, the case was transferred to the U.S. District Court for the Eastern District of New York.
- Both the government and Hazel Bishop, Inc. filed cross-motions for summary judgment.
- The District Court denied the government's motion and granted summary judgment in favor of Hazel Bishop, Inc.
- The United States (appellant) appealed the District Court's decision to the U.S. Court of Appeals for the Second Circuit.
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Issue:
Does a cosmetic product qualify as a 'drug' under the Federal Food, Drug, and Cosmetic Act solely based on labeling claims that suggest a physiological effect on the body's structure, such as providing a 'face lift without surgery,' regardless of the product's actual, temporary physical effects?
Opinions:
Majority - Anderson, J.
Yes. A product qualifies as a drug based on its intended use, which is determined by the claims made in its labeling and advertising, and these claims must be viewed from the perspective of the most vulnerable consumers. The court reasoned that the FDCA is a remedial statute intended to protect the public, including 'the ignorant, the unthinking and the credulous.' While some cosmetic claims might be dismissed as mere puffery, phrases like 'face lift without surgery' carry distinct physiological connotations. These claims suggest the product will affect the body's structure in a way that goes beyond merely 'altering the appearance,' which is the definitional boundary of a cosmetic. Therefore, regardless of its actual temporary effect, the product's promotional claims bring it within the statutory definition of a drug.
Dissenting - Mansfield, J.
No. A product should not be reclassified from a cosmetic to a drug based on isolated phrases when the 'net impression' of the advertising as a whole clearly indicates its cosmetic and temporary nature. The dissent argued that the majority improperly fragmented the product's labeling, ignoring contextual information that emphasized its temporary effects, such as the phrases 'lasts for hours' and 'does not change the structure or function of the skin.' Applying the majority's 'gullible consumer' standard for determining intent, rather than a 'reasonable person' standard, risks converting nearly all cosmetics into drugs, which contravenes congressional intent. The primary purpose of the drug definition is to protect public health, not to police economic fraud, and 'Sudden Change' posed no health risks.
Analysis:
This decision significantly broadens the FDA's regulatory power by solidifying the principle that a product's classification can be determined solely by its marketing claims, irrespective of its actual mechanism of action. By rejecting a 'reasonable person' standard in favor of protecting 'the ignorant, the unthinking and the credulous,' the court created a strict liability standard for advertising claims. This precedent forces manufacturers, particularly in the cosmetic industry, to meticulously avoid any language that could be interpreted as having physiological or structural connotations, thereby blurring the line between puffery and drug claims and increasing the risk of regulatory action.
