Labeling, Misbranding, and Adulteration

General Rule for Commercial Speech

commercial speech is generally more susceptible to regulation and censorship than speech in general

Adulteration

"Adulteration" is a legal term meaning that a food product fails to meet federal or state standards. Adulteration usually refers to noncompliance with health or safety standards as determined, in the United States, by the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA).

Misbranding (FDCA; Food §403) Ignoramus Standard is used for...

- FOOD (except for dietary supps) & - DRUG (under intended use doctrine, in jd/classification section above) - CHECK NOTES

Misbranding (FDCA; Food §403) Truth Defense

- can be defended with truth defense (similar to defamation)

Economic Adulteration False Superiority (FDCA; Food §402(b)(4)

A product is adulterated only if: o Any substance is added thereto so as to make it appear better or of greater value than it is, AND o A superior, more wholesome counterpart can be identified, described and defined, AND o The ordinary consumer can potentially confuse it with the counterpart (ignoramus standard not used) (ie Bierley's Orange Beverage

Economic Adulteration Concealed Inferiority (FDCA; Food § 402(b)(3)

A product is also adulterated if: o Its damage or inferiority is concealed in any manner

Misbranding (FDCA; Food §403) Cases

Apple Cider Candy Lollipops Diet Thins

Which test used for challenging commercial speech?

Central Hudson Test

Labeling (FDCA; Definitions § 201(m)) Definition

Labeling is: - All labels and other written, printed or graphic matter: ♣Upon any article or any of its containers or wrappers, OR ♣Accomp'g such article, & - Distributed by or on behalf of the manufacturer

Labeling (FDCA; Definitions § 201(m)) Definition "Accompanying" means...

Written, printed, or graphic matter: - That supplements (is meant to supplement), explains or markets the product, AND - Need not be attached to the product

Misbranding (FDCA; Food §403) Manufacturing Immateriality

method of manufacturing is irrelevant; if the end product doesn't have something in it, you can't mislead to say that it does (ie Apple Cider case)

Misbranding (FDCA; Food §403) TYPES

o False or misleading label o Incorrect name o Imitation o Misleading packaging container

Misbranding (FDCA; Food §403) RULE - A product is misbranded/mislabeled if:

o It makes false claims, OR o Labeling has false or misleading information (products must adhere to standards of classification as outlined above and below), OR o It fails to give adequate directions for the intended use

Examples of "accompanying" materials

o Pamphlets o Books - generally only if the book is meant to supplement or market it; FDA has to be careful about regulation of books o Press Release - again, if it is meant to supplement or market the product o Websites - same analysis

Economic Adulteration PENALTIES

o Warning Letter o Public warning letter; usually leads to court action and injunction o Criminal prosecution o FDA ask for profits and other fines

Commercial Speech

• A producer may challenge FDA regulation of product's labeling on grounds that it violates free speech rights