of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appearing on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.
2 (l)The term “immediate container” does not include package liners.
3 (m)The term “labeling” means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article….
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Food Labeling
21 C.F.R. Part 101
§ 101.1 Principal display panel of package form food
The term “principal display panel” as it applies to food in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part with clarity and conspicuousness and without obscuring design, vignettes, or crowding. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel ….
§ 101.2 Information panel of package form food
1 The term “information panel” as it applies to packaged food means that part of the label immediately contiguous and to the right of the principal display panel as observed by an facing the principal display panel with the following exceptions:If the part of the label immediately contiguous and to the right of the principal display panel is too small to accommodate the necessary information or is otherwise unusable label space, e.g., folded flaps or can ends, the panel immediately contiguous and to the right of this part of the label may be used.If the package has one or more alternate principal display panels, the information panel is immediately contiguous and to the right of any principal display panel.If the top of the container is the principal display panel and the package has no alternate principal display panel, the information panel is any panel adjacent to the principal display panel.
2 All information required to appear on the label of any package of food under … this chapter shall appear either on the principal display panel or on the information panel, unless otherwise specified by regulations in this chapter.
3 All information appearing on the principal display panel or the information panel pursuant to this section shall appear prominently and conspicuously, but in no case may the letters and/or numbers be less than one‐sixteenth inch in height unless an exemption pursuant to paragraph (f) of this section is established… . [A number of exemptions from size and placement requirements are omitted.]
4 All information appearing on the information panel pursuant to this section shall appear in one place without other intervening material.
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3.3.1 Label Versus Labeling
Mark Twain noted that the distinction between the right word and the almost right word is the difference between lightning and a lightning bug.1 Notice the distinction between the terms “label” and “labeling” as defined in section 201 of FD&C Act. The slight difference in the words creates an important distinction in meaning.
The Scope of Labeling
The term “labeling” is defined broadly in section 201 of FD&C Act to include “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.”
Kordel v. United States is a landmark case dealing with the jurisdictional reach of FDA’s authority of “labeling.” The Kordel case involved health foods—compounds of vitamins, minerals, and herbs—that were supplied with brochures and other literature. These health foods were deemed drugs, as defined by the FD&C Act, because of their intended use. Kordel contended that the literature was not “labeling” and, therefore, was not subject to the misbranding provisions of the FD&C Act.
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Kordel v. United States
335 U.S. 345 (1948)
Opinion of the Court by Mr. Justice Douglas, announced by Mr. Justice Reed
….
Kordel was charged by informations containing twenty counts of introducing or delivering for introduction into interstate commerce misbranded drugs… . Kordel writes and lectures on health foods from information derived from studies in public and private libraries. Since 1941, he has been marketing his own health food products, which appear to be compounds of various vitamins, minerals, and herbs. The alleged misbranding consists of statements in circulars or pamphlets distributed to consumers by the vendors of the products, relating to their efficacy. The petitioner supplies these pamphlets as well as the products to the vendors. Some of the literature was displayed in stores in which the petitioner’s products were on sale. Some of it was given away with the sale of products; some sold independently of the drugs; and some mailed to customers by the vendors.
… The question of whether the separate shipment of the literature saved the drugs from being misbranded within the meaning of the Act presents the main issue in the case.
Section 301(a) of the Act prohibits the introduction into interstate commerce of any drug that is adulterated or misbranded. It is misbranded according to 502(a) if its “labeling is false or misleading in any particular” and unless the labeling bears “adequate directions for use” per 502(f). The term labeling is defined in 201(m) to mean “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.” Section 303 makes the violation of any of the provisions of 301 a crime.
In this case, the drugs and the literature had a common origin and a common destination. The literature was used in the sale of the drugs. It explained their uses. Nowhere else was the purchaser advised how to use them. It constituted an essential supplement to the label attached to the package. Thus the products and the literature were interdependent, as the Court of Appeals observed.
It would take an extremely narrow reading of the Act to hold that these drugs were not misbranded. A criminal law is not to be read expansively to include what is not plainly embraced within the language of the statute … since the purpose fairly to apprise men of the boundaries of the prohibited action would then be defeated… . But there is no canon against using common sense in reading a criminal law, so that strained and technical constructions do not defeat its purpose by creating exceptions from or loopholes in it….
It would, indeed, create an obviously wide loophole to hold that these drugs would be misbranded if the literature had been shipped in the same container, but not misbranded if the literature left in the next or in the preceding mail. The high purpose of the Act to protect consumers who under present conditions are largely unable to protect themselves in this field would then be easily defeated. The administrative agency charged with its enforcement has not given the Act any such restricted construction. The textual structure of the Act is not agreeable to it. Accordingly, we conclude that the phrase “accompanying such article” is not restricted to labels that are on or in the article on package that is transported.
The first clause of 201(m)—all labels “upon any article or any of its containers or wrappers”—clearly embraces advertising