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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 or descriptive matter that goes with the package in which the articles are transported. The second clause—“accompanying such article”—has no specific reference to packages, containers, or their contents as did a predecessor statute… . It plainly includes what is contained within the package whether or not it is “upon” the article or its wrapper or container. But the second clause does not say “accompanying such article in the package or container,” and we see no reason for reading the additional words into the text.

One article or thing is accompanied by another when it supplements or explains it, in the manner that a committee report of the Congress accompanies a bill. No physical attachment of one to the other is necessary. It is the textual relationship that is significant. The analogy to the present case is obvious. We need not labor the point.

The false and misleading literature in the present case was designed for use in the distribution and sale of the drug, and it was so used. The fact that it went in a different mail was wholly irrelevant whether we judge the transaction by purpose or result….

Petitioner points out that in the evolution of the Act, the ban on false advertising was eliminated, the control over it being transferred to the Federal Trade Commission… . We have searched the legislative history in vain, however, to find any indication that Congress had the purpose to eliminate from the Act advertising which performs the function of labeling. Every labeling is in a sense an advertisement. The advertising which we have here performs the same function as it would if it were on the article or on the containers or wrappers. As we have said, physical attachment or contiguity is unnecessary under 201(m)(2) …

We have considered the other objections tendered by petitioner and find them without merit.

Affirmed.

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The Kordel court’s interpretation of labeling is considered an expansive one because the items were shipped at different times. Any doubt about the Court’s intent was eliminated by United States v. Urbuteit,² which found that pamphlets shipped separately from medical devices were interrelated enough to be considered labeling: “The problem is a practical one of consumer protection, not dialectics. The fact that the literature leaves in a separate mail does not save the article from being misbranded.”³

Note, however, that the Kordel defendant held responsibility for shipping both the products and the literature; and the literature was clearly a tool for marketing the products. Thus, there was a clear connection between the literature and the products even if not shipped together.

When the activities are not integrated, the courts are less likely to find that literature is labeling. For example, in United States v. 24 Bottles “Sterling Vinegar & Honey,” 338 F.2d 157 (2d Circ. 1964), the court found no inference that the books touting the health benefits of vinegar and honey were sold for the purpose of increasing the sales of Sterling Vinegar & Honey. For example, the books had been sold for two years prior to production of the Sterling product.

… The distinguishing characteristic of a label is that, in some manner or another, it is presented to the customer in immediate connection with his view and his purchase of the product. Such a connection existed at both wholesale and retail levels in Kordel: Although the pamphlets and drugs were mailed to retailers separately, they were mailed in ‘integrated transactions’; the vendors in turn gave the pamphlets away with the sale of the drugs in some cases….

“Folk Medicine” was a bestselling book which Balanced Foods and health food shops could be expected to carry without regard to Vinegar and Honey, as they did prior to introduction of the latter product. The book made broad claims for a vinegar and honey mixture, which led ultimately to Sterling’s marketing Vinegar and Honey. It is not disputed that these claims were misleading, but the Federal Food, Drug, and Cosmetic Act was not intended to deal generally with misleading claims; much more general proscriptions may be found in §§ 12‐15 of the Federal Trade Commission Act, 15 U.S.C. §§ 52‐55 (1958). In our view, the Food and Drug Act was intended to deal with such claims only when made in immediate connection with sale of the product….

U.S. v. 24 Bottles “Sterling Vinegar & Honey” at 159–60.

It should also be noted that since 1982, the FDA’s policy has recommended against the seizure of labeling when it is in the form of books. Instead, the agency has recommended the collection of an official sample of the book as evidence that the product is violative.⁴

The FDA’s policy recognizes that certain First Amendment free speech protections apply to commercial speech. In particular, the Supreme Court has established that free speech protections generally prohibit prior restraint of speech. A prior restraint exists where the dissemination of speech is restricted or prohibited before its violative nature has been judicially determined. Accordingly, FDA’s policy is to seek a court injunction before seizing books.