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.
3.3.2 Labeling Versus Food Advertising
Advertising is any commercial solicitation and anything published or transmitted to attract customers or sell a product. The definition of “labeling” is broad enough that it overlaps with advertising. For example, brochures, flyers, and booklets that accompany a food fall under the scope of “labeling.”
Before 1938, no federal agency was directly charged with the regulation of food advertising. The federal regulation of advertising began with passage of the Federal Trade Commission Act in 1914, which created the FTC, but at that time false advertising was only prohibited when there was evidence of injury to a competitor.
In the years leading to passage of the FD&C Act, Congress debated which agency should have jurisdiction over food advertising. The issue was decided with the passage of the Wheeler‐Lea Amendment of 1938,5 which designated the FTC as the agency to regulate the advertising of food. The Wheeler‐Lea Amendment amended section 5 of the FTC Act and empowered the FTC to act against unfair or deceptive acts or practices if there was evidence of injury to the public. Proof of injury to competition was no longer necessary. At the time, delegation of authority over advertising to FTC, rather than FDA, was considered a victory for the regulated industries.6
Nonetheless, FDA also has authority over advertising when it is also “labeling.” This creates overlapping authority on some advertising. The labeling requirements tend to be more proscriptive than the advertising requirements. Some statements permitted in advertising may be prohibited on labeling. This situation has resulted in considerable attention to the meaning and limits of term “labeling.”
3.3.3 The Internet and Labeling
* * * * *
FDA Letter on Labeling Food Products Presented or Available on the Internet
U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
November 1, 2001
[To: Washington Legal Foundation]
…
This letter responds to your citizen petition… . Your petition asked FDA to “formally adopt a rule, policy, or guidance stating that information presented or available on a company’s Internet website, including hyperlinks to other third party sites, does not constitute ‘labeling,’” as defined by the Federal Food, Drug, and Cosmetic Act (FD&C Act) at 21 U.S.C. § 321(m). In your petition, you further requested that the rule, policy, or guidance specify that such information may, but does not necessarily, constitute advertising. Alternatively, you asked FDA to adopt a rule, policy, or guidance “exempting Internet information of food companies from labeling requirements.”
… FDA, however, disagrees that information presented or available on a company’s website could never constitute labeling. “Labeling” is defined in section 201(m) of the FD&C Act (21 U.S.C. § 321(m)) as “all labels and other written, printed or graphic matter upon any article … or accompanying such article.” In Kordel v. United States, 335 U.S. 345 (1948), the Supreme Court concluded that the phrase “accompanying such article” included literature that was shipped separately and at different times from the drugs with which they were associated. “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 one to the other is necessary. It is the textual relationship that is significant.” Id. at 350. The Court also noted that the literature and drugs were parts of an integrated distribution program.
Based on this authority, FDA and the courts have interpreted “labeling” to include “[b] rochures, booklets, … motion picture films, film strips, … sound recordings, … and similar pieces of printed, audio, or visual matter descriptive of a drug … which are disseminated by or on behalf of its manufacturer, packer, or distributor… .”…
Lower court cases after Kordel reinforce a broad reading of the term “accompanying.”… In addition, the courts have considered
