From "Behind The Label: A Guide For Retailers," A Supplement to Natural Foods Merchandiser
Everyone in the dietary supplements industry realizes that supplement labels are not permitted to include any disease claims; only structural/function claims are permissible. But it is also well known that herbs and dietary ingredients have therapeutic value and can help to prevent, treat or mitigate certain diseases.
Can this medical information ever be conveyed to supplements consumers? Yes, via third-party literature, often taking the form of herb sheets found in the book section of health food stores. This is allowable under Section 5 of the Dietary Supplement Health and Education Act of 1994.
Section 5 literature is not considered labeling, so it is an acceptable vehicle for discussing scientific and medical information about how a dietary supplement ingredient treats or prevents disease.
For example, a piece of Section 5 literature about echinacea could legally discuss its effectiveness in preventing colds and flu, whereas the label claims for an echinacea product would be limited to structure/function claims such as "bolsters the immune system." Similarly, Section 5 literature on ginkgo biloba may discuss its therapeutic value for the memory loss symptoms of Alzheimer's disease, whereas the label of such a product may merely contain claims such as "maintains good memory as you age" or "maintains healthy brain function."
'Seize' And Desist
Before the implementation of DSHEA, there were several cases in which courts upheld the Food and Drug Administration's actions in seizing books, products or both, when materials discussing therapeutic values of a food or supplement were sold near or accompanied by the product.
These examples are summarized in a fascinating and useful book called Dietary Supplement Health and Education Act: A Legislative History and Analysis, by attorneys Scott Bass and Anthony Young (Food and Drug Law Institute, 1996). The FDA's reasoning was that these materials constituted "labeling" of the product, on which drug statements or disease claims were not permitted. A 1948 case involved the sale of vitamins, minerals and herbal products offered in the same store as booklets about how these products prevented or relieved certain medical conditions. The U.S. Supreme Court concluded that the booklets constituted labeling because they accompanied the product, and because "labels" and "labeling" are not restricted to language that is affixed to the container. In 1951, a New York court upheld an FDA seizure of books about home remedies and the medicinal benefits of molasses because these books accompanied the molasses itself.
Then in 1965, the FDA seized honey, a booklet and mailers generally discussing honey. Again the FDA prevailed when the court decided that the published materials were "labeling." The appeal judges' reasoning was: "Since both a copy of the booklet and the leaflet were shown to the Food and Drug inspector when he passed [posed] as a prospective customer and asked for information concerning honey, a permissible and reasonable inference is that this literature was shown to the inspector to induce him to purchase claimant's honey."
However, in 1964, a different appeals court reached a determination that seemed to conflict with the patterns above—but the facts were also different, namely the placement of the literature in question. In a case called United States v. "Sterling Vinegar and Honey," the FDA argued that a book recommending the honey and vinegar product for sale constituted labeling, simply by virtue of being sold in the same store. The court disagreed, noting that the book was offered in the general reading section of the store, and that there were no joint displays of the book and the vinegar and honey. The court thus upheld the retailer's right to sell the book, primarily because there was no immediate connection with product sales.
The Facts Of 5
In the 30 years between that case and the passage of DSHEA, while many health food stores displayed and offered books and magazines on health and medical subjects, this literature was separated from the foods and nutritional supplements on the shelves, displayed in a different section of the store. This retailer behavior, along with the judicial opinions and FDA actions, set the stage for the House and Senate debate about Section 5 of DSHEA.
When Congress passed DSHEA, it included findings in Section 2 of the act that unmistakably show the educational intent of the legislation and the relationship between educated consumers, good health and disease prevention:
- "(2) The importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies; . . .
- "(8) Consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements." (Emphasis added).
As a means toward consumer education, and to resolve a conflict between the industry and the FDA about labeling, Congress included in DSHEA a provision that allows medical or scientific information about dietary supplements to be given to consumers, including information about the therapeutic (drug) value of dietary ingredients—as long as certain conditions are met—for example, that the literature be separated from the product for sale.
Section 5 creates an exception or "safe harbor" to the general rule that a company cannot expressly or implicitly make therapeutic claims about its dietary supplement products by, among other things, making literature available to consumers that describes the therapeutic benefits of the formula or one of its ingredients. Scientific literature that is used in connection with the sale of a supplement is not considered "labeling" and is not, therefore, subject to the requirements of Section 6 of DSHEA (which allows only structure/function statements) as long as it meets all of the five requirements set forth in Section 5, including:
- (1) Section 5 literature must be used in connection with the sale of a dietary supplement product. However, the literature may not be promotional. Usually, it consists of scientific or medical information about a particular ingredient.
- (2) Section 5 literature may not be false or misleading. The government (i.e., FDA or FTC) has the burden of proving that the literature is false or misleading.
- (3) Section 5 literature may not promote a particular manufacturer or brand of dietary supplement. Literature is considered promotional if the net impression to the consumer is that it is a piece of advertising rather than a piece of scientific information.
- (4) Section 5 literature must be presented or displayed in a manner so as to present a balanced view of the available scientific information on the same subject matter. This can be accomplished by presenting another piece of literature that contains a different or conflicting point of view, or by providing the reader with a short bibliography or list of publications that reflect different opinions—for example, that the clinical trials described in other articles were flawed, or the results were inconclusive or merely preliminary.
- (5) If Section 5 literature is displayed in a retail establishment, it must be in an area that is physically separate from the area in which dietary supplements are displayed.
All of the requirements above must be met to be exempt from enforcement action related to making disease claims used in labeling. Note that the disclaimer required on labels with structure/function statements ("These statements have not been evaluated. . . ") is not required or even proper on herb sheets and other Section 5 literature, because these are not labels or labeling.
Section 5 is often referred to as the third-party literature section of DSHEA, thus giving the incorrect impression that companies that sell dietary supplements cannot prepare their own medical literature. There is no legal reason, however, that a company that sells dietary supplements cannot have an employee or paid consultant prepare a piece of scientific literature to be used in connection with the sale of one or more of its products. Nonetheless, Section 5 literature, whether prepared by the company or an independent party, may not summarize a scientific study or test unless the summary is the author's or editor's abstract of a peer-reviewed scientific publication.
Finally, Section 5 specifically states that DSHEA is not meant to restrict the right of supplements companies to sell publications as part of their businesses. Publications that could be used for or reprinted as Section 5 literature include:
- An entire short scientific or medical article;
- The author's abstract of that article;
- A magazine article on the subject of a clinical trial, or one that synthesizes other research on an ingredient or combination of ingredients;
- An in-house report or "tech report" about a clinical trial;
- A portion of a researcher's published monograph about a clinical trial of an ingredient or a formula;
- A chapter or a section of a chapter from a research book on the subject.
Wrangling The Web For DSHEA Compliance
Regardless of the type of publication used, it may not be promotional. This is why no Section 5 literature may be posted on a company's Web site as part of its marketing materials, and why such literature cannot be used by distributors to promote a product.
At least four years ago, savvy dietary supplement marketers got the idea of including Section 5 literature on their Web sites. On a Web site, though, no physically separate area is possible between the literature and the product for sale on the shelf. Where, then, must you place the Section 5 literature?
The law was silent on this issue; DSHEA was drafted and enacted before Web sites became common, thus Section 5 addresses placement of literature only in a retail store.
However, I reasoned by analogy that there must be "virtual distance" similar to the physical distance required. For example, if the Section 5 literature is placed in a "reading room" or "browsing room" on the Web site and is at least two clicks away from the page for ordering the product, or the shopping cart page, then this would probably be acceptable.
Over the years, this rule of thumb apparently spread, and became known as the "two-click rule," but it exists nowhere in statutes, regulations or FDA guidance documents.
Other companies have met this "physically separate" requirement by constructing a second, distinct Web site solely for scientific and medical information. This would be acceptable as long as this Web site does not promote, or even mention, particular products.
Whether in electronic or paper form, Section 5 literature can educate consumers about the most current scientific, medical advances concerning therapeutic supplement ingredients, and thus can lead to more informed choices in purchasing.
Susan D. Brienza is an attorney in the Denver office of the Washington, D.C.-based law firm Patton Boggs LLP. She specializes in regulatory compliance, FDA law (including DSHEA) and FTC law. She may be reached at [email protected].