Q: Which federal laws govern the signage, shelf-talkers and other materials retailers may use in stores to display and promote dietary supplements?
A: Both Federal Trade Commission law for advertising and Food and Drug Administration regulations apply. In particular, Section 6 of the Dietary Supplement Health and Education Act, which was enacted in 1994, defines structure/function claims. The final rule on s/f claims for supplements was published in the Federal Register more than six years ago, and this provides "the bible" for determining proper claims for supplements in almost all contexts (vol. 65, Federal Register, pages 999-1050, Jan. 6, 2000). The one exception is Section 5 literature. Title 21 of the Code of Federal Regulation, sections 101.93 (f) and (g), define "disease" and then explain 10 categories of disease claims that are forbidden. Essentially, disease claims and drug claims must be avoided in all labeling, signage and promotions for dietary supplements in retail stores. The disclaimer required for supplement labels bearing s/f claims gives the rule: "*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." If all your signage and verbiage in the store adheres to the second sentence above, then you will be in good shape with the FDA.
Q: Although no disease name appears in signage, what type of word, image or suggestion makes a statement an "implied drug claim," or "implied disease claim," according to the FDA?
A: The FDA, in determining an implied drug claim or disease claim, will look at the following aspects of the label or ad: the product name; common OTC ingredients in the formulation (e.g., aspirin); a publication citation referring to a disease use; pictures, vignettes or symbols ("Rx"); use of words such as "symptoms," "healing" or "therapeutic"; if the product is a substitute or alternative for a disease therapy ("Herbal Levitra"); and other factors.
For instance, a label might properly claim a product "promotes calmness," but if the label shows a person with a throbbing headache, and if the product advertisement or a company newsletter article is directed to "migraine sufferers," then the statement becomes an implied drug claim. Also, some phrases are considered by the FDA to be per se disease claims; for example, "joint stiffness" is so closely identified with arthritis that it is viewed as virtually synonymous with that disease. Remember that 1) any claim or element will be examined in the context of the signage, labeling and promotion as a whole, and 2) the FDA has the authority to consider all promotional materials for a supplement to determine its intended use.
Q: Why do you need to monitor signage, promotions, sales help, etc., in your retail store?
A: Such monitoring is important for supplements for at least two reasons. First, the FDA defines "labeling" very broadly to include any materials connected to or surrounding products—including Web sites, company newsletters, etc. Second, the "principle of intended use" means that both by law and in practice, the FDA has the authority to examine any labeling or advertising of a product for indications to determine how the marketer intends that product to be used by the consumer, e.g., as a drug.
Q: What about shelf-talkers, banners and shelf labels for supplement product categories?
A: These also should be within the parameters of structure/function claims and avoid drug claims and disease claims. For example, the category case can be headed Respiratory Health rather than Allergy/Asthma, and Immune System rather than Cold and Flu.
Q: What about the display of reading materials about dietary supplements?
A: For books and medical articles, authors have First Amendment rights to publish any medical and scientific information concerning nutrition or "natural remedies," provided that these books and articles are not promotional. For example, there would be enforcement implications if you sold a book entitled Nutrition for Joint Health, but at the bottom of the cover proclaimed: "From the makers of ArthroCure Supplement." In scientific, medical information for consumers about supplement ingredients (such as "Herb Sheets" displayed in a circular kiosk), discussion of druglike benefits is permitted. Indeed, the only "safe harbor" for dietary supplements to make disease and therapeutic claims is in educational, nonpromotional literature as provided in Section 5 of DSHEA—also called "third-party literature." See the August 2003 Behind The Label: A Guide For Retailers, a supplement to The Natural Foods Merchandiser, for more information.
There are five requirements for valid Section 5 literature, including that the piece be placed at a "physical distance" from any actual product or from the product it discusses, and may not promote or even identify any particular supplement, brand name or product line.
Q: May a retailer host a lecture or talk by a health care practitioner about the therapeutic benefits of dietary supplements?
A: Yes, this is permissible and can be quite useful to bring customers into the store—provided that the talk is not promoting any specific brand of dietary supplement or line of supplements to treat, cure, prevent or mitigate any disease or abnormal condition. The FDA is on record (in various speeches and policy statements) that it does not regulate or govern the practice of medicine. Thus, your speakers (M.D., N.D., R.N., Ph.D., R.D. or other health care practitioner) may generally discuss prescribing or recommending supplements to patients and their opinions about the therapeutic benefits of various ingredients. Also, in the spirit of Section 5 literature, an herbalist, nutritionist or scientist may present the therapeutic benefits of a particular dietary ingredient. However, in all the scenarios above, speakers may not promote specific supplements.
Q: Are there any rules about what sales people in the store may or may not say?
Susan Brienza is an attorney in the Denver office of the national law firm Patton Boggs LLP ([email protected]). She practices in the area of regulatory compliance, in FDA law (including DSHEA) and FTC law.
Natural Foods Merchandiser volume XXVII/number 10/p. 72-73