Before taking the quiz, please feel free to read the article below to refresh your knowledge.
By Charles J. Raubicheck, Esq., Sidley & Austin
Given the many DSHEA-related legal and regulatory developments over the past several years, natural products retailers often ask: "What can I say when selling supplements and not break the law?" To update retailers who sell dietary supplements as to what health-related information about their products they can properly give their customers, this guide is was created by Natural Products Association and Natural Products Foundation general counsel, Sidley Austin.
Verbal communications from retailer to customer about the health benefits of dietary supplements should be based on reliable information from suppliers and other sources. Typically, this information is documented in one or more of the written forms described below. Further, a retailer can convey product health benefits by providing access to, or by distributing, these written materials themselves.
Label and Package
The primary source of health information about dietary supplements is the list of claims made on the product label (including the package). Under DSHEA, suppliers of dietary supplements are permitted to make claims about their products called "statements of nutritional support" (which must be substantiated by data maintained by the supplier). These statements include claims about:
(a) a benefit relating to a classic nutrient deficiency disease;
(b) how a product affects any part of the structure of the human body, (e.g., "Glucosamine helps promote connective tissue"), or any function of the human body (e.g.,"Echinacea helps support the immune system");
(c) the mechanism of action by which a product acts to maintain body structure or function;
(d) general well being.
The most prevalent of these types of claims in the current marketplace are structure/function claims [(b)]. As a starting point, a retailer can use the body structure or function claims made on the label and package when telling customers about product benefits.
However, explicit claims about how a given dietary supplement may play a role in preventing or treating a particular disease condition are not permitted by the Dietary Supplement Health Education Act. Hence, structure/function claims are often vague, or not sufficiently specific for some consumers. The quandary often faced by the retailer is how to help this type of customer. Certain disease-specific information may be imparted to the customer, but only under the conditions explained in sections 3 through 6 below.
Structure/function claims can also be made in promotional materials for supplements e.g., brochures, booklets, flyers). These materials are allowed to be displayed and offered to consumers in retail stores. They are usually placed adjacent to the producton the shelf, in a product information section, or on a counter near a cash register.
Often, a supplier will make one or more structure/function claims in a promotional piece that is not made on the label or package. It therefore pays the retailer to be familiar with the promotional literature provided by suppliers.
Third Party Literature
Under DSHEA, publications written by third parties about the health benefits of dietary supplements may be distributed to consumers in connection with the sale of supplement products. This is so-called "third party literature."
Significantly, third party literature can lawfully discuss the role of dietary supplements in preventing or treating diseases, without subjecting the supplements to regulation by the FDA as drugs. To do so, the publication involved must satisfy all of the following conditions:
(i) it must be a reprint of an entire article authored by someone other than the supplier or retailer;
(ii) it must be physically separate in a store from the product it describes;
(iii) it must present a balanced view of available scientific information about the supplement and its health benefits;
(iv) it cannot mention the name of a manufacturer or the brand name of a product; and
(v) it cannot have any sticker or other information attached to it.
The obvious advantage to third party literature is that it can present health benefit information beyond structure/function claims, particularly statements about how a given dietary supplement can be useful in the prevention or treatment of some disease condition. Congress intentionally meant for consumers to have this type of information when it enacted the third party literature section of DSHEA. Many retailers may not be aware of this provision, or how to use it effectively.
To get the most advantage from third party literature, retailers should keep abreast of scientific studies or articles about particular dietary supplements, or request suppliers to supply them with third party literature pieces. Such pieces can be distributed by retailers directly to customers in retail stores (and can even be mailed with store catalogues). It is important, however, that these publications not mention particular companies or brands, or be displayed in a store in immediate physical proximity to the actual dietary supplements which are mentioned in the article.
Of notable importance, the piece should present a balanced view of available scientific information on the supplement being discussed. While neither Congress nor the FDA has defined "balanced" in the third party literature section of DSHEA, from other contexts this term can be construed to mean reporting or discussing negative or inconclusive studies as well as positive data, and not exaggerating benefits over known risks of taking a product.
To what extent can retailers talk to their customers about the information in a third party literature piece? This issue has not yet been addressed by the FDA or decided by the courts. While two recent court cases (Pearson and Washington Legal Foundation) suggest that some verbal communications about third party literature may be protected by the First Amendment, state laws governing the practice of medicine or pharmacy will have to be considered as well. Therefore, at this time, it is advisable to let third party literature pieces speak for themselves.
Certain software programs that supply health benefit information about dietary supplements are available, and are intended for use in the retail sale context. The programs are designed to qualify as third party literature (note that DSHEA does not restrict the term "publication" to a published journal article). As such, specific diseases that supplements may help to prevent or treat are covered. These programs are offered for viewing by the consumer at kiosks or other discrete places, physically apart from supplement products, in a number of retail establishments.
Retailers should not verbally answer questions about, or summarize, software program information, for the reasons noted in section 3 above. They may tell consumers that they stock a particular type of dietary supplement, and where to find it in the store, but they should not mention particular companies or brands.
DSHEA has an additional section whereby Congress explicitly recognizes the right of retailers to have separate sections in their stores (where no products are sold) in which they sell books and similar publications on dietary supplements. These books and publications can include information about disease prevention or treatment benefits of dietary supplements. They do not have to qualify as third party literature to do so.
Nonetheless, retailers should be careful about verbally summarizing books to customers; the publications are often lengthy, and may not always have balanced presentations about product-disease relationships. Again, the advisable course is to allow the books to speak for themselves.
Under the 1990 Nutrition Labeling and Education Act, the FDA has approved some health benefit claims (called "health claims") for dietary supplements. Health claims communicate the message that particular supplements play a role in reducing the risk of the occurrence of particular disease conditions. The permitted claims for supplements include the benefit of calcium in reducing the risk of developing osteoporosis, and the benefit of folic acid taken during pregnancy in preventing neural tube birth defects. There are other health claims permitted for particular foods (e.g., the benefit of low fat foods in reducing the risk of developing cancer; the benefit of soy protein in reducing the risk of coronary heart disease).
Health claims can be made on labels, packages and promotional literature. Retailers can use these sources to deliver the pertinent health benefit messages for the products involved.
The nutritional benefits provided by many dietary supplements, which can be gleaned from the Supplement Facts box on the product label, statements of nutritional support, third party literature, and books and other publications on particular supplements, can also be verbally communicated by retailers to consumers.
One caveat in this regard: a number of states have enacted dietitians' laws, which define "nutritional information" and state or imply that only licensed dietitians have the right to provide it. There have been a few states where the right of dietary supplement retailers to give nutritional information to their customers has been challenged by dietitians. NPA has consistently opposed these efforts, taking the position that DSHEA and the First Amendment permit retailers to verbally supply nutritional information that is supported by truthful and non-misleading labeling and other publications. To date, NPA has been successful in protecting retailers in this regard. However, individual retailers should check their own state laws and if any questions arise, should contact NPA.