Internet Marketing

FDA and FTC share responsibility over Internet ­claims.

By Todd Harrison

The Internet has become a major means of marketing products directly to consumers to promote health benefits. While the Internet does provide companies with the ability to provide important information to millions of consumers worldwide, it also provides easy access to regulators monitoring claims being made on a company’s website. Moreover, unlike advertising, website articles are often considered by FDA to be labeling, or at least an indication of the product's intended use and, thus, subject to FDA’s jurisdiction. FDA has already sent several warning letters, which specifically point out to companies that their websites contain impermissible drug claims for their dietary supplement products. Thus, claims appearing on a company’s website may be scrutinized by both the FTC and FDA.

Because both agencies consider claims appearing on company owned or sponsored websites to be within their enforcement authority, companies marketing products through the Internet should consider the following issues:

• The type of claims that may appear on the website (e.g., structure/function claims, health claims, disease or drug claims, etc).
• Whether the claims are truthful, nonmisleading and properly substantiated.
• Links to other Internet websites and whether those sites contain objectionable health-related information.

The FD&C Act permits companies to make truthful and nonmisleading structure/function claims on the label and labeling of dietary supplements. However, because FDA considers Internet websites to be labeling, structure/function claims that are not health maintenance claims, or based on the nutritive value of the dietary supplement must be accompanied by the FDA disclaimer.

Technically, this statement is ­required to appear on each label panel or promotional page in which a structure/function claim appears. As for Internet web pages, this means the disclaimer should appear on each web page on which a structure/function claim appears. Alternatively, it is likely that FDA would not challenge a hot-link at the bottom of the page stating “Click here to view limitations on FDA review of statements appearing on this page.” This approach is not without risk, but probably would not draw an objection by FDA.

Disease or drug claims may only appear on dietary supplement manufacturer, distributor, or retailer websites if the claim falls within one of the two DSHEA exceptions. The first exception, also known as “third-party literature” and/or the “reading room exception,” permits the use of certain publications such as scientific articles, chapters of books, official abstracts of peer reviewed scientific articles, or any other publication as a means of promoting the sale of dietary supplements if:

• Is not false or misleading.
• Does not promote a particular manufacturer or brand of dietary supplements.
• Presents a balanced view or appears with other publications in such a manner that a balanced view is presented.
• If displayed in a retail establishment, the literature is physically separated from the dietary supplement if (in the context of the Internet, this likely would require a separate web page for the articles and studies).
• Does not refer, by sticker or any other means, to the dietary supplement’s location in the store.

In the context of a retail establishment, it is fairly easy to envision how this exception would work. The Internet, however, presents some unique questions regarding the linking of third-party literature containing drug or disease claims and specific product web pages. While a dietary supplement company may provide legitimate third-party literature on its Internet website, care must be exercised to avoid linking such literature to specific products being promoted and/or sold on the site. To avoid potential regulatory problems with FDA (as well as the FTC), a company should consider the following points in developing and maintaining a website:

• The website’s home page should be the central point where all links are provided to various other web pages within the website and to other websites. The home page would contain links to separate product information web pages; separate reference or reading room web pagesand separate web pages that link the website to other Internet websites of interest.
• The product information web page(s) would provide information regarding the use of the dietary supplement, ingredient information, permissible structure/function claims and warnings.
• The reading room or reference web page(s) should only contain articles and publications that are truthful, nonmisleading, provide a balance view of the scientific evidence and do not contain direct references or hot links to the products being promoted or sold on the website.
• The product information page(s) should not be directly linked to the reference web page(s) or other Internet websites that contain drug or disease claims.

It should also be noted that the FD&C Act's safe harbors only apply to FDA’s regulation of publications used to promote dietary supplements. It is possible that the FTC would consider the articles or publications describing the benefits of dietary supplements on the company’s website to be advertising. The FTC could then apply its substantiation policy to any claims found in the publications. However, publications that fall within the safe harbor provisions are unlikely to create an FTC regulatory risk to a company. Indeed, there is a reasonable commercial free speech argument to be made if the articles that are posted provide a balanced view of the scientific evidence, and do not tend to mislead the public regarding the benefits of a particular product, or the extent of the supporting research

The second safe harbor exempts publications held for sale from being considered labeling. Arguably, this exemption is sufficiently broad to include the sale of books by direct and online marketers of dietary supplements. Although there is some debate regarding its exact contours, this exemption should also apply to publications held for sale on the Internet. However, some precautions should be taken to avoid the appearance that the publications are being used to promote the sale of dietary supplements. The best way to achieve this is to separate the bookstore’s web page(s) from the product information web page(s), with no cross linking directly to specific product pages. The purpose of this recommendation is to minimize the possibility that a regulatory agency will argue that the information provided on the bookstore web page(s) is merely promotional material for dietary supplements.

Another important issue is “metatags.” Metatags are those imbedded messages that do not necessarily appear on the website but permit search engines to find websites. The FDA and FTC both take the position that metatags are product claims. So, it is equally important that metatags are permissible structure/function claims and are truthful and nonmisleading.

Creating links to other Internet websites raises some interesting regulatory issues. One issue is whether a link may be provided directly from the dietary supplement web page(s) to another Internet website that discusses the use of a particular dietary ingredient or supplement in the cure, treatment or prevention of a disease. This would effectively permit virtual stores to avoid the reading room exception—a result probably not intended by Congress when it enacted DSHEA.

On the other hand, the reading room exception does provide a reasonable basis for creating links to other websites if done within the spirit and meaning of this provision. This may require creating a separate web page that is not linked to product information and ordering web page(s). Moreover, the information provided on the other websites should be consistent with the FD&C Act's reading room safe harbor and should contain truthful and nonmisleading information, a balanced view of the scientific literature, and should not refer to or promote the company’s products.

These sites, however, could provide general health and nutrition information as well as information regarding vitamins, minerals, herbs, amino acids, and other dietary ingredients within the balanced, nonmisleading framework discussed herein. To avoid issues with the FTC, it is essential that the information provided on the linked pages is truthful and nonmisleading.NW