Using Publications To Promote The Sale Of Dietary Supplements

Analyzing the ‘reading room exception.

By Todd Harrison

As has been discussed previously, the label and labeling of dietary supplements may not suggest that a supplement is useful in the diagnosis, cure, treatment or prevention of a disease or health-related condition, except pursuant to an FDA-approved “health claim” or “new drug application.” To do so would cause the supplement to be misbranded and potentially considered unapproved as a new drug. Should this type of promotion occur, FDA has a variety of enforcement tools to remedy violations, ranging from “courtesy” or “warning” letters requesting that the violative conduct cease (probably the initial step), to seizure, injunction or criminal prosecution.

The FD&C Act defines labeling as “all labels and other written, printed or graphic matter upon any article or any of its containers or wrappers or accompanying such article” (FD&C Act § 201(m). At first blush, it would appear that the definition of labeling would not encompass catalogs, brochures, handbills, etc., that do not literally accompany the product being sold. The Supreme Court, however, has held that the written or graphic materials need not accompany the product for them to be considered labeling (Kordel v. United States, 335 U.S. 345 (1948)).

In Kordel, the defendant was charged with introducing misbranded drugs into interstate commerce. The drugs had arrived in one shipment and circulars, pamphlets and other literature pertaining to the drugs arrived in another separate shipment. The Court interpreted the statutory phrase “accompany such article” broadly to mean that the literature, even though mailed separately, nonetheless amounted to labeling for the product if the information provided in the literature was necessary to the consumer’s understanding of the product. The Court reasoned that since the statute was meant to protect the public, there was no reason to read the phrase “accompanying” to literally mean accompanying the product in its package or container. Thus, Kordel stands for the proposition that no physical attachment is necessary for literature to be deemed labeling. Rather, it is the relationship of the printed matter to the product that is determinative.

Since Kordel, FDA has generally considered materials that are used to promote a product at the point of sale to be labeling, including product catalogs, brochures, handbills, pamphlets, free newsletters, books, etc. With the passage of DSHEA, however, Congress carved out two exceptions from the definition of “labeling” for certain publications. First, the so-called “reading room exception” exempts publications (third-party literature) used in the promotion of dietary supplements (FD&C Act § 403B(a)(1)). In short, this exception allows marketers to promote drug uses for dietary supplements, in general, if certain statutory conditions are satisfied. The second exception applies to publications “held for sale” by a retailer or wholesaler of dietary supplements (FD&C Act § 403B(b)).

The ‘Reading Room Exception’

The “reading room exception” provides dietary supplement companies an opportunity to promote the use of nutrients, dietary ingredients and supplements as a means of preventing or treating a disease via a “publication” as long as the publication meets the following requirements:

(1) The publication must be balanced, truthful and nonmisleading;
(2) The publication must not promote a particular brand of dietary supplements; and
(3) The publication must not be attached, whether by physical attachment or reference, to the dietary supplement’s label or labeling (FD&C Act § 403B(a)(1)-(5)).

This exception covers articles, chapters of books, official abstracts of peer reviewed scientific publications re­printed in their entirety, the scientific publication itself if reprinted in its entirety or any other publications that are used in connection with the sale of dietary supplements to consumers.

Neither FDA nor any court has specifically addressed the exact contours of the “reading room exception.” However, the language of the statute is sufficiently broad to include publications that are published by a company engaged in the sale of dietary supplements. Indeed, the initial draft of DSHEA required peer-reviewed articles, while the final draft broadened the language to include any publication. Thus, it is reasonable to conclude that Congress intended that “any” publication, whether it is derived from an independent third-party or a company engaged in the business of selling dietary supplements, could be used to promote the sale of dietary supplements as long as the requirements of the “reading room exception” are met.

The “reading room exception” also requires that “publications” used to promote the sale of dietary supplements provide a balanced, truthful and nonmisleading discussion of the supplement or nutrient. Generally, a publication that is well-balanced will also be truthful and nonmisleading. Indeed, it would be the unusual case that a properly balanced publication would be considered deceptive by FDA. What constitutes a balanced publication is neither defined by DSHEA, nor has it been addressed by FDA. At a minimum, balanced means that a publication must accurately reflect the science on the nutrient or the supplement. Balanced, however, does not mean that the publication is required to discuss negative information. Rather, negative information need only be disclosed if it would cast sufficient doubts on the validity of the claims being made in the publication.

In order to ensure balance, the publication should provide sufficient information regarding the nutrient, such as the necessary dosage that is required to achieve a particular effect, possible side effects, drug interactions and other warnings. It is unlikely that FDA would challenge a publication that provides sufficient information regarding a particular nutrient if it provides all relevant information necessary for a consumer to make an informed choice, including significant studies that may cast doubt on the nutrient’s efficacy.

Additionally, although the “reading room exception” does not apply to advertising, it is unlikely that the FTC would challenge a company over the use of a publication that conforms to this exception because the publication likely meets the FTC Act’s requirement that it be truthful and nonmisleading.

There is some question as to whether the publication may refer to a specific company or product. The exception only appears to limit the reference to a particular product or brand name. Arguably, a reference that stated, “This promotional material is being supplied to you by ‘XYZ Supplement Co.’” is permissible under the Act. Indeed, if the purpose of the “reading room exception” is to permit companies to use publications to promote the sale of dietary supplements, it would appear that a reference to a particular company is permissible under DSHEA.

The more difficult question is whether a publication may refer to a specific brand or product name. A reasonable argument exists, under the recent case of Washington Legal Foundation v. Henney, 1999 WL 557679 (D.D.C. 1999) (WLF), that once Congress permitted the use of publications to promote the sale of dietary supplements, it could not restrict a company’s ability to refer to a particular product. A more reasonable reading of WLF, however, is that FDA cannot stop the dissemination of a competent and reliable scientific study on a particular company’s supplement to consumers by the company on the grounds that the study refers to the supplement’s product name.

However, a court may consider such a restriction to be permissible since the sole focus of WLF was the dissemination of information regarding the off-label prescription uses of FDA-approved drug products to licensed healthcare professionals, which is different from disseminating the information to the general public. While WLF may have limited applicability to articles discussing the health-related benefits of dietary supplements, another plausible reading of WLF would permit dietary supplement manufacturers and distributors to disseminate articles and studies about their products to qualified healthcare practitioners, but not to consumers, without fear of causing their products to be considered unapproved drugs.

NW

Todd A. Harrison is a senior associate with the law firm Keller & Heckman, Washington D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on food and dietary supplement adulteration, labeling and advertising issues. He can be reached at Keller & Heckman, 1001 G. St. NW, Suite 500 W, Washington D.C. 20001; 202-434-4244; Fax: 202-434-4646; E-mail: [email protected].