Todd Harrison09.01.04
Dietary Supplement Marketing Review
In light of the recent Lane Labs case it is important to reexamine how information on supplements can be disseminated.
By Todd Harrison
The recent decision in the Lane Labs case has created great concern regarding how far companies may go when marketing their products along with express disease claims. It is important to remember that, as a general rule, “drug” or “disease” related claims are not permitted for dietary supplements. The Federal Food, Drug, and Cosmetic Act (FFDCA) 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.”
With the passage of the Dietary Supplement Health and Education Act (DSHEA), Congress carved out two safe harbors from the FFDCA’s definition for labeling. First, the so-called “reading room safe harbor,” exempts certain publications used in the promotion of dietary supplements. In short, this exemption allows marketers to promote drug uses for dietary supplements, in general, if certain statutory conditions are satisfied. The second exemption applies to publications “held for sale” by a retailer or wholesaler of dietary supplements. It is important to note that these two safe harbors do not restrict the FTC from considering these publications to be advertising.
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:
• The publication must be balanced, truthful and nonmisleading;
• The publication must not promote a particular brand of dietary supplements; and
• The publication must not be attached, whether by physical attachment or reference, to the dietary supplement’s label or labeling.
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 (the court in the Lane Labs case avoided addressing this issue head on) has specifically addressed the exact contours of the “reading room safe harbor.” However, the language of the statute could be read 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 requires that “publications” used to promote the sale of dietary supplements provide a balanced, truthfuland nonmisleading discussion of the supplement or nutrient. Generally, a publication that is well balanced will also be truthful and nonmisleading. Indeed, it would be unusual for FDA to consider a properly balanced publication deceptive. What constitutes a balanced publication is neither defined by DSHEA, nor has it been addressed by the agency. At a minimum, “balanced” means that a publication must accurately reflect the science on the nutrient or the supplement. It does not, however, 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 other words, negative information would need to be provided if the science surrounding the nutrient is not well-settled or is questionable.
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. Indeed, 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.
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 DSHEA. Indeed, if the purpose of the reading room exception is to permit companies to use publications to promote the sale of dietary supplements, it appears 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 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.
Conclusion
The decision with respect to Lane Labs is very specific to that particular case and should not be construed to limit the ability of companies to disseminate truthful and nonmisleading articles to consumers. That said, a company must be careful in how that material is disseminated and that it is not an advocacy piece. In other words, because the science of nutritional medicine is still evolving, it will be important that companies provide the positive as well as the negative information regarding a particular nutrient until such time that its impact on a particular disease state is accepted by the scientific community.NW