§9.1 Scientific Studies as Marketing Material

• Jurisdiction: United States
• Publication year: 2022

§9.1 Scientific Studies as Marketing Material

Dietary supplement manufacturers often arrange scientific studies or analyses of their new products. Depending on the conclusions, the studies are then used as a means of exhibiting to retailers or consumers the usefulness of the supplement. Under Section 5 of DSHEA, articles, book chapters, or official abstracts from peer-reviewed scientific publications are not deemed "labeling," and thus are not able to misbrand the supplement, if they conform to certain standards:

• not false or misleading;
• do not promote a particular manufacturer or brand;
• are displayed or presented with other items of the same subject matter in order to give a balanced view;
• if displayed in an establishment, are physically separate from the supplement; and
• no other information attached to the studies or articles via connecting means, e.g., adhesive or other method.¹

The report accompanying S. 784 stated Section 5 was inserted to clarify that third-party information (books, articles, etc.) is not labeling and can be made available in a store, brochure, or the home, so long as it is truthful and non-misleading.² The author writing the information must be affiliated with an accredited education institution ". . . who does not receive directly or indirectly any form of compensation from any person having a financial interest in such ingredient or supplement without disclosing the relationship."³ However, if the author did receive compensation from a person having a financial interest, this relationship must be disclosed.⁴

The Committee viewed third-party information as being useful in educating the consuming public. The Committee had as a goal the encouragement of manufacturer and industry trade associations to work with retailers to provide greater communication in this area.⁵ To accomplish such goal, the dissemination of the information could be made without pre-approval.⁶ The dissemination of third-party literature was part of a compromise where consumers would have guaranteed access to the literature in exchange for allowing the FDA "a fair claims process" to approve health labeling claims.⁷

If a claim of misbranding is made against third-party information, the FDA bears the burden of proving the information to be misbranded. The Report indicated this provision was added...