Can the FDA Seize Books as Labeling?

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Can the FDA Seize Books as Labeling?

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Title: Can the FDA Seize Books as Labeling?
Author: Sverdrup Stone, Stephanie
Citation: Stephanie Sverdrup Stone, Can the FDA Seize Books as Labeling? (March 2008).
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Abstract: In this paper, I examine the question of whether the FDA can seize books as labeling for products it regulates. First, I consider what constitutes labeling, looking at the statutory definition of labeling and its interpretation both by Congress in the Congressional Record and by the courts in case law. I will use these insights to determine that a book can, under certain circumstances, constitute labeling. Specifically, a book is labeling when it is EITHER 1) is written and published by the company that produces the product it describes, OR 2) is written and published independently of the company that produces the product it describes; AND it is used as part of a comprehensive scheme of marketing the product, whether or not it is shipped with or at the same time as that product in interstate commerce. Finally, I will ask what the ramifications are for considering books as labeling in this way, considering whether other forms of communication, from radio and newspaper advertisements to restaurant menus could be considered labeling.
Terms of Use: This article is made available under the terms and conditions applicable to Other Posted Material, as set forth at http://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of-use#LAA
Citable link to this page: http://nrs.harvard.edu/urn-3:HUL.InstRepos:8592049

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