title: DSHEA's third-party literature exemption; mail order sales, direct marketing, and Internet use.
abstract: This article examines ways in which marketers of dietary supplements can make use of the "third-party literature" section of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This provision permits persons or entities, other than manufacturers or distributors, to distribute to consumers certain publications in connection with the sale of particular supplements. These publications may include statements about the therapeutic benefits of such products without subjecting the products to regulation by the Food and Drug Administration (FDA) as unapproved new drugs. Specifically, this article addresses the following: Can a dietary supplement manufacturer or distributor send third-party literature about a dietary supplement to a customer in a mail order sales transaction? Can third-party literature be disseminated by mail with dietary supplement catalogues only? Can third-party literature be disseminated by sales representatives engaged in direct marketing of dietary supplements? Can third-party literature appear on the Internet? The answer appears to be affirmative in each of these situations.
authors.affiliation: Sidley & Austin, New York, NY, USA.
authors.forename: C J
authors.initials: CJ
authors.lastname: Raubicheck
mesh_terms: D019587:Dietary Supplements; D006293:Health Promotion; D006801:Humans; D020407:Internet; D008091:Literature; D008389:Marketing of Health Services; D011177:Postal Service / Q000331:legislation & jurisprudence*; D011356:Product Labeling / Q000331:legislation & jurisprudence*; D014481:United States