Complaint Counsel's Post Trial Brief - Federal Trade Commission

CCPF ~ 140 (emphasis in bold added).
3. Respondents' DSHEA Arguments
Respondents have argued that their representations, including those stated above, were
"strctue-fuction" claims rather than health claims, and thus Respondents are not required to
have competent and reliable scientific evidence to support those representations. See
Respondents' Opening Statement, Tr. 241, 261. Respondents also have attempted to minize
the impact of their cancer claims by assering that their representations were accompaned by
appropriate disclaimers under the Dietar Supplements Health and Education Act (DSHEA).
a. The Advertsements in Question Make Disease Claims, Not
Strcture-Function Claims
In makg their strctue-fuction asserion, Respondents ignore the applicable FDA law.
In a case that the FDA brought against a maker of cancer cures, the cour explained the proper
legal framework under DSHEA:
In sum, if this Cour finds Defendants, in the process of marketing
BeneFin, MGN-3 and SkinAswer, limted their claims to perssible
strctue- fuction claims, and those clais are trthful and not
misleading, this Cour may consider Defedants' arguents that the
Products are supplements pursuat to § 343(r)(6)(A) ofDSHEA. If,
however, ths Cour finds Defendants made claims that the Products
diagnose, mitigate, treat, cure, or prevent a specific disease or class of
diseases, the Products must be considered drugs under the FDCA.
Ths distiction is important because drugs are subject to much strcter
FDA compliance standards than are dietar supplements.
United States v. Lane Labs-USA, Inc., 324 F. Supp. 2d 547, 566 (D.N.J. 2004). Here,
Respondents' claims are not limited to strctue-fuction claims. Rather, Respondents represent
that the DCO Products mitigate, treat, cure, or prevent cancer or tuors, and, as a result,
Respondents' DSHEA arguent fails.
Respondents' arguent that their advertisements contai merely "strctue-fuction"
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