ring to broad-sense marketing, not just television and print advertising but anything intended to promote a product.

Despite their coordination and shared authority, the legal frameworks of FDA and FTC differ in significant ways. FTC is primarily a law enforcement agency. It does not engage in pre-market approval of claims, nor does it make regulatory distinctions between product categories (e.g., drugs versus supplements versus foods) or between types of claims (e.g., disease risk claim versus structure-function claim versus drug claim), although those distinctions probably impact which claims FTC chooses to investigate or challenge. FTC authority stems from two provisions of the FTC Act13: sections 5 and 12. Section 5 prohibits deceptive and unfair acts or practices in commerce, including deceptive advertising. Section 12 prohibits misleading advertising of foods and other products. Together, these two provisions are the basis for the FTC standard that advertising must be truthful and not misleading and that objective claims must be substantiated before they are made.

FTC Advertising Investigations

When FTC investigates a claim, it asks two basic questions. First, what claim is being conveyed? FTC examines the net impression of an ad and what the consumer takes away, not the intention; it also examines omissions of important information. Rusk remarked that many claims are problematic because they tell only “half the truth.” Information that needs to be disclosed must be clear and prominent and not buried in a “fine print footnote.” Second, are the claims substantiated? FTC typically requires claims about the efficacy or safety of dietary supplements to be supported with “competent and reliable scientific evidence,” defined as “tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results” (FTC, 2001). Rusk explained that while FTC applies a rigorous scientific standard, it is also flexible in its approach. There is no specific number or size of study required, rather the focus is on the quality of the evidence. FTC seeks guidance from experts and generally expects double-blind, placebo-controlled human clinical trials. Rusk noted that the substantiation standard in the FDA draft guidance for dietary supplement claims closely mirrors the FTC substantiation standard (FDA, 2011a).

FTC claims investigations usually involve three steps. First, FTC examines the internal validity of the studies, often with the help of a con-

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13 For more information on the FTC Act, visit the FTC website: http://www.ftc.gov/ogc/stat1.shtm.



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