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“Clinically proven…” “Laboratory tested.” “45% More Effective!” Claims like these sell product. They also carry with them the assertion that the advertising claim has been “established” or proven by competent and reliable testing. Establishment claims can be express (e.g., “Studies show…”) or implied (e.g., use of a caduceus or images of actors in lab coats). In all cases, however, they require that a company have the form of substantiation alluded to by the claim and that the touted performance benefit be both statistically and clinically meaningful. The risks for the unprepared advertiser are substantial, and include Lanham Act litigation, competitor-initiated challenges at the National Advertising Division (NAD), regulatory inquiries, consumer class actions, and adverse publicity.