FTC’s Substantiation Bar: TriVita Inc. (July 2014)


Searching for trends in recent FTC consent orders and related motions

In its July 15, 2014, FTC’s stipulated order for permanent injunction would ban the maker of Nopal cactus (prickly pear) drinks and products from making inflammation-related, pain-relief, and other claims unless the firm has “human clinical testing of the Covered Product or of an Essentially Equivalent Product that is sufficient in quality and quantity, based on standards generally accepted by experts in the relevant field, when considered in the light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. Such testing shall: (1) be randomized, double-blind, and placebo-controlled; and (2) be conducted by researchers qualified by training and experience to conduct such testing.” However, the FTC does not specify how many trials are needed.

FTC Requirement: Human studies (but doesn’t specify number of studies)


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Jennifer Grebow
Nutritional Outlook magazine jennifer.grebow@ubm.com


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