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
Editor-in-Chief
Nutritional Outlook magazine jennifer.grebow@ubm.com
Photo © iStockphoto.com/Laspi
DOJ asks Utah court to dismiss FTC lawsuit against Xlear Inc.
March 11th 2025On March 10, the DOJ and the defendant filed a stipulation to dismiss with prejudice the lawsuit in which each party agrees “to be responsible for its own costs and fees and agrees that no party shall be responsible to any other party for any fines, costs, fees, or penalties arising from this case.”
HHS announces efforts to eliminate independent conclusion of GRAS
Published: March 11th 2025 | Updated: March 11th 2025U.S. Department of Health and Human Services (HHS) Secretary, Robert F. Kennedy Jr., is directing the acting U.S. Food and Drug Administration’s (FDA) acting commissioner to explore rulemaking that would eliminate the independent conclusion of GRAS provision.
