FTC’s i-Health Settlement Features Evolving Substantiation and Fencing-In Standards

Kelley Drye

Earlier this week, the FTC announced that supplement marketers i-Health, Inc. and Martek Biosciences Corporation (the Companies) have agreed to settle charges of deceptive advertising for claiming that their BrainStrong Adult dietary supplement will improve adult memory and prevent cognitive decline. BrainStrong Adult, which is sold at drug stores nationally and advertised online and on television, is an omega-3 DHA-based supplement. The Companies claimed that the product was clinically shown to improve adult memory,” could naturally support mental clarity,” and helps protect against normal cognitive decline as we age.”

The FTC alleged that the terms memory” and cognitive” function mean many different things. For example, the FTC points out that there is episodic memory (memories of specific experiences), sensory memory (memories of specific sensory perceptions), working memory (short term mental manipulation of numbers), semantic memory (general knowledge, facts, concepts), and procedural memory (learned skills, such as riding a bike). The same is true of cognition. As such, even though BrainStrong Adult was supported by clinical trial evidence showing that participants who consumed 900 mg of DHA daily experienced certain memory-related improvements, because it did not support an improvement in all different variations of memory and cognition, the FTC alleged that the benefits communicated were not properly supported by the study and, thus, the claims were deceptive.

This case is significant for three main reasons. First, health claims - and cognition claims specifically - are enforcement priorities for the agency. Second, the substantiation standard required in the Order for cognition and memory claims is not the two-study standard seen in prior health claim-related orders. The Order does not specify the quantity of studies needed. Rather, it requires scientific evidence sufficient in quality and quantity to substantiate that the statement is true. Third, the Order includes a data collection provision regarding the clinical study data and documentation that is unprecedented in FTC orders. It would require the Companies to maintain the underlying data and related clinical study documents used to support memory and cognition claims such that those materials may be evaluated by the FTC in the future. These provisions may signal a shift in substantiation and fencing-in standards where competent and reliable scientific evidence” is concerned.

Tags: i-Health, Inc.