However, it determined that the muscle function-related claims should be modified or discontinued.
While Amazentis disagreed with parts of NAD’s assessment, it stated in its advertiser response that it will comply with the NAD’s recommendations.
Mitopure is marketed as a supplement designed to support aging muscular and cellular health. In evaluating Amazentis’s claims, NAD reviewed several studies submitted by the company, including human clinical trials related to mitochondrial function, mitophagy and muscle strength in aging populations.
NAD’s case decision overview
NAD found that the evidence provided was sufficient to support part of a broader cellular performance claim. Specifically, NAD concluded that the claim “Clinically proven to revitalize mitochondria” was substantiated, noting that the “submitted studies are sufficiently reliable and provide a reasonable basis” for that portion of the longer claim “Clinically proven to revitalize mitochondria & boost muscle function.”
However, NAD took issue with the framing of another cellular claim. It recommended modifying the statement, “Mitopure is the first nutrient clinically-proven to trigger a crucial recycling process within our cells called mitophagy, preventing age-related cellular decline,” citing concerns that the evidence “was not a good fit for the challenged claims for several reasons.” NAD recommended removing the “first” qualifier.
More significant revisions were recommended for the muscle function claims. NAD found that the advertiser’s studies did not adequately support the broad claim “boost muscle function” or the more specific performance-based statement “Muscle strength increases by up to 12% in 16 weeks.”
According to NAD, these claims should be narrowed to match the study population, “hamstring muscle in obese, sedentary middle-aged adults,” and advertising should avoid suggesting similar results would occur in fit or athletic individuals.
NAD also recommended discontinuation of the claim “Muscle endurance increases by up to 15% after 8 weeks,” as it was based on a dose that was “twice the recommended dose.”
Separately, Amazentis voluntarily agreed to modify another challenged muscle claim, “Muscle strength increases by up to 21% in 16 weeks,” to reflect study-specific data. NAD stated that this voluntary discontinuation will be treated “as though NAD recommended it be discontinued.”
The legal perspective
Attorney Jennifer Adams of Amin Wasserman Gurnani offered perspective on the NAD findings, emphasizing the need for advertisers to align claims closely with the available scientific evidence and the context in which those claims are presented.
“NAD agreed that certain aging claims don’t necessarily need a longevity study,” Adams told NutraIngredients. She explained that NAD found the “clinically proven” claims related to cellular aging to be adequately supported “by a strong body of human clinicals on cellular aging and genetic markers and a supportive narrative general mechanism literature.”
However, she emphasized the importance of claim-context alignment, particularly when it comes to visual cues in advertising. “The advertiser placed its muscle function claims near pictures of athletic, fit individuals, but the study was in sedentary, obese individuals,” she noted.
“While the study itself was sound, it was not a good fit for advertising, which implied a muscle strength benefit in healthy, active individuals,” she said, adding that “it’s an important reminder that even the strongest science is of little value if it doesn’t match the claim.”
