(PRESS RELEASE) New York, NY – In a challenge brought by Vision Elements, Inc., the National Advertising Division (NAD) of BBB National Programs recommended that MacuHealth, LP modify or discontinue certain claims for its dietary supplement products MacuHealth, MacuHealth Plus+, Vitreous Health, Vision Edge Pro, and TG Omega-3.
Of these supplements, MacuHealth, MacuHealth Plus+, and Vision Edge Pro, each contain a triple carotenoid formula (lutein, meso-zeaxanthin, and zeaxanthin) marketed to help consumers’ vision. VitreousHealth is marketed for managing eye floaters and TG Omega-3 Fish Oil is marketed for various benefits for eyes, heart, and brain health.
MacuHealth Product Claims
NAD determined that the studies submitted by MacuHealth indicating a growing body of research around supplementation with the cartenoids lutein, zeaxanthin, and mesozeaxanthin to effect macular pigmentation and visual performance are a poor fit to substantiate the challenged claims for various reasons, including that the studies were not conducted on MacuHealth as currently marketed to consumers.
Therefore, NAD recommended that MacuHealth discontinue any claims that its MacuHealth dietary supplements:
- Are clinically proven to rebuild or restore macular pigment, and
- Enhance vision or visual performance over a lifetime.
NAD also recommended that MacuHealth discontinue any claims that MacuHealth:
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- “reduces inflammation in the retina,”
- “protects against harmful blue light”
- “improves photo-stress recovery and contrast sensitivity.”
- Contains a “patented blend of antioxidants [that] nourishes the eye to protect it against oxidative stress and disease.”
NAD noted that nothing in its decision prevents MacuHealth from making claims regarding the carotenoid formula of 10 mg lutein, 10 mg meso-zeaxanthin, and 2 mg zeaxanthin as long as they are narrowly tailored and properly supported.
MacuHealth Plus+ Claims
NAD found that the record did not contain sufficient evidence to substantiate the claim that MacuHealth Plus+ is “formulated for those diagnosed with Age-Related Macular Degeneration (AMD)” and recommended that the claim be discontinued. Among other things, NAD found that there were significant differences between the formulas marketed to consumers and those tested.
VitreousHealth Claims
To support its VitreousHealth product performance claims, MacuHealth relied on the Floater Intervention Study (FLIES). NAD found that although the FLIES was conducted on the VitreousHealth product and showed some promising results, it was not a good fit for the broad claims that VitreousHealth is “scientifically proven to significantly reduce floaters, enhance visual function and improve a patient’s quality of life” or can “reduce the severity of floaters.” Therefore, NAD recommended that these claims be discontinued, as well as several other challenged claims related to the outcomes of the FLIES.
TG Omega-3 Claims
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NAD found that the articles and study provided by MacuHealth as substantiation did not support its TG Omega-3 product performance claims and recommended that the claims that TG Omega-3 “helps with joint pain, arthritis and other diseases” and “promotes eye, brain, heart and overall health” be discontinued.
NAD also noted that the challenged claims, “Both EPA & DHA have been studied and found to be beneficial for dry eye, and supplementation with omega-3 fatty acids is recognized as a key first step in the management of the disease and its symptoms” and “[B]ased on scientific studies, health care providers and optometrists are recommending patients increase their intake of Omega-3s” focus on product ingredients and not on the product as marketed to the consumer.
NAD found that the record did not contain sufficient evidence to support these claims and recommended that they be discontinued.
Improved Bioavailability Claims
NAD evaluated the study submitted by MacuHealth regarding its Micro-Micelle™ technology and determined that it is not competent and reliable scientific evidence to support the advertiser’s broad improved bioavailability claims. Therefore, NAD recommended that such claims be discontinued.
Natural & Gluten Free Claims
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NAD recommended that MacuHealth discontinue claims that its MacuHealth product is an “all-natural formulation” and “a natural extract product,” as well as claims that its MacuHealth Plus+ is “clinically tested and gluten-free.”
During the proceeding the advertiser agreed to permanently discontinue many other challenged claims. Therefore, NAD did not review these claims on their merits.
In its advertiser statement, MacuHealth stated that it “believes that the challenged claims are thoroughly supported” and that it “strongly disagrees with the factual conclusions” reached in the decision, but nonetheless will comply with NAD’s recommendations.
All BBB National Programs case decision summaries can be found in the case decision library. For the full text of NAD, NARB, and CARU decisions, subscribe to the online archive. Per NAD Procedures, this release shall not be used for advertising or promotional purposes.
