New York, NY – Sept. 9, 2016 – The National Advertising Division has recommended that American Dream Nutrition, LLC, modify or discontinue certain claims for the company’s PhytoZon Dietary Supplement, although NAD determined that the presence of lutein and lycopene in the product was sufficient to support a “heart health” benefit claim.

NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.

NAD opened its inquiry into claims made for the product as part of its ongoing monitoring program and in conjunction with an initiative with the Council for Responsible Nutrition to expand the review of advertising claims for dietary supplements. The advertiser initially declined to participate and the advertising at issue was referred to the Federal Trade Commission. The advertiser returned to the self-regulatory forum and asserted that it had modified certain of the challenged claims and discontinued all of the challenged consumer testimonials:

• “Helped Lower My Blood Sugar”
• “Helped Manage My Breast Cancer”
• “Helped with my Macular Degeneration”

NAD reviewed the advertiser’s revised claims, including:

• “With Over 500 Hundred ingredient specific Research and Clinical Studies, PhytoZon was scientifically formulated to Enhance, Promote and Support: 

• Brain/Body Balance – Mental Clarity, Focus/Recall
• Mental Cognition and Concentration
• Energy, Vitality, Increased Strength, Well Being
• Joint Health, Flexibility, Endurance
• Skeletal Health, Posture, Back and Neck
• DNA Repair on a Cellular Level
• Helps Cells Produce IGF-1 to Repair/Rebuild Cartilage
• Heart Health, Eye Health, So Much More…”

When an advertising claim promotes the health benefits of a product, the basis for the claim must be established by competent and reliable scientific evidence.  The FTC defines competent and reliable scientific evidence as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated by persons qualified to do so, using procedures generally accepted in the profession to yield accurate results.”  When applied to claims regarding human health, that generally means randomized, placebo-controlled studies on humans that reach statistical significance and yield clinically meaningful results.

A study must not only be competent and reliable, but also a good fit for the claim at issue. In the case, the advertiser provided hundreds of study citations related to various PhytoZon ingredients, but it did not provide any studies conducted on the PhytoZon supplement itself.

Here, NAD determined that consumers who read the claim that “over 500 hundred ingredient specific research and clinical studies,” went into the formulating PhytoZon could reasonably take away the message that the studies related in some way to the health benefits the advertiser has promoted.

Because this was not the case, NAD recommended that the advertiser discontinue its claim that, “with over 500 hundred ingredient specific research and clinical studies, PhytoZon was scientifically formulated to enhance, promote and support …”

NAD further recommended the advertiser discontinue or modify many of the remaining challenged health claims, noting that the various ingredient studies provided did not establish that taking PhytoZon would provide consumers with the claimed benefit.

However, NAD noted that nothing in this decision prevents the advertiser from making a certain more limited claims that explain the state of the current science related to the impact of one PhytoZon ingredient, cat’s claw, on pain associated with osteoarthritis of the knee.

NAD noted that the advertiser provided a reasonable basis for its “heart health” claim, but recommended that such claims should make clear that such claims are based on ingredient studies and not on any study of the supplement itself. NAD also recommended the advertiser modify its claim that PhytoZon can “Enhance, Promote and Support … Eye Health,” to clearly limit the claim to the specific benefits of lutein supplementation supported in the scientific literature.

American Dream Nutrition, in its advertiser’s statement, said the company agreed to comply with NAD’s recommendations, although it “disagrees with the standard NAD applied to its claims for its dietary supplement. … ADN believes that it was correct to rely, in part, on historical use, in vitro/vivo studies, mechanism of action studies and small-scale (n<100) peer-reviewed and published clinical studies. Although ADN disagrees with many of NAD’s critiques, it nonetheless agrees to comply with NAD’s recommendations and will act upon them.”

Note: A recommendation by NAD to modify or discontinue a claim is not a finding of wrongdoing and an advertiser’s voluntary discontinuance or modification of claims should not be construed as an admission of impropriety. It is the policy of NAD not to endorse any company, product, or service. Decisions finding that advertising claims have been substantiated should not be construed as endorsements.