TriDrive Marketer Misses Claim Substantiation Mark For Whole Product, Separate Ingredients
This article was originally published in The Rose Sheet
Executive Summary
CBBB's National Advertising Division says VH Nutrition Inc. did not submit testing on its TriDrive supplement but relied on evidence from studies of the efficacy of the ingredients in the product.The firm said it has ceased marketing the product, though it remains available online labeled with claims NAD recommended pulling.
VH Nutrition Inc. is the latest dietary supplement marketer to learn in a Council of Better Business Bureaus advertising review that studies of separate ingredients do not support ad claims for a product's formulation.
In a review started from its routine monitoring program of dietary supplement advertising supported by the Council of Responsible Nutrition, CBBB's National Advertising Division said in a reported published July 2 that VH Nutrition did not submit testing on its TriDrive supplement but relied on evidence from studies of the efficacy of the ingredients in the product.
The firm offering testosterone boosters, estrogen blockers and supplements for weight loss or gain and hair-loss prevention said it has ceased marketing the product, though it remains available online labeled with claims NAD recommended pulling.
Based on Federal Trade Commission guidelines for health claims, NAD says that when substantiation is offered only for the efficacy of separate ingredients and not for the product itself, any claims must be clearly expressed as ingredient claims. It recommended that VH Nutrition discontinue health-related performance claims for TriDrive supplement as a whole.
The San Luis Obispo, Calif., firm didn't fare any better with its support for separate ingredients in TriDrive, a proprietary blend of cordyceps, eurycoma longfolia, ginko, rhodiola rosea and aswagandha.
An in vitro study to support an improved stamina claim for cordyceps was no help. While FTC advises that in vitro studies can be examined for health claim substantiation when they are widely considered acceptable substitutes for human clinical trials research or where human research is not feasible, NAD attorneys said, "No such showing of infeasibility has been made here."
A clinical trial that VH Nutrition submitted showed improvement from baseline for the cordyceps group, but little difference between it and the placebo group.
NAD attorneys said with ashwagandha use historically acknowledged as relieving stress and anxiety VH Nutrition can make "carefully tailored claims regarding" the herb's traditional use. However, the firm failed with two studies it submitted to support its claim that ashwagandha will improve mood or cardiorespiratory endurance capacity.
One study, a meta-analysis of five trials, showed narrow and qualified support, according to the report. The study authors said “all five studies exhibited unclear or high risk of bias, and heterogeneous design and reporting prevented the possibility of a meta-analysis” and they couched any positive findings regarding ashwagandha as “somewhat promising but early, and possibly biased, results,” according to NAD's report
The second study compared treatment and placebo groups that did not follow the same training regimens and featured subjects in an age group non-representative of an accurate sampling for likely TriDrive users. "FTC guidance and NAD [recommendations] are clear that studies offered as substantiation should look at the same populations as the consumers targeted in the claims," the report states.
VH Nutrition's support for claims that 300 mg of proprietary extract of eurycoma longolia (Physta) and ployonum minus in TriDrive improves recovery and boosts testosterone levels was a randomized, placebo-controlled study of healthy men who supplemented with clinical endpoints that included sexual performance and sexual well-being, with tertiary endpoints including free and total testosterone levels.
It had the appearance of a strong study, perhaps, but VH Nutrition is only the latest supplement marketer to be told NAD that support for ingredient claims must come from underlying studies that use an ingredient in the same amount and formulation as it is used in a product. The study formulation was a proprietary extract of Physta, and also ployonum minus, "neither of which are present in TriDrive," the report states.
An abstract of a study VH Nutrition submitted to support an increased respiratory function for rhodiola rosea in TriDrive met the same fate as other abstracts NAD receives: "Abstracts and informal summaries do not impart enough information for NAD to properly evaluate whether they constitute competent and reliable scientific evidence."
And the study the firm submitted for rhodiola rosea looked at rhodiola crenulata and had greater doses of both rhodiola and cordyceps than found in TriDrive, according to NAD.
VH Nutrition took the NAD recommendation in stride, saying it stands "by its product and disagrees with some of NAD’s determinations" but it "would continue to comply with NAD's recommendations" should it re-launch the product.