NAD Recommends Nanoceutical Solutions Discontinue Dietary Supplement Claims and Modify Instagram Ad

Advertising Law

In a recent decision, the National Advertising Division (NAD) determined that Nanoceutical Solutions Inc. had failed to adequately substantiate efficacy and establishment claims for its product Nano Glutathione. The claims at issue, which the NAD recommended be discontinued, were challenged by the Council for Responsible Nutrition (CRN).

Nano Glutathione is a liquid dietary supplement containing glutathione, an antioxidant produced in cells. It is mainly composed of three amino acids: glutamine, glycine, and cysteine. Glutathione levels in the body may be reduced by a number of factors, including poor nutrition, environmental toxins, stress and age.

The advertiser claimed that its product provides “Incredible Health Benefits” and stated, “Glutathione has been a celebrity secret to help prevent aging, obesity, cancer, heart disease, dementia, joint pain, and more. It is necessary to treat everything from Fibromyalgia, Alzheimer’s disease, Immune Disorders, Heart Disease, Diabetes, and even Cancer.” The advertiser agreed to permanently discontinue this claim and similar claims. However, it defended several claims that were challenged.

In a detailed analysis, the NAD determined that the claim “The problem is that glutathione was only effectively available through injections . . . until now – thanks to our Nanotechnology,” in context, conveys a strong message regarding Nano Glutathione’s efficacy as a treatment and preventative therapy.

After reviewing the studies relied on by the advertiser as support, the NAD was concerned that the evidence was preliminary in nature and not a good fit for the message conveyed. One of the studies was an in vitro diffusion study which, the NAD stated, “provides no support as to whether the oral ingestion of glutathione will have the same effect as directly applying the ingredient to animal tissue in a laboratory setting.” Another study was a pilot clinical study, for which the NAD had two concerns: 1) it was not a robust clinical study, and 2) its only objective was to evaluate the absorption of a single dose of glutathione as a proxy for its bioavailability, rather than to substantiate any health effects produced by long-term supplementation.

Therefore, NAD determined that the advertiser had failed to provide a reasonable basis, in the form of competent and reliable evidence, for the claim and recommended that it be discontinued.

CRN also objected to the claim “We have published clinical studies. In a double-blind study, levels of Glutathione in the test group increased by 804% compared to the placebo group. The clinical implications of reducing oxidative stress and therefore reduction of a vast majority of diseases is staggering!” The NAD determined that one message reasonably conveyed is that Nano Glutathione has been clinically proven to reduce oxidative stress, and consequently to reduce or prevent various diseases. The NAD determined that the advertiser’s evidence was insufficient support for this establishment claim because the claim exaggerates both the amount of evidence the advertiser possessed and the substantive findings of that evidence. Therefore, NAD recommended that this claim also be discontinued.

CRN also took issue with an advertisement that appeared in the advertiser’s Instagram feed. In the ad, five boxes appear under the headline “Conditions Associated with LOW Glutathione,” each labeled with a health category: “Neurological,” “Cardiovascular,” “Immune,” “Cancer,” and “Other – Thyroid/Pancreatic/Inflammatory.” In each box, the advertiser lists a number of serious diseases that are “associated with low glutathione,” including ADHD, Alzheimer’s, depression, bipolar disorder, schizophrenia, HIV/AIDS, Lyme disease, arthritis, heart disease, numerous types of cancer, diabetes, cystic fibrosis, infertility, kidney disease and pancreatitis, among others.

The NAD concluded that, in context, the claim is misleading because it implies that supplementation with Nano Glutathione can play a role in preventing or treating serious diseases associated with low levels of glutathione. Because this claim was unsupported, the NAD recommended that the advertiser modify the Instagram advertisement to avoid conveying the misleading message that supplementation with Nano Glutathione can prevent or reduce the risk of the listed health conditions.

The advertiser stated that it would comply with the NAD’s recommendations.

Why it matters: The NAD carefully reviewed the substantiation for these claims and found that it was insufficient. In its analysis, the NAD discussed important principles regarding the types of substantiation submitted by the advertiser for its health claims.

The NAD stated that while it recognized that “in vitro studies can provide some background evidence about a substance, suggesting further clinical research, in vitro studies are of limited value in predicting the effect of a substance when consumed by humans and in most cases such studies cannot by themselves support health claim[s].”

With respect to pilot clinical studies, the NAD stated, “Generally speaking, a pilot study is a small-scale preliminary study conducted to evaluate feasibility, time, cost, adverse events, and effect size (statistical variability) for further research.” The NAD expressed concern about “the reliability of extrapolating information from preliminary findings to support” performance claims.

The NAD also stressed that “[w]hile advertising can communicate meaningful information about health and disease prevention, it is well-established that the nature and extent of claims made by an advertiser should mirror the precision and specificity of the data relied on as substantiation.”

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