In a new decision, the National Advertising Division (NAD) recommended that the marketer of a dietary supplement discontinue claims about its product performance and safety, its testimonials, and its “doctor recommended” assertions.
As part of an initiative with the Council for Responsible Nutrition (CRN) designed to expand NAD’s dietary supplement ad review process, CRN challenged the Internet advertising claims disseminated by Nexus Formulas for its Plavinol dietary supplement.
The advertiser claimed that Plavinol provides—with no side effects and in a short period of time—significant and meaningful symptom reduction and improved health for consumers who suffer from metabolic syndrome or associated conditions such as increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol or triglyceride levels. CRN said that the advertiser lacked evidence to back up its express claims.
Performance claims included the following: “This pill contains an active ingredient that also triggers weight loss and lowers high blood pressure, cholesterol and triglyceride levels” and “Clinical studies in the U.S. have shown it blocks sugar in the foods you eat from entering your blood.” A safety claim regarding Plavinol stated, “A pill that lowers high blood pressure in 30-days has been used safely in China for 54 years. It is now available in the United States.”
To support its claims, Nexus made references to doctors in its advertising, such as the following: “U.S. doctors recommend new Plavinol because it lowers blood sugar, triggers weight loss and restores cholesterol, blood pressure and triglycerides levels to normal without side effects” and “‘Plavinol is an excellent choice for overweight people. The clinical trials in support of the pill show it caused weight loss over a 90-day period,’ said Dr. Holly Lucille, who has appeared on award winning TV shows like The Doctor and PBS’ Healing Quest.”
NAD noted that Nexus, in support of its claims, provided only one “White Paper” that referred to the product as a whole, along with several studies on individual ingredients, none of which satisfied the requirement that health-related product performance claims must be supported by competent and reliable scientific evidence on the actual product as it is marketed, the NAD said. It noted that since the White Paper lacked information on its authorship, it could not be deemed sufficiently reliable to support any product performance claims. The NAD also found several problems with the individual ingredient studies. Some of them were not blinded or randomized, some had very small samples sizes, and others were conducted outside of the United States, all of which left questions about their applicability to the U.S. population where the diet of test subjects was a critical study-related factor.
As for the safety claim, the advertiser failed to submit any testing demonstrating that Plavinol, or its ingredients, are safe, non-addictive or that it has been used safely in China for 54 years.
Similarly, Nexus did not provide the self-regulatory body with evidence—specifically, a survey of doctors demonstrating that a substantial percentage of them recommend Plavinol to their patients suffering from metabolic syndrome or any of the conditions associated with it—to back up the “doctor recommended” claims.
Finally, the testimonials also failed review because of a lack of evidence, as the advertisers did not demonstrate that the doctors cited had assessed the reliability of any studies on Plavinol.
The NAD recommended that all the challenged claims be discontinued.
To read the NAD’s press release about the decision, click here.
Why it matters: The NAD’s decision provides advertisers with a powerful reminder about the importance of having the necessary evidence to back up advertising claims. Health-related product performance claims must be supported by competent and reliable scientific evidence on the actual product as it is marketed (with human clinical trials as the “gold standard”). “Doctor recommended” claims require a well-conducted, random and statistically significant survey of doctors showing that a substantial percentage of doctors recommend the product, and that their conclusions are based on their actual experience and what they actually recommend in their daily practice.