BBB National Programs Archive

NAD Recommends Eli Nutrition Discontinue Certain Challenged Claims for TummyZen Dietary Supplement; Advertiser to Appeal to NARB

New York, NY – Nov. 27, 2018 – The National Advertising Division has recommended that Eli Nutrition discontinue certain claims for the company’s TummyZen dietary supplement. The advertiser has said it will appeal NAD’s findings to the National Advertising Review Board.

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

GlaxoSmithKline Consumer Healthcare, L.P., maker of Tums antacids, challenged express claims made by Eli Nutrition for its TummyZen dietary supplement on product packaging and in online advertising that, GlaxoSmithKline argued, were unsupported, powerful, unqualified, broad health claims, including:

  • “Total Heartburn Relief”
  • “Stops Acid Production”
  • “Acid Inhibiting”
  • “Halts the secretion of Chloride ions in your parietal cells to help regulate the release of acid into your stomach.”
  • “Supports your stomach lining.”
  • “Proven ingredients like protective zinc.”
  • “Its Revolutionary Formula Relieves almost instantly.”

The challenger also contended that advertisements for TummyZen reasonably conveyed the unsupported messages that TummyZen works as well as drug products that are proven to provide long-lasting heartburn relief and that competing products have “scary side effects.”

Eli Nutrition maintained that its heartburn relief and other claims for TummyZen were fully substantiated. In support its claims, the advertiser relied on two human clinical studies of zinc sulfate, a series of in vitro and animal studies, and a consumer use survey.

NAD first considered the advertiser’s argument that the claim “Total Heartburn Relief” was part of TummyZen’s product name.  NAD reviewed the challenged advertising, and noted that “TummyZen” frequently appears without the phrase “Total Heartburn Relief.”

Although NAD is generally hesitant to recommend a product name change absent extrinsic evidence that consumers have been confused or misled, NAD noted that a product name change can be required even in the absence of such evidence if the product name itself conveys a message that false or misleading. NAD concluded that “Total Heartburn Relief” was not part of the TummyZen name but an express performance claim that consumers will not feel any significant sensation of heartburn after taking TummyZen, and that TummyZen was effective on all types of heartburn, including heartburn that is distinct from occasional heartburn and indicative of more serious conditions.

NAD next considered whether Eli Nutrition’s health-related heartburn claims were supported by competent and reliable scientific evidence affirmatively demonstrating that TummyZen, as formulated for sale, actively performs the function promised and provides consumer meaningful benefits that relate directly to the performance attributes advertised.

NAD reviewed the human clinical studies offered in support of TummyZen’s claims. For several reasons, NAD concluded that they were not a good fit for the claim that TummyZen or the zinc in TummyZen provides “Total Heartburn Relief.” These studies were ingredient studies which did not study the TummyZen product as it is sold to consumers but, rather, only one form of one ingredient in TummyZen, zinc. The studies also did not evaluate “relief” or “total” relief,” and studied zinc sulfate not the zinc acetate contained in TummyZen. NAD was also troubled by the studies’ small sample sizes and questioned whether the test subjects (healthy young adults) were representative of heartburn sufferers seeking “total” relief for their heartburn.

NAD also considered the results from the advertiser’s in vitro USP testing on the TummyZen product. Because TummyZen passed the FDA’s mandated acid neutralization capacity threshold on the USP test, NAD determined that the advertiser had provided a reasonable basis for a narrowly tailored claim that TummyZen provides “relief from occasional heartburn and acid indigestion” as permitted by the FDA monograph for OTC antacids. This testing, however, did not support Eli Nutrition’s claim that TummyZen, or the ingredients in TummyZen, provides “total heartburn relief” and recommended that these claims be discontinued.

NAD similarly found the human clinical trials as well as the advertiser’s in vitro and animal studies insufficient to support its unqualified acid inhibition-related and “supports the stomach lining” related claims, as well as its claim that TummyZen contains “proven ingredients like protective zinc,” and recommended these claims be discontinued.

Although NAD found the advertiser’s evidence sufficient to support its claims that TummyZen’s zinc formula “relieves almost instantly,” it had not demonstrated that its formula is “revolutionary” in its ability to relieve heartburn, that TummyZen is “long lasting” or that that competing calcium carbonate products, such as Tums, have “scary side effects” and recommended that these claims be discontinued.

In its advertiser’s statement, Eli Nutrition, Inc. stated that it will appeal to NARB the NAD’s recommendations that it change the product’s name “Total Heartburn Relief”; and that it discontinue or modify its claims that its product “stops acid production,” is “acid inhibiting,” “halts the secretion of chloride ions in your parietal cells to regulate the release of acid into your stomach,” “supports stomach lining,” and is “long lasting.”  However, Eli Nutrition stated that it will comply with NAD’s other recommendations.

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.