IBgard Falsely Advertised as ‘Clinically Proven,’ Class Action Claims

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A proposed class action lawsuit alleges IBgard peppermint oil capsules are falsely advertised as a medical food that is “clinically proven” to relieve symptoms of irritable bowel syndrome (IBS).

The 12-page case argues that the studies upon which defendant Nestle Health Science US Holdings, Inc. has based its claim that IBgard is “Clinically Proven to Help Relieve Irritable Bowel Syndrome (IBS) Symptoms” do not meet certain FDA criteria, which include factors such as the length of the studies, conflicts of interest, sample size, outcome measures and subsets of IBS that were considered.

“No competent or reliable scientific evidence supports the claims that the Product is clinically proven to have the effects promised,” the complaint alleges, noting that scientific studies have shown that both peppermint oil and a placebo pill have demonstrated “clinically meaningful” improvement of IBS symptoms with “no significant differences between them.”

The lawsuit goes on to claim that the IBgard product is misleadingly described as a medical food despite failing to meet the definition of such. Per the suit, a medical food is a specially formulated and processed product that is administered under the supervision of a physician and intended to help manage a disease or condition with specific nutritional requirements.

In order to be categorized as a medical food, the case relays, a product must:

• Be a specially formulated and processed product, as opposed to a naturally occurring food;
• Be intended for the dietary management of a patient who has limited or impaired capacity to ingest, digest, absorb or metabolize regular food or has other medically determined nutrient requirements that cannot be achieved through modification of the normal diet alone;
• Provide nutritional support for the management of a specific condition or disease as determined by a medical evaluation;
• Be intended to be administered under medical supervision; and
• Be intended for a patient who receives ongoing medical supervision.

The lawsuit alleges that although the IBgard product is advertised as a medical food for the treatment of IBS symptoms, the FDA has said it is not aware of any distinctive nutritional requirements for those with IBS.

“Therefore, the Product does not meet the definition of a medical food or the regulatory criteria for a medical food,” the complaint charges.

The suit further claims that IBgard is essentially an unapproved new drug given that Nestle Health Science has positioned the product as intended for “the cure, mitigation, treatment, or prevention of disease,” and that it is not generally recognized as safe for treating IBS.

According to the suit, the gold seal on the IBgard product’s label further misleads consumers because it elicits “an additional level of trust” even though the FDA has not established standards for the treatment of IBS.

The case claims consumers would not have purchased IBgard, or would not have paid as much for it, had they known it was not worth as much as represented.

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