Nestle Health Science US Holdings, Inc. makes IBgard-brand peppermint oil capsules that it sells as a treatment for irritable bowel syndrome (IBS). But the complaint for this class action alleges that the representations on the front of the package—that the product has been “Clinically Proven” and that it is a “Medical Food”—are misleading.
Two classes have been proposed for this action:
- The Illinois Class is all persons in Illinois who bought the product during the applicable statutes of limitations.
- The Consumer Fraud Multi-State Class is all persons in Minnesota, Arizona, New Jersey, Rhode Island, Maine, Oregon, Washington, North Dakota, Texas, Iowa, Kansas, Georgia, Ohio, West Virginia, Virginia, North Carolina, Delaware, Montana, Kentucky, Tennessee, New Hampshire, Alaska, South Dakota, Oklahoma, Utah, Nebraska, Maine, and Wyoming who bought the product during the applicable statutes of limitations.
The first page of the complaint has an image of two IBgard product boxes. On one are the words “Clinically Proven to Help Relieve Irritable Bowel Syndrome,” on the other are the words “A Medical Food for the Dietary Management of Irritable Bowel Syndrome,” and on both is a gold deal that claims that the product has the approval of doctors.
The Food and Drug Administration (FDA), the complaint alleges, “has established guidance to assist the pharmaceutical industry and investigators who are developing drugs for the treatment of IBS.”
First, the complaint alleges, “The studies upon which [the] claims that the Product is ‘Clinically Proven’ fail to meet the FDA’s criteria.” The complaint alleges that “no competent or reliable scientific evidence supports the claim that the Product is clinically proven to have the effects promised.” In fact, the complaint claims that studies show no significant difference between the effects of peppermint oil and a placebo.
Second, while the product is labeled as a “medical food,” the complaint alleges that it does not meet the criteria for a medical food under the US Code. The complaint alleges, “Medical foods are distinguished from the broader category of foods for special dietary use by the requirement that medical foods be intended to meet distinctive nutritional requirements of a disease or condition and must be intended to be used under medical supervision.”
Among a number of requirements, the complaint claims that medical foods must be intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
“However,” the complaint alleges, “the FDA has stated that it is not aware of any distinctive nutritional requirements for individuals with irritable bowel syndrome.”
Finally, the complaint alleges that the gold seal, doctor-approval statements are misleading.
The claims that the product is intended to be used for the cure, mitigation, treatment, or prevention of a disease (IBS) are drug claims, the complaint contends, which makes the product an unapproved new drug.
Article Type: LawsuitTopic: Consumer
Most Recent Case Event
IBgard “Clinically Proven” and “Medical Food” Claims Complaint
December 12, 2021
Nestle Health Science US Holdings, Inc. makes IBgard-brand peppermint oil capsules that it sells as a treatment for irritable bowel syndrome (IBS). But the complaint for this class action alleges that the representations on the front of the package—that the product has been “Clinically Proven” to work and that it is a “Medical Food”—are misleading.
IBgard “Clinically Proven” and “Medical Food Claims ComplaintCase Event History
IBgard “Clinically Proven” and “Medical Food” Claims Complaint
December 12, 2021
Nestle Health Science US Holdings, Inc. makes IBgard-brand peppermint oil capsules that it sells as a treatment for irritable bowel syndrome (IBS). But the complaint for this class action alleges that the representations on the front of the package—that the product has been “Clinically Proven” to work and that it is a “Medical Food”—are misleading.
IBgard “Clinically Proven” and “Medical Food Claims Complaint