An Illinois woman filed a lawsuit on Sunday against Nestle Health Science, claiming the company mislabels its peppermint oil capsules as a treatment for irritable bowel syndrome.
Nestle sells the capsules under the IBgard brand with package labels stating that they are “Clinically Proven to Help Relieve Irritable Bowel Syndrome (IBS) Symptoms” and “A Medical Food for the Dietary Management of Irritable Bowel Syndrome.” The lawsuit claims neither of these statements meet federal rules and regulations, violating the Illinois Consumer Fraud and Deceptive Business Practices Act and the Magnuson-Moss Warranty Act.
The Food and Drug Administration’s guidance on IBS clinical trials considers the length of the studies, conflicts of interest, sample size, outcome measures and consideration of IBS subsets, according to court documents. The plaintiff argues that no reliable scientific evidence supports claims that the product is clinically proven to treat IBS, and that studies have shown peppermint oil has the same impact as a placebo on IBS symptoms.
In addition, the lawsuit argues the product does not meet requirements for a medical food under Title 21 Section 101.9(j)(8) of the Code of Federal Regulations. Under the CFR, medical foods are foods specially formulated for seriously ill patients who require the use of the product as a major component of a disease or condition’s dietary management.
The plaintiff is seeking to declare the lawsuit a class action; preliminary and permanent injunctive relief; restitution and disgorgement for members of the class; monetary, statutory and/or punitive damages; and attorney’s fees.
The plaintiff is represented by Sheehan & Associates PC.
