The victory came in the form of a ruling by the National Advertising Division, a part of BBB National Programs.
The product, which is marketed by DSM’s subsidiary i-Health, Inc. is a prebiotic product based on two human milk oligosaccharides (HMOs), 2’-fucosyllactose and lactose-N-neotetraose, which are found in breast milk. It is offered in a stick pack that can be dissolved in water or other beverage or sprinkled on top of any food. Culturelle IBS is labeled and marketed as a medical food for the nutritional management of IBS and IBS-related symptoms.
NAD takes issue with study used to support claims
NAD ruled that i-Health should drop a variety of claims connected to the product including that is has been ‘clinically shown’ to improve the symptoms of irritable bowel syndrome (IBS). This is a so-called ‘establishment claim.’
NAD found that the scientific backing that i-Health used to shore up the ‘clinically shown’ claim was a study that had methodological shortcomings, which including being an open label study with no placebo control. The NAD ruling said that a ‘clinically shown’ claim goes beyond the mere existence of a study on the product, and implies the product has been studied in a manner that is reproducible.
“NAD determined that because the advertiser’s study lacks blinding and controls, the product has not been ‘clinically shown’ to provide the claimed benefits,” the ruling stated.
NAD recommended that i-Health drop a broad array of such establishment claims, which can including:
- “Clinically Shown To Relieve Abdominal Pain • Bloating • Constipation • Diarrhea Due to IBS”
- “Formulated with a proprietary blend of HMO bioactive prebiotics that are clinically shown to help restore your digestive balance”
- “In a clinical study with more than 300 participants, people using Culturelle IBS Complete Support every day reported improvements in their symptoms: 58% reduction of days with abdominal pain, Decreased bloating by 59%, More normal bowel movements.”
NAD: Product's name is also a claim
NAD also ruled that the product’s name—IBS Complete Support—is a claim in and of itself and should be dropped.
The NAD ruling also found that the medical food positioning implied that the product had particular proven benefits, which were found to be unsubstantiated.
In its advertiser statement, i-Health stated that it “agrees to comply with NAD’s recommendations.” The advertiser further stated that while it is “disappointed” in the NAD decision because it believes that its clinical trial substantiates the labeling and advertising claims, it will not appeal because “we support the NAD’s self-regulatory process and as a result, are committed to implementing the changes consistent with NAD’s recommendations.”
As of publication time, many of the things cited in the NAD ruling could still be found on the culturelle.com website. DSM did not respond in time for publication as to whether it actually intends to rebrand the product in addition to removing the claims.