National Advertising Division Recommends i-Health Discontinue Health-Related Claims for Culturelle IBS Complete Support

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New York, NY – May 31, 2022 – The National Advertising Division (NAD) of BBB National Programs recommended that i-Health, Inc. (DSM North America) discontinue health-related claims for its Culturelle IBS Complete Support, including:

• Establishment claims that Culturelle IBS has been “clinically shown” to improve symptoms of irritable bowel syndrome (IBS);
• Product efficacy claims;
• The claim “IBS Complete Support” in the product name; and
• Claims that convey a message that the product provides specific symptom relief benefits due to its status as a medical food.

The claims, which appeared on product packaging, the advertiser’s website, and in third-party online advertising, were challenged by The Procter & Gamble Company (P&G), a competing manufacturer of products aimed at gut health, including those containing probiotics and prebiotics. 

Culturelle IBS contains five grams of bioactive HMO prebiotics 2’-fucosyllactose and lactose-N-neotetraose. 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.

Establishment Claims

NAD noted that the advertiser’s claims that Culturelle IBS has been “clinically shown” to provide benefits to IBS sufferers are “establishment” claims, which promise the consumer that scientific evidence proves or “establishes” the truth of its claims. 

In assessing whether the study relied on by the advertiser was a good fit for the message conveyed by the advertiser’s “clinically shown” claims, NAD determined that these claims convey more to the consumer than the mere existence of a trial conducted on the product. NAD has stated that “clinical” means the study has “controlled, consistent, and reproducible conditions,” pursuant to which NAD has noted the importance of blinding and a control. NAD determined that because the advertiser’s study lacks blinding and controls, the product has not been “clinically shown” to provide the claimed benefits.

Therefore, NAD determined that the advertiser’s studies were not sufficiently reliable substantiation and recommended that the advertiser discontinue the claims that Culturelle IBS has been “clinically shown” to improve IBS symptoms.

Product Efficacy Claims

NAD concluded that the advertiser did not provide a reasonable basis in the form of competent and reliable clinical evidence for its product efficacy claims. In so finding, NAD:

• Identified methodological flaws in a study relied on by the advertiser, such as failure to use a placebo control and lack of blinding; 
• Found that studies regarding the product’s mechanism of action were inadequate evidence to support product efficacy claims; and
• Noted that the advertiser’s claims are not qualified in any material manner and fail to alert consumers to the emerging nature of the support.

For these reasons, NAD recommended that the advertiser discontinue the claims:

• “Clinically Shown To Relieve^ Abdominal Pain • Bloating • Constipation • Diarrhea Due to IBS”
• “clinically shown^ to help relieve the intensity & reduce the frequency of severe digestive symptoms associated with all types of IBS which can take a toll on your mind and body”
• “Shown in a clinical study^ to improve IBS symptoms within 4 weeks”
• “Formulated with a proprietary blend of HMO bioactive prebiotics that are clinically shown^ to help restore your digestive balance”
• “They also support your body’s intestinal barrier helping to relieve your IBS symptoms”
• “More Symptom Free Days^”
• “Living with IBS is difficult, taking Culturelle® IBS complete support to help manage symptoms is easy”
• “Helps Normalize Bowel Movements”
• “Clinically shown^ to relieve abdominal pain, bloating, constipation and diarrhea due to IBS”
• “HMO Bioactive Prebiotics: Clinically Shown^ to Make Real Changes”
• “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^”
• “In an open label clinical study of over 300 participants, patients using Culturelle™ IBS Complete Support everyday reported significant improvement in their symptoms: • Fewer days with stomach pain • More normal bowel movements • Reduced bloating severity • Quality of life improvements as reported by users – such as energy, mood, and irritability.”
• “Shown in a clinical study^ to improve IBS symptoms within 4 weeks”
• “More symptom free days^”
• “Culturelle™ IBS Complete Support helps you nutritionally manage your symptoms, such as bloating, constipation, diarrhea, and abdominal pain”
• “for The Dietary Management of Irritable Bowel Syndrome (IBS), Clinically Shown to Relieve IBS Symptoms Including Bloating, Constipation and Diarrhea”
• “CLINICALLY SHOWN – Clinically shown to help relieve the intensity & reduce the frequency of severe digestive symptoms associated with all types of Irritable Bowel Syndrome (IBS), including abdominal pain, bloating, constipation, and diarrhea”
• “MORE SYMPTOM FREE DAYS – Clinically shown to improve IBS symptoms within 4 weeks so you can have more symptom free days”

Product Name: “IBS Complete Support”

NAD determined that the product name “IBS Complete Support” conveys the message that the product provides broad support for consumers suffering from IBS, a message which is not supported by the evidence. Therefore, NAD recommended that the advertiser discontinue the claim “IBS Complete Support” in the product name.

Medical Food Claims

Pursuant to NAD’s Procedures, the challenge to the claim “MEDICAL FOOD USE UNDER MEDICAL SUPERVISION” and claims directly connected to Culturelle’s status as a legally marketed medical food were administratively closed because an assessment of whether describing Culturelle IBS as a medical food is misleading would require a determination as to whether the product meets the criteria set forth by the FDA for this product category.

However, NAD reached a different conclusion regarding claims that convey a message that the product provides specific symptom relief benefits due to its status as a medical food, such as:

• “Find Relief with A Medical Food” 
• “Culturelle™ IBS Complete Support is a medical food that goes beyond symptom relief to help at the source of your issues by using HMO bioactive prebiotics to selectively feed good bacteria. Restoring the balance of bacteria in the gut microbiome may help by strengthening the gut barrier which may improve the health of your gut and balance your digestive system.”
• “Culturelle™ IBS Complete Support helps you nutritionally manage your symptoms, such as bloating, constipation, diarrhea, and abdominal pain.”

NAD determined that these claims convey the message that Culturelle IBS can provide specific benefits related to IBS symptom relief and management and that the product can even treat or cure the underlying conditions by going “beyond” symptom relief. However, because the advertiser failed to provide a reasonable basis for the product’s ability to provide effective symptom relief, NAD determined that these claims were also unsupported and recommended they be discontinued.

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.”

All BBB National Programs case decision summaries can be found in the case decision library. For the full text of NAD, NARB, and CARU decisions, subscribe to the online archive.