New York, NY – July 2, 2018 – The National Advertising Division has recommended that i-Health Inc., discontinue advertising claims made in television and online advertising, and on product packaging for its Culturelle probiotic supplements. The claims at issue were challenged by The Procter & Gamble Company, maker of Align probiotic supplements.

P&G challenged express claims that included:

• “Exclusively with the #1 Proven Effective Probiotic*”
  • *Based on the studies of a range of benefits throughout the lifespan.
  • In close proximity to the claims: “works naturally with your body to keep your digestive system in balance,” “helps with occasional digestive upset, including diarrhea, gas and bloating,” and “helps your digestive system work better.”
• “LGG is the most clinically proven effective strain*”
  • *Based on the studies of a range of benefits throughout the lifespan.
  • In close proximity to the claim: “[LGG is] the only one you need to help support good digestion and immune health.”
• “LGG is the most proven effective strain*”
  • *Based on the number of Lactobacillus rhamnosus GG clinical studies, as of May 2017 (emphasis added).
  • In close proximity to the claim: “[LGG is] the only one you need to help support good digestion and immune health.”
• “Culturelle supports digestive health in overall wellness with the most proven effective probiotic*”
  • *Lactobacillus rhamnosus GG is the most proven effective probiotic strain based on studies for a range of benefits throughout the lifespan.

NAD also considered whether the advertising at issue implied that i-Health’s LGG is the most effective probiotic in terms of overall health-related benefits or is the most effective probiotic in balancing the digestive system, supporting immune health, and treating diarrhea, gas, and bloating.

NAD noted in its decision that probiotics are identified by three markers: first, the genus, which indicates a group of closely related species; second, the species, which indicates a group of individual bacteria that share certain similarities, and finally, the strain, which is the unique identifier for the specific ingredient.  Importantly, not all species of probiotics are part of the normal human gut flora and the beneficial effects attributed to one strain cannot be generalized to other strains. For these reasons, there is a potential for consumer confusion regarding the specific beneficial attributes of any probiotic.  As more strains are discovered, researched and introduced to the marketplace, NAD noted, the potential for confusion rises.

Culturelle supplements contain between 2.5 and 20 billion colony-forming units (CFUs) of the probiotic Lactobacillus rhamnosus GG.  The challenged advertising includes television, online, and package advertising that all feature similar iterations of the same core claim – that Culturelle is the “most clinically proven effective” or “#1 proven effective” probiotic.

NAD considered the message conveyed by the advertiser’s “most proven effective,” “most clinically proven effective,” and “#1 proven effective” claims.

The challenger contended that the claims communicated that i-Health’s LGG is the most effective probiotic strain for overall health-related benefits.

The advertiser argued that the express claims “most proven effective,” “most clinically proven effective,” and “#1 proven effective” convey the message that its probiotic ingredient had been the subject of the highest number of studies showing clinical efficacy over a range of conditions.  To support this message, the advertiser provided a numerical count of studies, sourced from the PubMed clinical studies repository, based on “positive outcomes” and “positive primary outcomes.”

NAD had several significant concerns with this approach. Further, NAD was not convinced by the advertiser’s argument that the claims at issue were not comparative in nature.

Following its review, NAD determined that at least one message reasonably conveyed by the claim “most clinically proven effective” is that Culturelle is more effective than competing products at providing the benefits associated with probiotics.  When considered in light of the other health-related advertising claims made in close proximity to the claims, such as “helps with occasional digestive upset, including diarrhea, gas and bloating” and “it’s the only one you need to help support good digestion and immune health,” NAD determined one reasonable interpretation would be that the advertiser’s LGG ingredient has been clinically proven to be the best probiotic on the market for treating various types of occasional digestive upset and supporting immune health.

NAD noted in its decision that the use of the terms “most clinically proven effective” and “#1 clinically proven effective” indicate to consumers that there is scientific evidence that proves or “establishes” the truth of the advertiser’s claim.

Without comparative studies in support of the advertiser’s claim, NAD could not evaluate whether the strain of probiotic in Culturelle was the “#1 clinically proven,” or “most clinically proven.”  Further, unqualified comparative superiority claims require substantiation against all significant competitors in the product category, evidence which was not provided here.   NAD concluded that the advertiser’s evidence was not a good fit for the messages reasonably conveyed by the challenged claims and recommended that the advertiser discontinue its “most proven effective,” “most clinically proven effective,” and “#1 proven effective” claims.

In its advertiser’s statement, i-Health said it would comply with NAD’s recommendation. While the company “respectfully disagrees with the NAD’s decision in this matter, i-Health supports the self-regulatory process afforded by the NAD and will take NAD’s guidance into account in developing future advertising,” the company said.

Note: A recommendation by NAD to modify or discontinue a claim is not a finding of wrongdoing and an advertiser’s voluntary discontinuance or modification of claims should not be construed as an admission of impropriety. It is the policy of NAD not to endorse any company, product, or service. Decisions finding that advertising claims have been substantiated should not be construed as endorsements.