Mid-Year Check-in on NAD Food, Supplement and Personal Care Product Cases
The halfway point of 2022 finds NAD digging deep on supplement substantiation and looking closely at whether product names convey misleading claims. Here are highlights from the past quarter and links to our posts from earlier this year. Enjoy!
The Proof Is In the Testing (NAD Case No. 7067): NAD recommended that Dakota Nutrition, Inc., discontinue a broad range of claims relating to the presence of elderberry in the company’s Elderberry Capsules and Elderberry Gummies products, including claims that the products even contain elderberry or provide benefits commonly associated with elderberry. NAD also recommended that Dakota Nutrition discontinue use of the term “elderberry” in the product name given that Dakota Nutrition was unable to provide a reasonable basis that its products contain elderberry, based on HPLC and HPTLC testing provided by the advertiser. This case is a reminder of the importance of robust ingredient and finished product testing, particularly as many companies have shifted to alternate suppliers during the pandemic to meet consumer demands.
Mmmm…Chicle (NAD Case No. 7077): NAD also went deep into ingredient testing in a challenge filed by global confectioner Perfetti Van Melle USA, Inc., against Mazee, LLC, maker of Glee Gum. Mazee advertised Glee Gum as, among other things, an all-natural, eco-friendly chewing gum made from chicle, a tree sap that Mazee claimed is sustainably harvested from the rainforests of Central America. To support its claims that Glee Gum contained chicle, Mazee provided information from its supplier stating that the gum base is 94% chicle tree sap (the other 6% consists of candelilla wax and natural citrus acid), along with the results of Carbon-14 testing by Beta Analytic.
Perfetti rebutted that the supplier information did not show that chicle is an ingredient because the CAS Registry Number it listed to identify “Chicle Tree Sap” is not the CAS Registry Number of chicle or any other known chemical substance. Further, the challenger argued that the results of Mazee’s Carbon-14 tests do not provide any information as to whether the gum base in Glee Gum contains chicle, but only purport to provide information regarding whether the carbon in Glee Gum is plant or fossil-based. Perfetti further attacked Mazee’s claims with analysis from two experts who concluded that Glee Gum did not exhibit typical chicle-related characteristics and, instead, their analysis suggested the presence of synthetic materials. Based on this, NAD recommended that the advertiser discontinue claims that the gum base of Glee Gum is “made with chicle.”
Lack of Blinding and Placebo Doom Establishment and Efficacy Claims for IBS Medical Food (NAD Case No. 7080): NAD recommended that i-Health discontinue “clinically shown” claims as well as efficacy claims relating to treatment of IBS symptoms on the company’s Culturelle IBS Complete Support product. Despite i-Health supporting the claims with the first large-scale trial to show that adult patients with IBS (irritable bowel syndrome) can achieve an improvement of IBS symptoms with supplementation of HMOs (human milk oligosaccharides) – a 317-person multicenter, open-label, single-arm clinical trial involving IBS patients from 17 sites across the United States – NAD found that the failure to blind the product and the lack of placebo caused the study to fall short of meeting the “competent and reliable scientific evidence” standard. Given these weaknesses and the emerging nature of the evidence supporting use of HMOs to manage IBS symptoms, NAD recommended that i-Health discontinue the challenged establishment (“clinically shown”) claims, the product efficacy claims, and the use of “Complete Support” in the product name. Further, NAD declined to issue a recommendation on whether the product was properly categorized as a medical food but recommended discontinuation of medical food-related claims that addressed product efficacy. In addition to being a thorough discussion of the “competent and reliable scientific evidence” standard, this opinion is a cautionary tale both of the importance of placebo and blinding as well as the need to consider qualified claims for emerging evidence.
Good Goli (NAD Case No. 7059): NAD also flexed its clinical study analysis muscles in a challenge filed by Church & Dwight against Goli Nutrition regarding weight loss and sexual health claims that Goli was making on its Goli Ashwagandha Gummies. In that matter, despite producing blinded, placebo-controlled ingredient (not finished product) studies to support its claims, NAD found the studies to be unreliable because of small sample sizes, sample populations that either did not represent the U.S. population or did not represent a healthy population, inadequate directions to study participants, lack of statistical significance, or lack of consumer relevance.
One issue with particular relevance given the products gaining popularity as we emerge from the pandemic, with regard to claims that KSM-66 Ashwagandha could help promote weight loss and weight management, NAD rejected research based solely on overweight or obese individuals experiencing chronic stress to support the weight management claims because the products were not targeted solely to those populations and testimonials did not reflect those specific populations. It is always a challenge to square the reality that much dietary supplement research is conducted on a diseased population while the products are marketed primarily to a healthy population but, as NAD points out, this can be addressed in how the product is marketed to help ensure a solid fit between the substantiation and the claim.
***For other recent food and personal care highlights, check out our posts here.