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.”
Continue Reading Mid-Year Check-in on NAD Food, Supplement and Personal Care Product Cases

The FDA and FTC jointly issued warning letters to three companies selling CBD products online.  The letters allege violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”) and the Federal Trade Commission Act (“FTCA”).  Although this is the first time the FDA and FTC have issued joint warning letters relating to CBD, the FDA

A panel of the Ninth Circuit Court of Appeals ruled May 17 on an appeal from summary judgment in a case filed by pomegranate juice maker POM Wonderful against the Coca-Cola Company’s Minute Maid division. The dispute was over a Minute Maid pomegranate-blueberry juice blend that POM alleged misrepresented itself on its label as containing a far higher proportion of pomegranate juice than was present in the beverage. According to POM, this overselling of pomegranate falsely communicated to consumers that the juice blend conferred the unique health benefits of pomegranate juice — benefits which, themselves, have been heavily advertised by POM but called into question by the FTC and litigants. POM’s deceptive labeling claims against other marketers of juice products touched off a network of related competitor, class action, and FTC cases that have become known as the "Juice Wars".

Coca-Cola successfully moved for summary judgment on the ground that FDA regulations issued under the Food, Drug & Cosmetic Act comprehensively govern the content of juice labeling, including permitting marketers of juice blends to identify the products through the juice name and pictures by the juices that provide their characterizing flavors, regardless of whether these juices predominate by volume. Affirming, the Ninth Circuit panel concluded that "Pom’s challenge to the name ‘Pomegranate Blueberry Flavored Blend of 5 Juices’ would create a conflict with FDA regulations and would require us to undermine the FDA’s apparent determination that so naming the product is not misleading" and that " forc[ing] Coca-Cola to alter the size of the words on its labeling so that the words “Pomegranate Blueberry” no longer appear in larger, more conspicuous type on Coca-Cola’s label than do the words ‘Flavored Blend of 5 Juices’ … would again undermine the FDA’s regulations and expert judgments." Under the preclusion doctrine, the challenge was therefore barred.
 

Continue Reading Ninth Circuit Pulps POM Wonderful’s Lanham Act Claims Against Coca-Cola, Affirming FDA Preclusion of Challenge to Regulated Food Labeling