Probiotics, defined by the World Health Organization as “live microorganisms, which, when administered in adequate amounts, confer a health benefit to the host,” have become a “hot” ingredient in foods, drinks and supplements. In fact, over the past decade, more than 500 functional food and beverage, and supplement products have been brought to market.[i] 
 
However, along with this proliferation of probiotic products, so too has there been a rise in lawsuits challenging the advertising and marketing claims for such products.  While there have been significant legal victories for some defendants—as was the case in a series of class actions challenging Nestlé Healthcare Nutrition, Inc.’s advertising claims for its BOOST Kid Essentials Drink (“BKE”) product[ii]—there also have been some expensive lessons learned by others, including a $45 million settlement resolving a class action filed against Dannon arising out of advertising for its DanActive and Activia yogurt products. This article provides an overview of the types of probiotic advertising claims that have attracted false advertising suits, and some takeaways from those litigations.
 
Probiotic Advertising Litigation           
Lawsuits challenging advertising claims for probiotic products are not new. For example, in 2000, Jarrow Formulas, Inc. filed a Lanham Act lawsuit against a competitor, alleging that the defendant falsely advertised that its probiotic dietary supplement contained 14 billion “good” bacteria per capsule and eight different types of bacteria, and did not require refrigeration.[iii] Since then, plaintiffs have shifted gears, focusing instead on advertising claims about the specific health benefits conferred by probiotics. In recent years, a number of class actions have challenged express and implied claims that probiotics:
 
·               Confer immunity benefits;[iv]
·               Aid in and/or promote digestive health;[v]
·               Promote regularity and reduce the incidence and/or duration of diarrhea;[vi]
·               Help prevent upper respiratory tract infections in children;[vii] and
·               Help protect against cold and flu viruses.[viii]
 
In some cases, the plaintiffs have alleged further that the purported health benefits were “clinically proven” or “scientifically proven.”[ix]  Often, plaintiffs have argued that the defendants did not possess substantiation (i.e., lacked a “reasonable basis”) at the time they made the challenged advertising claims, and, as a result, the claims were false under state law. This “unsubstantiated advertising” theory of liability, however, largely has been rejected by courts.[x]
 
While there have been a number of false advertising actions involving probiotic products, few of those cases have been resolved on their merits. Most either have been dismissed on procedural grounds[xi] or settled for substantial sums. For example, in 2010, Dannon agreed to pay $45 million into a class action settlement fund to resolve allegations that its DanActive and Activia probiotic yogurt products were “scientifically proven” to naturally regulate digestion.[xii]More recently, this past June, General Mills agreed to pay $8.5 million to settle a class action challenging digestive health benefit claims for its Yo-Plus probiotic yogurt.[xiii]  
 
A Decision on the Merits: Burden on Plaintiffs to Prove False Advertising
However, in mid-July 2012, the U.S. District Court for the District of New Jersey delved into the merits of a probiotic product false advertising action filed against Nestlé. In Scheuerman v. Nestlé Healthcare Nutrition, Inc.,[xiv] a putative nationwide class action challenging Nestlé’s advertising and marketing campaign for BKE, the court awarded summary judgment to Nestlé. The plaintiffs argued that Nestlé had made express and implied claims that BKE—a nutritional supplement that formerly was sold in a carton attaching a separately-packaged straw containing a probiotic—provided a number of health benefits, including, among other things, immunity protection; a strengthened immune system; reduced absences from daycare or school due to illness; reduced duration of diarrhea; and protection against cold and flu viruses. They also claimed that Nestlé advertised that those challenged health benefits were “clinically shown.” 
       
In a thorough decision, the court held that the plaintiffs could not prevail on their New Jersey and California statutory fraud claims on the theory of liability that Nestlé lacked substantiation for the challenged advertising statements at the time they were made. The court found that the burden was on the plaintiffs to present affirmative evidence that the advertising claims were actually false or misleading, and because they failed to meet their burden, summary judgment was appropriate.
 
More specifically, the court explained that the plaintiffs’ two scientific experts, both of whom criticized the strength and significance of the 41 studies on which Nestlé relied and concluded that the current body of science did not did not support Nestlé’s advertising claims, could not save the plaintiffs’ claims from summary judgment. Neither expert explained why Nestlé’s claims were actually false, or how the advertising statements might mislead a reasonable consumer. Rather, they merely opined that Nestlé’s scientific substantiation was not strong and could be better. The court concluded that that testimony was not enough to demonstrate that Nestlé’s “clinically shown” claim was false or misleading. 
 
Rather, the court found that substantiation, in fact, did exist for Nestlé’s BKE health benefit claims and, at best, the plaintiffs’ arguments and their experts’ testimony went to the quality of that substantiation rather than its existence, which simply was not enough for a finding of false, deceptive, or misleading advertising. Scheuerman is a landmark decision with respect to both probiotic and “clinically shown” advertising claims. 
   
Key Takeaways From Probiotic Product Advertising Litigation
As described above and identified in the end notes to this article, there have been a number of class actions and other litigation filed challenging the advertising claims for a variety of probiotic food, beverage and supplement products. Certain types of claims, such as immunity-support and digestive health benefit claims, are lightening rods for attracting such litigation.
 
While the plaintiffs in these actions have the burden to prove affirmatively that the challenged advertising claims are false—as opposed to simply being unsubstantiated—under the “prior substantiation” doctrine, advertisers should ensure that they have competent and reliable scientific evidence to support their advertising claims before those claims are made in the first instance. Moreover, in order to meet the standard for competent and reliable scientific evidence, each piece of potentially supportive evidence must be (1) internally valid, (2) relevant to the product and claims at issue and (3) consistent with the totality of available scientific evidence. Having a reasonable basis to support an advertising claim makes it difficult for a plaintiff to meet his or her burden of demonstrating falsity. Indeed, that is one of the key lessons that defendants can learn from the Scheuerman decision.      
 
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Daniel S. Blynn is an attorney in the Washington, D.C. office of Kelley Drye. A member of the advertising and marketing practice, Mr. Blynn concentrates primarily on false advertising litigation and complex consumer class actions, and provides counseling on a number of FTC-, general advertising- and telemarketing-related issues. He obtained summary judgment on behalf of Nestlé Healthcare Nutrition, Inc. in a false advertising class action alleging that Nestlé lacked substantiation for express and implied advertising claims made in conjunction with one of its probiotic products (Scheuerman v. Nestlé Healthcare Nutrition, Inc.,  No. 10-3684, 2012 WL 2916827 (D.N.J. July 17, 2012)). He can be reached at dblynn@kelleydrye.com.