On April 22, a consumer filed a class action lawsuit in California against Bayer HealthCare LLC accusing the company of false and deceptive advertising regarding benefits of its Phillips Probiotics Colon Health supplement purchased on April 7 for $15.99.
The complaint, which can be read here, states: “Bayer manufactures, markets and sells health products known as Phillips Probiotics Colon Health, Probiotics + Fiber and Probiotics Caps. Through an extensive and comprehensive nationwide marketing campaign, Bayer claims that the products help ‘support’ consumers’ health benefits that other products cannot.
“Bayer claims in its advertising that these exclusive health benefits result from the combination of strains of ‘probiotic’ bacteria that are unique to the products. Bayer’s representations are false, misleading and reasonably likely to deceive the public,” adds the complaint.
Bayer were unable to comment at the time of publishing.
Surging class actions?
Leading lawyers in the food, beverage and dietary supplements segment recently pointed to an upsurge in class actions. Commenting recently as General Mills lost its bid to derail a class action lawsuit over digestive health claims for Yo-Plus yogurts at the Eleventh Circuit Court of Appeals, Seattle-based attorney Ken Odza, who heads up the food liability practice at law firm Stoel Rives, noted: “I think these kind of cases are going to explode”.
Marc Ullman, a partner at New York-based firm Ullman, Shapiro & Ullman LLP, added that it was “procedurally easier” to file such suits in certain states, he added. “California and New Jersey come to mind.”
High profile cases include Dannon regarding its probiotic yogurts Activia and DanActive, Wrigley for claims made about its Eclipse fresh breath gum, and General Mills for its Yo-Plus product.
Increased risk?
Virginia-based food law attorney Jonathan Emord, concurred on the ease of submitting such claims in California.
"California’s very liberal construction of unfair competition, consumer protection, and deceptive advertising laws has made it a Mecca for plaintiffs’ lawyers intent on gathering tidy sums from large industry because the costs and risks of suit outweigh those of settlement," Emord told NutraIngredients-USA.com "The ultimate victims of this liberality are consumers who lose access to potentially valuable nutritional products."
Emord also noted that probiotics are backed by "sound but inconclusive science" and that the industry needs to rely on claim qualifications that accurately reveal the shortcomings.
"Those who sell probiotics with unqualified claims of health benefit are definitely at an increased risk of attack from plaintiffs’ attorneys and district attorneys in California and from the FTC," he added.
Overstepping the boundaries?
Commenting on the class action, Cara Welch, PhD, VP of scientific & regulatory affairs for the Natural Products Association (NPA) told NutraIngredients-USA.com that “it's pretty obvious the topic of probiotics is hot these days - both in the science of probiotics and in figuring how to appropriately market their effect.
“There are definitely issues lately where companies overstepped the boundaries of probiotics but there is also a real opportunity with these products.
“I don't think this case will have that much effect in the long run but it's always a good idea, when you're in this industry, to keep an eye on these cases,” she added.
Basis of the claim
The new complaint alleges that Bayer does not provide references to the data on which its claims are based. The class action states that the plaintiffs have reviewed the literature on the topic of probiotics; particularly the strains and doses used in the Bayer formulation, and they allege the science is lacking.
“Bayer’s claims about the benefits of Phillips Colon Health are not substantiated by the vast majority of generally accepted scientific literature currently available relating to probiotics,” reads the complaint.
“Despite Bayer’s advertisements and websites depicting the benefits of Phillips Colon Health, few if any studies have looked at beneficial effects on health children and adults to determine if probiotics at the concentration of 1.5 billion per capsule convey any health benefits whatsoever.”
Money back
“In addition to making untested and unsubstantiated claims, Bayer’s nationwide advertising claim that ‘it works or its free’ is likely to deceitfully induce a placebo effect on consumers, irrespective of any actual probiotic effect,” added the complaint.
Fast action class action
In the FDA Law Blog, Riëtte van Laack, an attorney with Hyman, Phelps & McNamara, PC, notes that: “Bayer’s offer of a 3-week money back guarantee for its [Phillips Probiotics Colon Health] products carried no weight with plaintiff (if a consumer takes [Phillips Probiotics Colon Health] as part of a balanced diet and healthy lifestyle every day for three weeks and is not completely satisfied, Bayer offers to refund the purchase price).
“Plaintiff claims that this money back guarantee is just another ploy to ‘deceitfully induce a placebo effect on consumers irrespective of any actual probiotic effect.’ But plaintiff was not to be fooled. She purchased a bottle of PPCH on April 7, 2011 and filed the complaint on April 22, 2011 - in time to avoid any possible placebo effect,” added van Laak.