Earlier this week, Judge Cynthia Bashant of the Southern District of California granted a plaintiff’s second bite at the apple (or rather biscuit) to certify a class of purchasers of belVita breakfast biscuits in McMorrow v. Mondelez International, Inc.  The plaintiff alleged that Mondelez falsely labeled its belVita biscuits as providing “NUTRITIOUS SUSTAINED ENERGY;”  “NUTRITIOUS

Welcome to our monthly roundup of regulatory and litigation highlights impacting the dietary supplement and personal care products industries.  Sit back, relax, and enjoy the read.  February was a short month, with a lot going on.

NAD

Health claim substantiation was front and center before NAD in a monitoring case involving Pendulum Therapeutics and a “medical probiotic” product featuring claims such as “The only medical probiotic clinically shown to lower A1C & blood glucose spikes for the dietary management of T2D*” (*Consult your physician as part of your total diabetes management plan.  Results may vary from person to person.”)

The advertiser submitted a 12-week multi-center, randomized, double-blind, placebo-controlled study (the “Perraudeau Study”) to assess Pendulum Glucose Control’s safety and effectiveness in improving glycemic control in Type 2 diabetics and, ultimately, their dietary management of the disease – specifically, the role of certain probiotic strains found in prior research to be associated with the promotion of a healthy gut microbiome through the production of short-chain fatty acids (SCFAs).

The advertiser also provided clinical studies and research articles demonstrating the roles of A1C, fasting glucose and postprandial glucose levels in managing Type 2 diabetes. The advertiser also referred to the FDA’s Guidance document (Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention) to demonstrate what level of reduction in HbA1c was clinically meaningful.

While NAD expressed some concerns about the evidence, ultimately, NAD determined that the Perraudeau Study was a good fit for the challenged claim “The only medical probiotic clinically shown to lower A1C & blood glucose spikes for the dietary management of T2D*” (*Consult your physician as part of your total diabetes management plan. Results may vary from person to person.”) but recommended the following modifications: (1) limiting the claim to individuals who are taking metformin; (2) modifying the claim to clarify that the product can be used as part of the dietary management of type 2 diabetes; and (3) removing the references to percent reductions in blood glucose spikes in the absence of evidence in the record demonstrating that the reductions were clinically relevant.

This decision is a helpful discussion of the competent and reliable scientific evidence standard.  Anyone seeking to understand health claims substantiation better should check it out.
Continue Reading Dietary Supplement and Personal Care Products Regulatory Highlights – February 2021

Welcome to our monthly roundup of regulatory and litigation highlights impacting the dietary supplement and personal care products industries.

NAD

NAD tackled substantiation for “#1 Dermatologist Recommended” claims in a challenge involving L’Oreal’s CeraVe moisturizer and use of syndicated survey data to support related claims.

Health claim substantiation was front and center in

In a series of orders issued earlier this month, Judge Dale S. Fischer of the Central District of California dealt two strikes to putative class claims against ticket merchants Ticketmaster/LiveNation and StubHub that seek refunds for Major League Baseball games cancelled or “postponed” in the wake of the coronavirus pandemic.  See Ajzenman, et al. v.

Last week, a federal judge in the Southern District of New York dismissed a putative class action alleging that L’Oreal’s “EverSleek Keratin Caring” hair products deceived consumers into believing the products contained keratin. United States District Court Judge George B. Daniels rejected these allegations, finding that the challenged statements were clear both on their own

Last month, a California court, for a second time, dismissed a class action complaint asserting that Ghirardelli’s advertising for its “Classic White” “Premium Baking Chips” created the false impression that the product contained real chocolate—this time with prejudice.  Plaintiffs in Cheslow v. Ghirardelli Chocolate Co., Case No. 19-cv-07467-PJH, alleged that they purchased Ghirardelli’s product

As we previously reported, “Phase I” of class action filings relating to the COVID-19 pandemic has become a significant contagion of its own with more than 500 cases being filed since March challenging refund policies, school closures, event cancellations, and marketing and pricing practices.  As the economy gradually reopens, “Phase II”—how companies respond to these cases—is just beginning.  Not surprisingly, defendants are fighting hard and early to defeat these claims, with many opting to file motions to dismiss rather than answering the complaint and entering into lengthy and expensive discovery.

Early Action in Cases Against Public-Facing Businesses

Public-facing businesses—such those in the retail, travel and hospitality industries—have been the first to re-open and are currently navigating a patchwork of state guidelines on how to do so safely.  Compounding this burden, these same companies are facing a wave of lawsuits by customers and employees alleging negligence, breach of contract, and unfair business practices during the pandemic.

These industries are not new to class action litigation and many companies have included arbitration clauses and class arbitration waivers in their consumer contracts.  These defendants have, not surprisingly, moved to compel arbitration, and plaintiffs have responded with unique (but likely ineffective) allegations of unconscionability, fraud and duress to try to stay in court.  For example, in a case against Amazon, the plaintiffs alleged that the arbitration agreement was unconscionable because they were under duress during the pandemic and were forced to purchase products from Amazon.  Amazon’s response was based on the black-letter principle that unconscionability is measured at the time of contracting, and not at the time of the challenged conduct.

Other companies have focused on substance, arguing that they complied with their contractual obligations and that their customers have not suffered damages.  For example, in the case of recurring monthly payments for fitness club memberships, defendants have argued that their membership agreements do not mandate refunds for temporary closures, and therefore plaintiffs who filed suit within days or weeks of the initial closure did so too quickly.
Continue Reading What will “Phase II” of COVID-19 Class Actions Look Like?

A federal judge in Florida recently dismissed a false advertising case against Tyson Fresh Meats and The Fresh Market challenging the use of the word “prime” to describe Tyson’s “Chairman’s Reserve Prime Pork.” Specifically, the plaintiffs alleged that the defendants “misrepresented that the USDA had graded their product as prime,” but notably did not allege

On July 13, consumers filed a class action complaint in California federal court against Bigelow Tea, alleging the company falsely and deceptively represented that its tea products were made in the United States.  Plaintiffs claim that the tea manufacturer advertised that its tea products were “Manufactured in the USA 100% American Family Owned” and “America’s

On July 9, 2020, the Supreme Court granted Facebook’s petition for certiorari in a case with potentially broad implications for both class action litigation and business communications with their current and potential customers.  The Supreme Court’s disposition of Facebook’s petition may settle the complex question of what qualifies as an automatic telephone dialing system (“ATDS”) under the Telephone Consumer Protection Act, 47 U.S.C. § 227, et seq. (“TCPA”).

The TCPA prohibits telemarketing calls to be placed using an ATDS without the requisite level of prior consent.  Thus, the definition of what technology qualifies as an ATDS is often a fundamental, threshold question upon which TCPA litigation turns.  Prior to 2015, the FCC had offered various, sometimes vague, interpretations of the term.  In 2015, the FCC offered an expansive definition, which was set aside in March 2018 in the ACA International decision.  While the issue has been before the FCC on remand for over two years now, courts nevertheless engaged in their own analysis of the statute, resulting in a broadening Circuit split on how the law is interpreted and applied and divergent outcomes based on the court in which the case is filed.  Now the Supreme Court is poised (potentially) to resolve that dispute.
Continue Reading Supreme Court to Weigh-in on the Definition of an Autodialer Under TCPA