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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…

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?

It’s no secret that the Justice Department and state Attorneys General don’t like coupon settlements in class actions.  Since 2007, groups of state AGs have been objecting regularly to coupon settlements that would force class members to pay more money to defendants accused of consumer fraud.  On February 4, the Justice Department filed an amicus…

On Friday, the Second Circuit Court of Appeals’ decision in In re Petrobras Securities refused to adopt what it called a “’heightened’ two-part ascertainability test in class action cases.  The Second Circuit agreed that class action plaintiffs must show that ‘the class is defined with reference to objective criteria,’ but did not agree that plaintiffs…

From the first month of district court decisions issued since the United States Supreme Court decided Spokeo, Inc. v. Robins, No. 13-1339, 2016 WL 2842447, *3 (U.S. May 16, 2016), it appears the needle on Article III standing has moved slightly, but so far only slightly, in favor of the defense. Spokeo held that (i) in order to establish Article III standing, a plaintiff must allege an injury-in-fact that is both “concrete and particularized,” and (ii) the plaintiff cannot “automatically satisf[y] the injury-in-fact requirement whenever a statute grants a person a statutory right and purports to authorize that person to sue to vindicate that right.” Courts have begun to give that requirement teeth, dismissing claims where a defendant may have violated a statute’s technical requirements, but where the plaintiff suffered no adverse consequence as a result. At the same time, however, courts have recognized Spokeo’s other holding that a “concrete” injury is not necessarily synonymous with a “tangible” injury, and that the “risk of real harm” counts as such an injury (even when such harm has not materialized). Dismissals on Spokeo grounds, therefore, have been sparse.…
Continue Reading Who’s Still “Standing” Following Spokeo, Inc. v. Robins?