Stay ADvised: What's New This Week, March 15
In This Issue:
- Mostly Pain, Little Gain for Salonpas "Pain Relief Patch"
- NAD Swings Towards Modification of Pendulum Glucose Control Claims
- Reckitt Benckiser Moved to Settle Dietary Supplement False Ad Suit
Mostly Pain, Little Gain for Salonpas "Pain Relief Patch"
It's a familiar image: a medical professional in a blue lab coat extolling the virtues of an over-the-counter drug, in this case, Salonpas Pain Relief Patches. The challenged commercial claimed that "all OTC pain relievers, including Voltaren, have one thing in common. None are proven stronger or more effective against pain than that Salonpas Pain Relief Patch Large."
GlaxoSmithKline Consumer Healthcare L.P. (GSK), makers of Voltaren Arthritis Pain, an NSAID gel targeted to arthritis patients, challenged the claim at NAD. GSK argued that reasonable consumers would expect that Hisamitsu had clinical data to support, at a minimum, a top parity claim when compared to other over-the-counter pain relievers. Moreover, given the express reference to Voltaren, GSK argued that consumers would believe the manufacturer had tested Salonpas had in an arthritis population.
In fact, the advertiser's clinical support was limited to a study in acute muscle strain. NAD agreed with the challenger GSK and recommended that Hisamitsu discontinue the challenged claim.
In addition to the claim that no other OTC pain reliever has been proven stronger, NAD recommended that the advertiser discontinue comparative pain relief claims that characterized the Salonpas patch as the "only pain reliever labeled to relieve mild to tougher, moderate pain" and "the strongest labeled OTC topical pain reliever."
Here, NAD found that the Salonpas indication was limited to relief of mild to moderate aches and pains. By contrast, Voltaren Arthritis Pain is labeled for the treatment and relief of arthritis pain without limitation and has been extensively studied in arthritis sufferers.
As NAD noted, "[t]he NDA approval of Salonpas patch evaluated only the efficacy of the Salonpas patch for the specific indications on the label. It did not evaluate the comparative efficacy to Voltaren, which was approved in an NDA as an effective treatment for arthritis pain, without qualification."
NAD also recommended that Hisamitsu modify its onset of action claims to avoid the misleading message that arthritic consumers will receive pain relief within one hour of application and clinically meaningful pain relief in the first day. Although NAD recognized the validity of the advertiser's acute muscle strain study, NAD concluded that a "study on the onset of pain relief for muscle strain patients does not demonstrate the onset of pain relief a consumer suffering from arthritis might experience."
NAD further recommended that Hisamitsu discontinue claims that misleadingly implied that the Salonpas patch has been shown to provide meaningful relief of arthritis pain faster than Voltaren, which were likewise unsupported by any clinical data.
Claims that no competing OTC product is more efficacious must be supported by clinical evidence demonstrating that the advertised product performs as well as or better than other products in its category. Here, NAD clarified that the mere fact that two products bear an "arthritis" label indication is not a measure or finding of their "equivalence" by FDA. Rather, NAD will expect to see head-to-head clinical testing in the relevant patient population as to the claimed product attributes.
NAD Swings Towards Modification of Pendulum Glucose Control Claims
Following an investigation conducted as part of its routine monitoring program, NAD has recommended that the manufacturer of a probiotic marketed for the dietary management of Type 2 diabetes modify its health-related establishment claims. The advertiser broadly targeted Type 2 diabetics, claiming that Pendulum Glucose is "[t]he only medical probiotic clinically shown to lower A1C & blood glucose spikes for the dietary management of T2D*."
Followers of NAD will recall that NAD subjects scientific evidence proffered in support of health-related claims to particularly rigorous review. As a general matter, "[h]ealth-related claims generally should be supported by competent and reliable evidence and … accurately reflect any limitations in the evidence."
Additionally, NAD noted that the advertiser in this case used the language "clinically shown," "which is an establishment claim held to a very high standard of proof because it promises that there is scientific evidence proving … the truth of an advertiser's claims." Such an establishment claim necessitates that the advertiser show "reliable and well-controlled" testing providing a reasonable basis for the claim.
The primary evidence Pendulum relied on in support of the claim was a "12-week multi-center" study (the Perradeau Study). NAD found that the Perradeau Study had numerous "appropriate methodological components," including that it was "double-blind, randomized, [and] placebo-controlled;" "[had] sufficiently large sample size to elicit statistically significant and clinically meaningful results;" "test[ed] the marketed product," and had "clearly defined endpoints."
That said, NAD also identified several concerns. First, NAD noted that the test population was limited to those with a recent diabetes diagnosis who were taking the drug metformin. By contrast, the company advertised the supplement to people with Type 2 diabetes more broadly, which would sweep in patients taking insulin. NAD found that there was no evidence to show that the results could be projected to insulin-dependent diabetics.
NAD also took issue with a number of the study endpoints. More specifically, NAD agreed that a reduction in A1C levels was a clinically meaningful endpoint, relying on an FDA Guidance document (Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention). However, NAD found that the advertiser had not shown that the reduction in total glucose area under the curve (AUC) and incremental glucose AUC observed in its study was clinically relevant and, thus, was insufficient to support a claim that the product reduced glucose spikes.
Ultimately, NAD recommended that the company modify the claim to clearly limit it to people taking metformin, clarify that the product "could be used as part of the dietary management" of Type 2 diabetes, and remove any references to blood glucose spikes.
Merits aside, one of the interesting aspects of this decision is that the advertiser modified its claims more than once during the course of the challenge, and NAD reviewed those modified claims on the merits. This could be very helpful for advertisers who want to work with NAD to narrow their claims rather than risking a compliance procedure or a later challenge.
Reckitt Benckiser Moved to Settle Dietary Supplement False Ad Suit
Despite some recent victories by the defense bar, dietary supplement false ad class action suits continue to proliferate. A recent settlement by consumer goods giant Reckitt Benckiser (RB) may provide further incentive for the plaintiffs' bar. Following a number of unsuccessful motions, RB has agreed to pay $53 million to settle class action allegations that it falsely advertised its "Move Free Advanced" dietary supplement.
If approved, the class action settlement would represent what plaintiffs have called the "largest dietary class action settlement ever reached." The "landmark" settlement would also conclude nationwide litigation centering on the same allegations on behalf of class plaintiffs in California and New York and parallel class actions in Vermont and Illinois.
The suit, filed in the Northern District of California in 2017, alleges that RB violated California's Consumer Legal Remedies Act, False Advertising Law, and Unfair Competition Law, and New York's General Business Law Sections 349 and 350 by falsely advertising that its "Move Free" dietary supplements promoted and improved joint health.
The supplements contain glucosamine hydrochloride and chondroitin sulfate, two ingredients widely touted as helping to improve joint pain associated with degenerative joint diseases such as arthritis. RB advertised the products as "joint health supplements capable of supporting and benefiting joint health" alleged plaintiffs, who said they purchased the products based on these representations.
Plaintiffs averred that RB deliberately marketed the product to arthritis sufferers, including by labeling the product with the Arthritis Foundation logo. Additionally, the product label featured the slogan "MOVE BETTER, FEEL BETTER" and highlighted the impact of hydrochloride and chondroitin sulfate on joint health, lubrication and "rebuilding."
According to plaintiffs, however, the science behind these claims did not add up. The complaint alleged that multiple scientific studies since the 1990s showed that the product ingredients had no impact on or benefit to joints. Plaintiffs also alleged that RB, a sophisticated multinational company with resources and "specialized knowledge," knew or should have known of this fact and its advertising of the products despite this constituted false advertising.
In 2019, Plaintiffs obtained class certification for California and New York buyers of RB's "Move Free Advanced" supplement. The court granted class certification despite RB's arguments—mirroring others asserted in comparable putative class actions—that evaluating plaintiffs' claims would require inquiry into a series of individualized issues, that plaintiffs were not adequate class representatives, and that damages could not be calculated on a class-wide basis.
RB thereafter moved for summary judgment, again asserting a number of grounds familiar in such suits, more specifically that plaintiffs' claims were preempted by the Food Drug & Cosmetic Act; that plaintiffs could not prove that the Move Free Advanced advertising was false; and that plaintiffs' full refund theory failed because Move Free Advanced was not a completely worthless product.
In March 2020, the Court denied RB's motion, finding that there were material facts at issue that precluded granting summary judgment.
Following a number of mediation sessions, the parties reached a proposed settlement. Under the terms of the proposed settlement, class members would receive a cash refund for up to three purchases of Move Free Advances for a total of $66, without the need of proof of purchase. Alternatively, consumers can spend up to $225 on certain RB products. Consumers with proof of purchases will receive refunds for all of their purchases. If approved, plaintiffs' counsel will receive up to $12.5 million in attorneys' fees and costs, and the named Plaintiffs will receive $7500 each.
There is some modicum of evidence suggesting that hydrochloride and chondroitin sulfate have a positive effect on osteoarthritis pain, although this is subject to ongoing scientific debate. Given the size of the settlement and, more particularly, the fee award here, false advertising class actions like this one against dietary supplement companies are likely to continue to proliferate.