Avadim Health Hit with False Advertising Lawsuit Over Efficacy Claims for Theraworx Muscle Cramp & Spasm Relief Foam

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Avadim Health faces a proposed class action in New York in the wake of a National Advertising Division (NAD) recommendation that the company stop making health-related claims for its Theraworx Muscle Cramp & Spasm Relief Foam, which is allegedly far less effective than advertised.

The 18-page lawsuit claims the product, which is sold with a knee compression sleeve and contains magnesium sulfate as its active ingredient, is advertised on the basis of “numerous false, deceptive and misleading claims about its ability provide pain relief,” including to relieve muscle cramps and tightness, reduce muscle soreness, prevent cramps and spasms and offer fast relief.

NAD, a division of the Better Business Bureau National Programs, issued on October 21, 2020 a press release in which it said it determined Avadim Health “did not provide a reasonable basis for health-related claims appearing on product packaging, in website and social media advertising and elsewhere” for Theraworx foam, noting that the company’s representations were challenged by Sanofi-owned Chattem, Inc., the maker of Icy Hot and Aspercreme.

Per the complaint, the relevant Food and Drug Administration Monograph for external analgesic products, to which the Theraworx foam is described as “similar” and which contain the active ingredients capsaicin, trolamine salicylate and/or lidocaine, limits the indications for use to temporary relief of minor aches and pains for muscles and joints that may be “associated with” simple backaches, arthritis, strains, bruises and sprains. Moreover, the Monograph states that the indications for over-the-counter external analgesic drug products should emphasize that these products relieve only minor pain and have an action that is only temporary, the lawsuit reads. 

Avadim Health’s Theraworx Muscle Cramp & Spasm Relief Foam, on the other hand, is emphasized by the company as able to provide a more significant and enduring type of pain relief than what’s permitted under the FDA’s Monograph, even though the foam’s active ingredient—magnesium sulfate—“has not been reviewed or found to be generally recognized as safe or effective by the FDA to diagnose, treat, cure, prevent or mitigate any diseases or conditions,” the suit charges. 

Per the case, the defendant’s efficacy claims for Theraworx, including that it’s “clinically proven,” are required to undergo double-blind, randomized studies, and even statements attesting to effectiveness that do not require clinical review are required by the FDA to be based on double-blind, randomized evidence given they pertain to pain relief. The efficacy evidence proffered by Avadim Health simply falls short of what’s allowable when it comes to touting a product’s apparent pain-relieving properties as anything other than temporary, according to the case: 

“A competent and reliable study must include blinding, randomization, and be appropriately-controlled, demonstrating that the treatment group experienced statistically significant difference to the 95% confidence level as compared to the control group, to mitigate bias and avoid placebo effects. 

Defendant has offered five studies in support of its claims, which fail to establish the Product is effective in support of its muscle cramp and spasm relief claims. 

The studies focus on treating leg cramps/spasms and symptoms associated with RLS and nocturnal leg cramps.

However, Defendant’s advertising is focused on relieving muscle cramps and spams [sic] more generally (i.e., everyday muscle cramps and spams [sic]).”

None of the defendant’s studies evaluated Theraworx foam’s effect on muscle soreness, post-cramp soreness, foot cramps, muscle tightness or leg cramps associated with many “important, commonly prescribed medications,” the suit claims, alleging that none of Avadim’s studies were designed to assess whether the product can prevent muscle cramps.

“None of the studies support the Product’s claims of ‘fast-acting muscle cramp and spasm relief’ or ‘quick[] release [o]f muscle tightness,’ since the time to relief was not measured,” the case alleges. “In fact, the time period of the studies were [sic] several weeks long, which is inconsistent with the ‘fast-acting’ claims.” 

Picking at the defendant’s studies even further, the lawsuit says the analyses were also not consistent with typical consumer usage based on the product’s instructions, i.e. whether the foam was used alongside the accompanying compression sleeve. Additionally, the subject populations in “many” of the submitted studies focused on target audiences, such as Division I college athletes, not relevant to the product advertising’s target audience, the suit says.

Alleging Avadim’s studies failed to account for “potential confounding factors,” the case goes on to claim that more “[m]ore than half” of the studies were not blinded, which calls into question whether the results were biased by either the technician or those participating in the study. At any rate, the defendant has not presented evidence about adequate controls or safeguards to ensure the studies were not biased, the suit alleges, summarizing that there exists “no genuine scientific research and no scientifically reliable studies that support the extraordinary claims that the Product can provide the effects indicated.” 

More from the lawsuit: 

“Defendant makes Product claims based on the recommendations of medical professionals: ‘HEALTHCARE PROFESSIONALS RECOMMEND THERAWORX RELIEF.’

Such claims are significant to consumers, yet they are not supported by reliable evidence such as statistically significant surveys showing that a substantial portion of them recommend the product.” 

As far as consumers go, the lawsuit stresses the defendant’s advertising claims for Theraworx Muscle Cramp & Spasm Relief Foam are “harmful and misleading” in that they cause buyers to rely on the company’s representations of the product’s supposed therapeutic benefits, leading many to “forgo proven treatments.” As a result, painful and potentially serious underlying muscle or joint issues, or moderate to severe joint inflammation from arthritis or other conditions, go untreated or are dealt with inadequately, the case asserts. 

“Even if the Product has no harmful side effects, consumers are still harmed due to the failure to seek proven treatments and the economic deception through purchasing the Product based on false and misleading claims,” the suit rounds out. “Defendant’s branding, marketing and packaging of the Product is designed to – and does – deceive, mislead, and defraud plaintiff and consumers.”

Proposed class members—those residing in New York who bought Theraworx Muscle Cramp & Spasm Relief Foam—would not have purchased the product, or would have paid less for it, had they known of Avadim’s “misrepresentations and omissions,” the case claims. 

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