NARB Refers Health-Related Claims for Theraworx Relief for Muscle and Joint Products to the FTC

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New York, NY – January 12, 2021 – A panel of the National Advertising Review Board (NARB), the appellate advertising law body of BBB National Programs, has referred advertising claims made by Avadim Health, Inc. to the Federal Trade Commission (FTC) for review and possible enforcement action. The referral comes after the company declined to comply with an NARB recommendation to discontinue unsupported health-related claims for Avadim’s Theraworx Relief Products.

This challenge originally brought before the National Advertising Division (NAD) by Chattem, Inc., a Sanofi Company, involved claims for two related homeopathic external analgesic products: Theraworx Relief for Muscle Cramps and Spasm Foam with its active ingredient magnesium sulfate and Theraworx Relief for Joint Discomfort & Inflammation Foam with its active ingredient olibanum. 

These ingredients have not been reviewed or found to be generally recognized as effective by the FDA to diagnose, treat, cure, prevent, or mitigate any disease conditions.

The challenged claims fell into four categories:

1. Efficacy claims for each of the products individually, including that “in multiple clinical studies” Theraworx Muscle Foam has been proven to “Provide fast acting relief of muscle cramps and spasms, as well as post-cramp soreness -- most people get relief within minutes . . . [and] Reduce symptoms associated with restless leg syndrome (RLS)”; and that Theraworx Joint Foam provides “MAXIMUM JOINT RELIEF,” as well as “Relieves arthritic, inflamed, sore, or overused joints.”
2. Line claims that promote both Theraworx Relief Products together, such as the claim that “all Theraworx Relief products are clinically proven safe and effective.”
3. Video endorsements by pharmacists appearing under a banner heading that “Healthcare Professionals Recommend Theraworx Relief,” including statements that “Before Theraworx Relief there wasn’t really a lot of options on the market . . . nothing really to get to the root of the problem.”
4. Comparative superiority claims that Theraworx Relief Products are more effective than other external analgesic OTC products, such as the claim that “Theraworx Relief is better than any product out there for leg cramps or spasms or even muscle soreness.”

NAD recommended that 18 express claims be discontinued and determined that the challenge to 8 “line claims” had been rendered moot given NAD’s rejection of the advertiser’s substantiation for each of the Theraworx Relief products considered separately. 

Following NAD’s decision ( Case No. 6418), Avadim appealed all of NAD’s findings and recommendations to NARB.

After concluding its review, the NARB panel recommended that all 26 of the express claims challenged in the underlying proceeding be discontinued. 

The panel agreed that the requirements for a well-controlled clinical study provide the applicable standard by which to measure the advertiser’s scientific and clinical evidence. The panel determined that none of the advertiser’s clinical evidence meets the standards for a well-controlled clinical study or provides data that supported the broad advertising claims at issue. 

Further, the panel noted that even if the studies were considered methodologically sound, the advertiser would not have proper support for the challenged claims, which are targeted to the adult population in general. Deficiencies in the evidence included the lack of a placebo control in many of the studies, data that only addressed a specific condition (for example, Nocturnal Leg Cramps, or basilar thumb arthritis), or limited populations (participants over the age of 50 or Division One Collegiate Athletes).  

The panel also determined that the advertiser’s implied superiority comparisons, that the Theraworx products are more effective than other external OTC products, are unsupported because Avadim did not offer any comparative testing data. Thus, the panel recommended that the advertiser avoid making any comparative superiority claims reasonably conveying the message that its Theraworx Relief Products are more effective than other external analgesic OTC products, including the challenger’s Icy Hot and Aspercreme, or prescription medications.

In addition, the panel concluded that the advertiser failed to support the claim that its products were “clinically proven” to prevent muscle cramps, or that its products prevented muscle cramps.

Regarding professional endorsements, the panel concluded that such endorsements must not only represent the honest opinion of the endorser, but any efficacy claims made by the expert endorser must also qualify as claims that would be proper if made directly by the advertiser. The panel determined that no evidence in the record supports the efficacy and implied superiority claims made in the advertiser’s pharmacist testimonials. Therefore, the panel recommended that the advertiser discontinue its claim that “health care professionals recommend” Theraworx products, discontinue the challenged pharmacist endorsements, and avoid the use of any endorsement making unsupported claims.  

Finally, the panel agreed with NAD that the challenged “line” claims, i.e., those that promote both Theraworx products, are unsupported.

In responding that it will not comply with the panel’s recommendations, Avadim stated that it “disputes the findings of NARB that Avadim’s advertising claims for its Theraworx products were not sufficiently substantiated and improperly used testimonials by Healthcare Professionals and, therefore, will not comply with NARB’s flawed analysis.”

Given the advertiser’s decision not to accept the panel’s recommendations, NARB has referred this matter to the attention of the appropriate government agency, in this case the FTC, for possible enforcement action.

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About BBB National Programs: BBB National Programs is where businesses turn to enhance consumer trust and consumers are heard. The non-profit organization creates a fairer playing field for businesses and a better experience for consumers through the development and delivery of effective third-party accountability and dispute resolution programs. Embracing its role as an independent organization since the restructuring of the Council of Better Business Bureaus in June 2019, BBB National Programs today oversees more than a dozen leading national industry self-regulation programs, and continues to evolve its work and grow its impact by providing business guidance and fostering best practices in arenas such as advertising, child-directed marketing, and privacy. To learn more, visit bbbprograms.org.

About the National Advertising Review Board (NARB): The National Advertising Review Board (NARB) is the appellate body for BBB National Programs’ advertising self-regulatory programs. NARB’s panel members include 87 distinguished volunteer professionals from the national advertising industry, agencies, and public members, such as academics and former members of the public sector. NARB serves as a layer of independent industry peer review that helps engender trust and compliance in NAD, CARU, and DSSRC matters.