NAD Recommends Avadim Health, Inc. Discontinue Health-Related Claims for Theraworx Relief for Muscle and Joint Products; Advertiser to Appeal

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New York, NY – October 21, 2020 – The National Advertising Division (NAD) of BBB National Programs determined that Avadim Health, Inc. (Avadim) did not provide a reasonable basis for health-related claims appearing on product packaging, in website and social media advertising and elsewhere, for its Theraworx Relief for Muscle Cramps and Spasm Foam (“Theraworx MCS”) and Theraworx Relief for Joint Discomfort & Inflammation Foam (“Theraworx JDI”) (collectively “Theraworx Relief Products”) which promise consumers that its Theraworx Relief Products, respectively, relieve and prevent muscle cramps and spasms including those associated with nocturnal cramps and restless legs syndrome, and relieve joint pain stemming from arthritis as well as moderate to severe joint inflammation.  The claims were challenged by Chattem, Inc., a Sanofi Company, maker of Icy Hot and Aspercreme. 

Therefore, NAD recommended that the advertiser discontinue its unsupported health-related, product effectiveness, endorsement, and superiority claims.  

Theraworx Relief Muscle Cramp & Spasm Foam Claims 

• “FAST-ACTING MUSCLE CRAMP RELIEF.”  
• “Clinically proven to prevent foot and leg cramps when used daily.” 
• “REDUCES the severity of symptoms associated with RLS [restless leg syndrome].” 
• “PREVENTS cramps and spasms when used daily.” 
• “RELEASES muscle tightness.” 
• “RELIEVES muscle soreness.” 
• “[Q]uickly relieves muscle cramps and even prevents them when used daily.” 
• “Fast-acting muscle cramp and spasm relief.” 
• “Use Theraworx Relief twice daily (in the morning and before bedtime) to prevent nighttime muscle cramps and spasms, or three times daily if you also experience cramps or spasms during the day.”   
• “As soon as you feel a muscle cramp or spasm coming on, use Theraworx Relief to quickly release muscle tightness and reduce the soreness afterwards. There’s no limit to how many times you can apply it per day!” 
• “In multiple clinical studies, Theraworx Relief 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).” 
• “In a research study including patients diagnosed with RLS, Theraworx Relief was shown to reduce symptoms commonly associated with and accompanying RLS, including muscle cramps and spasms.” 
• “Theraworx Relief for Muscle Cramps and Spasms can be used as a companion product to manage the leg cramps associated with many important, commonly prescribed medications.” 
• “In a clinical study, participants noticed a significant reduction in the frequency of their leg & foot cramps within the first 2 weeks of daily use.” 
• “Nothing Else Like It on the Shelves.” 

Theraworx Relief Joint Discomfort & Inflammation Foam Products Claims 

• “MAXIMUM JOINT RELIEF.”  
• “Relieves arthritic, inflamed, sore, or overused joints.” 
• “[S]tudied in patients with moderate-to severe joint inflammation.”  

NAD also recommended that the advertiser discontinue its claim that “health care professionals recommend” Theraworx products, discontinue the challenged endorsements (e.g., “Theraworx Relief is better than any product out there for leg cramps or spasms or even muscle soreness”), and avoid the use of any endorsement making unsupported claims.  

Finally, NAD 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. 

This challenge involved claims for two related homeopathic external muscle and joint relief products – Theraworx MCS with its active ingredient magnesium sulfate, and Theraworx JDI with its active ingredient olibanum - each of which comes with a compression garment. There are no FDA-approved OTC indications for the active ingredients in the advertiser’s products, and these ingredients have not been reviewed or found to be generally recognized as safe by the FDA to diagnose, treat, cure, prevent or mitigate any disease conditions. 

NAD noted that in order to support its claims, Avadim should demonstrate via competent and reliable scientific evidence that its Theraworx MCS product, when used as directed, not only relieves muscle cramps and spasms, including those associated with nocturnal cramps and restless leg syndrome, but prevents muscle cramps and spasms, and that its Theraworx JDI, relieves moderate to severe joint inflammation and pain due to arthritis and overused joints, after controlling for other confounding factors like a placebo effect. NAD carefully reviewed the studies submitted by Avadim in support of its health-related claims for both of its Theraworx Relief Products but determined that the evidence was not a good fit for such claims. Therefore, NAD concluded that the advertiser did not provide a reasonable basis for such claims and recommended that they be discontinued.  

With regard to the advertiser’s healthcare professional endorsements (“Healthcare Professionals Recommend Theraworx”), NAD noted that the advertiser presented no survey evidence of healthcare professionals (or pharmacists) to show that a substantial portion of healthcare professionals recommend its products. Further, NAD concluded that the FTC Endorsement Guides necessitate that the specific testimonials featured on the advertiser’s website be discontinued because these endorsements would be deceptive if made directly by the advertiser due to a lack of support for such claims. 

In its advertiser’s statement, Avadim stated that it will appeal the entirety of NAD’s decision to the National Advertising Review Board. 

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