Editor's Note
The FTC issued a letter announcing the closure of a matter regarding alleged efficacy, establishment and endorsement claims made by Avadim Health, Inc (Avadim) about their Theraworx Relief homeopathic products. The matter regarding Avadim had been referred to FTC by the National Advertising Review Board (NARB), the self-regulatory appellate entity of the Better Business Bureau (BBB).
 
In the closing letter, FTC alleged that Avadim had previously made claims regarding the Theraworx product line including:

  • “clinically proven to prevent foot and leg cramps when used daily”
  • “[r]educes symptoms associated with restless leg syndrome (RLS).”
  • “relieves arthritic . . . joints.”
  • “[a]ll Theraworx Relief products are clinically proven safe and effective”

FTC also asserted that the advertisements involved expert endorsements and customer testimonials. These alleged claims had been challenged by the BBB National Advertising Divison, and Avadim had appealed this challenge to the NARB, where its findings were upheld. Avadim disputed the findings and stated it would not comply with the NARB decision, and the matter was referred to the FTC for further consideration.
 
During negotiations with FTC, Avadim filed for bankruptcy and its successor holding company agreed to revise its advertising practices. FTC stated that they have determined to not take additional action on the matter, and also noted that the agency reserves the right to take further action in the future. 
Thank you for your letter referring a NARB Decision involving efficacy and establishment claims by Avadim Health, Inc. (“Avadim”) for Theraworx Relief homeopathic external relief products. Avadim claimed that its Theraworx Relief for Muscle Cramp & Spasm Foam, among other things, is “clinically proven to prevent foot and leg cramps when used daily” and “[r]educes symptoms associated with restless leg syndrome (RLS).” The advertiser also made claims that its Theraworx Relief for Joint Discomfort & Inflammation Foam “relieves arthritic . . . joints.” Avadim further claimed that “[a]ll Theraworx Relief products are clinically proven safe and effective” and prominently featured consumer testimonials and expert endorsements in its advertising.

In October 2020, NAD recommended that Avadim discontinue the claims at issue in the NAD Challenge, including efficacy, establishment, and endorsement claims. Avadim timely appealed. On appeal from NAD’s initial determination, the NARB panel affirmed the NAD’s Decision on December 16, 2020. In its Advertiser’s Statement, Avadim disputed the findings of the NARB panel and stated it would not comply with NARB’s recommendation. Accordingly, NARB referred this matter to the FTC on January 11, 2021.

In addition to reviewing the NAD and NARB case record, we had several meetings with Avadim’s counsel regarding the claims at issue. While in negotiations with FTC staff, Avadim filed for bankruptcy, and its assets were purchased by Avadim Holdings, Inc., an unaffiliated entity. Subsequently, Avadim Holdings agreed to make significant modifications of the television and online advertising at issue, including discontinuing certain television ads, removing all references to clinical proof, deleting other implied establishment claims, and eliminating claims about disease conditions, including arthritis and Restless Leg Syndrome. Accordingly, we have determined not to take additional action at this time. In coming to this conclusion, we considered a number of factors related to resource allocation and enforcement priorities, as well as the nature of any FTC Act violation and the type and severity of any consumer injury.  
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